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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
5
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Participants (n=20) will be identified at routine care visits performed at the Rochester Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity muscle group. Participants will be seen at s... | This is a randomized, placebo controlled, double-blind, parallel group trial of memantine in patients with MS and spasticity. Participants will be identified at routine care visits at the Rochester Multiple Sclerosis Center. After obtaining informed consent, patients will undergo screening, which will include a physica... | Multiple Sclerosis | multiple sclerosis | null | 2 | arm 1: Memantine 10 mg bid arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: matched tablets bid intervention 2: 10 mg bid | intervention 1: placebo intervention 2: memantine | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00638027 |
[
3
] | 421 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN) | This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximatel... | Neuropathy, Diabetic | Peripheral Diabetic Neuropathy (PDN) Neuropathic Pain | null | 5 | arm 1: Placebo arm 2: Pregabalin 300mg/day (positive control), maintenance treatment 14 weeks arm 3: gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks arm 4: gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks arm 5: gabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks | [
2,
5,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: placebo intervention 2: gabapentin enacarbil 1200mg/day intervention 3: gabapentin enacarbil 2400mg/day intervention 4: gabapentin enacarbil 3600mg/day intervention 5: pregabalin 300mg/day | intervention 1: Placebo intervention 2: GEn 1200mg/day intervention 3: GEn 2400mg/day intervention 4: GEn 3600mg/day intervention 5: Pregabalin | 90 | Alabaster | Alabama | United States | -86.81638 | 33.24428
Birmingham | Alabama | United States | -86.80249 | 33.52066
Dothan | Alabama | United States | -85.39049 | 31.22323
Hoover | Alabama | United States | -86.81138 | 33.40539
Jasper | Alabama | United States | -87.27751 | 33.83122
Muscle Shoals | Alabama | United ... | 0 | NCT00643760 |
[
2
] | 25 | RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents | Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients. | Nerve Pain | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Oral, 75mg or 150mg capsules, BID intervention 2: Oral, matched capsules, BID | intervention 1: Pregabalin (Lyrica) intervention 2: Placebo | 5 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Sarnia | Ontario | Canada | -82.40407 | 42.97866
Jönköping | N/A | Sweden | 14.15618 | 57.78145
Linköping | N/A | Sweden | 15.62157 | 58.41086 | 0 | NCT00654940 | |
[
4
] | 339 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching place... | null | Erectile Dysfunction | Erectile Dysfunction | null | 2 | arm 1: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. arm 2: Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT) intervention 2: Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet | intervention 1: Vardenafil ODT (STAXYN, BAY38-9456) intervention 2: Placebo | 40 | Chandler | Arizona | United States | -111.84125 | 33.30616
Mesa | Arizona | United States | -111.82264 | 33.42227
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -... | 0 | NCT00655629 |
[
4
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI). | This is a randomized, placebo-controlled, double-blind withdrawal, multicenter study to evaluate the effectiveness of pancrelipase MT capsules compared with placebo in the treatment of adult (\>18 to 60 years of age) and children/adolescent (7 to \<18 years of age) patients with CF and who require pancreatic enzyme rep... | Exocrine Pancreatic Insufficiency Steatorrhea Malabsorption Syndromes Cystic Fibrosis | Exocrine pancreatic insufficiency Steatorrhea Malabsorption syndromes Cystic fibrosis Pediatrics Adult Pancrelipase | null | 2 | arm 1: Pancrease MT 10.5 or MT 21 Pancrease MT capsules for maximum dose of 10 000 lipase units / Kg / day arm 2: Placebo for Pancrease MT 10.5 or MT 21 Capsules with Pancrease MT excipients without the active enzymes | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Pancrease MT capsules for maximum dose of 10,000 lipase units / Kg / day intervention 2: Capsules with Pancrease MT excipients without the active enzymes | intervention 1: Pancrease MT 10.5, or MT 21 intervention 2: Placebo for Pancrease MT 10.5 or MT 21 | 11 | Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Orlando | Florida | United States | -81.37924 | 28.53834
Louisville | Kentucky | United States | -85.75941 | 38.25424
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Long Branch | ... | 0 | NCT00662675 |
[
3,
4
] | 140 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia | POPULATION:
Subjects with mixed dyslipidemia (non-HDL cholesterol \> 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label ex... | Dyslipidemia | LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol LDL cholesterol Atorvastatin Fenofibrate | null | 1 | arm 1: Open-label LCP-AtorFen | [
0
] | 1 | [
0
] | intervention 1: All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals. | intervention 1: LCP-AtorFen | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00664859 |
[
3
] | 134 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma. | During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of ... | Asthma | null | 2 | arm 1: mometasone arm 2: montelukast followed by placebo; or placebo followed by montelukast. | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks) intervention 2: montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks) intervention 3: Placebo (Placebo once-daily, for approximately 2 weeks) | intervention 1: Comparator: mometasone intervention 2: Comparator: montelukast intervention 3: Comparator: placebo (unspecified) | 0 | null | 0 | NCT00666679 | |
[
4
] | 877 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram. | null | Major Depressive Disorder | Depression Major Depressive Disorder Escitalopram | null | 3 | arm 1: Escitalopram low dose arm 2: Escitalopram high dose arm 3: Placebo | [
1,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Escitalopram low dose, oral administration, once daily dosing for 8 weeks. intervention 2: Placebo, oral administration, once daily dosing for 8 weeks intervention 3: Escitalopram high dose, oral administration, once daily dosing for 8 weeks | intervention 1: Escitalopram intervention 2: Placebo intervention 3: Escitalopram | 45 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Arcadia | California | United States | -118.03534 | 34.13973
Encino | California | United States | -118.50119 | 34.15917
Garden Grove | California | United States | -117.94145 | 33.77391
Irvine | California | United States | -117.82311 | 33.66946
Los Alamitos | ... | 0 | NCT00668525 |
[
5
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time. | The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant b... | Periodontitis | chronic periodontitis, antibiotic resistance | null | 2 | arm 1: Minocycline HCl microspheres arm 2: No drug intervention | [
0,
4
] | 1 | [
0
] | intervention 1: At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm. | intervention 1: Minocycline HCl microspheres | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00668746 |
[
0
] | 8 | NON_RANDOMIZED | SINGLE_GROUP | 9OTHER | 1SINGLE | true | 1FEMALE | false | The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women w... | null | Healthy | menses women healthy controls Healthy females with regular menstrual cycles | null | 3 | arm 1: Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle. arm 2: Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle. arm 3: Fluoxetine will be administered twice to each ... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant. intervention 2: Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant. intervention 3: Progesterone 800 mg by mouth will be administered to each participant on... | intervention 1: Fluoxetine intervention 2: Zolpidem intervention 3: Progesterone | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00676026 |
[
4
] | 93 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone | null | Type 2 Diabetes | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, 5mg, once daily, 4 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 4 weeks | intervention 1: Saxagliptin intervention 2: Placebo | 27 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Escondido | California | United States | -117.08642 | 33.11921
Irvine | California | United States | -117.82311 | 33.66946
Redlands | California | United States | -117.18254 | 34.05557
Santa Ana | California | United States | -117.86783 | 33.74557
Tustin | Calif... | 0 | NCT00683657 | |
[
2,
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet | Patients will be initially deemed eligible for study consideration if, after MGH ED nursing triage, an X-ray is ordered for suspected isolated extremity injury and the triage acuity level is "Minor". Study staff (physicians) will monitor the ED registration and triage areas to assess whether triaged patients are potent... | Pain, Fracture, Sprain | Emergency Department acute | null | 2 | arm 1: Intervention Group:
