phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers. | OBJECTIVES: The long-term objective of this research program is to improve treatments for tobacco smokers by investigating the effects of medications on self-reported and psychophysiological responses to smoking cues and on behavioral-economic measures of smoking reinforcement during a period of tobacco deprivation. Th... | Nicotine Use Disorder Nicotine Dependence Smoking Tobacco Use Disorder | Baclofen Conditioning, Classical Nicotine Smoking | null | 2 | arm 1: Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Da... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day... | intervention 1: Baclofen intervention 2: Placebo | 1 | Providence | Rhode Island | United States | -71.41283 | 41.82399 | 0 | NCT00257894 |
[
3
] | 99 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine. | null | Myelodysplastic Syndrome | Myelodysplastic Syndrome Decitabine Dacogen MGI Pharma | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops. | intervention 1: Decitabine | 21 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Boca Raton | Florida | United States | -80.0831 | 26.35869
Fort Myers | Florida | United States | -81.84059 | 26.62168
Jacksonville | Florida | United States | -81.65565 | 30.33218
New Port Richey | Flo... | 0 | NCT00260065 |
[
0
] | 51 | RANDOMIZED | FACTORIAL | 0TREATMENT | 1SINGLE | false | 0ALL | true | The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be te... | Obesity is a major risk factor for non-alcoholic fatty liver disease (NAFLD), which represents a spectrum of liver diseases. NAFLD is a major health problem in the US because of its high prevalence and causal relationship with serious liver abnormalities. However, the mechanism(s)responsible for developing NAFLD in obe... | Non-alcoholic Fatty Liver Disease | non-alcoholic fatty liver disease obesity fatty liver disease | null | 4 | arm 1: Subjects, having previously diagnosed with NAFLD, were given Niacin for 16 weeks. The dosage was 500mg/day for week 1, 1000mg/day for week 2, 1500mg/day for week three and 2000mg/day for weeks 4 through 16. arm 2: Subjects were found to have intrahepatic triglyceride levels below the threshold for Non-Alcoholic ... | [
0,
4,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Subjects randomized to Niacin therapy will be treated with Niacin at night for 16 wks to reduce plasma free fatty acid concentrations. The dose of medication will be gradually increased: 500 mg/day during week 1, 1000 mg/day during week 2, 1500 mg/day during week 3, and 2000mg/day during weeks 4-16. int... | intervention 1: Niacin intervention 2: fenofibrate intervention 3: placebo | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00262964 |
[
4
] | 237 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD). | Clostridium difficile is a bacterium that proliferates when normal colonic flora have been altered, most commonly due to antibiotic use. Clostridium difficile is non-invasive and localized to the lumen of the colon. Once established, it produces 2 potent toxins, A and B. The principal reservoir for Clostridium difficil... | Clostridium Infections Diarrhea | Clostridium difficile-associated Diarrhea (CDAD) CDAD C diff | null | 2 | arm 1: rifaximin 400mg taken 3 times a day arm 2: vancomycin 125mg taken 4 times a day | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Rifaximin (Xifaxan) intervention 2: Vancomycin | 63 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Redlands | California | United States | -117.18254 | 34.05557
Longmont | Colorado | United States | -105.10193 | 40.16721
Bristol | Connecticut | United States | -72.94927 | 41.67176
Washington D.C. | District of Columbia | United States | -77.03637 | 38.8951... | 0 | NCT00269399 |
[
0
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET. | The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate corr... | Borderline Personality Disorder | Borderline Personality Disorder BPD PET olanzapine brain | null | 1 | arm 1: Open-label Olanzapine. | [
0
] | 1 | [
0
] | intervention 1: Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks. | intervention 1: olanzapine | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00275301 |
[
3
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a protective role in patients with moderate to severe asthma. The investigators believe that a natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma exacerbations and improve the asthma care of mo... | The primary objective of this 3 month clinical study is to determine if supplemental L-arginine can decrease the number of asthma exacerbations in patients with severe asthma. L-arginine, a natural amino acid, produces nitric oxide (NO) when it is converted to L-citrulline in the presence of the nitric oxide synthase e... | Asthma | Airway Inflammation Moderate persistent asthma Severe Persistent Asthma | null | 2 | arm 1: Enrolled subjects will take L-arginine orally, at 0.1 g/kg/day. Subjects will take three to four 1 g capsules (based on weight) of L-arginine twice daily for three months. L-arginine capsules were obtained from Jarrow Pharmaceuticals. arm 2: Enrolled subjects took three to four placebo capsules that matched colo... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months. intervention 2: Placebo tablets that match the L-arginine intervention tablets will be given for three months | intervention 1: L-arginine intervention 2: Placebo | 1 | Sacramento | California | United States | -121.4944 | 38.58157 | 0 | NCT00280683 |
[
4
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis. | null | Psychosis | null | 2 | arm 1: Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID) arm 2: Dose titration from 5 mg to 10 mg BID | [
0,
0
] | 1 | [
0
] | intervention 1: Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6). | intervention 1: Asenapine | 0 | null | 0 | NCT00281320 | |
[
5
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) ... | The insulin resistance syndrome (IRS) afflicts approximately 25% of the US adult population. Its principal components include some or all of the following: central obesity, elevated triglyceride levels, decreased high density lipoprotein cholesterol (HDL-C) levels, a preponderance of small, dense low density lipoprotei... | Metabolic Syndrome Hypertriglyceridemia | triglycerides HDL-cholesterol insulin resistance omega-3 fatty acids niacin | null | 4 | arm 1: Dual placebo arm 2: niaspan arm 3: lovaza arm 4: combined therapy | [
2,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 4 q qd intervention 2: 2 g qpm intervention 3: omacor placebo plus niaspan placebo intervention 4: 4 g qd intervention 5: omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm | intervention 1: omega-3 acid ethyl esters intervention 2: extended release niacin intervention 3: placebo intervention 4: omega-3 acid ethyl esters intervention 5: combined treatment | 1 | Sioux Falls | South Dakota | United States | -96.70033 | 43.54997 | 0 | NCT00286234 |
[
0
] | 49 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abili... | null | Schizophrenia Schizoaffective Disorder Bipolar Disorder | schizophrenia schizoaffective disorder bipolar disorder metabolic syndrome | null | 2 | arm 1: aripiprazole (Abilify) arm 2: ziprasidone (Geodon) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: ziprasidone vs. aripiprazole dosed according to package insert intervention 2: aripiprazole vs. ziprasidone dosed according to package insert | intervention 1: ziprasidone vs. aripiprazole intervention 2: aripiprazole vs. ziprasidone | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00288366 |
[
0
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this research is to evaluate the usefulness of memantine, compared to placebo (sugar pill), for the treatment of cognitive impairment in patients with idiopathic Parkinson's disease (PD) and dementia. Memantine is used as a safe and effective treatment for patients with Alzheimer's disease. Cognitive imp... | This is a randomized, placebo-controlled, parallel, double-blind 24-week prospective study of memantine at the dosage range 5-20 mg/day in 20 outpatients with idiopathic PD and dementia secondary to PD. Using the dosage escalation regimen approved for Alzheimer disease, subjects will start memantine or comparable place... | Parkinson's Disease Cognitive Impairment Dementia | Parkinson's Disease Cognitive Impairment Dementia Memory | null | 2 | arm 1: Memantine tablets, formulated in appearance to match the placebo comparator, were initiated at 5 mg daily and advanced by 5mg /week to 20 mg/week by week 4 with dosing at 10 mg bid over the remaining 20 weeks of the trial. Over the 6 month duration of the trial, dosage could be titrated downward in increments of... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Active memantine and placebo, taken by mouth, will be titrated from 5mg a day to 20mg a day over 4 weeks. The subject will remain on 20mg (10mg twice a day) through week 24 unless unable to tolerate. The dose will be decreased as needed. intervention 2: Placebo, taken by mouth, will be titrated from 5mg... | intervention 1: Memantine intervention 2: Placebo Oral Tablet | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00294554 |
[
5
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease. | Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as ... | Depressive Disorder Parkinson Disease | Depression Parkinson's Disease Atomoxetine | null | 2 | arm 1: Participants will receive 40-80mgs of atomoxetine orally once daily. arm 2: Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 40 to 80 mg orally once daily for 8 weeks intervention 2: 40 to 80 mg orally once daily for 8 weeks | intervention 1: Atomoxetine intervention 2: Placebo | 2 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00304161 |
[
3,
4
] | 167 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness of uridine supplementation in treating HIV infected individuals on stable ART with lipoatrophy. | Lipoatrophy is a distressing long-term complication of ART and is associated with decreased quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood. However, past research suggests that mitocho... | HIV Infections Lipoatrophy | Treatment Experienced Uridine | null | 2 | arm 1: Participants received NucleomaxX for 48 weeks arm 2: Participants received NucleomaxX placebo for 48 weeks | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 36 g sachet taken orally three times daily intervention 2: 36 g placebo sachet taken orally three times daily | intervention 1: NucleomaxX intervention 2: NucleomaxX placebo | 30 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
San Diego | California | United States | -117.16472 | 32.71571
Torr... | 0 | NCT00307164 |
[
3
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment. | 852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability. | Breast Cancer Ovarian Cancer Endometrial Cancer Cervical Cancer | Breast Ovarian Endometrial Cervical Metastatic 852A IRM Oncology Metastatic Cervical Cancer Metastatic Ovarian Cancer Metastatic Breast Cancer Metastatic Endometrial Cancer | null | 2 | arm 1: Patients treated with at least one dose - 852A subcutaneous injection. arm 2: Patients who received all 24 doses of 852A per protocol. | [
0,
0
] | 1 | [
0
] | intervention 1: 0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2. | intervention 1: 852A | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00319748 |
[
4
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R). Half of the patients received Zevalin and the other half receive no further anti-cancer treatment. ... | The objectives of this study were to evaluate the efficacy and safety of the Zevalin study regimen compared with observation alone in patients with complete remission (CR or CRu) after first-line CHOP-R, the study was to include patients 60-years-of-age or older with histologically confirmed Ann Arbor stage II, III, or... | Lymphoma, Large Cell, Diffuse | null | 2 | arm 1: Patients received Zevalin.
