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
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms | null | Renal Transplantation | Renal Transplantation Immunosuppression Renal transplant recipients Gastrointestinal symptoms associated with MMF therapy | null | 2 | arm 1: Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B. arm 2: Mycopheno... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Enteric-coated Mycophenolate Acid (EC-MPA) intervention 2: Mycophenolate Mofetil (MMF) intervention 3: Placebo MMF intervention 4: Placebo EC-MPA | 37 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
San Die... | 0 | NCT00658333 |
[
4
] | 502 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a pla... | OBJECTIVES:
Primary
\* To compare the effects of IV iron, oral iron, or placebo in combination with darbepoetin alfa on the hematopoietic response rate, defined as a hemoglobin increment of ≥ 2.0 g/dL from baseline or achievement of hemoglobin of ≥ 11 g/dL in the absence of red blood cell transfusions (RBC) in the pr... | Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | unspecified adult solid tumor, protocol specific monoclonal gammopathy of undetermined significance extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma primary systemic amyloidosis Waldenstrom macroglobulinem... | null | 3 | arm 1: Patients receive darbepoetin alfa subcutaneously and sodium ferric gluconate complex IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity. arm 2: Patients receive darbepoetin alfa as in arm I and oral ferrous sulfate once daily on days 1-21. Trea... | [
0,
0,
0
] | 4 | [
2,
7,
0,
10
] | intervention 1: Given by injection intervention 2: Given by mouth intervention 3: Given by IV intervention 4: Given by mouth | intervention 1: darbepoetin alfa intervention 2: ferrous sulfate intervention 3: sodium ferric gluconate complex in sucrose intervention 4: placebo | 2 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00661999 |
[
4
] | 822 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin. | null | Type 2 Diabetes | Type 2 diabetes metformin | null | 2 | arm 1: saxagliptin add-on to metformin arm 2: sitagliptin add-on to metformin | [
0,
1
] | 2 | [
0,
0
] | intervention 1: tablet, per oral, once daily intervention 2: capsule, per oral, once daily | intervention 1: saxagliptin intervention 2: sitagliptin | 87 | Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Lanús | Buenos Aires | Argentina | -58.39132 | -34.70757
Mar del Plata | Buenos Aires | Argentina | -57.5562 | -38.00042
Santa Fe | Santa Fe Province | Argentina | -60.70868 | -31.64881
Caba | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
C... | 0 | NCT00666458 |
[
5
] | 750 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression. | null | Depression | Severe Depressive Episode | null | 5 | arm 1: study drug arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
1,
1,
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 30-120 milligrams (mgs) orally daily for 12 weeks intervention 2: 20-80 mgs orally daily for 12 weeks intervention 3: 20-40 mgs orally daily for 12 weeks intervention 4: 20-50 mgs orally daily for 12 weeks intervention 5: 50-200 mgs orally daily for 12 weeks | intervention 1: duloxetine intervention 2: fluoxetine intervention 3: citalopram intervention 4: paroxetine intervention 5: sertraline | 61 | Carson | California | United States | -118.28202 | 33.83141
Irvine | California | United States | -117.82311 | 33.66946
San Diego | California | United States | -117.16472 | 32.71571
Sherman Oaks | California | United States | -118.44925 | 34.15112
Torrance | California | United States | -118.34063 | 33.83585
Pueblo | ... | 0 | NCT00666757 |
[
3
] | 153 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism. | This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4 ± 1 µg, and 4 ± 2 µg) and 1 maxacalcitol regimen (initial dose and dose adjustment range was 5 µg ± 2.5 µg or 10 µg ± 2.5 µg) as a refere... | Chronic Kidney Disease on Hemodialysis Secondary Hyperparathyroidism | chronic kidney disease secondary hyperparathyroidism hemodialysis paricalcitol maxacalcitol | null | 5 | arm 1: Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg arm 2: Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg arm 3: Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg arm 4: Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg arm... | [
0,
0,
0,
0,
5
] | 2 | [
0,
0
] | intervention 1: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus level... | intervention 1: Maxacalcitol intervention 2: Paricalcitol | 12 | Tokyo | Metropolis | Japan | 139.69171 | 35.6895
Aichi | Prefecture | Japan | 130.62158 | 32.51879
Chiba | Prefecture | Japan | 140.11667 | 35.6
Fukuoka | Prefecture | Japan | 130.41667 | 33.6
Hokkaido | Prefecture | Japan | N/A | N/A
Ibaraki | Prefecture | Japan | 135.56828 | 34.81641
Kanagawa | Prefecture | Japan | 1... | 0 | NCT00667576 |
[
4
] | 830 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo. | Methodology:
This will be a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study consists of a baseline screening (Study Day 1), during which subjects will be evaluated for inclusion/exclusion crit... | Lower Back Pain | null | 3 | arm 1: Carisoprodol 700 mg twice daily arm 2: Carisoprodol SR 500 mg twice daily arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 700 mg twice daily tablet intervention 2: carisoprodol SR 500 mg tablet intervention 3: placebo tablet | intervention 1: Carisoprodol SR 700 mg intervention 2: Carisoprodol SR 500 mg intervention 3: Placebo | 73 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Gulf Shores | Alabama | United States | -87.70082 | 30.24604
Hueytown | Alabama | United States | -86.99666 | 33.45122
Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | Uni... | 0 | NCT00671879 | |
[
3
] | 94 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452. | The primary objective of this study is to assess the effect of intravenous (i.v.) CK-1827452 on symptom-limited exercise tolerance in patients with ischemic cardiomyopathy and angina. The secondary objectives are to assess the tolerability of CK-1827452 administered three times daily (tid) to steady state in an immedia... | Heart Failure Myocardial Ischemia Angina Pectoris | null | 2 | arm 1: CK-1827452 I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose arm 2: CK-1827452 I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr or placebo, followed by 6 days three times a day oral dose ... | [
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr intervention 2: 12.5mg oral immediate release capsule intervention 3: I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr intervention 4: 25mg oral immediate release capsule intervention 5: Matching placebo iv infusion ... | intervention 1: CK-1827452 24mg and 6 mg iv infusion intervention 2: CK-1827452 12.5mg capsule intervention 3: CK-1827452 48 mg and 11 mg iv infusion intervention 4: CK-1827452 25mg capsule intervention 5: Placebo iv infusion intervention 6: Placebo capsule | 14 | Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Barnaul | N/A | Russia | 83.7456 | 53.3598
B... | 0 | NCT00682565 | |
[