Subject receives:
1. placebo oral/swallowed pill
2. Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet arm 2: Active Comparator Group:
Subject receives:
1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill
2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving tr... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Fentanyl rapid dissolving tablet 100mcg intervention 2: lansoprazole 15mg rapidly dissolving tablet intervention 3: Oxycodone 5/325 mg tablet | intervention 1: Fentanyl intervention 2: Lansoprazole intervention 3: Oxycodone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00685295 |
[
4
] | 459 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulg... | Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075) | Severe Acne Vulgaris | Acne | null | 2 | arm 1: Adapalene-BPO + Doxycyline arm 2: Vehicle + Doxycycline | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks. intervention 2: Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 1... | intervention 1: Adapalene BPO Gel associated with Doxycyline Hyclate intervention 2: Vehicle Gel associated with Doxycycline Hyclate | 34 | Oceanside | California | United States | -117.37948 | 33.19587
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Longmont | Colorado | United States | -105.10193 | 40.16721
Miami | Florida | United States | -80.19366 | 25.77427
Snellville | Georgia |... | 0 | NCT00688064 |
[
3
] | 360 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD). | null | Pulmonary Disease, Chronic Obstructive | null | 4 | arm 1: BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 2: BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 3: BI 1744 CL high dose plu... | [
0,
0,
0,
0
] | 3 | [
0,
0,
1
] | intervention 1: BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 2: tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 3: None | intervention 1: BI 1744 CL/tiotropium bromide fixed dose combination intervention 2: tiotropium bromide intervention 3: Respimat® Inhaler | 37 | Riverside | California | United States | -117.39616 | 33.95335
San Diego | California | United States | -117.16472 | 32.71571
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Clearwater | Florida | United States | -82.8001 | 27.96585
DeLand | Florida | United States | -81.30312 | 29.02832
Tampa | Florida |... | 0 | NCT00696020 | |
[
2
] | 76 | RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 3TRIPLE | true | 2MALE | false | This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline. | This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healt... | Healthy | healthy weight gain anti-psychotic risperidone mifepristone mitigation weight loss | null | 3 | arm 1: risperidone plus mifepristone daily for 28 days arm 2: risperidone plus mifepristone-matched placebo daily for 28 days arm 3: risperidone-matched placebo plus mifepristone daily for 28 days | [
0,
2,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: risperidone daily for 28 days intervention 2: mifepristone daily for 28 days intervention 3: risperidone-matched placebo daily for 28 days intervention 4: mifepristone-matched placebo daily for 28 days | intervention 1: Risperidone intervention 2: Mifepristone intervention 3: Risperidone-matched placebo intervention 4: Mifepristone-matched placebo | 1 | Mumbai | N/A | India | 72.88261 | 19.07283 | 0 | NCT00698022 |
[
2,
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with... | null | Type 2 Diabetes Mellitus | Diabetes TA-7284 | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days) intervention 2: Patients will receive placebo tablets in each step, once daily, 15 days (1 day follo... | intervention 1: TA-7284 intervention 2: Placebo of TA-7284 | 1 | Hachiōji | Tokyo-to | Japan | 139.32389 | 35.65583 | 0 | NCT00707954 |
[
3
] | 141 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD). | null | Pulmonary Disease, Chronic Obstructive | null | 2 | arm 1: BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 2: BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation | [
0,
0
] | 2 | [
0,
1
] | intervention 1: BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 2: None | intervention 1: BI 1744 CL plus tiotropium bromide intervention 2: Respimat® Inhaler | 24 | Clearwater | Florida | United States | -82.8001 | 27.96585
Tampa | Florida | United States | -82.45843 | 27.94752
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Killeen | Texas | United States | -97.7278 | 31.11712
Spokane | Washington | United States | -117.42908 | 47.65966
Brussels | N/A | Belgium... | 0 | NCT00720499 | |
[
3
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this pilot study is to compare the effects (effectiveness and safety)of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]) with a placebo nasal spray for the treatment of irritant (non-allergic) rhinitis. | null | Rhinitis, Allergic, Perennial | Adolescents Irritant(non-allergic)rhinitis Adults GW685698 Air Pollution | null | 2 | arm 1: Fluticasone Furoate Nasal Spray 110mcg intranasally once daily arm 2: Matching placebo nasal spray intranasally once daily | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Fluticasone furoate nasal spray 110mcg intranasally once daily for 4 weeks intervention 2: Matching placebo nasal spray intranasally once daily for 4 weeks | intervention 1: Fluticasone Furoate Nasal Spray intervention 2: Placebo Nasal Spray | 5 | Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Chiang Mai | N/A | Thailand | 98.98468 | 18.79038
Khon Kaen | N/A | Thailand | 102.833 | 16.44671 | 0 | NCT00730756 |
[
4
] | 457 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder. | Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.
Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitmen... | Generalized Anxiety Disorder | Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy | null | 3 | arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks. arm 3: Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks. | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Vortioxetine placebo-matching capsules | intervention 1: Vortioxetine intervention 2: Placebo | 40 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anaheim | California | United States | -117.9145 | 33.83529
Cerritos | California | United States | -118.06479 | 33.85835
Costa Mesa | California | United States | -117.91867 | 33.64113
Orange | California | United States | -117.85311 | 33.78779
Redlands | Cal... | 0 | NCT00731120 |
[
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to assess the safety and efficacy of a single dosage strength of GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD). | null | Pulmonary Disease, Chronic Obstructive | Chronic Obstructive Pulmonary Disease Novel Dry Powder Inhaler Chronic Obstructive Pulmonary Disease (COPD) GW685698/GW642444 | null | 0 | null | null | 1 | [
0
] | intervention 1: GW685698/GW642444 | intervention 1: GW685698/GW642444 | 9 | Bergen | N/A | Norway | 5.32415 | 60.39299
Elverum | N/A | Norway | 11.56231 | 60.88191
Fredrikstad | N/A | Norway | 10.9298 | 59.2181
Sandvika | N/A | Norway | 13.59125 | 64.46377
Trondheim | N/A | Norway | 10.39506 | 63.43049
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Luleå | N/A | Sweden | 22.15465 | 65.58415
L... | 0 | NCT00731822 |
[
4
] | 255 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses. | null | Actinic Keratoses | Peplin Actinic keratosis PEP005 | null | 2 | arm 1: PEP005 (ingenol mebutate) Gel arm 2: Vehicle gel | [
1,
2
] | 2 | [
0,
0
] | intervention 1: two day treatment intervention 2: two day treatment | intervention 1: PEP005 (ingenol mebutate) Gel intervention 2: Vehicle gel | 20 | Mesa | Arizona | United States | -111.82264 | 33.42227
Denver | Colorado | United States | -104.9847 | 39.73915
Kissimmee | Florida | United States | -81.41667 | 28.30468
Orange Park | Florida | United States | -81.70648 | 30.16607
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Newnan | Georgia | United ... | 0 | NCT00742391 |
[
4
] | 204 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | false | Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs. | Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital st... | Hemorrhoids | hemorrhoids | null | 2 | arm 1: 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. arm 2: 300 mg SKY0402 in a 40-m... | [
1,
5
] | 2 | [
0,
0
] | intervention 1: 100 mg Bupivacaine HCl intervention 2: Single administration 300 mg SKY0402 in a 40-mL injection volume | intervention 1: Bupivacaine HCl intervention 2: SKY0402 | 20 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Montgomery | Alabama | United States | -86.29997 | 32.36681
Pasadena | California | United States | -118.14452 | 34.14778
San Clemente | California | United States | -117.61199 | 33.42697
San Diego | California | United States | -117.16472 | 32.71571
Orlando |... | 0 | NCT00744848 |
[
4
] | 245 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | false | The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty. | The primary objective is to demonstrate the superiority of SKY0402, compared with bupivacaine HC1, with respect to the extent and duration of the analgesic effect achieved by a single intraoperative administration of the study drug via local infiltration in subjects undergoing total knee arthroplasty (TKA).