Zevalin Therapeutic Regimen:
Day 1: Initial administration of 250 mg/m\^2 rituximab, followed immediately by administration of 185 MBq of \[111In\]-ibritumomab tiuxetan ,in centers where centers where biodistribution imaging or dosimetry had not been required, the first rituximab inf... | [
0,
4
] | 1 | [
0
] | intervention 1: Zevalin study treatment regimen consisted of 2 rituximab i.v. infusions (Day 1 and Day 7-9) and one \[90Y\]-ibritumomab tiuxetan infusion in connection with the second rituximab infusion.
The core treatment regimen in the Zevalin arm was:
Day 1: Rituximab i.v. infusion 250 mg/m\^2
Day 7-to 9: Rituxim... | intervention 1: Zevalin | 90 | Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Bakersfield | California | United States | -119.01871 | 35.37329
Berkeley | California | United States | -122.27275 | 37.87159
Beverly Hills | Cal... | 0 | NCT00322218 | |
[
3
] | 358 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure activity in children under the age of 18 years with epilepsy in the community setting. The primary hypothesis is that nasal midazol... | Study Design: This is a prospective randomized controlled study.
Study Procedures: Parents/guardians will be provided with a stopwatch to help record seizure times on the "Parent Form". All parents of children who have a seizure lasting longer than five minutes will be randomized to treat their seizure with the study ... | Seizures | Seizures | null | 2 | arm 1: GIve once for seizure longer than 5 minutes arm 2: Given once for seizure longer than 5 minutes | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Intranasal Midazolam 0.2 mg/kg given once for seizures longer than 5 minutes. intervention 2: Rectal Diazepam (Diastat) given once for seizure greater than 5 minutes. | intervention 1: Midazolam intervention 2: Diazepam | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00326612 |
[
4
] | 581 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS). | Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT003... | Restless Legs Syndrome | null | 1 | arm 1: 1200 mg XP13512, orally, once daily for 52 weeks | [
0
] | 1 | [
0
] | intervention 1: 1200 mg XP13512, orally, once daily for 52 weeks | intervention 1: XP13512 (GEn) | 0 | null | 0 | NCT00333359 | |
[
4
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters. | Postnasal drip (PND) is a common complaint that brings patients to the attention of their primary care physicians. It is also one of the most common reasons for patients to seek care from otolaryngologists. Traditionally, PND has been considered and treated as a symptom of sinonasal pathology. It has also been shown, a... | Larynx Disease | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 5 | [
0,
3,
3,
0,
0
] | intervention 1: 40 mg bid x 16 weeks intervention 2: 24 hour ph monitoring intervention 3: done prior to pH probe to measure length of esophagus intervention 4: 40mg bid intervention 5: one tablet bid | intervention 1: Lansoprazole Tablet intervention 2: PH and impedence testing intervention 3: manometry intervention 4: lansoprazole intervention 5: placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00335283 | |
[
3
] | 140 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence. | null | Methamphetamine | methamphetamine addiction | null | 2 | arm 1: Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. arm 2: After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Topiramate intervention 2: Placebo Oral Tablet | 8 | Costa Mesa | California | United States | -117.91867 | 33.64113
San Diego | California | United States | -117.16472 | 32.71571
Torrance | California | United States | -118.34063 | 33.83585
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Des Moines | Iowa | United States | -93.60911 | 41.60054
Kansas City | Mi... | 0 | NCT00345371 |
[
4
] | 240 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa. | Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with mid-peripheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients hav... | Retinitis Pigmentosa | Retinitis Pigmentosa, Inherited Retinal Degeneration | null | 2 | arm 1: Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate arm 2: Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate | [
0,
2
] | 2 | [
0,
7
] | intervention 1: 12mg/d intervention 2: Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate | intervention 1: Lutein intervention 2: Cornstarch control | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00346333 |
[
3
] | 139 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement o... | null | Coronary Arteriosclerosis Acute Coronary Syndrome | null | 3 | arm 1: Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days. arm 2: Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon... | [
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 10 mg tablet taken orally intervention 2: 75 mg tablet taken orally intervention 3: oral, as blinding mechanism. intervention 4: 60 mg (six 10-mg tablets) taken orally intervention 5: oral, as blinding mechanism | intervention 1: prasugrel 10 mg intervention 2: clopidogrel intervention 3: prasugrel placebo intervention 4: prasugrel 60 mg intervention 5: clopidogrel placebo | 9 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Baltimore | Maryland | United States | -76.61219 | 39.29038
Worcester | Massachusetts | United States | -71.80229 | 42.26259
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Columbus | Ohio ... | 0 | NCT00356135 | |
[
3
] | 55 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML). | null | Acute Myeloid Leukemia | Acute Myeloid Leukemia AML Decitabine Dacogen MGI PHARMA, INC. | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops. | intervention 1: Decitabine | 3 | Duarte | California | United States | -117.97729 | 34.13945
Los Angeles | California | United States | -118.24368 | 34.05223
St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00358644 |
[
0
] | 411 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 0ALL | true | Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH. | Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression \[IPC\]) and pharmacological (anticoagulant). Both are effective; however each carries its own advantages and disadvant... | Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding | SAFE CECT SFT ActiveCare ActiveCare+SFT Deep Vein Thrombosis prevention Total Hip Replacement Total Hip Arthroplasty Low Molecular Weight Heparin MCS | null | 2 | arm 1: The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. arm 2: Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patie... | [
0,
1
] | 2 | [
1,
0
] | intervention 1: Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the ... | intervention 1: ActiveCare CECT device intervention 2: Enoxaparin | 9 | La Jolla | California | United States | -117.2742 | 32.84727
Loma Linda | California | United States | -117.26115 | 34.04835
Los Angeles | California | United States | -118.24368 | 34.05223
Mooresville | Indiana | United States | -86.37416 | 39.61282
Baltimore | Maryland | United States | -76.61219 | 39.29038
Rochester... | 0 | NCT00358735 |
[
4
] | 72 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram). | Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addi... | Major Depressive Disorder | depression biology | null | 1 | arm 1: citalopram or escitalopram | [
5
] | 1 | [
0
] | intervention 1: Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. | intervention 1: open-label selective serotonin reuptake inhibitor (SSRI) | 0 | null | 0 | NCT00361218 |
[
5
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | People with high fasting glucose can develop type 2 diabetes with the passage of time. This study is being done to determine the effect of a novel medication in people with this elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally found in the blood. This hormone, called glucago... | Impaired fasting glucose (IFG) confers a high risk of progression to diabetes. Its pathogenesis has been an area of active investigation, with defects in insulin and glucagon secretion as well as insulin action likely to play a role. Several studies have suggested that the prediabetic and diabetic state are associated ... | Pre-diabetes | null | 2 | arm 1: People with impaired fasting glucose randomized to treatment with sitagliptin 100 mg once daily. arm 2: People with impaired fasting glucose randomized to treatment with placebo once daily. | [
1,
2
] | 2 | [
0,
10
] | intervention 1: 100 mg once daily intervention 2: once daily for duration of the study | intervention 1: Sitagliptin intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00364377 | |
[
3
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater effica... | OUTLINE: This is a multi-center study.