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The objective of this clinical study is to examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma. | This is a randomized, modified single-blind, placebo-controlled dose escalation, multi-center Emergency Department (ED) study. Each subject will receive MN-221 or placebo administered through a continuous intravenous infusion in addition to the standardized care treatment for an acute exacerbation of asthma. The study ... | Asthma Status Asthmaticus | Asthma Dose-Escalation Controlled MN-221 | null | 2 | arm 1: MN-221 total dose of 240 mcg arm 2: i.v. infusion of MN-221 Placebo for 15 min | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: IV infusion of MN-221 16 mcg/min for 15 min; total dose of 240 mcg intervention 2: i.v. infusion of placebo for 15 minutes intervention 3: i.v. infusion of MN-221 30 mcg/min for 15 minutes (total dose of 450 mcg) intervention 4: i.v. infusion of MN-221 16 mcg/min for 15 minutes followed by 8 mcg/min for... | intervention 1: Dose Group 1 intervention 2: MN-221 placebo intervention 3: Dose Group 2 intervention 4: Dose Group 3 | 9 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Sylmar | California | United States | -118.44925 | 34.30778
Detroit | Michigan | United States | -83.04575 | 42.33143
St Louis | Missouri | United States | -90.19789 | 38.62727
Brooklyn | New York ... | 0 | NCT00683449 |
[
4
] | 481 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. | This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enrol... | Major Depressive Disorder | null | 2 | arm 1: vilazodone arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: titration to 40 mg tablets qd (once a day) for 8 weeks intervention 2: placebo | intervention 1: vilazodone intervention 2: placebo | 9 | Newport Beach | California | United States | -117.92895 | 33.61891
Bradenton | Florida | United States | -82.57482 | 27.49893
Atlanta | Georgia | United States | -84.38798 | 33.749
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Dallas | Texas... | 0 | NCT00683592 | |
[
3
] | 106 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to assess the effects of AZD 2624 in patients with schizophrenia | null | Schizophrenia | Schizophrenia | null | 3 | arm 1: AZD2624 40 mg arm 2: Olanzapine 15 mg arm 3: Matching Placebo | [
0,
5,
2
] | 3 | [
0,
0,
0
] | intervention 1: Oral Suspension intervention 2: PO BID intervention 3: None | intervention 1: AZD2624 intervention 2: Olanzapine intervention 3: Placebo | 1 | Rockville | Maryland | United States | -77.15276 | 39.084 | 0 | NCT00686998 |
[
3
] | 19 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Evaluation of treatment in participants with mild asthma. | To evaluate the effect of navarixin (MK-527123, SCH 527123) treatment on allergen-induced late asthmatic response (LAR) in participants with mild asthma. | Asthma | Neutrophilic Asthma | null | 2 | arm 1: Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2 arm 2: Matching placebo capsule to be taken once daily in the mornin... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 30 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2 intervention 2: Matching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2 | intervention 1: Navarixin intervention 2: Placebo | 0 | null | 0 | NCT00688467 |
[
5
] | 31 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This is a prospective, placebo-controlled, cross-over trial comparing the the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women diagnosed with hypercholesterolemia. The primary ... | The study will compare the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) on: 1) the efficiency of endogenous (plasma-derived) cholesterol excretion (%/day) 2) de novo cholesterol (DNC) synthesis ((%/day) 3) cholesterol efflux from tissues into blood (Ra), and 4) global RCT (ef... | Hypercholesterolemia | metabolic diseases metabolic disorder dyslipidemias lipid metabolism disorders | null | 2 | arm 1: ezetimibe (10mg/day)for 7 weeks arm 2: Placebo control | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1 tablet,10mg, once a day, for 7 weeks intervention 2: 1 tablet, once a day, for 7 weeks | intervention 1: ezetimibe intervention 2: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00701727 |
[
3
] | 591 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you ... | The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.
Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), ... | Acne Vulgaris | Acne Acne Vulgaris Pimples | null | 6 | arm 1: Benzoyl peroxide/clindamycin gel + tazarotene cream arm 2: Benzoyl peroxide/clindamycin gel + vehicle cream arm 3: Benzoyl peroxide gel + tazarotene cream arm 4: Clindamycin gel + tazarotene cream arm 5: Vehicle gel+ tazarotene cream arm 6: Vehicle gel + vehicle cream | [
0,
1,
1,
1,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 5% benzoyl peroxide in a gel applied topically once a day intervention 2: 1% clindamycin phosphate applied topically once a day intervention 3: 0.1 % tazarotene in a cream applied topically once a day intervention 4: Vehicle gel is an identical gel without the active ingredients intervention 5: Vehicle ... | intervention 1: Benzoyl peroxide gel intervention 2: Clindamycin gel intervention 3: Tazarotene cream intervention 4: Vehicle gel intervention 5: Vehicle cream | 16 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fremont | California | United States | -121.98857 | 37.54827
Sacramento | California | United States | -121.4944 | 38.58157
Boulder | Colorado | United States | -105.27055 | 40.01499
Coral Gables | Florida | United States | -80.26838 | 25.72149
Newnan | Geor... | 0 | NCT00713609 |
[
3
] | 88 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | null | The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more... | null | Major Upper or Lower Abdominal Surgery | null | 3 | arm 1: Oral Sufentanil arm 2: Oral sufentanil arm 3: Oral dosage of placebo | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral dosage of sufentanil intervention 2: Oral dosage of placebo | intervention 1: Oral sufentanil intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00718081 | |
[
3
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension. | null | Portal Hypertension | null | 3 | arm 1: Participants receive matching placebo capsules three times daily (TID) arm 2: Participants receive 12 mcg Cobiprostone TID arm 3: Participants receive 18 mcg Cobiprostone TID | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: Matching placebo capsules for oral administration intervention 2: Cobiprostone capsules for oral administration | intervention 1: Placebo intervention 2: Cobiprostone | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00737594 | |
[
5
] | 332 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension. | null | Hypertension | Hypertension African American aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure amlodipine stage 2 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks intervention 2: Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks | intervention 1: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks intervention 2: Amlodipine: 8 weeks | 1 | East Hanover | New Jersey | United States | -74.36487 | 40.8201 | 0 | NCT00739596 |
[
2,
3
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study. | null | HIV Infections HSV-2 Genital Herpes | Prevention | null | 1 | arm 1: 3%w/w SPL7013 vaginal gel (VivaGel) | [
0
] | 1 | [
0
] | intervention 1: A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days. | intervention 1: 3% SPL7013 Gel (VivaGel) | 1 | Melbourne | N/A | Australia | 144.96332 | -37.814 | 0 | NCT00740584 |
[
3