The second... | Postoperative Pain | Total knee arthroplasty Pain Analgesia | null | 2 | arm 1: Single dose of 200 mg bupivacaine HCl administered intraoperatively via local infiltration arm 2: Single dose of 600 mg SKY0402 (study drug) administered intraoperatively via local infiltration | [
1,
5
] | 2 | [
0,
0
] | intervention 1: 200 mg bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug). | intervention 1: Bupivacaine HCl intervention 2: SKY0402 | 19 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Sun City West | Arizona | United States | -112.34127 | 33.66198
La Jolla | California | United States | -117.2742 | 32.84727
Laguna Hills | Cali... | 0 | NCT00745290 |
[
4
] | 427 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder. | null | Excessive Sleepiness | null | 3 | arm 1: armodafinil - dosage of 50 mg/day arm 2: armodafinil - dosage of 150 mg/day arm 3: matching placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 50 mg/day orally, once daily in the morning for 3 days intervention 2: 150 mg/day orally, once daily in the morning for 3 days intervention 3: placebo tablets, once daily in the morning for 3 days | intervention 1: armodafinil intervention 2: armodafinil intervention 3: placebo | 4 | Atlanta | Georgia | United States | -84.38798 | 33.749
Crestview | Kentucky | United States | -84.41744 | 39.02534
New York | New York | United States | -74.00597 | 40.71427
Columbia | South Carolina | United States | -81.03481 | 34.00071 | 0 | NCT00758498 | |
[
3
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A national, prospective single arm phase II study investigating the pharmacokinetics and safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be enrolled. | null | Secondarily Infected Traumatic Lesions (SITL) Impetigo | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Application 3 times daily for 7 days | intervention 1: 2% TD1414 Cream | 1 | College Station | Texas | United States | -96.33441 | 30.62798 | 0 | NCT00758862 | |
[
3
] | 86 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes. | null | Type 2 Diabetes Mellitus | null | 4 | arm 1: Microcrystaline cellulose once daily arm 2: Pioglitazone 45 mg once daily arm 3: MSDC-0160 90 mg once daily arm 4: MSDC-0160 220 mg once daily | [
2,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Once daily, oral intervention 2: Once daily, oral intervention 3: Once daily, oral intervention 4: Once daily, oral | intervention 1: Placebo intervention 2: Pioglitazone intervention 3: MSDC-0160 90 mg intervention 4: MSDC-0160 220 mg | 8 | Los Angeles | California | United States | -118.24368 | 34.05223
Miami Gardens | Florida | United States | -80.2456 | 25.94204
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Greenville | South Carolina | United States | -82.39401 | 34.85262
D... | 0 | NCT00760578 | |
[
0
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused stimulants in the past. Daytrana® is a stimulant medication that has been approved by the Food and Drug Administration for the treatment of ADH... | Methylphenidate and amphetamines are considered to be the first line of treatment for ADHD in children (Biederman et al, 1997). Although treating children and adolescents with stimulants does not appear to increase the risk of substance use disorders (Wilens et al, 2003), little is known about the abuse of prescription... | Adult Attention Deficit Hyperactivity Disorder (ADHD) | Attention Deficit Hyperactivity ADHD | null | 1 | arm 1: Methylphenidate patch | [
5
] | 1 | [
0
] | intervention 1: Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is ... | intervention 1: Daytrana (methylphenidate patch) | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00780208 |
[
5
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will examine whether combined use of an antidepressant medication and the medication nimodipine reduces risk of depression relapse in patients with vascular depression. | Depressed elderly patients often show signs of cerebrovascular disease, commonly known as a stroke. Some scientists theorize that having cerebrovascular disease may affect depression in older adults in one of three ways: by causing depression, by making it more likely that people who have been depressed have a relapse,... | Depression | Depressive Disorder, Major Cerebrovascular Disorders Risk Factors Nimodipine | null | 1 | arm 1: In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo. | [
5
] | 2 | [
0,
0
] | intervention 1: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be main... | intervention 1: Nimodipine intervention 2: Placebo | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00781326 |
[
4
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when ... | null | Multiple Sclerosis | Multiple Sclerosis - Relapsing | null | 1 | arm 1: Avonex 30 mcg given subcutaneously, once weekly, for 18 months. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: BG9418 (interferon beta 1-a) | 2 | Detroit | Michigan | United States | -83.04575 | 42.33143
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00784836 |
[
4
] | 707 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR. | This is a randomized, double blind, placebo controlled, parallel group, multicenter study to demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was... | Seasonal Allergic Rhinitis | SAR | null | 3 | arm 1: 80 mcg Ciclesonide once daily arm 2: 160 mcg Ciclesonide once daily arm 3: Placebo once daily | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril) intervention 2: 160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril) intervention 3: Placebo HFA Inhaler once daily (one actuation per nostril) | intervention 1: 80 mcg Ciclesonide intervention 2: 160 mcg Ciclesonide intervention 3: Placebo | 4 | Austin | Texas | United States | -97.74306 | 30.26715
Kerrville | Texas | United States | -99.14032 | 30.04743
New Braunfels | Texas | United States | -98.12445 | 29.703
San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00790023 |
[
3
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive. | null | Acute Otitis Media | azithromycin, pharmacokinetics, pediatrics | null | 2 | arm 1: 60 mg/kg azithromycin ER (Extended Release)arm arm 2: 30 mg/kg azithromycin IR (Immediate Release) arm | [
1,
1
] | 2 | [
0,
0
] | intervention 1: subjects taken 60 mg/kg azithromycin ER intervention 2: subjects taken 30 mg/kg azithromycin IR (Immediate Release) | intervention 1: 60 mg/kg azithromycin ER intervention 2: 30 mg/kg azithromycin IR | 2 | San José | Provincia de San José | Costa Rica | -84.08489 | 9.93388
San José | Provincia de San José | Costa Rica | -84.08489 | 9.93388 | 0 | NCT00796224 |
[
3,
4
] | 231 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit | null | Bladder, Neurogenic | tamsulosin pediatric neurogenic bladder | null | 4 | arm 1: Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 2: Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks arm 3: Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened c... | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Oral intervention 2: Oral | intervention 1: tamsulosin hydrochloride intervention 2: Placebo | 52 | Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
St Louis | Missouri | United States | -90.19789 | 38.62727
Buffalo | New York | United States | -78.87837 | 42.88645
Tarrytown | New York | United States | -73.85875 | 41.07621
Winston-Salem | North C... | 0 | NCT00796614 |
[
0
] | 100 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 1FEMALE | false | It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local ... | The female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak aro... | Pharyngitis | lidocaine tetracaine tracheal intubation pharyngitis | null | 4 | arm 1: air was used to inflate the cuff. arm 2: Normal saline was used to inflate the cuff. arm 3: 2% lidocaine was used to inflate the cuff. arm 4: 1% tetracaine was used to inflate the cuff. | [
2,
2,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume intervention 2: Air injected into the cuff to seal the space between the trachea and the tube at minimal volume intervention 3: tetracaine: 1%, injected into the cuff to seal the space between the ... | intervention 1: 2% lidocaine intervention 2: placebo intervention 3: 1% tetracaine intervention 4: N.S | 1 | Chengdu | Sichuan | China | 104.06667 | 30.66667 | 0 | NCT00798018 |
[
5
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older. | null | Bacterial Conjunctivitis | Bacterial Conjunctivitis | null | 2 | arm 1: Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL) arm 2: Balanced Salt Solution | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Moxifloxacin 5mg/mL 3 times daily for 7 days intervention 2: Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days | intervention 1: Vigamox Ophthalmic Solution intervention 2: BSS placebo | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00798577 |
[
3
] | 53 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and pseudoephedrine compared to placebo (medication with no active ingredients) in participants with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen, dust or animal hair). | This is a randomized (the study drug is assigned by chance), single-dose, single-blind (a clinical trial in which the person giving the treatment, but not the participant, knows which treatment the participant is receiving), double-dummy, placebo-controlled, three-treatment period, cross-over (participants may receive ... | Allergic Rhinitis | Allergy Rhinitis Allergic Rhinitis JNJ-39220675 Pseudoephedrine | null | 6 | arm 1: Single-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudo... | [
0,
0,
0,
0,
0,
0
] | 3 | [
10,
0,
0
] | intervention 1: Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods. intervention 2: Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods. intervention 3:... | intervention 1: Placebo intervention 2: JNJ-39220675 intervention 3: Pseudoephedrine | 1 | Mississauga | Ontario | Canada | -79.6583 | 43.5789 | 0 | NCT00804687 |
[
3