* Bevacizumab 15 mg/kg IV on day 1
* Erlotinib 150 mg po qd days 1-21
* Disease Assessment during even numbered cycles
If no progressive disease observed, continue (combination or single agent- see below) until unacceptable toxicity or progressive disease.
If progressive diseas... | Lung Cancer | null | 1 | arm 1: Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease. | [
0
] | 2 | [
0,
0
] | intervention 1: Erlotinib 150 mg qd days 1-21 intervention 2: Bevacizumab 15 mg/kg IV, day 1 | intervention 1: Erlotinib intervention 2: Bevacizumab | 13 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Bloomington | Indiana | United States | -86.52639 | 39.16533
Evansville | Indiana | United States | -87.55585 | 37.97476
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Ind... | 0 | NCT00367601 | |
[
3
] | 71 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT). | This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiv... | HIV Infections | mitochondria HIV lipoatrophy | null | 2 | arm 1: Rosiglitazone active 4 mg BID arm 2: Matching Placebo BID | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Rosiglitazone 4mg BID intervention 2: Placebo for rosiglitazone | intervention 1: Rosiglitazone intervention 2: Placebo | 2 | Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00367744 |
[
5
] | 228 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | null | This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy. | null | Renal Transplantation | null | 2 | arm 1: The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the ... | [
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Everolimus (RAD001) intervention 2: Tacrolimus intervention 3: Basiliximab intervention 4: Corticosteroids | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00369161 | |
[
4
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | null | 0ALL | null | This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg\*h/L compared to a standard dosi... | null | Renal Transplantation | Renal transplantation, mycophenolate | null | 2 | arm 1: Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 180 days. arm 2: Enteric-coated mycophenolate sodi... | [
0,
1
] | 1 | [
0
] | intervention 1: Tablets for oral administration | intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) | 1 | Various Cities | N/A | Germany | N/A | N/A | 0 | NCT00369278 |
[
4
] | 548 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial. | The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting... | Fibromyalgia | FMS Fibro pain Body pain tenderness joint pain stiffness muscular pain | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: two doses intervention 2: Oral Solution | intervention 1: Xyrem® intervention 2: Placebo | 70 | Anniston | Alabama | United States | -85.83163 | 33.65983
Huntsville | Alabama | United States | -86.58594 | 34.7304
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Burbank | California | Unit... | 0 | NCT00371137 |
[
0
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. Thi... | Patients with gastroparesis, or delayed gastric emptying, present with early satiety, postprandial bloating, nausea, vomiting, and abdominal pain or discomfort.1 Gastric emptying is a highly regulated process reflecting the integration of propulsive forces generated by proximal fundic tone and distal antral contraction... | Gastroparesis | gastroparesis vomiting nausea bloating dyspepsia | null | 2 | arm 1: 200 U of Botox injected endoscopically into pylorus arm 2: saline into pylorus. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 200 U given by injection into the pylorus. intervention 2: saline injection into pylorus. | intervention 1: Botulinum toxin A intervention 2: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00372970 |
[
3
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. The administration of erythropoietin is designed... | OUTLINE: This is an open label, multi-center, randomized study.
Eligible patients will be randomized to one of two treatment arms:
Arm A (Azacitidine + Erythropoietin)
* Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy i... | Myelodysplastic Syndromes | null | 2 | arm 1: Azacitidine + Erythropoietin arm 2: Azacitidine | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks. intervention 2: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy intervention 3: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks. | intervention 1: Azacitidine intervention 2: Erythropoietin intervention 3: Azacitidine (Monotherapy) | 9 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lafayette | Indiana | United States | -86.87529 | 40.4167
Lafayette | Indiana | United States | -86.87529 | 40.4167
Muncie | Indiana | U... | 0 | NCT00379912 | |
[
4
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a Phase III, randomized, double-blind, placebo-controlled study conducted at 37 centers in the United States. 150 subjects ≥ 16 years of age who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study. | null | Dysfunctional Hemodialysis Catheters | HD Hemodialysis Catheter clearance TNKase Renal Insufficiency | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase intervention 2: For the initial treatment, 2 mL of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatment... | intervention 1: placebo intervention 2: tenecteplase | 0 | null | 0 | NCT00396032 |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested:
Hypothesis 1: treatment ( 3 week... | This will be a rater-blinded, head-to-head comparison (no placebo) of divalproex ER and quetiapine in patients with symptoms of an active manic or mixed mania (symptoms of mania and depression). Forty subjects are expected to be enrolled. After screening for eligibility, eligible subjects will be randomized while hospi... | Bipolar Disorder | quetiapine divalproex | null | 2 | arm 1: Divalproex ER arm 2: quetiapine fumarate | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Dose: 30mg per kg, rounded to nearest 500mg, dosed PO QHS. Adjustments made through trial to obtain serum valproic acid levels of 85-125 mcg/ml intervention 2: Dose: 200mg PO QHS, titrated up to therapeutic dose of 600-800mg. | intervention 1: divalproex ER intervention 2: quetiapine | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00397020 |
[
4
] | 66 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic ... | Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophy... | Hodgkin Disease Non-Hodgkin Lymphoma Multiple Myeloma Bacteremia | prophylaxis bacteremia moxifloxacin stem cell transplantation Hodgkin disease non-Hodgkin lymphoma multiple myeloma solid tumor autologous stem cell transplantation | null | 2 | arm 1: moxifloxacin 400 mg tablets once daily arm 2: identical appearing placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 400 mg p.o. per day intervention 2: one tablet per day p.o. | intervention 1: moxifloxacin intervention 2: placebo | 1 | Cologne | N/A | Germany | 6.95 | 50.93333 | 0 | NCT00398411 |
[
4
] | 1,271 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated P falciparum malaria in South East Asia, India an... | This is a multi-centre, comparative, randomised, open-label, parallel-group, non-inferiority study comparing the efficacy and safety of a fixed combination of PA to a loose combination of MQ + AS for patients with acute, symptomatic, uncomplicated P. falciparum malaria. The study population will include 1271 patients, ... | Falciparum Malaria | malaria antimalarial P falciparum pyronaridine artesunate artemisinin based combination therapy (ACT) pyronaridine artesunate (Pyramax) | null | 2 | arm 1: Oral pyronaridine artesunate (180:60mg tablets) once a day for 3 consecutive days (Day 0, 1, and 2). Posology based on body weight ranges. arm 2: Mefloquine (250mg tablets) plus artesunate (100mg tablets) once a day for 3 consecutive days (Day 0, 1, and 2). Posology based on body weight ranges. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: once a day for 3 days intervention 2: once a day for 3 days | intervention 1: Pyronaridine - artesunate intervention 2: Mefloquine plus artesunate | 9 | Bobo-Dioulasso | Houet Province | Burkina Faso | -4.2979 | 11.17715
Pailin | Pailin | Cambodia | 102.60928 | 12.84895
Abidjan | N/A | Côte d’Ivoire | -4.00167 | 5.35444
Mangalore | N/A | India | 74.85603 | 12.91723
Bagamoyo | N/A | Tanzania | 38.90422 | -6.44222
Mae Ramat | Changwat Tak | Thailand | 98.51665 | 16.98403... | 0 | NCT00403260 |
[
5
] | 1,121 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) ... | null | Asthma | Asthma Alvesco® Ciclesonide | null | 2 | arm 1: Alvesco 320mcg / Alvesco 640mcg arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Asthma Care with Alvesco intervention 2: Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment | intervention 1: Ciclesonide intervention 2: Usual Care Inhaled Glucocorticosteroids | 186 | Abbotsford | N/A | Canada | -122.25257 | 49.05798
Ajax | N/A | Canada | -79.03288 | 43.85012
Alma | N/A | Canada | -71.6491 | 48.55009
Anjou | N/A | Canada | -73.54917 | 45.60008
Anjou | N/A | Canada | -73.54917 | 45.60008
Barrie | N/A | Canada | -79.66634 | 44.40011
Brampton | N/A | Canada | -79.76633 | 43.68341
Bramp... | 0 | NCT00404547 |
[
4
] | 604 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis. | null | Osteoporosis | osteoporosis bisphosphonate biomarker zoledronic acid alendronate postmenopausal | null | 2 | arm 1: Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 8... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid. intervention 2: Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomac... | intervention 1: Zoledronic acid 5 mg solution intervention 2: Alendronate 70 mg tablets intervention 3: Calcium/Vitamin D | 1 | Multiple Cities | N/A | Germany | N/A | N/A | 0 | NCT00404820 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill... | PRIMARY OBJECTIVES:
I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma.