] | 20 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | The objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome. | The purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant ma... | Marijuana Smoking | quetiapine smoked marijuana marijuana use | null | 2 | arm 1: Quetiapine (200mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (200 mg) were administered 2 times per day ((1100 and 2300 hours).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking o... | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 0,6.2% THC intervention 2: 200 mg/day intervention 3: None | intervention 1: Marijuana intervention 2: Quetiapine intervention 3: Placebo oral capsule | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00743366 |
[
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up. | null | Lymphocytic Leukemia, Chronic | null | 1 | arm 1: Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles. | [
0
] | 1 | [
0
] | intervention 1: Bevacizumab was supplied as a sterile liquid in single-use vials. | intervention 1: Bevacizumab | 1 | Salzburg | N/A | Austria | 13.04399 | 47.79941 | 0 | NCT00754650 | |
[
3
] | 74 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments. | null | Chronic Obstructive Pulmonary Disease | COPD | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral tablet, 75 mg, twice daily during 6 weeks intervention 2: Dosing to match AZD1236 | intervention 1: AZD1236 intervention 2: Placebo | 14 | Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Helsinki | N/A | Finland | 24.93545 | 60.16952
Oulu | N/A | Finland | 25.46816 | 65.01236
Preitilä | N/A | Finland | 22.73781 | 60.46203
Berlin | N/A | Germany | 13.41053 | 52.52437
Grobhansdorf | N/A | Germany | N/A | N/A
Győr | ... | 0 | NCT00758459 |
[
3
] | 554 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy. | Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in I... | Irritable Bowel Syndrome | Irritable Bowel Syndrome Bowel disease | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oral tablet, dose level 1 (10 mg), once daily intervention 2: Oral tablet, dose level 2 (30 mg), once daily intervention 3: Oral tablet, dose level 3 (60 mg), once daily intervention 4: Oral tablet matching the three dose levels of ibodutant, once daily | intervention 1: Ibodutant intervention 2: Ibodutant intervention 3: Ibodutant intervention 4: Placebo | 6 | Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165
Berlin | N/A | Germany | 13.41053 | 52.52437
Riga | N/A | Latvia | 24.10589 | 56.946
Moscow | N/A | Russia | 37.61556 | 55.75222
Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664
Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 | 0 | NCT00761007 |
[
4
] | 308 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP). | The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, ... | Chronic Low Back Pain | Effect on sleep interference by pain | null | 3 | arm 1: 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). arm 2: 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). arm 3: 2 placebo tablets, twice daily, for 4 weeks (double-blind period). | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: ABT-712 extended-release tablet intervention 2: Placebo tablet | intervention 1: ABT-712 intervention 2: Placebo | 32 | Tempe | Arizona | United States | -111.90931 | 33.41477
Tempe | Arizona | United States | -111.90931 | 33.41477
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Lomita | California | United States | -118.31507 | 33.79224
Clearwater | Florida | United S... | 0 | NCT00761150 |
[
3
] | 88 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis. | null | Psoriasis | psoriasis spray calcitriol | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. intervention 2: Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. | intervention 1: CD 2027 intervention 2: Calcitriol Vehicle | 6 | Fridley | Minnesota | United States | -93.26328 | 45.08608
Nashville | Tennessee | United States | -86.78444 | 36.16589
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Barrie | Ontario | Canada | -79.66634 | 44.40011
North Bay | Ontario | Canada | -79.46633 | 46.3168
Waterloo | Ontario | Canada | -80.51639 | 43.466... | 0 | NCT00763555 |
[
3
] | 190 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to compare once and twice daily GW685698 in asthma | null | Asthma | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Inhaled Corticosteroid | intervention 1: GW685698X | 16 | Long Beach | California | United States | -118.18923 | 33.76696
Long Beach | California | United States | -118.18923 | 33.76696
Torrance | California | United States | -118.34063 | 33.83585
Cocoa | Florida | United States | -80.742 | 28.38612
Tallahassee | Florida | United States | -84.28073 | 30.43826
Bethesda | Maryl... | 0 | NCT00766090 | |
[
2
] | 49 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either don... | This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking an AChEI medication (donepezil or rivastigmine).
Study drug will be supplied as capsules and will be orally administered once daily for... | Alzheimer's Disease Central Nervous System Diseases | Alzheimer's Disease Central Nervous System Diseases Pharmacokinetics Cognition | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: EVP-6124 was administered as one 0.1 mg capsule per day for 28 days. intervention 2: EVP-6124 was administered as one 0.3 mg capsule every day for 28 days. intervention 3: EVP-6124 was administered as one 1.0 mg capsule every day for 28 days. intervention 4: Matching placebo was administered as one caps... | intervention 1: EVP-6124 (0.1 mg/day) intervention 2: EVP-6124 (0.3 mg/day) intervention 3: EVP-6124 (1.0 mg/day) intervention 4: Comparator: Placebo intervention 5: Donepezil intervention 6: Rivastigmine | 4 | San Diego | California | United States | -117.16472 | 32.71571
Hallandale | Florida | United States | -80.14838 | 25.9812
Berlin | New Jersey | United States | -74.92905 | 39.79123
Princeton | New Jersey | United States | -74.65905 | 40.34872 | 0 | NCT00766363 |
[
5
] | 386 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension | null | Hypertension | Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2 | null | 2 | arm 1: Aliskiren Hydrochlorothiazide(HCTZ) arm 2: Ramipril | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks intervention 2: Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks | intervention 1: Aliskiren Hydrochlorothiazide intervention 2: Ramipril | 6 | Beverly Hills | California | United States | -118.40036 | 34.07362
Santa Ana | California | United States | -117.86783 | 33.74557
Conyers | Georgia | United States | -84.01769 | 33.66761
Lexington | Kentucky | United States | -84.47772 | 37.98869
Columbia | South Carolina | United States | -81.03481 | 34.00071
Houston ... | 0 | NCT00772577 |
[
3
] | 22 | null | CROSSOVER | 0TREATMENT | 1SINGLE | false | 0ALL | false | Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs. In this study, rHuPH20... | Participants received all 4 interventions in the same order.
Dose-finding visits were conducted to identify the appropriate dose of Humalog and Humulin-R. For each Humalog dose-finding visit, a total of 24 U of rHuPH20 was injected SC per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per mi... | Type 1 Diabetes Mellitus | Recombinant Hyaluronidase Type 1 Diabetes Mellitus Humalog Humulin R rHuPH20 Hylenex | null | 1 | arm 1: Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.
Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, ... | [
0
] | 4 | [
0,
0,
0,
10
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Humalog intervention 2: Humulin-R intervention 3: Recombinant human hyaluronidase PH20 (rHuPH20) intervention 4: Liquid meal | 1 | Chula Vista | California | United States | -117.0842 | 32.64005 | 0 | NCT00774800 |
[
0
] | 10 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to determine the importance of uptake drug transporters in the drug disposition of warfarin. We predict that the elimination of warfarin will be decreased when co-dosed with an inhibitor of uptake drug transporters. | null | Healthy | warfarin pharmacokinetics drug transporter healthy volunteer drug interaction rifampin | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: warfarin 7.5mg po x 1; rifampin 600mg IV x 1 intervention 2: warfarin 7.5mg po x 1 | intervention 1: warfarin plus rifampin intervention 2: warfarin | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00777855 |
[
2
] | 27 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | true | 2MALE | null | This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe. | null | The Methodology Assessment of Glucose Dependent Insulin Secretion | null | 3 | arm 1: exenatide 5mcg arm 2: exenatide 1.5mcg arm 3: Placebo | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI. intervention 2: exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. Af... | intervention 1: Comparator: exenatide intervention 2: Comparator: exenatide intervention 3: Comparator: Placebo | 0 | null | 0 | NCT00782418 | |
[
4
] | 82 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associated with CP. This st... | After screening, eligible participants will start the placebo baseline ambulatory phase (4 days). On day 5, they will be hospitalized for three to five days, to undergo a "baseline" 72-hour CFA determination under a controlled diet and using a stool marker to indicate the beginning and end of the controlled diet period... | Chronic Pancreatitis Exocrine Pancreatic Insufficiency | Chronic Pancreatitis Exocrine Pancreatic Insufficiency | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Placebo matching to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which will then be randomized to either high dose or low dose of EUR-1008 (APT-1008). intervention 2: EUR-1008 (APT-1008) total high dose 140,000 lipas... | intervention 1: Placebo intervention 2: EUR-1008 (APT-1008) High Dose intervention 3: EUR-1008 (APT-1008) Low Dose | 18 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Gainesville | Florida | United States | -82.32483 | 29.65163
Port Orange | Florida | United States | -80.99561 | 29.13832
Hines | Illinois | United States | -87.8395 | 41.85364
Iowa Ctiy | Iowa... | 0 | NCT00788593 |
[
2
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clin... | null | Diabetes Mellitus, Non-Insulin-Dependent | null | 3 | arm 1: Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods. arm 2: Participants received a single ris... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C. intervention 2: Matching placebo to MK-1006 in a single oral dose | intervention 1: MK-1006 intervention 2: Placebo | 0 | null | 0 | NCT00791661 | |
[
2
] | 49 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 3TRIPLE | true | 0ALL | false | The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement. | null | Bacterial Infections | Linezolid, QTc interval, pharmacokinetics, therapeutic dose, supra-therapeutic dose | null | 7 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None | [
2,
0,
0,
2,
0,
0,
1
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Intravenous, Placebo control for blinding, Normal Saline, Single dose intervention 2: Intravenous, 900 mg linezolid, single dose intervention 3: Intravenous, 1200 mg linezolid, single dose intervention 4: Intravenous, Placebo control for blinding, Normal Saline, Single dose intervention 5: Intravenous, ... | intervention 1: Placebo intervention 2: Linezolid 900 mg intervention 3: Linezolid 1200 mg intervention 4: Placebo intervention 5: Linezolid 600 mg intervention 6: Linezolid 1200 mg intervention 7: Moxifloxacin 400 mg | 1 | Singapore | N/A | Singapore | 103.85007 | 1.28967 | 0 | NCT00795145 |
[
5
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 1FEMALE | true | The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned t... | The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned t... | Urinary Incontinence | Stress urinary incontinence, Mixed, Urge | null | 2 | arm 1: Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. arm 2: The non-surgical treatment will include two components:
1. Pharmacological therapy with any FDA approved overactive bladder (OA... | [
1,
1
] | 2 | [
0,
3
] | intervention 1: Both oral urge incontinence medication and behavioral treatment intervention 2: Initial surgical (stress incontinence surgery) treatment approach. | intervention 1: Non-Surgical Intervention intervention 2: Surgical | 10 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Maywood | Illinois | United States | -87.84312 | 41.8792
Baltimore | Maryland | United States | -76.61219 | 39.29038
Dearborn | Michigan | United States | -83.17631 | 42.32226
Royal Oak | Michigan ... | 0 | NCT00803270 |
[
0
] | 51 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 3TRIPLE | true | 0ALL | false | Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use. | Several types of solutions are used in contact lens wear.
Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.
The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to... | Normal Contact Lens Wear | confocal microscopy contact lens wear contact lens solutions sodium fluorescein | null | 3 | arm 1: Subjects that have never worn contacts with no ocular problems were selected. A baseline HRT was performed. Trial contact lenses were soaked in clear care solution for 10 hours. After 10 hours of the lenses soaking in clear care the subject returned. The contacts lenses that were soaked in clear care were insert... | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: neutralized Clear Care intervention 2: overnight soak in solution intervention 3: overnight soak in solution | intervention 1: Clear Care intervention 2: ReNu intervention 3: OPTI-FREE | 1 | Iowa City | Iowa | United States | -91.53017 | 41.66113 | 0 | NCT00804999 |
[
3
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating patients with myelodysplastic syndromes. | OBJECTIVES:
Primary
* Determine the clinical activity (improvement in erythroid response and/or improvement in other cytopenias, bone marrow morphology/cytogenetics) of RAD001(everolimus) in patients with low or intermediate-1 risk myelodysplastic syndromes.
* Assess the toxicity of this drug in these patients.
Seco... | Myelodysplastic Syndromes | de novo myelodysplastic syndromes secondary myelodysplastic syndromes previously treated myelodysplastic syndromes | null | 1 | arm 1: RAD001 (everolimus) at 10mg/day with Bone marrow aspirate/biopsy and other laboratory biomarker analysis | [
0
] | 3 | [
0,
10,
3
] | intervention 1: Patients will receive monotherapy with RAD001(everolimus)for 21 days within the 28 day cycle. intervention 2: Laboratory correlates (cytotoxic t cell populations, S6K1 levels, GSTT-1 mutations, and the presence or absence of HLA-DR15) will be assessed to see if any of these correlates correspond to resp... | intervention 1: everolimus intervention 2: laboratory biomarker analysis intervention 3: Bone marrow aspirate/biopsy | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00809185 |
[
5
] | 106 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers. | 0.1 % of hospitalized patients are attributed to upper gastrointestinal bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper gastrointestinal bleeding. Endoscopic hemostasis procedure in the management of bleeding due to peptic ulcers was safe as well as effective and l... | Peptic Ulcer Hemorrhage | peptic ulcer bleeding rabeprazole proton pump inhibitor | null | 2 | arm 1: Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. arm 2: Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maint... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. intervention 2: Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4,... | intervention 1: omeprazole sodium IV intervention 2: Rabeprazole | 2 | Bucheon-si | Kyungkido | South Korea | 126.78306 | 37.49889