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To review safety and effectiveness of two doses compared to current standard of care. | Evaluate the efficacy of intercostal nerve block using SKY0402 compared to epidural bupivacaine HCl in subjects undergoing posterolateral thoracotomy. The primary outcome metric for this will be the amount of rescue PCA fentanyl administered for breakthrough pain during the first 72 hours. | Postoperative Pain | Pain postoperative thoracotomy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal) intervention 2: Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of thr... | intervention 1: Low Dose SKY0402 intervention 2: High Dose SKY0402 intervention 3: Placebo intervention 4: Fentanyl via PCA intervention 5: Bupivacaine via epidural | 5 | Pasadena | California | United States | -118.14452 | 34.14778
Orlando | Florida | United States | -81.37924 | 28.53834
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Tacoma | Washington | United States | -122.44429 | 47.25288 | 0 | NCT00807209 |
[
4
] | 506 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone | null | Seasonal Allergic Rhinitis | null | 2 | arm 1: Placebo arm 2: 0.15% azelastine hydrochloride | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride 822 mcg | intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride | 7 | Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715
New Braunfels | Texas | United States | -98.12445 | 29.703
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States... | 0 | NCT00824473 | |
[
5
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered. | No additional details provided | Acute Decompensated Heart Failure | Natriuretic peptides BNP Heart Failure Nitoglycerin Biomarkers | null | 2 | arm 1: Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. arm 2: Nitroglycerin was initiated at 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP\<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Bolus 2 mcg/kg followed by 0.01 mcg/kg/min intervention 2: 5-10 mcg/min titrating per protocol based on blood pressure | intervention 1: Nesiritide intervention 2: Nitroglycerin | 1 | Inglewood | California | United States | -118.35313 | 33.96168 | 0 | NCT00842023 |
[
0
] | 10 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | false | 0ALL | false | Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by reactive oxygen species produced by the metabolism of most nutrients, including glucose. Glutathione is a small peptide made ... | Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:
* in the hyper-glycemic range (200-250 mg/dL) on one study day, and
* near normoglycemia (80-140 mg/dL) ... | Diabetes Mellitus, Type 1 | Glutathione | null | 2 | arm 1: 80-140 mg/dL arm 2: 200-250 mg/dL | [
0,
0
] | 2 | [
10,
0
] | intervention 1: L-\[3,3-2H2\]cysteine intervention 2: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies | intervention 1: Cysteine isotope infusion at normoglycemia vs hyperglycemia intervention 2: Regular Insulin | 1 | Jacksonville | Florida | United States | -81.65565 | 30.33218 | 0 | NCT00858897 |
[
5
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment ... | A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turn... | Prostate Cancer | Non-metastatic | null | 2 | arm 1: 35 mg by mouth every week as directed arm 2: Calcium and vitamin D | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 35 mg/week by mouth intervention 2: One tablet by mouth every week as directed | intervention 1: risedronate intervention 2: Placebo risedronate oral tablet | 1 | Farmington | Connecticut | United States | -72.83204 | 41.71982 | 0 | NCT00859027 |
[
5
] | 64 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery. | null | Cataract | Cataract | null | 1 | arm 1: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops | [
0
] | 1 | [
0
] | intervention 1: 1 drop every 6 hours into the study eye | intervention 1: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00870103 |
[
4
] | 116 | RANDOMIZED | CROSSOVER | null | 2DOUBLE | true | 0ALL | false | Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-bli... | null | Blood Pressure Human Experimentation | null | 2 | arm 1: Phenylephrine HCl Extended Release tablets 30 mg arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days. intervention 2: Placebo taken twice daily (12 hours apart) for 7 days. | intervention 1: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg intervention 2: Placebo | 0 | null | 0 | NCT00874120 | |
[
2
] | 14 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | true | This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated. | null | Partial Epilepsy | Partial Epilepsy Eslicarbazepine acetate Pharmacokinetics Tolerability | null | 2 | arm 1: Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9 arm 2: Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9 | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9 intervention 2: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9) | intervention 1: Eslicarbazepine acetate intervention 2: Oxcarbazepine | 1 | Antwerp | N/A | Belgium | 4.40026 | 51.22047 | 0 | NCT00900237 |
[
5
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performanc... | At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'ma... | Overactive Bladder Syndrome | Bladder Urinary Urgency Solifenacin Vesicare(R) | null | 1 | arm 1: The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days. | [
0
] | 1 | [
0
] | intervention 1: Participants take 10mg daily solifenacin succinate for 30 days | intervention 1: Solifenacin Succinate | 1 | Maywood | Illinois | United States | -87.84312 | 41.8792 | 0 | NCT00909428 |
[
0
] | 23 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug ap... | This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (\>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve ba... | Parkinson's Disease | parkinsons disease falling | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: donepezil, 5 mg, capsule, once a day, 3 weeks intervention 2: sugar pill, one capsule, once a day, 3 weeks | intervention 1: Donepezil intervention 2: Sugar Pill (placebo) | 0 | null | 0 | NCT00912808 |
[
0
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study doctor will give EVOLENCE® mixed with Lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles.
The product being used in this study is EVOLENCE®, which is currently marketed in the United States for the cosmetic correction of soft tissu... | The aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of EVOLENCE® while achieving cosmetic correction. | Aging Pain | wrinkles dermal filler collagen soft tissue augmentation lidocaine aesthetic | null | 2 | arm 1: Assess injection pain severity for a one time 1.0 mL injection of Evolence with 0.2 ml of topical anesthetic, applied 30 minutes prior to injection, to the left nasolabial fold of each participant . arm 2: Assess injection pain severity for a one time 1.0 mL injection of Evolence mixed with 0.18 mL of 2% lidocai... | [
0,
0
] | 3 | [
1,
1,
0
] | intervention 1: Injectable collagen intervention 2: admix anesthetic intervention 3: None | intervention 1: Evolence intervention 2: Lidocaine intervention 3: topical anesthetic | 1 | Bradenton | Florida | United States | -82.57482 | 27.49893 | 0 | NCT00929071 |
[
5
] | 99 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12. | This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galant... | Alzheimer's Disease | Alzheimer's disease Galantamine Dementia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day. | intervention 1: Galantamine | 0 | null | 0 | NCT01054976 |
[
5
] | 103 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narc... | This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-... | Pain; Cancer | Pain; Cancer TTS-Fentanyl D-trans Durogesic D-trans | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr. | intervention 1: Fentanyl D-trans | 0 | null | 0 | NCT01060124 |
[
4
] | 223 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison... | null | Transplantation Infection | immunosuppression kidney transplantation everolimus safety | null | 2 | arm 1: Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the mo... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range. intervention 2: The dose of cyclosporine for each... | intervention 1: Everolimus 0.25 and 0.75 mg tablets intervention 2: Cyclosporine very low dose (150-300 ng/mL) microemulsion intervention 3: Cyclosporine low dose (350-500 ng/mL) microemulsion | 0 | null | 0 | NCT01276457 |
[
3
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | The goal of this study is to determine whether a study medication (d-cycloserine) improves the ability of older adults to perform on tests of neuropsychological functioning. Tests of neuropsychological functioning assess attention, memory, and executive functioning skills (for example, problem-solving, planning and org... | Accumulating data support the augmenting effects of d-cycloserine (DCS) when combined with exposure-based treatment for anxiety disorders. Additional research is needed to determine whether DCS facilitates other forms of cognitive processing (e.g., attention, memory, executive functioning) that are involved in cognitiv... | Treatment Placebo | d-cycloserine geriatric neuropsychology cognition cognitive-enhancer aging neuropsychological functioning | null | 2 | arm 1: 250 mg d-cycloserine arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: single oral administration of 250 mg d-cycloserine intervention 2: Single oral administration 250 mg Sugar Pill | intervention 1: d-cycloserine intervention 2: Sugar Pill | 1 | Hartford | Connecticut | United States | -72.68509 | 41.76371 | 0 | NCT01361633 |
[
2
] | 46 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option. | null | Advanced Non-Hematologic Malignancies | non-hematologic cancer advanced solid tumors prostrate cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: CP-751,871 was given intravenously \[IV\] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.
Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year)... | intervention 1: CP-751,871 intervention 2: Docetaxel | 1 | Sutton | Surrey | United Kingdom | -0.2 | 51.35 | 0 | NCT01653158 |
[
5
] | 80 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizop... | This is an open-label (all people know the identity of the intervention), longitudinal (participants are followed over time with continuous or repeated monitoring of risk factors or health-outcomes), non-randomized (a clinical trial in which the participants are not assigned by chance to different treatment groups), si... | Schizophrenia Schizophreniform Disorder Schizoaffective Disorder | Schizophrenia Schizophreniform Disorder Schizoaffective Disorder Risperidone Risperdal consta | null | 1 | arm 1: Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion. | [
0
] | 1 | [
0
] | intervention 1: Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion. | intervention 1: Risperidone | 0 | null | 0 | NCT01855074 |
[
4
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks. | null | Heart Transplantation | null | 1 | arm 1: Participants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted t... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 1.0 g PO BID intervention 2: Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL intervention 3: As per the practice of each participating center | intervention 1: mycophenolate mofetil (MMF) intervention 2: cyclosporine A (CsA) intervention 3: corticosteroids | 3 | Beijing | N/A | China | 116.39723 | 39.9075
Fuzhou | N/A | China | 119.30611 | 26.06139
Shanghai | N/A | China | 121.45806 | 31.22222 | 0 | NCT02091414 | |
[
2
] | 30 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy subjects. | null | Healthy Subjects | null | 2 | arm 1: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet taken with 240 mL of water after an overnight fast arm 2: Vicks Cough Syrup for Chesty Coughs 200 mg every 4 hours taken with 240 mL of water after an overnight fast | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet intervention 2: Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup | intervention 1: Mucinex® SE intervention 2: Vicks Cough Syrup for Chesty Coughs | 0 | null | 0 | NCT03644095 | |
[
3
] | 33 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease. | null | Alzheimer's Disease | Alzheimer's Disease Rosiglitazone | null | 1 | arm 1: Extended Release Tablets | [
0
] | 1 | [
0
] | intervention 1: Extended Release Tablets | intervention 1: rosiglitazone | 7 | Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Sun City | Arizona | United States | -112.27182 | 33.59754
Belmont | Massachusetts | United States | -71.17867 | 42.39593
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Durham | North... | 0 | NCT00381238 |
[
3
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the sympto... | null | Arthritis, Rheumatoid | rheumatoid arthritis DMARD methotrexate | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 500 mg po BID intervention 2: no active ingredient | intervention 1: CE-224,535 intervention 2: Placebo | 27 | Mesa | Arizona | United States | -111.82264 | 33.42227
DeBary | Florida | United States | -81.30868 | 28.88305
Lake Mary | Florida | United States | -81.31784 | 28.75888
Tampa | Florida | United States | -82.45843 | 27.94752
Avon | Indiana | United States | -86.39972 | 39.76282
New Orleans | Louisiana | United States |... | 0 | NCT00628095 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the feasibility of giving four weekly doses of Rituximab (anti-CD20 antibody) in the treatment of children with refractory neuroblastoma associated opsoclonus-myoclonus. Patients must have continued symptoms of opsoclonus, myoclonus and or ataxia despite surgical resection and a... | Opsoclonus-myoclonus ataxia syndrome (OMS) is a rare immune mediated paraneoplastic syndrome that occurs in approximately 2 to 3% of children with neuroblastoma. Children with neuroblastoma associated opsoclonus-myoclonus tend to have a favorable prognosis from the standpoint of the cure of their cancer. Unfortunately,... | Neuroblastoma Opsoclonus-myoclonus | neuroblastoma Opsoclonus-myoclonus rituximab | null | 1 | arm 1: Single Arm | [
5
] | 1 | [
0
] | intervention 1: 4 weekly doses of IV rituxan at 375 mg/m2 on days 1, 8, 15 and 22 | intervention 1: anti-CD20 (Rituximab) | 0 | null | 0 | NCT00202930 |
[
3
] | 415 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was admini... | null | Diabetes Diabetes Mellitus, Type 2 | null | 14 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None | [
0,
0,
0,
0,
0,
0,
2,
2,
2,
2,
2,
2,
0,
0
] | 13 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 0.1 mg, once weekly, s.c. injection intervention 2: 0.2 mg, once weekly, s.c. injection intervention 3: 0.4 mg, once weekly, s.c. injection intervention 4: 0.8 mg, once weekly, s.c. injection intervention 5: 0.8 mg with titration, once weekly, s.c. injection intervention 6: 1.6 mg with titration, once w... | intervention 1: semaglutide intervention 2: semaglutide intervention 3: semaglutide intervention 4: semaglutide intervention 5: semaglutide intervention 6: semaglutide intervention 7: placebo intervention 8: placebo intervention 9: placebo intervention 10: placebo intervention 11: placebo intervention 12: liraglutide i... | 77 | Gratwein | N/A | Austria | 15.31667 | 47.11667
Graz | N/A | Austria | 15.45 | 47.06667
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Mödling | N/A | Austria | 16.28921 | 48.08605
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vien... | 0 | NCT00696657 | |
[
3
] | 7 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery. | Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision. Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic p... | Pain, Postoperative | Gastrointestinal surgery Post operative pain | null | 2 | arm 1: Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision. arm 2: Either three or four 5x5-cm placebo sponges implanted at 2 sites w... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: placebo | intervention 1: Bupivacaine Collagen Sponge intervention 2: Placebo | 1 | Albany | New York | United States | -73.75623 | 42.65258 | 0 | NCT00661466 |
[
4
] | 1,912 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind t... | null | Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus | null | 4 | arm 1: None arm 2: Rivoglitazone 1.0 mg arm 3: Rivoglitazone 1.5 mg arm 4: Pioglitazone 45 mg | [
2,
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 45 mg over-encapsulated tablet administered orally, once daily intervention 2: Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule intervention 3: 1.0 mg tablet administered o... | intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Rivoglitazone intervention 4: Rivoglitazone | 183 | Anniston | Alabama | United States | -85.83163 | 33.65983
Birmingham | Alabama | United States | -86.80249 | 33.52066
Hoover | Alabama | United States | -86.81138 | 33.40539
Muscle Shoals | Alabama | United States | -87.66753 | 34.74481
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Jonesboro | Arkansas |... | 0 | NCT00484198 |
[
4
] | 331 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG X... | null | Alzheimer's Disease | open-label extension tolerability Alzheimer's disease Rosiglitazone extended-release (XR) safety cognition BRL-049653 | null | 1 | arm 1: Rosiglitazone XR | [
0
] | 1 | [
0
] | intervention 1: experimental drug | intervention 1: Rosiglitazone XR | 70 | Palo Alto | California | United States | -122.14302 | 37.44188
Deerfield Beach | Florida | United States | -80.09977 | 26.31841
Hialeah | Florida | United States | -80.27811 | 25.8576
Melbourne | Florida | United States | -80.60811 | 28.08363
Plantation | Florida | United States | -80.23184 | 26.13421
Tampa | Florida |... | 0 | NCT00550420 |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD. | null | Pulmonary Disease, Chronic Obstructive | COPD long-acting beta agonist Emphysema Chronic Bronchitis Chronic Obstructive Pulmonary Disease (COPD) bronchodilator long acting muscarinic antagonist | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: matching placebo intervention 2: The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler. | intervention 1: Placebo intervention 2: GSK233705/GW642444 | 12 | Mobile | Alabama | United States | -88.04305 | 30.69436
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Biddeford | Maine | United States | -70.45338 | 43.49258
St Louis | Missouri | United States | -90.19789 | 38.62727
Summit | New Jersey | United States | -74.36468 | 40.71562
Medford | Oregon | United S... | 0 | NCT00749411 |
[
4
] | 750 | NON_RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 0ALL | null | The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and ... | The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. | Infections, Streptococcal | Streptococcus Pneumoniae Vaccines Meningococcal disease Carriage Prophylactic antipyretic Safety Pneumococcal vaccine Fever Pneumococcal disease Immunogenicity Meningococcal vaccine Booster vaccination | null | 5 | arm 1: Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic ant... | [
0,
0,
0,
0,
1
] | 4 | [
2,
2,
2,
0
] | intervention 1: 1 intramuscular injection. intervention 2: 1 intramuscular injection. intervention 3: 1 intramuscular injection. intervention 4: Body weight of \< 7 kg: none; Body weight of ≥ 7 kg to \< 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppo... | intervention 1: Pneumococcal conjugate vaccine GSK1024850A. intervention 2: Infanrix hexa. intervention 3: Meningococcal vaccine GSK134612. intervention 4: Paracetamol. | 10 | Brno | N/A | Czechia | 16.60796 | 49.19522
Hradec Králové | N/A | Czechia | 15.83277 | 50.20923
Jindřichův Hradec | N/A | Czechia | 15.00301 | 49.14404
Náchod | N/A | Czechia | 16.16289 | 50.4167
Ostrava | N/A | Czechia | 18.28204 | 49.83465
Pardubice | N/A | Czechia | 15.77659 | 50.04075
Prague | N/A | Czechia | 14.42... | 0 | NCT00496015 |
[
5
] | 9 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%). | null | Hemophilia A | null | 2 | arm 1: Advate rAHF-PFM arm 2: Recombinate rAHF | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Infusion of 50 +/- 5 IU/kg bodyweight intervention 2: Infusion of 50 +/- 5 IU/kg bodyweight | intervention 1: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) intervention 2: Recombinant Factor VIII (rAHF) | 1 | Bonn | N/A | Germany | 7.09549 | 50.73438 | 0 | NCT00666406 | |
[
3
] | 62 | RANDOMIZED | CROSSOVER | 1PREVENTION | 1SINGLE | false | 0ALL | true | This study will examine whether the experimental drug R115777 (Tipifarnib) can shrink or slow the growth of plexiform neurofibromas in children and young adults with neurofibromatosis type 1 (NF1) and determine what side effects are related to treatment. Plexiform tumors arise from nerves; the only effective treatment ... | R115777 (Tipifarnib) is a farnesyltransferase inhibitor that blocks the post-translational isoprenylation of ras and other farnesylated proteins. The ras proteins are integral in cell signaling pathways, and farnesylation is essential for the function of both mutant and non-mutant ras proteins. Patients with neurofibro... | Neurofibroma, Plexiform Neurofibromatosis Type I | Surrogate Markers 3-Dimensional Magnetic Resonance Imaging (MRI) Natural History of Neurofibromatosis Type 1 (NF1) Tumor Tissue Bank Neurofibromatosis NF1 Neurofibromatosis Type 1 Plexiform Neurofibroma Neurofibroma | Prot_SAP_ICF_000.pdf:
CTEP Protocol No:
T-99-0090
CC Protocol No: 01-C-0222
Amendment: J
Revised:
4/21/09
IRB Approval Date:
1
A Phase II Randomized, Cross-Over, Double-Blinded, Placebo-Controlled
Trial of the Farnesyltransferase Inhibitor R115777 in Pediatric Patients with
Neurofibromatosis Type 1 a... | 2 | arm 1: Patients receive oral R115777 (Tipifarnib) first followed by placebo. 200 mg/m\^2/dose BSA every 12 hours by mouth (po)on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive oral placebo first followed by R115777 (Tipifarnib). 200 mg/m\^... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Given orally, 200 mg/m\^2/dose BSA every 12 hours by mouth (po) daily x 21 days, Course is every 28 days intervention 2: Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. | intervention 1: tipifarnib intervention 2: placebo | 12 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Bethesda | Maryland | United States | -77.10026 | 38.98067
Boston | Massachus... | 0 | NCT00021541 |
[
4
] | 167 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.