SECONDARY OBJECTIVES:
I. To evaluate the effect of MLN518 on progression-free survival and overall survival in patients with metastatic clear cell renal carcinoma.
II. To evaluate the toxicity ... | Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer | null | 1 | arm 1: Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
10
] | intervention 1: Given orally, 500 mg bid daily intervention 2: Correlative studies | intervention 1: tandutinib intervention 2: laboratory biomarker analysis | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00408902 | |
[
0
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients. | The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp... | HIV Infections | HIV Kaletra Reyataz Insulin sensitivity Lipids Body Composition Receiving Kaletra Treatment Experienced | null | 2 | arm 1: Boosted Reyataz (300mg atazanavir + 100mg ritonavir) arm 2: Kaletra (pre-study dose) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: atazanavir 300mg + ritonavir 100mg once daily intervention 2: patient remains on their pre-study dose of lopinavir/ritonavir | intervention 1: atazanavir/ritonavir intervention 2: lopinavir/ritonavir | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00413153 |
[
0
] | 21 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance. | Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater r... | Obesity Impaired Glucose Tolerance Type 2 Diabetes Mellitus | Childhood and Adolescent Obesity Metabolic phenotype Impaired Glucose Tolerance Type 2 Diabetes Mellitus Insulin Sensitivity Insulin Resistance Abdominal fat partitioning Impaired Glucose Tolerance (IGT) Type 2 Diabetes Mellitus (T2DM) | null | 2 | arm 1: Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months. arm 2: Subject has ogtt, hyperinsulinemic-... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 2mg to begin then 4mg, twice daily for 4 months intervention 2: Subject receives placebo. | intervention 1: Rosiglitazone intervention 2: Placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00413335 |
[
0
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To investigate the efficacy and safety of once daily enoxaparin as a "bridge" to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism. | Background and Significance:
Low molecular weight heparin (LMWH) as a "bridge" to warfarin has become the standard of care for outpatient treatment of acute deep venous thrombosis (DVT). LMWH is also often prescribed as a "bridge" to warfarin for patients with acute pulmonary embolism (PE). In the United States, the F... | Deep Vein Thrombosis Pulmonary Embolism | Lovenox Enoxaparin Prophylaxis Pulmonary Embolism Acute Deep Vein Thrombosis Venous Thrombosis Thrombosis Anticoagulation | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: Patient takes 1.5 mg per kilogram, once daily, subcutaneous injections until INR is therapeutic, then medication is stopped. | intervention 1: Enoxaparin | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00413374 |
[
4
] | 1,030 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxyc... | The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) ... | Osteoarthritis, Knee Pain | Chronic Pain Osteoarthritis, Knee tapentadol Pain Assessment | null | 3 | arm 1: tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks arm 2: oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks arm 3: placebo matching placebo twice a day (BID) during 15 weeks | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks intervention 2: matching placebo twice a day (BID) during 15 weeks intervention 3: 50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks | intervention 1: oxycodone intervention 2: placebo intervention 3: tapentadol (CG5503) | 0 | null | 0 | NCT00421928 |
[
5
] | 173 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery) | The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial. | Angina, Unstable Myocardial Infarction | Non-ST Elevation Acute Coronary Syndromes coronary interventions | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours. intervention 2: Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of ... | intervention 1: Dalteparin ( Fragmin) intervention 2: Unfractionated heparin | 8 | Hyderabad | Andhra Pradesh | India | N/A | N/A
Hyderabad | Andhra Pradesh | India | N/A | N/A
Nagpur | Maharashtra | India | 79.08491 | 21.14631
Pune | Maharashtra | India | 73.85535 | 18.51957
Pune | Maharashtra | India | 73.85535 | 18.51957
Ludhiana | Punjab | India | 75.85379 | 30.91204
Coimbatore | Tamil Nadu | Ind... | 0 | NCT00435487 |
[
5
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Effect of nicotine patch as an adjutant for acute pain after surgery. | This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes. | Pain | acute pain nicotine nausea sedation | null | 4 | arm 1: Smokers who were treated with nicotine arm 2: Nonsmokers who were treated with nicotine arm 3: Smokers who were treated with placebo arm 4: Nonsmokers who were treated with placebo | [
0,
0,
2,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: nicotine patch (0,5,10 or 15mg/day) applied to smokers intervention 2: nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers intervention 3: placebo patch applied to smokers intervention 4: placebo patch applied to nonsmokers | intervention 1: nicotine patch intervention 2: nicotine patch intervention 3: placebo intervention 4: placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00440830 |
[
4
] | 307 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement. | null | Osteoarthritis Postoperative Pain | opioid | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 150 milligram (mg)/ day (double blind) intervention 2: 300 mg/day (double blind) intervention 3: Placebo | intervention 1: pregabalin intervention 2: pregabalin intervention 3: Placebo | 27 | Northport | Alabama | United States | -87.57723 | 33.22901
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Miami | Florida | Uni... | 0 | NCT00442546 |
[
5
] | 77 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control... | Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Levodopa is the most effective symptomatic treatment; however, long term use is associated with motor fluctuations (periods of return of PD symptoms when medication ef... | Parkinson's Disease | Parkinson's disease Dopamine agonist adverse effects MAO-B inhibitor orally disintegrating selegiline Zelapar | null | 1 | arm 1: This is a one arm open label study of patients who are experiencing a dopamine agonist (DA) related adverse effects (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder. All subjects received orally disintegrating selegiline. | [
5
] | 1 | [
0
] | intervention 1: 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated | intervention 1: orally disintegrating selegiline (Zelapar) | 17 | Irvine | California | United States | -117.82311 | 33.66946
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Sunnyvale | California | United States | -122.03635 | 37.36883
Boca Raton | Florida | United States | -80.0831 | 26.35869
Tampa | Flor... | 0 | NCT00443872 |
[
3
] | 14 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well... | BACKGROUND: Patients who have been exposed to human tissue by prior transplants, blood transfusion or pregnancy may develop and maintain anti-bodies against these foreign human cells (SENSITIZATION). As a result of sensitization these patients are more likely to reject an organ donated from an individual who possesses ... | Kidney Failure, Chronic Diabetic Nephropathies Glomerulonephritis, IGA Hypertension, Renal | Dialysis Kidney Renal Nephropathy Glomerulonephropathy Immunosuppression Graft Compatibility Transplant Diabetes Hypertension Transplantation, Kidney | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: Rituximab dose is 1,000 mg given as an IV infusion every two weeks for 2 doses (days 1 and 15). intervention 2: Cellcept is continued from prior study, taken 500 - 1,000 mg BID, P.O. | intervention 1: Rituximab intervention 2: Mycophenolate mofetil (MMF) | 0 | null | 0 | NCT00446251 |
[
3
] | 45 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a 12-month, phase II, prospective, open label study, to evaluate the effect of mycophenolate mofetil (MMF) among patients on the kidney transplant list with high Panel of Reactive Antibody (PRA) levels.
On average, increasing the PRA from 0 to 50% specifically in the Washington Organ Procurement Organization (... | HYPOTHESIS: mycophenolate mofetil given over 8 months to highly sensitized subjects awaiting kidney transplant, will result in a decrement in the PRA by 10% or more in approximately 40% of patients. This decrement should allow an improved rate of transplantation.