Uijeongbu-si | Kyungkido | South Korea | 127.0474 | 37.7415 | 0 | NCT00838682 |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations | The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Bloo... | Healthy | bioavailability pharmacokinetics healthy crossover trazodone | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 100 mg immediate-release tablet, dosing q8h intervention 2: 300 mg extended-release caplet, single dose | intervention 1: Trazodone HCl intervention 2: Trazodone HCl | 1 | Laval | Quebec | Canada | -73.692 | 45.56995 | 0 | NCT00839072 |
[
2
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX. | null | Rheumatoid Arthritis | null | 2 | arm 1: Daily oral intake of LX3305 for 14 days. arm 2: Matching placebo dosing with daily oral intake for 14 days. | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Daily oral intake of LX3305 for 14 days. intervention 2: Matching placebo dosing with daily oral intake for 14 days. intervention 3: Once weekly stable-dose methotrexate. | intervention 1: LX3305 intervention 2: LX3305 Placebo intervention 3: Methotrexate | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00847886 | |
[
3
] | 56 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device. | A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Cente... | Cutaneous Leishmaniasis | null | 2 | arm 1: 20 mg/kg/day Sodium stibogluconate intravenous arm 2: ThermoMed device, single heat treatment at 50 degrees Celsius | [
1,
0
] | 2 | [
0,
1
] | intervention 1: intravenous 20 mg/kg/day for 10 days intervention 2: ThermoMed heat treatment device, one treatment | intervention 1: Sodium stibogluconate (Pentostam) intervention 2: ThermoMed | 1 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT00884377 | |
[
2
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses of atorvastatin on the pharmacokinetic prof... | Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4 /5 competitive and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses of atorvastatin on the pharmacokinetic pro... | Healthy | pharmacokinetics | null | 2 | arm 1: baseline colchicine pharmacokinetics arm 2: Colchicine pharmacokinetics in the presence of atorvastatin at steady state. | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: A single dose of 0.6 mg colchicine administered alone in the morning on Day 1. intervention 2: Atorvastatin (1 x 40 mg tablet) administered once daily on Days 15-28. intervention 3: A single dose of 0.6 mg colchicine administered with a single dose of 40 mg atorvastatin in the morning on Day 28 after an... | intervention 1: Colchicine intervention 2: Atorvastatin intervention 3: Colchicine | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT00960323 |
[
2
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV. | null | HIV-1 Infection HIV Infections | Treatment experienced | null | 3 | arm 1: MK0518 arm 2: famotidine + MK0518 arm 3: omeprazole + MK0518 | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. intervention 2: Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518 intervention 3: 20 mg oral tablet of omeprazole, on... | intervention 1: MK0518 (Raltegravir) intervention 2: famotidine intervention 3: omeprazole | 0 | null | 0 | NCT01000818 |
[
4
] | 65 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | true | 0ALL | false | This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model | null | Caries | remineralization enamel in situ fluoride caries | null | 6 | arm 1: Placebo arm 2: Sodium fluoride toothpaste arm 3: Amine Fluoride arm 4: Dose response arm 5: Sodium monofluorophosphate/sodium fluoride Toothpaste arm 6: None | [
5,
0,
1,
5,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Test product intervention 2: Test product intervention 3: test product intervention 4: placebo and washout treatment intervention 5: dose response | intervention 1: Sodium Fluoride Toothpaste intervention 2: Amine Fluoride Toothpaste intervention 3: Sodium monofluorophosphate/Sodium Fluoride Toothpaste intervention 4: Placebo intervention 5: 675 ppmf toothpaste | 0 | null | 0 | NCT01005966 |
[
4
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative... | Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms. | Insomnia Obstructive Sleep Apnea | null | 2 | arm 1: Ramelteon 8 mg oral before bedtime arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ramelteon (rozerem) 8mg oral before bedtime intervention 2: placebo | intervention 1: rozerem intervention 2: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT01048242 | |
[
4
] | 30 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:
1. provide pharmacodyn... | Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week wash... | Intragastric Acidity | Gastric Acid Human Experimentation | null | 3 | arm 1: 20 mg omeprazole and 1100 mg sodium bicarbonate arm 2: 20.6 mg omeprazole-magnesium complex. arm 3: Inert substance | [
0,
1,
2
] | 3 | [
0,
0,
10
] | intervention 1: Zegerid taken once daily for 11 days. intervention 2: Prilosec OTC™ Tablets taken once daily for 11 days. intervention 3: Placebo taken once daily for 11 days. | intervention 1: Zegerid intervention 2: Prilosec OTC™ Tablets intervention 3: Placebo | 0 | null | 0 | NCT01077076 |
[
4
] | 237 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Primary objective:
To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.
Secondary objectives:
1. To assess the local tol... | null | Uremic Xerosis | null | 2 | arm 1: cream arm 2: cream | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: V0034CR01B intervention 2: V0034CR01B vehicle | 0 | null | 0 | NCT01084148 | |
[
0
] | 200 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality | Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function. | Nosocomial Infection External Causes of Morbidity and Mortality Hypoglycemia | tight glycemic control cardiac surgery | null | 2 | arm 1: TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU... | intervention 1: TGC intervention 2: Conventional glycaemic control | 1 | Hat Yai | Changwat Songkhla | Thailand | 100.47668 | 7.00836 | 0 | NCT01225159 |
[
5
] | 56 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 0NONE | false | 0ALL | true | The primary goal of the study is to measure in the intact human heart, the alterations in gene expression over time that are associated with reverse remodeling in response to β-blockade. The second goal is to investigate the signaling mechanisms which in turn are responsible for these changes in gene expression, and th... | null | Idiopathic Dilated Cardiomyopathy | ejection fraction beta-blocker carvedilol metoprolol myocardial gene expression human heart ventricular remodeling wall stress adrenergic signaling myosin heavy chain | null | 4 | arm 1: Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy arm 2: Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months arm 3: Idiopathic dilated cardiomyopathy patients who we... | [
4,
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Carvedilol intervention 2: Metoprolol succinate intervention 3: Metoprolol succinate + doxazosin | 2 | Denver | Colorado | United States | -104.9847 | 39.73915
Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT01798992 |
[
5
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly... | null | Induction of Labor | induction of labor pitocin foley bulb | null | 2 | arm 1: Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. arm 2: Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. | [
1,
1
] | 1 | [
0
] | intervention 1: None | intervention 1: pitocin | 0 | null | 0 | NCT02150954 |
[
0
] | 20 | RANDOMIZED | PARALLEL | 5SCREENING | 0NONE | false | 0ALL | false | The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus. | null | Kidney Transplantation | null | 2 | arm 1: Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monothera... | [
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively. ... | intervention 1: MabCampath, intervention 2: Remicade intervention 3: Sirolimus intervention 4: Tacrolimus | 0 | null | 0 | NCT02711202 | |
[
0
] | 149 | RANDOMIZED | PARALLEL | 9OTHER | 0NONE | false | 0ALL | false | Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral).