Primary objective:
• To evaluate the efficac... | This is a randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.
Eligible patients were randomised i... | Vaginal Atrophy | Postmenopausal women | null | 2 | arm 1: 0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week. arm 2: Placebo gel for vaginal administration. Route: Vaginal by a can... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Gel for vaginal application intervention 2: Gel for vaginal application | intervention 1: Estriol intervention 2: Placebo | 12 | Torrelavega | Cantabria | Spain | -4.04785 | 43.34943
Madrid | Castiglia | Spain | -3.70256 | 40.4165
Barcelona | Catalonia | Spain | 2.15899 | 41.38879
Barcelona | Catalonia | Spain | 2.15899 | 41.38879
Granada | N/A | Spain | -3.60667 | 37.18817
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.7025... | 0 | NCT04574999 |
[
3
] | 3 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | null | RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .
PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy. | OBJECTIVES:
Primary
* Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.
Secondary
* Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients ... | Diarrhea Gastrointestinal Complications Unspecified Childhood Solid Tumor, Protocol Specific | unspecified childhood solid tumor, protocol specific gastrointestinal complications diarrhea | null | 1 | arm 1: Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover | [
0
] | 2 | [
2,
0
] | intervention 1: Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover intervention 2: Administered IV over 1 hour on days 1-4 | intervention 1: filgrastim intervention 2: cyclophosphamide | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00258180 |
[
3
] | 115 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Primary
• Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
Secondary
* Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when admi... | This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL.
Pralatrexate will be given over 3-5 minutes intravenously (IV),... | Peripheral T-cell Lymphoma | Peripheral T-cell Lymphoma T-cell Lymphoma Lymphoma PDX Pralatrexate Vitamin B12 Folic acid | null | 0 | null | null | 1 | [
0
] | intervention 1: Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle. | intervention 1: Pralatrexate Injection | 32 | Duarte | California | United States | -117.97729 | 34.13945
Los Angeles | California | United States | -118.24368 | 34.05223
New Haven | Connecticut | United States | -72.92816 | 41.30815
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Iowa City | Iowa | ... | 0 | NCT00364923 |
[
2
] | 211 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control. | null | Type 2 Diabetes Mellitus (T2DM) | Type 2 Diabetes Mellitus (T2DM) | null | 4 | arm 1: Arm 1: drug arm 2: Arm 2: active comparator arm 3: Arm 3: drug + active comparator arm 4: Arm 4: placebo comparator | [
0,
1,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily. intervention 2: pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. intervention 3: pioglitazone 30 mg placebos will be supplied as oral tablets. E... | intervention 1: Comparator: sitagliptin phosphate intervention 2: Comparator: pioglitazone intervention 3: Comparator: placebo to pioglitazone intervention 4: Comparator: placebo to sitagliptin | 0 | null | 0 | NCT00511108 |
[
3
] | 192 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections. | null | Skin Diseases, Infectious Skin Diseases, Bacterial | Skin Infection Complicated Skin and Skin Structure Infection | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: oral TR-701 200 mg for 5 to 7 days intervention 2: oral TR-701 300 mg for 5 to 7 days intervention 3: TR-701 400 mg for 5 to 7 days | intervention 1: TR-701 200 mg intervention 2: TR-701 300 mg intervention 3: TR-701 400 mg | 12 | Dothan | Alabama | United States | -85.39049 | 31.22323
Chula Vista | California | United States | -117.0842 | 32.64005
Long Beach | California | United States | -118.18923 | 33.76696
Oceanside | California | United States | -117.37948 | 33.19587
Pasadena | California | United States | -118.14452 | 34.14778
San Francis... | 0 | NCT00761215 |
[
3
] | 113 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | null | This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis | This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis. | Seborrheic Dermatitis | seborrheic dermatitis | null | 2 | arm 1: Elidel Cream to be applied twice daily for 4 weeks arm 2: Ketoconazole Cream to be applied twice daily for 4 weeks | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Elidel intervention 2: Ketoconazole Cream | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 0 | NCT00403559 |
[
4
] | 571 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and T... | null | HIV Infections | null | 3 | arm 1: ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice
ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study arm 2: ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice
ATV, SQV, and TDF once daily, nucleoside per label 48 ... | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Active Comparator, Capsules, tablets, Oral intervention 2: Active Comparator, Capsules, tablets, Oral intervention 3: Active Comparator, Capsules, tablets, Oral | intervention 1: Atazanavir + ritonavir + tenofovir + nucleoside intervention 2: Atazanavir + saquinavir + tenofovir + nucleoside intervention 3: Lopinavir/ritonavir + tenofovir + nucleoside | 29 | San Francisco | California | United States | -122.41942 | 37.77493
Torrance | California | United States | -118.34063 | 33.83585
Boulder | Colorado | United States | -105.27055 | 40.01499
Altamonte Springs | Florida | United States | -81.36562 | 28.66111
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
... | 1 | NCT00035932 | |
[
4
] | 668 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients. | This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.
The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availab... | Kidney Transplantation | De Novo Kidney Transplant cyclosporine Prograf® mycophenolate mofetil tacrolimus | null | 3 | arm 1: Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse e... | [
0,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter. intervention 2: The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 ... | intervention 1: Tacrolimus Modified Release (MR) intervention 2: Tacrolimus intervention 3: cyclosporine microemulsion intervention 4: mycophenolate mofetil | 57 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Loma Linda | California | United States | -117.26115 | 34.04835
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angele... | 1 | NCT00064701 |
[
5
] | 501 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal. | A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal. | Kidney Transplantation | Treatment Effectiveness Treatment Efficacy Anti-rejection therapy Immunosuppression Therapy, antirejection Renal Transplantation Transplantation, Kidney Transplantation, Renal Grafting, Kidney | null | 4 | arm 1: Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American arm 2: Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African ... | [
0,
1,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: IV intervention 2: IV intervention 3: oral intervention 4: Intravenous (IV) intervention 5: oral intervention 6: IV and/or oral | intervention 1: basiliximab intervention 2: rabbit anti-thymocyte globulin intervention 3: tacrolimus intervention 4: alemtuzumab intervention 5: mycophenolate mofetil intervention 6: steroids | 29 | Birmingham | Alabama | United States | -86.80249 | 33.52066
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
San Francisco | California | United States | -122.41942 | 37.77493
Sa... | 1 | NCT00113269 |
[
5
] | 896 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection. | null | Hepatitis C, Chronic | null | 2 | arm 1: Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the r... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms. intervention 2: Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks. | intervention 1: PEG-IFN alfa-2a intervention 2: Ribavirin | 51 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
La Plata | N/A | Argentina | -57.95442 | -34.92126
Rosario | N/A | Argentina | -60.63932 | -32.94682
Adelaide | N/A | Australia | 138.59863 | -34.92866
Adelaide | N/A | Australia | 138.59863 | -34.92866
Banksto... | 1 | NCT00192647 | |
[
4
] | 7,554 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patient... | null | Atrial Fibrillation Vascular Risk | Atrial fibrillation Anticoagulant therapy Thromboembolic prevention | null | 2 | arm 1: Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) arm 2: Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral administration (tablets) intervention 2: oral administration (tablets) | intervention 1: clopidogrel (SR25990C) intervention 2: placebo | 30 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Macquarie Park | N/A | Australia | 151.12757 | -33.78105
Vienna | N/A | Austria | 16.37208 | 48.20849
Diegem | N/A | Belgium | 4.43354 | 50.89727
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Laval |... | 1 | NCT00249873 |
[
4
] | 284 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia | Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified. | Schizophrenia | Adolescent Subjects With Schizophrenia | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing \<45 kg, th... | intervention 1: placebo intervention 2: Ziprasidone oral capsules | 92 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Stanford | California | United States | -122.16608 | 37.42411
Aurora | Colora... | 1 | NCT00257192 |
[
4
] | 517 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler | null | Cystic Fibrosis | tobramycin | null | 2 | arm 1: Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles. arm 2: Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) ... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Tobramycin Inhalation Powder (TIP) capsules for inhalation. intervention 2: Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer | intervention 1: Tobramycin Inhalation Powder intervention 2: Tobramycin Solution for Inhalation | 72 | Hartford | Connecticut | United States | -72.68509 | 41.76371
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Louisville | Kentucky | United States | -85.75941 | 38.25424
Boston | Massachusetts | United States | -71.05977 | 42.35843
Lebanon | New Hampshir... | 1 | NCT00388505 |
[
4
] | 222 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated ... | null | Renal Transplantation | Steroids avoidance, enteric-coated mycophenolate sodium (EC-MPS), de novo renal transplantation | null | 2 | arm 1: Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. arm 2: Pati... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose ... | intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Prednisone | 1 | Poitiers | N/A | France | 0.34348 | 46.58261 | 1 | NCT00413920 |
[
5
] | 296 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe, Africa and the United States of America (USA).