BACKGROUND: Patients who have been exposed to human tis... | Kidney Failure, Chronic Diabetic Nephropathies Glomerulonephritis, IGA Hypertension, Renal | CellCept Dialysis Kidney Renal Nephropathy Glomerulonephropathy Immunosuppression Allograft Compatibility HLA PRA Transplant Sensitization Antibodies Diabetes Hypertension Transplantation, Kidney | null | 0 | null | null | 1 | [
0
] | intervention 1: 500mg - 1,000mg, taken PO, twice daily. | intervention 1: mycophenolate mofetil (CellCept) | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00446459 |
[
4
] | 59 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home. | Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection. Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not... | Acromegaly | Acromegaly Somatostatin Analogs Somatuline® Autogel® lanreotide growth hormone IGF-1 Inappropriate Growth Hormone Secretion Syndrome Somatotropin Hypersecretion Syndrome Inappropriate GH Secretion Syndrome | null | 1 | arm 1: Somatuline Autogel (lanreotide acetate) Injection | [
0
] | 2 | [
0,
5
] | intervention 1: Injections intervention 2: Questionnaire | intervention 1: Somatuline Autogel (lanreotide acetate) intervention 2: Home administration | 13 | La Mesa | California | United States | -117.02308 | 32.76783
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachuse... | 0 | NCT00447499 |
[
5
] | 50 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | true | 0ALL | false | The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. | The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor ... | Myopia Hyperopia | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: lens care system intervention 2: lens care system | intervention 1: Optifree RepleniSH Multipurpose Disinfecting Solution intervention 2: ReNu Multiplus Multipurpose Solution | 1 | Waterloo | Ontario | Canada | -80.51639 | 43.4668 | 0 | NCT00455455 | |
[
4
] | 793 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone. | The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensiv... | Obesity Overweight | Obesity Behavior Modification | null | 2 | arm 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group lifestyle modification counseling arm 2: Placebo with intensive group lifestyle modification counseling | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Intensive group lifestyle modification counseling | 9 | La Jolla | California | United States | -117.2742 | 32.84727
Denver | Colorado | United States | -104.9847 | 39.73915
Gainesville | Florida | United States | -82.32483 | 29.65163
St Louis | Missouri | United States | -90.19789 | 38.62727
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylv... | 0 | NCT00456521 |
[
3
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II trial is studying the side effects and how well pazopanib works in treating patients with recurrent glioblastoma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor | PRIMARY OBJECTIVES:
I. Determine the therapeutic efficacy of pazopanib hydrochloride, as measured by 6-month progression-free survival (PFS), in patients with recurrent glioblastoma.
II. Determine the safety profile of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the efficacy of this drug, as mea... | Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor | null | 1 | arm 1: Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis | [
0
] | 2 | [
0,
10
] | intervention 1: Given orally intervention 2: Correlative studies | intervention 1: pazopanib hydrochloride intervention 2: laboratory biomarker analysis | 9 | Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Bethesda | Maryland | United States | -77.10026 | 38.98067
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Durham |... | 0 | NCT00459381 | |
[
4
] | 109 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score. | This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score. | Post-Stroke Spasticity Cerebrovascular Accident | Spasticity Post-Stroke botulinum toxin type A Upper Limb | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
2,
1,
1
] | 2 | [
0,
0
] | intervention 1: botulinum toxin type A intervention 2: Placebo | intervention 1: GSK1358820 intervention 2: Placebo | 18 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Hiroshima | N/A | Japan | 132.45 | 34.4
Hiroshima | N/A | Japan | 132.45 | 34.4
Hokkaido | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Ibaraki | N/A | Japan | 135.56828 | 34.81641
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kan... | 0 | NCT00460564 |
[
4
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score. | This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score. | Post-Stroke Spasticity Cerebrovascular Accident | Post-Stroke Lower Limb botulinum toxin type A Spasticity | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: botulinum toxin type A intervention 2: Placebo | intervention 1: GSK1358820 intervention 2: Placebo | 20 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Hiroshima | N/A | Japan | 132.45 | 34.4
Hiroshima | N/A | Japan | 132.45 | 34.4
Hokkaido | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Ibaraki | N/A | Japan | 135.56828 | 34.81641
Kanagawa | N/A... | 0 | NCT00460655 |
[
0
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 1FEMALE | true | The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there ... | The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated... | Early Pregnancy Failure Miscarriage Fetal Demise Anembryonic Pregnancy | early pregnancy failure mifepristone misoprostol buccal miscarriage fetal demise anembryonic progesterone | null | 2 | arm 1: Women in this arm receive placebo and misoprostol 800 mcg buccally arm 2: Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Women in this group receive 800 mcg misoprostol plus a placebo intervention 2: This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally | intervention 1: Misoprostol and placebo intervention 2: Mifepristone and misoprostol | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00468299 |
[
2,
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objectives:
1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients wi... | Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. Arsenic trioxide may cause can... | Myeloma | Multiple Myeloma Melphalan Trisenox Arsenic Trioxide Ascorbic Acid Vitamin C Velcade Bortezomib | null | 3 | arm 1: Arm 1: Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily arm 2: Arm 2: Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily arm 3: Arm ... | [
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3). intervention 2: Arm 1 (Level 1):
1.0 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).
Arm 2 (Level 2):
1.5 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. A... | intervention 1: Trisenox (Arsenic Trioxide) intervention 2: Velcade (Bortezomib) intervention 3: Melphalan intervention 4: Vitamin C (Ascorbic Acid) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00469209 |
[
3,
4
] | 183 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay... | null | Thyroidectomy | Surgery Thyroid gland cervical block Pain, Postoperative | null | 4 | arm 1: bilateral superficial cervical block, placed before surgery (just before skin incision) arm 2: placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision) arm 3: bilateral superficial cervical block, placed after surgery (just after skin closure) arm 4: placebo bil... | [
0,
2,
0,
2
] | 2 | [
0,
0
] | intervention 1: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incis... | intervention 1: bilateral superficial cervical block intervention 2: placebo bilateral superficial cervical block | 1 | Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 | 0 | NCT00472446 |
[
3
] | 257 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatm... | null | Bipolar I Depression | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) o... | intervention 1: Armodafinil intervention 2: Placebo | 55 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Escondido | California | United States | -117.08642 | 33.11921
Lafayette | California | United States | -122.11802 | 37.88576
National City | California | United States | -117.0992 | 32.67811
Oceansid... | 0 | NCT00481195 | |
[
4
] | 443 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | false | The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC. | The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC. | Inflammatory Bowel Disease Ulcerative Colitis | IBD UC Ulcerative Colitis Inflammatory Bowel Disease | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: None | intervention 1: Balsalazide Disodium | 95 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tempe | Arizona | United States | -111.90931 | 33.41477
Fayetteville | Arkansas | United States | -94.15743 | 36.06258
Anaheim | California | United States | -117.9145 | 33.83529
Encinitas | California | United States | -117.29198 | 33.03699
Garden Grove | Cal... | 0 | NCT00486031 |
[
3
] | 78 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA) | null | Rheumatoid Arthritis | ACR20, ACR50, ACZ885 (anti-interleukin-1beta monoclonal antibody), rheumatoid arthritis, methotrexate | null | 2 | arm 1: Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. MTX was given as variable dosing regimen of 7.5 mg-15 mg weekly. arm 2: Methotrexate (MTX) was given as variable dosing regime... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 2: Matching placebo was supp... | intervention 1: Canakinumab (investigational) intervention 2: Placebo intervention 3: Methotrexate (MTX) | 22 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Paradise Valley | Arizona | United States | -111.94265 | 33.53115
Jacksonville | Florida | United States | -81.65565 | 30.33218
South Miami | Florida | United States | -80.29338 | 25.7076
Tamarac | Flo... | 0 | NCT00487825 |
[
0