This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in t... | 6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether t... | Acute Upper Respiratory Tract Infections | Respiratory infections Primary care Antibiotics Delayed prescriptions | null | 2 | arm 1: a delayed prescription dated 2 days after clinical office visit arm 2: usual date | [
5,
5
] | 2 | [
10,
0
] | intervention 1: None intervention 2: None | intervention 1: A delayed prescription dated 2 days after clinical office visit intervention 2: Usual Dated | 1 | St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 | 0 | NCT02732847 |
[
3
] | 27 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease. | null | Chronic Kidney Disease | Chronic Kidney Disease Sitaxsentan | null | 3 | arm 1: Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) arm 2: Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm) arm 3: Placebo for sitaxsentan, orally administered once daily (double blind arm) | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Sitaxsentan sodium 100 mg orally administered once daily (double blind arm) intervention 2: Nifedipine = 30 mg extended release tablets, orally administered once daily (open label arm) intervention 3: Placebo for sitaxsentan, orally administered once daily (double blind arm) | intervention 1: Open intervention 2: Nifedipine intervention 3: Placebo | 2 | Edinburgh | Scotland | United Kingdom | -3.19648 | 55.95206
Edinburgh | Scotland | United Kingdom | -3.19648 | 55.95206 | 0 | NCT00810732 |
[
3
] | 67 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH 900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or placebo will be administered in a crossover fashion for two 3-week treatment periods. The two 3-week treatment periods will be separated by ... | null | Attention Deficit Hyperactivity Disorder | randomized double blind placebo controlled | null | 4 | arm 1: Participants receive a fixed dose (FD) of MK-8777 100 mg twice each day (BID) for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo (PBO) BID for 3 weeks (Treatment Period 2). arm 2: Participants receive a fixed dose of placebo BID for 3 weeks (Trea... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: MK-8777 intervention 2: Placebo | 0 | null | 0 | NCT00610441 |
[
3
] | 62 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients. | null | Parkinson Disease | Parkinson's Disease PD | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed ... | intervention 1: Ropinirole prolonged release/extended release(PR/XR) | 12 | Aichi | N/A | Japan | 130.62158 | 32.51879
Aichi | N/A | Japan | 130.62158 | 32.51879
Chiba | N/A | Japan | 140.11667 | 35.6
Ehime | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kyoto | N/A | Japan | 135.75385 | 35.02107
Numakunai | N/A | Japan | 141.21667 | 3... | 0 | NCT00434304 |
[
2,
3
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Objectives:
The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d. for 8 consecutive weeks, to induce complete healing of mucosal ulcerations of ileum and/or colon, assessed by endoscopy, in patients with endoscopic and clinical evidence of active mo... | The study was conducted according to a randomized, double-blind placebo-controlled, parallel group design in up to 25 clinical sites in Europe.
Eligible patients were randomly assigned to two parallel treatment groups (1:1 randomization ratio) receiving either ITF2357, as hard gelatine capsule for oral administration,... | Crohn's Disease | null | 2 | arm 1: Oral matching placebo capsules, administered bid. arm 2: Oral ITF2357 50 mg bid | [
2,
0
] | 2 | [
0,
10
] | intervention 1: ITF2357 was administered as hard gelatin capsules for oral administration at the dose strength of 50 mg. Capsules were administered as follow: one capsule in the morning and one in the evening. intervention 2: Placebo was supplied as matching capsules for oral administration with the same outer appearan... | intervention 1: ITF2357 intervention 2: Placebo | 10 | Assebroek | N/A | Belgium | 3.2623 | 51.19367
Bonheiden | N/A | Belgium | 4.54714 | 51.02261
Brussels | N/A | Belgium | 4.34878 | 50.85045
Ghent | N/A | Belgium | 3.71667 | 51.05
Kortrijk | N/A | Belgium | 3.26487 | 50.82803
Leuven | N/A | Belgium | 4.70093 | 50.87959
Rozzano | N/A | Italy | 9.1559 | 45.38193
Amsterdam... | 0 | NCT00792740 | |
[
4
] | 120 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1... | null | Rheumatoid Arthritis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 1000 mg intravenously on Days 1 and 15 | intervention 1: rituximab | 41 | Edmonton | Alberta | Canada | -113.46871 | 53.55014
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Kelowna | British Columbia | Canada | -119.48568 | 49.88307
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Winnipeg | Manitoba | Canada | -97... | 0 | NCT01272908 | |
[
2
] | 64 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will assess the safety of telcagepant in coronary artery disease (CAD) participants with stable angina during exercise treadmill testing and evaluate whether calcitonin gene-related peptide (CGRP) receptor antagonism by telcagepant reduces exercise tolerance in these participants. Primary hypothesis is that ... | Amendment 3 of the protocol reduced the dose of telcagepant to be administered from a single dose of 900 mg to a single dose of 600 mg. Pooled data from both the 600-mg and the 900-mg group wiil be utilized in the analyses. Also due to supply issues regarding the 300 mg telcagepant capsules, 280 mg telcagepant tablets ... | Angina Pectoris Coronary Heart Disease Calcitonin Gene-related Peptide Receptor | angina pectoris coronary artery disease calcitonin gene-related peptide exercise tolerance, | null | 2 | arm 1: Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossove... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: telcagepant intervention 2: Placebo to telcagepant | 0 | null | 0 | NCT01294709 |
[
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the g... | OBJECTIVES:
* To determine the maximum tolerated dose of monoclonal antibody RAV12 when administered with standard gemcitabine hydrochloride in patients with previously untreated metastatic pancreatic cancer.
* To determine the proportion of these patients surviving at 8 months after initiation of this regimen.
* To p... | Pancreatic Cancer | adenocarcinoma of the pancreas stage IV pancreatic cancer recurrent pancreatic cancer | null | 1 | arm 1: None | [
0
] | 2 | [
2,
0
] | intervention 1: RAV12 at 0.375 mg/kg weekly escalated to 0.75 mg/kg weekly, intravenously. intervention 2: 1000 mg/m2 weekly, intravenously | intervention 1: RAV12 intervention 2: Gemcitabine | 2 | South San Francisco | California | United States | -122.40775 | 37.65466
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00625586 |
[
4
] | 1,468 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.