The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes. | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the t... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin) intervention 2: Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin) intervention 3: Administered 1 - 3 times daily, at largest meals, injection s... | intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin aspart | 69 | Fresno | California | United States | -119.77237 | 36.74773
Mission Viejo | California | United States | -117.672 | 33.60002
Miami | Florida | United States | -80.19366 | 25.77427
Athens | Georgia | United States | -83.37794 | 33.96095
Atlanta | Georgia | United States | -84.38798 | 33.749
Des Moines | Iowa | United St... | 1 | NCT00537303 | |
[
4
] | 76 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so. | null | Parkinson Disease | ropinirole IR efficacy safety open-label long term safety; REQUIP ropinirole XL ropinirole CR Parkinson's disease | null | 1 | arm 1: Open label medication - Ropinirole CR | [
1
] | 1 | [
0
] | intervention 1: Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day. | intervention 1: Ropinirole XL (formerly CR) | 10 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Los Angeles | California | United States | -118.24368 | 34.05223
Oxnard | California | United States | -119.17705 | 34.1975
Miami | Florida | United States | -80.19366 | 25.77427
Tampa | Florida | United States | -82.45843 | 27.94752
Augusta | Georgia | Unite... | 1 | NCT00650104 |
[
4
] | 415 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients | null | COPD | COPD adults β2-agonist indacaterol | null | 3 | arm 1: Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).
The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).
The short acting (beta) β2-a... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI) intervention 2: Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI) | intervention 1: Indacaterol intervention 2: Placebo | 190 | Homewood | Alabama | United States | -86.80082 | 33.47177
Jasper | Alabama | United States | -87.27751 | 33.83122
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Pine Bluff | Arkansas | United States | -92.0032 | 34.22843
Encinitas | California | United... | 1 | NCT00677807 |
[
4
] | 304 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder. | The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.
The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping... | Generalized Anxiety Disorder | Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy | null | 2 | arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Vortioxetine placebo-matching capsules | intervention 1: Vortioxetine intervention 2: Placebo | 33 | Anaheim | California | United States | -117.9145 | 33.83529
Arcadia | California | United States | -118.03534 | 34.13973
Irvine | California | United States | -117.82311 | 33.66946
National City | California | United States | -117.0992 | 32.67811
Sherman Oaks | California | United States | -118.44925 | 34.15112
Upland ... | 1 | NCT00734071 |
[
2
] | 47 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | true | 0ALL | null | This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension. | null | Hypertension | null | 2 | arm 1: amlodipine arm 2: Placebo to amlodipine | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Two 5 mg tablets amlodipine daily for 6 weeks. intervention 2: Two 5 mg tablets placebo to amlodipine daily for 6 weeks | intervention 1: Comparator: amlodipine besylate intervention 2: Comparator: Placebo | 0 | null | 1 | NCT00789321 | |
[
2
] | 42 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant. | null | Chemotherapy-Induced Nausea and Vomiting | null | 4 | arm 1: aprepitant 165 mg arm 2: aprepitant 185 mg arm 3: fosaprepitant 150 mg arm 4: aprepitant with food | [
1,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3. intervention 2: Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3. intervention 3: Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state duri... | intervention 1: aprepitant 165 mg intervention 2: Comparator: aprepitant 185 mg intervention 3: Comparator: fosaprepitant 150 mg intervention 4: Comparator: aprepitant with food | 0 | null | 1 | NCT00945321 | |
[
4
] | 252 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction b... | null | Kidney Transplantation | null | 2 | arm 1: Participants received 3 grams (g) mycophenolate mofetil (MMF) tablets per os (p.o.) in divided doses (every 12 hours \[q12h\]) adapted to mycophenolic acid (MPA) by area under the curve (AUC) beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, ... | [
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (\*) height (h)/ liter(L). intervention 2: 2 g p.o. in divided d... | intervention 1: mycophenolate mofetil intervention 2: mycophenolate mofetil intervention 3: anti-IL-2R intervention 4: methylprednisolone intervention 5: cyclosporine | 24 | Bordeaux | N/A | France | -0.5805 | 44.84044
Brest | N/A | France | -4.48628 | 48.39029
Clermont-Ferrand | N/A | France | 3.08682 | 45.77969
Créteil | N/A | France | 2.46569 | 48.79266
Dijon | N/A | France | 5.01667 | 47.31667
La Tronche | N/A | France | 5.74629 | 45.20507
Le Kremlin-Bicêtre | N/A | France | 2.36073 | ... | 1 | NCT02005562 | |
[
4
] | 2,368 | RANDOMIZED | FACTORIAL | 0TREATMENT | 0NONE | false | 0ALL | true | The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or ... | BACKGROUND:
Type 2 diabetes mellitus, which is becoming more prevalent in our society as the population ages, is one of the strongest risk factors for coronary artery disease (CAD) and consequent mortality. In addition to generating an enormous toll in human suffering, diabetes places an economic burden approaching 10... | Coronary Disease Cardiovascular Diseases Heart Diseases Insulin Resistance Diabetes Mellitus Diabetes Mellitus, Non-Insulin-Dependent | null | 4 | arm 1: Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy arm 2: Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy arm 3: Intensive medical therapy with delayed revascularization if clinically indicated and insu... | [
1,
1,
1,
1
] | 5 | [
3,
3,
0,
0,
0
] | intervention 1: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions intervention 2: Coronary Artery Bypass intervention 3: Biguanides, thiazolidinediones intervention 4: Insulin, sulfonylurea intervention 5: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel B... | intervention 1: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions intervention 2: Coronary Artery Bypass intervention 3: Biguanides, thiazolidinediones intervention 4: Insulin, sulfonylurea intervention 5: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel B... | 0 | null | 0 | NCT00006305 | |
[
3
] | 103 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. | PRIMARY OBJECTIVES:
I. Determine the frequency and duration of complete and partial response rates in patients with grade I, II, or III follicular lymphoma or mantle cell lymphoma treated with bortezomib.
SECONDARY OBJECTIVES:
I. Determine the response of minimal residual disease by polymerase chain reaction (PCR) d... | Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma | null | 1 | arm 1: Patients receive an infusion of bortezomib (dose of 1.8 mg/m2) over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment. | [
0
] | 1 | [
0
] | intervention 1: Given IV | intervention 1: bortezomib | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00023764 | |
[
5
] | 219 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia. | Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.
Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch ... | Schizophrenia | null | 2 | arm 1: Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typ... | [
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: As prescribed by routine prescriber (not dictated by study protocol) intervention 2: As prescribed by routine prescriber (not dictated by study protocol) intervention 3: As prescribed by routine prescriber (not dictated by study protocol) intervention 4: As prescribed by routine prescriber (not dictated... | intervention 1: Risperidone intervention 2: Olanzapine intervention 3: Ziprasidone intervention 4: Quetiapine intervention 5: Aripiprazole | 0 | null | 0 | NCT00044655 | |
[
4
] | 502 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension. | null | Glaucoma, Open-angle Ocular Hypertension | Glaucoma POAG OAG OHT | null | 1 | arm 1: Travoprost (0.004%) | [
0
] | 1 | [
0
] | intervention 1: Travoprost (0.004%) 1 drop each eye once daily | intervention 1: Travatan | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00051168 |
[
2,
3
] | 72 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's lymphoma. | OBJECTIVES:
* Determine the efficacy of 10-propargyl-10-deazaaminopterin, in terms of objective response rate, duration of response, and time to disease progression, in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma.