] | 28 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. | The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. The study is a double blind, placebo controlled, crossover study with the order of treatment randomized. Patients will receive each treatment for 8 weeks w... | Diabetes Mellitus Metabolic Syndrome | endothelium obesity diabetes mellitus dyslipidemia | null | 2 | arm 1: Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second arm 2: Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 140 mg/day for 8 weeks intervention 2: 20 mg/day for 8 weeks | intervention 1: Fenofibrate intervention 2: Atorvastatin | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00491400 |
[
3
] | 218 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis. | null | Onychomycosis | null | 6 | arm 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. arm 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. arm 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. arm 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. arm 5: Terbinafine 250 mg QD for 12 ... | [
0,
0,
0,
0,
1,
2
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks. intervention 2: Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. intervention 3: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. intervention 4: Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. ... | intervention 1: SCH 56592 intervention 2: SCH 56592 intervention 3: SCH 56592 intervention 4: SCH 56592 intervention 5: Terbinafine intervention 6: Placebo | 0 | null | 0 | NCT00491764 | |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protec... | Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot... | Gastroparesis Gastroesophageal Reflux Disease | Gastroparesis Gastroesophageal reflux disease heartburn | null | 2 | arm 1: subjects receive immediate release omeprazole for 7 days then delayed release for 7 days arm 2: subjects receive delayed release omeprazole for 7 days then immediate release for 7 days | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Immediate-release omeprazole 40 mg qam for 7 days intervention 2: Delayed-release omeprazole 40 mg qam for 7 days | intervention 1: Immediate-release omeprazole intervention 2: Delayed-release omeprazole | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 0 | NCT00492622 |
[
4
] | 119 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at ... | COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. COPD is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Treatment usually includes inhaled bronch... | Pulmonary Disease, Chronic Obstructive | Chronic Obstructive Pulmonary Disease COPD Exacerbation Anti-leukotriene Length of Stay LOS | null | 2 | arm 1: Zileuton (Zyflo, 600 mg 4 times a day) arm 2: Placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Zyflo tablets, 600 mg, 4 times a day intervention 2: Placebo 4 x daily | intervention 1: Zileuton intervention 2: Placebo | 18 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Denver | Co... | 0 | NCT00493974 |
[
5
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturbances of CFS leading t... | Medically unexplained fatigue occurs in about 5% of the population with 10% of that number fulfilling formal case definitions for chronic fatigue syndrome1. Medically unexplained fatigue is a major problem for both patient and practitioner - for both because there is no effective FDA-approved treatment for the symptom.... | Chronic Fatigue Syndrome | chronic fatigue pain sleep xyrem must have chronic fatigue syndrome no hypertension no sleep apnea | null | 2 | arm 1: Patients were randomized and these received placebo arm 2: Patients were randomized and these received the active drug | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Subjects will be randomly assigned to either placebo or drug. The medication and the placebo come as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than ... | intervention 1: Placebo intervention 2: Sodium Oxybate | 1 | Newark | New Jersey | United States | -74.17237 | 40.73566 | 0 | NCT00498485 |
[
4
] | 246 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study... | null | Rheumatoid Arthritis | null | 1 | arm 1: Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed du... | [
0
] | 2 | [
0,
0
] | intervention 1: \>=15 mg po/week intervention 2: 1g iv on days 1 and 15 | intervention 1: Methotrexate intervention 2: rituximab [MabThera/Rituxan] | 49 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Córdoba | N/A | Argentina | -64.18853 | -31.40648
San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601
Belém | N/A | Brazil | -48.50444 | -1.455... | 0 | NCT00502996 | |
[
4
] | 186 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD. | This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease. | Idiopathic Parkinson's Disease | Rotigotine Neupro® | null | 1 | arm 1: Rotigotine | [
0
] | 1 | [
0
] | intervention 1: Rotigotine transdermal patches:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
Optimal dosing:
The maximum rotigotine dose allowed is 16 mg/24 hours. | intervention 1: Rotigotine | 26 | Birmingham | Alabama | United States | -86.80249 | 33.52066
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Southfield | Michigan | United States | -83.22187 | 42.47337
Forest Hills | New York | United States | -73.85014 | 40.71621
Asheville | N... | 0 | NCT00505687 |
[
5
] | 86 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy. | Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial. | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: Individually adjusted dose of insulin detemir once daily arm 2: Individually adjusted dose of insulin NPH once daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Treat-to-target, s.c. (under the skin) injection, once daily intervention 2: Treat-to-target, s.c. (under the skin) injection, once daily | intervention 1: insulin detemir intervention 2: insulin NPH | 2 | Paris La Défense | N/A | France | N/A | N/A
Cambridge | N/A | United Kingdom | 0.11667 | 52.2 | 0 | NCT00506662 | |
[
5
] | 158 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study is looking at three seizure medicines. Patients with seizures are usually treated with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also. This study will compare IV phenytoin (Dilan... | More than one in every one hundred patients presenting to the emergency department for care do so for seizures. More than half of these patients will require medications, often intravenously (IV), while in the emergency department. For many years the standard treatment has been phenytoin. However, there are many known ... | Tonic-clonic Seizure | tonic-clonic seizure emergency department IV levetiracetam Keppra seizures phenytoin Dilantin Grand Mal seizure | null | 2 | arm 1: Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals). arm 2: Patients in the intervention arm will receive IV Keppra (1 gram of Kepp... | [
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: The patient will receive 1 gram of Keppra added to 100ml diluent and will be infused over 15 minutes. intervention 2: IV load will be dependant on dilantin level. If no dilantin is detected in the patient, the patient will receive 1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vit... | intervention 1: Keppra intervention 2: Fosphenytoin intervention 3: Dilantin | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00510783 |
[
5
] | 4 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | Objectives:
The primary objective of this study is to determine the efficacy of eszopiclone at treating sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking cessation.
Sleep disturbances are a significant problem for smokers who are trying to quit smoking. Smokers may be more likel... | null | Insomnia Nicotine Dependence | insomnia nicotine dependence smoking smoking cessation zyban | null | 2 | arm 1: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + Lunesta (3 mg qd x 6 weeks) arm 2: Zyban (150 mg qd x 7 days then 150 mg bid x 6 weeks) + placebo (1 pill per day x 6 weeks) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: eszopiclone (lunesta) - 3 mg qd x 6 weeks, oral capsule intervention 2: bupropion SR in oral capsule will be begun at the beginning of week 1 (150 mg qd x 7 days) with an increase to the full dose (150 mg bid x 6 weeks) at the beginning of week 2. | intervention 1: Eszopiclone intervention 2: Bupropion | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00511134 |
[
2,
3
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the treatment of patients with an accelerated phase... | Systemic sclerosis is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin. In some cases, systemic sclerosi... | Alveolitis Systemic Sclerosis | active alveolitis in systemic sclerosis | null | 1 | arm 1: SSc patients receiving Imatinib (Gleevec, up to 600 mg) QD PO for up to 1 year. | [
0
] | 2 | [
0,
0
] | intervention 1: All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg ... | intervention 1: Imatinib intervention 2: Imatinib | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00512902 |
[
3
] | 510 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded... | null | Acute Coronary Syndrome | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Iodofiltic acid I 123 | 38 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mesa | Arizona | United States | -111.82264 | 33.42227
Los Angeles | California | United States | -118.24368 | 34.05223
Mission Viejo | California | United States | -117.672 | 33.60002
Newport Beach | ... | 0 | NCT00514501 | |
[
0
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | A. Null Hypothesis:
In term pregnancies complicated by diabetes, there is no difference in the time interval from start of induction to delivery when outpatient cervical ripening and labor induction is initiated with orally administered misoprostol, a prostaglandin El analogue, compared to placebo.