This study tests whether RS... | A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's diseas... | Alzheimer's Disease | adjunctive therapy moderate Alzheimer's disease apolipoprotein E mild rosiglitazone cognition | null | 3 | arm 1: Rosiglitazone Extended Release 2mg OD arm 2: Rosiglitazone Extended Release 8mg OD arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: Rosiglitazone Extended Release 2mg OD intervention 2: Rosiglitazone Extended Release 8mg OD intervention 3: Placebo | intervention 1: Rosiglitazone Extended Release 2mg intervention 2: Rosiglitazone Extended Release 8mg intervention 3: Placebo | 194 | Sun City | Arizona | United States | -112.27182 | 33.59754
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Laguna Hills | California | United States | -117.71283 | 33.61252
Redlands | California | United States | -117.18254 | 34.05557
San Diego | Ca... | 0 | NCT00348140 |
[
5
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 2MALE | false | The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct disorder. The initial dose depending on the weight of the patient will be as follows: \< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5... | The use of atypical antipsychotics in children began in 1992 with several small case series with clozapine. Since that time, five other atypical agents, risperidone, olanzapine, quetiapine, ziprasidone and aripiprazole have been introduced into the US market. The newer atypical agents are not associated with agranulocy... | Conduct Disorder | Aripiprazole | ICF_002.pdf:
FOR IRB USE ONLY
$STAMP_IRB
$STAMP_IRB_ID
$STAMP_APPRV_DT
$STAMP_EXP_DT
Page 1 of 7
INFORMED CONSENT DOCUMENT
Project Title:
An Open Label Trial of Aripiprazole in the Treatment of Conduct Disorder in
Adolescents
Research Team: Samuel Kuperman, MD, Chadi Calarge, MD, Anne Kolar, MD... | 1 | arm 1: All subjects were male and had a diagnosis of conduct disorder. All subjects were offered treatment with aripiprazole. | [
5
] | 1 | [
0
] | intervention 1: The initial dose depending on the weight of the patient will be as follows: \< 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; \> 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. A... | intervention 1: Aripiprazole | 1 | Iowa City | Iowa | United States | -91.53017 | 41.66113 | 0 | NCT00250705 |
[
3
] | 205 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This randomized phase II trial studies how well giving celecoxib with or without eflornithine works in preventing colorectal cancer in patients with familial adenomatous polyposis. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib and eflornithine may keep cancer from forming... | PRIMARY OBJECTIVES:
I. To determine the relative efficacy of celecoxib plus eflornithine (DFMO) versus celecoxib plus DFMO placebo in participants with familial adenomatous polyposis (FAP), as evidenced by the percent change from baseline in the number of polyps in focal area(s) of the colorectum in participants havin... | Colorectal Cancer Familial Adenomatous Polyposis | null | 2 | arm 1: Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. arm 2: Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m\^2/day rounded down to the nearest 250 mg dose. Treatment continues for 6 months i... | [
1,
0
] | 5 | [
0,
10,
0,
10,
10
] | intervention 1: Given 400 mg PO twice a day intervention 2: Given PO to match DFMO intervention 3: Given PO at 0.5 gm/m\^2/day rounded down to the nearest 250 mg dose (BSA of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day). intervention 4: Correlative st... | intervention 1: Celecoxib intervention 2: Placebo intervention 3: eflornithine intervention 4: Laboratory biomarker analysis intervention 5: Questionnaire administration | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00033371 | |
[
4
] | 2,336 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder. | null | Urinary Bladder, Overactive | Micturition Urinary incontinence Urinary urge incontinence Overactive bladder (OAB) Urgency YM178 Frequency | null | 4 | arm 1: Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks. arm 2: Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. arm 3: Participants received mir... | [
2,
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Tablets intervention 2: Capsules intervention 3: Matching mirabegron placebo tablets. intervention 4: Matching tolterodine placebo capsules. | intervention 1: Mirabegron intervention 2: Tolterodine intervention 3: Placebo to Mirabegron intervention 4: Placebo to Tolterodine | 218 | Auchenflower | N/A | Australia | 152.99213 | -27.47443
Clayton | N/A | Australia | 145.11667 | -37.91667
Kogarah | N/A | Australia | 151.13564 | -33.9681
Randwick | N/A | Australia | 151.24895 | -33.91439
Woolloongabba | N/A | Australia | 153.03655 | -27.48855
Graz | N/A | Austria | 15.45 | 47.06667
Innsbruck | N/A | A... | 0 | NCT00689104 |
[
4
] | 1,935 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pai... | null | Migraines | multiple attacks of moderate to severe migraine headaches | null | 4 | arm 1: Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo. arm 2: Telcagepa... | [
0,
0,
2,
2
] | 3 | [
0,
0,
0
] | intervention 1: Telcagepant 140 mg tablets intervention 2: Telcagepant 280 mg tablets intervention 3: Placebo tablets | intervention 1: Telcagepant 140 mg intervention 2: Talcagepant 280 mg intervention 3: Placebo | 0 | null | 0 | NCT00483704 |
[
4
] | 102 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet | null | Epilepsy | epilepsy Incidence of rash safety evaluation for initial dose patients with Valproic acid | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: anti-epileptic drug | intervention 1: lamictal | 2 | Kumamoto | N/A | Japan | 130.69181 | 32.80589
N/A | N/A | N/A | N/A | N/A | 0 | NCT00395694 |
[
2,
3
] | 7 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 1SINGLE | false | 2MALE | true | Duchenne muscular dystrophy (DMD), a fatal muscle degenerative disorder, arises from mutations in the dystrophin gene. Antisense therapy with the use of antisense oligonucleotides (AON) has the potential to restore effectively the production of dystrophin, the defective protein, in \>70% of DMD. This could result in in... | Duchenne Muscular Dystrophy (DMD) is the most common form of muscular dystrophy affecting 1 in every 3500 live male births. The disease is characterised by severe muscle wasting and weakness, which becomes clinically evident between the ages of 3 to 5 years. Affected individuals stop walking by 12 years of age and usua... | Duchenne Muscular Dystrophy | Duchenne muscular dystrophy; antisense oligonucleotides; gene restoration; deletion | null | 2 | arm 1: Low dose of AVI-4658 arm 2: High dose of AVI-4658 | [
0,
0
] | 1 | [
0
] | intervention 1: morpholino antisense oligonucleotide | intervention 1: AVI-4658 (PMO) | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00159250 |
[
2
] | 3 | RANDOMIZED | CROSSOVER | 9OTHER | 1SINGLE | true | 0ALL | false | The purpose of this study is to compare subjective drug liking using the Drug Rating Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and ADDERALL XR® when administered as an oral solution.