* Determine the impact of pharmacokinetics on toxicity a... | Lymphoma | recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent mantle cell lymphoma recurrent adult Hodgkin lymphoma recurrent grade 3 follicular lymphoma | null | 5 | arm 1: Pralatrexate (PDX) 135 mg/m\^2 administered as an intravenous (IV) infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks. arm 2: PDX 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3... | [
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: pralatrexate | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00052442 |
[
3
] | 31 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treat... | OBJECTIVES:
Primary
* Determine the response rate in patients with carcinoma of unknown primary when treated with gemcitabine and irinotecan.
* Determine the adverse event profile and tolerability of this regimen, based on the presence or absence of the UGT1A1\*28 polymorphism, in these patients. (Cohort I closed to ... | Carcinoma of Unknown Primary | adenocarcinoma of unknown primary newly diagnosed carcinoma of unknown primary squamous cell carcinoma of unknown primary undifferentiated carcinoma of unknown primary | null | 2 | arm 1: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive g... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Given IV intervention 2: Given IV | intervention 1: gemcitabine hydrochloride intervention 2: irinotecan hydrochloride | 4 | Mason City | Iowa | United States | -93.20104 | 43.15357
Rochester | Minnesota | United States | -92.4699 | 44.02163
Lincoln | Nebraska | United States | -96.66696 | 40.8
Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00066781 |
[
2,
3
] | 50 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth | PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of FR901228 (depsipeptide) in patients with recurrent malignant gliomas who are taking enzyme-inducing antiepileptic drugs (EIAEDs). (Phase I) II. Determine the safety profile of this drug in these patients. (Phase I) III. Determine the pharmacokinetics... | Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor | null | 2 | arm 1: Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose escalation two dose levels:
Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2
Pharmacokinetics arm 2: Patients receive FR901228 (romid... | [
0,
0
] | 1 | [
0
] | intervention 1: Given IV | intervention 1: depsipeptide | 8 | 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
Pittsbur... | 0 | NCT00085540 | |
[
4
] | 403 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50. | The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, o... | Tobacco Use Disorder | Smoking cessation Tobacco | null | 4 | arm 1: Pharmacological Treatment - Subjects received 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment (NRT)
Brief Counseling - The counseling intervention consisted of five 90-minute group meetings.
There was no further treatment during Weeks 12-52. arm 2: Pharmacological Treatment - Fol... | [
1,
0,
0,
0
] | 1 | [
0
] | intervention 1: Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement. | intervention 1: Nicotine polacrilex, Bupropion | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00086385 |
[
4
] | 332 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 1FEMALE | null | This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population. | null | Postmenopausal Osteoporosis | Osteoporosis Postmenopausal | null | 2 | arm 1: 60 mg/mL denosumab given day 1, month 6, month 12 and month 18 arm 2: Placebo given day 1, month 6, month 12 and month 18 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 60 mg/mL denosumab given day 1, month 6, month 12 and month 18 intervention 2: Placebo given at day 1, month 6, month 12 and month 18 | intervention 1: AMG 162 intervention 2: Placebo | 0 | null | 0 | NCT00091793 |
[
3,
4
] | 30 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the... | BACKGROUND:
Although patients with follicular non-Hodgkin's lymphoma (NHL) typically experience a relatively indolent course, the disease is rarely curable with conventional chemotherapy. Patients with follicular NHL are usually treated only when symptoms require palliation or if bulky disease exists since no survival... | Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Follicular Lymphoma | Prot_SAP_ICF_000.pdf:
BMT CTN 0202
Autologous vs. Non-Myeloablative Allogeneic
Hematopoietic Stem Cell Transplantation (HSCT)
for Patients with Chemosensitive Follicular Non-
Hodgkin’s Lymphoma Beyond First Complete
Response or First Partial Response
NCT00096460
Autologous vs. Non-Myeloablative Allogeneic ... | 2 | arm 1: Cyclophosphamide and Rituximab with Filgrastim conditioning and chemotherapy or radiation therapy prior to autologous Hematopoietic Stem Cell Transplant (HSCT). Rituximab maintenance therapy following HSCT. arm 2: Non-myeloablative conditioning regimen followed by allogeneic Hematopoietic Stem Cell Transplant (H... | [
1,
1
] | 8 | [
0,
0,
4,
0,
3,
3,
0,
0
] | intervention 1: Prior to undergoing HSCT, all patients will receive Cyclophosphamide 4 gm/m2 with Rituximab 375 mg/m2 x 2 doses and G-CSF support. intervention 2: Autologous HSCT patients will receive 10 mcg/kg/day and allogeneic HSCT patients will receive 5 mcg/kg/day subcutaneous (SQ) or intravenous (IV) starting 2 d... | intervention 1: Cyclophosphamide and Rituximab intervention 2: Filgrastim intervention 3: Chemotherapy or Radiation therapy intervention 4: Non-myeloablative Conditioning regimen intervention 5: Allogeneic transplant intervention 6: Autologous transplant intervention 7: Rituximab maintenance therapy intervention 8: GVH... | 30 | Duarte | California | United States | -117.97729 | 34.13945
La Jolla | California | United States | -117.2742 | 32.84727
La Jolla | California | United States | -117.2742 | 32.84727
Stanford | California | United States | -122.16608 | 37.42411
Gainesville | Florida | United States | -82.32483 | 29.65163
Tampa | Florida... | 0 | NCT00096460 | |
[
0
] | 42 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I, stage... | OBJECTIVES:
Primary
* Determine the effects of neoadjuvant gefitinib on downstream signaling pathways, including Src-Stat3, PI3K/Akt, ERK activity, and Bcl-2 family members in patients with resectable stage I-IIIA non-small cell lung cancer.
* Determine the effects of this drug on cell cycle and apoptosis within the ... | Lung Cancer | stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IA non-small cell lung cancer stage IB non-small cell lung cancer | null | 1 | arm 1: The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.
At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: ZD1839 | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00104728 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant melan... | OBJECTIVES:
Primary
* Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide).
Secondary
* Determine the progression-free and overall survival of patients treated with this drug.
* Determine the toxicity profile of this drug in these pa... | Malignant Melanoma Melanoma | stage III melanoma stage IV melanoma Depsipeptide | null | 1 | arm 1: Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression. | [
0
] | 1 | [
0
] | intervention 1: Given IV | intervention 1: Depsipeptide | 0 | null | 0 | NCT00104884 |
[
3
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of the trial was to determine whether a 36-ingredient micronutrient supplement (primarily vitamins and minerals) is beneficial for the treatment of bipolar disorder, when studied under randomized and fully blinded conditions and compared to a placebo. The supplement is referred to as MCN36, because it conta... | This RCT (randomized clinical trial) compared MCN36 to placebo in patients randomized to receive one or the other for 8 weeks. Close medical supervision was provided with weekly appointments. At the end of the 8 weeks, all participants were offered the opportunity of entering an 8-week open-label extension.
The effica... | Bipolar Disorder | bipolar disorder mood disorders manic depression nutrition | null | 2 | arm 1: Placebo comparator, 6 placebo capsules three times a day arm 2: nutritional supplement intervention, 6 nutritional supplement capsules three times a day; the nutritional supplement is a 36-ingredient micronutrient supplement (primarily vitamins and minerals) and is referred to as MCN36, because it contains 36 nu... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: nutritional supplement intervention 2: nutritional supplement | intervention 1: MCN36 (nutritional supplement) intervention 2: Placebo | 2 | San Diego | California | United States | -117.16472 | 32.71571
Calgary | Alberta | Canada | -114.08529 | 51.05011 | 0 | NCT00109577 |
[
3
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Giving cilengitide before and after surgery may be an effective treatment for glioblastoma multiforme. This phase II trial is studying how well cilengitide works in treating patients who are undergoing surgery for recurrent ... | PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival rate in operative patients with recurrent or progressive glioblastoma multiforme treated with cilengitide.
SECONDARY OBJECTIVES:
I. Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients ... | Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor | null | 2 | arm 1: Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)
Resection: All patients undergo tumor resection on day 0.
Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice wee... | [
0,
0
] | 4 | [
0,
3,
10,
10
] | intervention 1: Given IV intervention 2: Undergo tumor resection intervention 3: Correlative studies intervention 4: Correlative studies | intervention 1: cilengitide intervention 2: therapeutic conventional surgery intervention 3: pharmacological study intervention 4: laboratory biomarker analysis | 1 | Watertown | Massachusetts | United States | -71.18283 | 42.37093 | 0 | NCT00112866 |
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