B. Specific aims:
... | The study proposed is a single center study. Study participants will be recruited from the high risk obstetrical diabetic resident clinic, the Magella Women's Perinatal Group, and Fetal Diagnostics at Miller Children's hospital. The resident clinic is supervised by the faculty from the division of Maternal Fetal Medici... | Diabetes, Gestational | Term Pregnancy Diabetes Cervical Ripening Induction misoprostol Term Gestational Diabetics | null | 2 | arm 1: patients will be treated with misoprostol 50 mcg PO arm 2: patients will receive placebo (Vitamin C) | [
1,
2
] | 2 | [
0,
7
] | intervention 1: patients will be treated with misoprostol 50 mcg PO q day for two days (days 1 and 4) intervention 2: patients will receive placebo (vitamin C) q day for two days (days 1 and 4) | intervention 1: Misoprostol intervention 2: Placebo | 1 | Long Beach | California | United States | -118.18923 | 33.76696 | 0 | NCT00514618 |
[
0
] | 96 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This project aims to a) evaluate the effects of selected antipsychotic medications on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on abdominal adipose tissue mass, total body fat... | Hyperglycemia and type 2 diabetes mellitus are more common in schizophrenia than in the general population. Type 2 diabetes mellitus is characterized by disturbances in insulin action on skeletal muscle, liver and adipose tissue. Diabetes causes increased morbidity and mortality due to acute (e.g., diabetic ketoacidosi... | Schizophrenia Schizoaffective Disorder Type 2 Diabetes Mellitus Hyperglycemia | control risperidone olanzapine quetiapine ziprasidone | null | 4 | arm 1: Participants in this group were randomized to flexibly-dosed treatment with olanzapine. arm 2: Participants in this group were randomized to flexibly-dosed treatment with risperidone. arm 3: Participants in this group were randomized to flexibly-dosed treatment with quetiapine. arm 4: Participants in this group ... | [
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: randomized to 12 week trial of risperidone. intervention 2: randomized to 12 week trial of olanzapine. intervention 3: randomized to 12 week trial of quetiapine. intervention 4: randomized to 12 week trial of ziprasidone. | intervention 1: risperidone intervention 2: olanzapine intervention 3: quetiapine intervention 4: ziprasidone | 2 | St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00515723 |
[
2,
3
] | 16 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 1FEMALE | true | The purpose of this study was to determine whether giving insulin like growth factor-I (IGF-I) to adolescent low weight girls is safe and whether this increases levels of bone formation markers. | Adolescents with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor I (IGF-I), the bone trophic factor made in the li... | Anorexia Nervosa | Adolescents Anorexia nervosa (AN) Bone formation markers Insulin like growth factor-1 (IGF-I) | null | 1 | arm 1: Adolescent girls with AN meeting inclusion criteria were administered recombinant human (rh) rhIGF-1 at a dose of 35-40 mcg/k twice daily by subcutaneous injections for a 7-10 day period. | [
0
] | 1 | [
0
] | intervention 1: 35-40 mcg/k/dose twice daily SC | intervention 1: RhIGF-1 | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00516386 |
[
4
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms. | The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings | Myopia | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: contact lens care system intervention 2: contact lens care system | intervention 1: ClearCare intervention 2: Optifree Replenish | 1 | Waterloo | Ontario | Canada | -80.51639 | 43.4668 | 0 | NCT00520351 | |
[
2,
3
] | 10 | RANDOMIZED | CROSSOVER | 9OTHER | 3TRIPLE | true | 1FEMALE | false | The purpose of this research study is to see if giving women a hormone called "ghrelin" will increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally occurring hormone that is produced mostly by the stomach and causes secretion of another hormone called growth hormone. It also increa... | Five community-dwelling women aged 70 or over with unintentional weight loss of \>5% in the prior year plus at least 2 of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria were enrolled. Women with conditions that can cause weight loss or taking an appetite stimulant or cort... | Frailty | frailty ghrelin appetite weight loss | null | 4 | arm 1: Healthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. arm 2: Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin in... | [
2,
2,
1,
1
] | 4 | [
0,
0,
10,
10
] | intervention 1: At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped. intervention 2: At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the I... | intervention 1: Ghrelin Infusion - Healthy intervention 2: Ghrelin Infusion - Frail intervention 3: Placebo Infusion -Healthy intervention 4: Placebo Infusion - Frail | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00520884 |
[
4
] | 460 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC). | null | Constipation | Opioid-Induced Constipation | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 2 | [
0,
10
] | intervention 1: Subcutaneous intervention 2: placebo | intervention 1: N-methylnaltrexone bromide (MOA-728) intervention 2: placebo | 78 | Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United States | -88.04305 | 30.69436
Sun City | Arizona | United States | -112.27182 | 33.59754
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United Sta... | 0 | NCT00529087 |
[
4
] | 602 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodo... | null | Adult Periodontitis | null | 3 | arm 1: sham treatment arm 2: Placebo arm 3: Minocycline HCL 2.1% | [
3,
2,
1
] | 2 | [
0,
3
] | intervention 1: Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. intervention 2: scaling and root planing | intervention 1: minocycline HCl 2.1% intervention 2: Scaling and root planing | 10 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Francisco | California | United States | -122.41942 | 37.77493
Gainsville | Florida | United States | N/A | N/A
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan |... | 0 | NCT00529555 | |
[
4
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | Primary Objectives:
1. To assess the ratio in sensitivities of OraTest® in combination with visual examination versus visual examination alone in the detection of serious pathology defined as severe dysplasia, CIS, or cancer of the O/OP cavity in patients who are at high risk for squamous cell carcinoma, carcinoma in ... | OraTest® is a blue dye that is designed to stain cancer cells differently than normal cells.
SCHEDULED EVALUATION (FIRST VISIT):
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your medical history w... | Head And Neck Cancer Oropharynx Cancer | Head And Neck Oropharynx Oral Cancer OraTest OraTest Dye Rinse Staining Procedure Visual Examination | null | 1 | arm 1: OraTest dye | [
5
] | 2 | [
10,
0
] | intervention 1: Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck. intervention 2: Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit. | intervention 1: Visual Examination intervention 2: OraTest | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00537199 |
[
4
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients | null | Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic | thrombopoietin, immunosuppressive therapy, eltrombopag, idiopathic thrombocytopenic purpura, blood platelet, splenectomy | null | 2 | arm 1: Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg. arm 2: Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet co... | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: SB-497115-GR 12.5mg tablet once a day intervention 2: SB-497115-GR 25mg tablet once a day intervention 3: SB-497115-GR 12.5mg matching placebo x1 or 2 tablet once a day intervention 4: SB-497115-GR 25mg tablet x2 once a day | intervention 1: SB-497115-GR 12.5mg intervention 2: SB-497115-GR 25mg intervention 3: SB-497115-GR 12.5mg matching placebo intervention 4: SB-497115-GR 50 mg | 7 | Gifu | N/A | Japan | 136.76039 | 35.42291
Hiroshima | N/A | Japan | 132.45 | 34.4
Ibaraki | N/A | Japan | 135.56828 | 34.81641
Osaka | N/A | Japan | 135.50107 | 34.69379
Osaka | N/A | Japan | 135.50107 | 34.69379
Tochigi | N/A | Japan | 139.73333 | 36.38333
Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00540423 |
[
2,
3
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents. | This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest ef... | Cannabis Dependence | Cannabis Marijuana Pharmacotherapy Adolescent | null | 1 | arm 1: All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated. | [
0
] | 1 | [
0
] | intervention 1: N-Acetylcysteine 1200 mg twice daily for four weeks | intervention 1: N-Acetylcysteine | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00542750 |
[
5
] | 56 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis. | null | Atopic Dermatitis | null | 1 | arm 1: Receive between 22 and 29 days of Cutivate lotion treatment | [
0
] | 1 | [
0
] | intervention 1: Daily applications | intervention 1: Fluticasone propionate 0.05% lotion | 10 | Poway | California | United States | -117.03586 | 32.96282
San Diego | California | United States | -117.16472 | 32.71571
Miami | Florida | United States | -80.19366 | 25.77427
Overland Park | Kansas | United States | -94.67079 | 38.98223
Eagan | Minnesota | United States | -93.16689 | 44.80413
St Louis | Missouri | Un... | 0 | NCT00546000 | |
[
3
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders. | When protein is broken down in the body, nitrogen is formed. In healthy individuals, the body combines this nitrogen with other molecules to create a harmless substance called urea, which is excreted in the urine. Patients with Urea Cycle Disorders (UCD) are unable to create as much urea from nitrogen, and therefore, t... | Urea Cycle Disorders | Buphenyl Sodium Phenylbutyrate Urea Cycle Disorder UCD | null | 1 | arm 1: Buphenyl treatment for one week was followed by dose escalation to HPN-100. Dose of Buphenyl was gradually decreased while HPN-100 dose was gradually increased until subject reached dosing of 100% HPN-100. HPN-100 at 100% of the dose was given for 1 week before subject was switched back to original Buphenyl trea... | [
1
] | 2 | [
0,
0
] | intervention 1: Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased ... | intervention 1: HPN-100 intervention 2: BUPHENYL® | 2 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00551200 |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a two-arm, double-blind, placebo-controlled study. | null | Parkinson's Disease | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2 mg/d for 14 days followed by 4 mg/d for 14 days intervention 2: Matching placebo for for 14 days followed by 4 mg/d for 14 days | intervention 1: perampanel intervention 2: placebo | 3 | New Haven | Connecticut | United States | -72.92816 | 41.30815
New Haven | Connecticut | United States | -72.92816 | 41.30815
The Woodlands | Texas | United States | -95.48938 | 30.15799 | 0 | NCT00566462 | |
[
2,
3
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one se... | Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A cycle of chronic, persistent infections with CF-related pathogens and an excessive inflammatory response progressively damages the airways and lung p... | Cystic Fibrosis | Inhaled Nitric oxide Cystic Fibrosis | null | 3 | arm 1: Subjects in the low dose cohort receive 20 part per million (ppm) of nitric oxide via nasal cannula over a 44 hour period. arm 2: Subjects in the high dose cohort receive 40 ppm of nitric oxide via nasal cannula over a 44 hour period. arm 3: 100% Nitrogen (placebo) will be administer at 20 ppm or 40 ppm via nasa... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Nitric oxide will be administered at 20 ppm via nasal cannula over a 44 hour period. intervention 2: Nitric oxide will be administered at 40 ppm via nasal cannula over a 44 hours period. intervention 3: 100% nitrogen (placebo) will be administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour per... | intervention 1: Nitric Oxide for Inhalation intervention 2: Nitric Oxide for Inhalation intervention 3: Nitrogen | 1 | Denver | Colorado | United States | -104.9847 | 39.73915 | 0 | NCT00570349 |
[
0
] | 204 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record ho... | Periodic reports are made to the IRB. | Pain Relief Adverse Events | helicopter aeromedical pain relief analgesia fentanyl morphine adverse events | null | 2 | arm 1: Morphine given to trauma patients transported by helicopter arm 2: Fentanyl given to trauma patients transported by helicopter | [
1,
1
] | 1 | [
0
] | intervention 1: either morphine 4mg IV or fentanyl 50mcg IV | intervention 1: either fentanyl or morphine | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00580489 |
[
5
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | true | The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and qua... | Postmenopausal women with vitamin D insufficiency will participate in this one-year study. We will study the change in intestinal calcium absorption from baseline (vitamin D insufficiency) to follow up (vitamin D repletion and whether increased absorption results in subsequent increased retention of calcium within bone... | Osteoporosis Osteopenia Vitamin D Deficiency Hypoparathyroidism Hypercalciuria Hypercalcemia | Calcium Absorption Intestinal Absorption of Calcium Fractional Calcium Absorption Stable Calcium Isotopes Hypovitaminosis D Vitamin D Bone Mineral Density Physical Function | null | 1 | arm 1: Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months). | [
0
] | 1 | [
0
] | intervention 1: 50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year) | intervention 1: Vitamin D | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00581828 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | true | 0ALL | true | Automobile driving is a crucial aspect of everyday life, yet vehicular crashes represent a serious public health problem. Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and financial costs to society. Most collisions involving epileptic drivers are not seizure relat... | Patients with epilepsy are at elevated risk for automobile crashes, causing great personal suffering and financial costs to society. Most collisions involving epileptic drivers are not seizure related but may instead result from cognitive effects upon driving performance of epilepsy and antiepileptic drugs (AEDs). Seve... | Cognitive Measures Driving Simulator Performance | epilepsy cognitive impairment driving simulation cross-over study | null | 2 | arm 1: Phenytoin administration arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Phenytoin will be dosed to a target dose of 5 mg/kg qhs for one month intervention 2: Placebo | intervention 1: Phenytoin intervention 2: Placebo oral capsule | 1 | Iowa City | Iowa | United States | -91.53017 | 41.66113 | 0 | NCT00581893 |
[
0
] | 141 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes.
The pr... | Patients will then receive, in a randomized double-blinded fashion, levalbuterol, 1.25mg every 20 minutes for a total of 3 aerosolized doses combined with ipratropium, 0.5mg every 20 minutes for a total of 3 aerosolized doses. The medication will be premixed by the pharmacy in a total of 3 ml of normal saline and the n... | Asthma | Asthma Bronchodilators Levalbuterol Ipratropium | null | 2 | arm 1: levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline) arm 2: ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses | [
1,
0
] | 1 | [
0
] | intervention 1: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses | intervention 1: ipratropium | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00583778 |
[
3
] | 53 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | To determine the safety and tolerability of Arformoterol Tartrate in children with asthma | A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age w... | Asthma | Asthma Respiratory Tract Diseases | null | 2 | arm 1: Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.
Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per neb... | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). intervention 2: Levalbuterol... | intervention 1: arformoterol intervention 2: levalbuterol | 14 | Beverly Hills | California | United States | -118.40036 | 34.07362
Orange | California | United States | -117.85311 | 33.78779
Savannah | Georgia | United States | -81.09983 | 32.08354
Normal | Illinois | United States | -88.99063 | 40.5142
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Oklahoma City |... | 0 | NCT00583947 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.
Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynam... | null | Heart Failure | null | 1 | arm 1: All randomized patients receive drug. | [
0
] | 1 | [
0
] | intervention 1: 10-minute infusion | intervention 1: levosimendan | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00585104 | |
[
5
] | 36 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime ... | null | ADHD Attention Deficit Hyperactivity Disorder | ADHD Attention Deficit Hyperactivity Disorder Daytrana MTS Patch Methylphenidate Transdermal System | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses) intervention 2: Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses) | intervention 1: Methylphenidate Transdermal System intervention 2: Placebo | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00586157 |
[
0
] | 36 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by the abnormal QT response to exercise testing (f... | null | Long QT Syndrome Cardiac Repolarization | QT interval beta-blocker exercise electrocardiogram repolarizaton | null | 2 | arm 1: Subjects are assigned to placebo. arm 2: Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test. | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Placebo will be given 1 pill daily for a week, then 2 pills daily, followed by the exercise test. intervention 2: Subjects will receive propranolol LA 80 mg one pill daily for 1 week then 2 pills daily for 1 week followed by exercise test. | intervention 1: Placebo intervention 2: Propranolol LA | 0 | null | 0 | NCT00588965 |
[
2,
3
] | 9 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | true | The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement... | This protocol is investigating novel pharmaceutical agents (Phenylbutyrate and Genistein), which are aimed at improving the physiologic function of mutant Cystic Fibrosis Transmembrane conductance Regulator (CFTR). CFTR is absent or dysfunctional in cystic fibrosis. Nasal epithelial CFTR function will be assessed by th... | Cystic Fibrosis | null | 2 | arm 1: The standard oral adult dose is 20 g/day for 4 days.
Every participant will receive Genistein during the NPD. arm 2: The placebo is given to match the active comparator for 4 days. Every participant will receive Genistein. | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: The standard oral adult dose is 20 g/day (tablets) for 4 days. intervention 2: Every participant will be administered a perfusion of 50 MicroM of Genistein (Unconjugated Isoflavones 100) during the modified NPD procedure. intervention 3: The placebo is given to match the active comparator for four days. | intervention 1: Sodium 4-Phenylbutyrate intervention 2: Genistein (Unconjugated Isoflavones 100) intervention 3: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00590538 | |
[
3
] | 19 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate | null | Essential Tremor | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: Dose 1 intervention 2: Dose 2 intervention 3: Dose 3 | intervention 1: Sodium Oxybate intervention 2: Sodium Oxybate intervention 3: Placebo | 1 | Bingham Farms | Michigan | United States | -83.27326 | 42.51587 | 0 | NCT00598078 | |
[
4
] | 381 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease | This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease | Early Stage Parkinson's Disease | Rotigotine Neupro® | null | 1 | arm 1: Rotigotine | [
0
] | 1 | [
0
] | intervention 1: Rotigotine trans-dermal patches, once daily:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);
Optimal dosing:
During the first year: The maximum Rotigotin... | intervention 1: Rotigotine | 63 | Concord | N/A | Australia | 151.10381 | -33.84722
Darlinghurst | N/A | Australia | 151.21925 | -33.87939
East Gosford | N/A | Australia | 151.35338 | -33.43874
Westmead | N/A | Australia | 150.98768 | -33.80383
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Vienna | N/A | Austria | 16.37208 | 48.20849
Brussels | N/A |... | 0 | NCT00599196 |
[
4
] | 1,067 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris. | This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female s... | Acne Vulgaris | Acne Vulgaris Adapalene | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Vehicle will be applied topically to the face, once a day, for 12 weeks | intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle | 34 | San Diego | California | United States | -117.16472 | 32.71571
Vista | California | United States | -117.24254 | 33.20004
Denver | Colorado | United States | -104.9847 | 39.73915
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Pinellas Park | Florida | United States | -82.69954 | 27.8428
Champaign | Illin... | 0 | NCT00599521 |
[
0
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study will evaluate the effectiveness of adding guided self-help group therapy to a weight loss program in achieving weight loss and reducing binge eating in overweight binge eaters. | Binge eating disorder is one of the most common eating disorders, with more than 4 million Americans affected. Following a binge eating episode, in which a person eats an excessive amount of food in a short period of time, the person often experiences feelings of guilt, depression, embarrassment, and disgust. Beyond th... | Overweight Eating Disorders | Binge Eating Orlistat Alli Guided Self-Help | null | 2 | arm 1: Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy arm 2: Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone | [
0,
1
] | 2 | [
5,
0
] | intervention 1: Emotion regulation guided self-help group therapy involves twelve 2-hour sessions of guided self-help group psychotherapy. intervention 2: The orlistat/alli program involves taking 60 mg orlistat three times a day and participating in the alli program, a comprehensive behavioral weight loss program with... | intervention 1: Emotion regulation group therapy intervention 2: Orlistat/alli program | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00601354 |
[
0
] | 23 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 1FEMALE | true | Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), whi... | null | Anorexia Nervosa | eating disorders anorexia nervosa anorexia PET brain imaging serotonin fMRI Prozac fluoxetine | null | 1 | arm 1: Participants recovered from anorexia nervosa before and after administration of fluoxetine | [
0
] | 1 | [
0
] | intervention 1: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day. | intervention 1: Fluoxetine | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00603018 |
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