Hypothesis: DRQ-S, question 2 will show no difference between the two drugs | Not required | Healthy | Not required | null | 2 | arm 1: 50mg capsule that has been emptied and made into solution arm 2: 20mg capsule that has been emptied, crushed, and made into solution | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been sol... | intervention 1: Lisdexamfetamine Dimesylate intervention 2: Racemic mixture of dextroamphetamine and lisdexamfetamine | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00776555 |
[
4
] | 8,231 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 2MALE | null | This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months ... | null | Neoplasms, Prostate | Prostate cancer prevention prostate BPH enlarged prostate PSA prostate cancer | null | 2 | arm 1: Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio. arm 2: Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally... | intervention 1: Dutasteride intervention 2: Placebo | 932 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Homewood | Alabama | United States | -86.80082 | 33.47177
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Anchorage | Alaska | United States | -149.90028 | 61.21806
Phoenix | Arizona | United S... | 1 | NCT00056407 |
[
4
] | 2,035 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receiv... | This study was conducted in 2 parts: An initial 2-arm part in which patients were randomized to 1 of 2 different treatment groups (XELOX or FOLFOX-4), and a subsequent 2 x 2 factorial part, added to the study through a protocol amendment, in which additional patients were randomized into one of 4 different treatment gr... | Colorectal Cancer | null | 4 | arm 1: Patients in the 2-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab ... | [
0,
0,
1,
1
] | 9 | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine. intervention 2: Capecitabine was taken within 30 min after the end of breakfast and dinner. intervention 3: Bevacizumab was administered in a 30 to 90 min infusion. intervention 4: Placebo control for bevacizumab (volu... | intervention 1: Oxaliplatin 130 mg/m^2 intervention 2: Capecitabine 1000 mg/m^2 intervention 3: Bevacizumab 7.5 mg/kg intervention 4: Placebo for bevacizumab 7.5 mg/kg intervention 5: Oxaliplatin 85 mg/m^2 intervention 6: Leucovorin 200 mg/m^2 intervention 7: Fluorouracil 400 mg/m^2 intervention 8: Bevacizumab 5 mg/kg ... | 236 | Berkeley | California | United States | -122.27275 | 37.87159
Fountain Valley | California | United States | -117.95367 | 33.70918
Fullerton | California | United States | -117.92534 | 33.87029
Gilroy | California | United States | -121.56828 | 37.00578
Greenbrae | California | United States | -122.5247 | 37.94854
Los ... | 0 | NCT00069095 | |
[
4
] | 4,844 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | null | This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 mon... | A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign pro... | Prostatic Hyperplasia | Combination Therapy dutasteride BPH | null | 3 | arm 1: dutasteride 0.5mg once daily arm 2: Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily arm 3: tamsulosin 0.4mg once daily | [
1,
0,
1
] | 2 | [
0,
0
] | intervention 1: combination or single agent intervention 2: combination agent or single agent | intervention 1: dutasteride 0.5mg once daily for 4 years intervention 2: tamsulosin 0.4mg once daily for 4 years | 503 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Columbiana | Alabama | United States | -86.60721 | 33.17817
Hoover | Alabama | U... | 0 | NCT00090103 |
[
4
] | 1,913 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma. | This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of... | Multiple Myeloma | Multiple Myeloma MM Revlimid CC5013 celgene cc-5013 relapsed/refractory lenalidomide dexamethasone Decadron | null | 1 | arm 1: single-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone | [
5
] | 2 | [
0,
0
] | intervention 1: Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone intervention 2: Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens | intervention 1: lenalidomide intervention 2: dexamethasone | 69 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Berkeley | California | United States | -122.27275 | 37.87159
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Stanford... | 1 | NCT00179647 |
[
3
] | 65 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patie... | null | Breast Cancer | null | 1 | arm 1: Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).
Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of ch... | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8) intervention 2: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4) intervention 3: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8) intervention 4: Surgery follow... | intervention 1: gemcitabine intervention 2: doxorubicin intervention 3: cisplatin intervention 4: surgery | 3 | Pune | Maharashtra | India | 73.85535 | 18.51957
Vellore | Tamil Nadu | India | 79.13255 | 12.9184
Delhi | N/A | India | 77.23149 | 28.65195 | 1 | NCT00191789 | |
[
4
] | 626 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure. | null | Gastroesophageal Reflux | Acid reflux disease Gastroesophageal Reflux Disease | null | 2 | arm 1: Surgery arm 2: Esomeprazole (NEXIUM) therapy | [
1,
0
] | 2 | [
0,
3
] | intervention 1: 40 mg oral tablet administered daily intervention 2: Surgery | intervention 1: esomeprazole intervention 2: Laparoscopic fundoplication (surgery) | 59 | Linz | N/A | Austria | 14.28611 | 48.30639
Vienna | N/A | Austria | 16.37208 | 48.20849
Zell am See | N/A | Austria | 12.79839 | 47.32306
Brussels | N/A | Belgium | 4.34878 | 50.85045
Brussels (Anderlecht) | N/A | Belgium | 4.34878 | 50.85045
Brussels (Woluwé-St-Lambert) | N/A | Belgium | 4.34878 | 50.85045
Ghent | N/A... | 1 | NCT00251927 |
[
5
] | 167 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants ... | This is a Phase 4, an open-label (all people know the identity of the intervention), multi-country and multi-centric (conducted in more than one center) study of risperidone long-acting formulation versus oral (having to do with the mouth) atypical antipsychotics in participants with a Diagnostic and Statistical Manual... | Schizophrenia | Schizophrenia Risperidone Risperdal Consta | null | 2 | arm 1: Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatmen... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of... | intervention 1: Risperidone long-acting injection (LAI) intervention 2: Oral atypical Antipsychotic | 44 | Dandenong | N/A | Australia | 145.2 | -37.98333
Frankston | N/A | Australia | 145.12291 | -38.14458
Mount Claremont | N/A | Australia | 115.78337 | -31.96177
Newcastle | N/A | Australia | 151.7801 | -32.92953
Southport | N/A | Australia | 153.39796 | -27.96724
Calgary | Alberta | Canada | -114.08529 | 51.05011
Bathurst... | 1 | NCT00256997 |
[
4
] | 18,113 | RANDOMIZED | PARALLEL | 1PREVENTION | null | false | 0ALL | null | The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism. | null | Atrial Fibrillation Stroke | null | 3 | arm 1: twice a day arm 2: once a day arm 3: twice a day | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: once a day intervention 2: twice daily intervention 3: twice a day | intervention 1: warfarin intervention 2: Dabigatran dose 1 intervention 3: Dabigatran dose 2 | 984 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | Un... | 1 | NCT00262600 | |
[
5
] | 415 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be... | null | Hepatitis C, Chronic | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 180 µg subcutaneously weekly for 48 weeks intervention 2: 800 mg orally daily for 48 weeks intervention 3: 1000 mg or 1200 mg (based on patient weight of \< 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks | intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin intervention 3: Ribavirin | 0 | null | 1 | NCT00353418 | |
[
4
] | 585 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder. Oral olanzapine was used to assess the valid... | This is a randomized, double-blind, double-dummy multicenter study with 3 parallel arms (risperidone long-acting injectable (LAI), placebo, and olanzapine) to evaluate the efficacy and safety of risperidone LAI versus placebo in the prevention of a mood episode (recurrence event). The primary objective of this study is... | Bipolar Disorder | Bipolar I Disorder Intramuscular injection prevention of mood episodes long acting injectable risperidone | null | 3 | arm 1: Risperidone Long Acting Injectable (LAI) Intramuscular injections of risperidone LAI (25 37.5 or 50 mg) every 2 weeks and oral placebo daily arm 2: Placebo Intramuscular injections of placebo every 2 weeks and oral placebo daily arm 3: Olanzapine Intramuscular injections of placebo every 2 weeks and oral olanzap... | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily intervention 2: Intramuscular injections of placebo every 2 weeks and oral placebo daily intervention 3: Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily | intervention 1: Olanzapine intervention 2: Placebo intervention 3: Risperidone Long Acting Injectable (LAI) | 63 | Baoding | N/A | China | 115.46246 | 38.87288
Beijing | N/A | China | 116.39723 | 39.9075
Guangzhou | N/A | China | 113.25 | 23.11667
Nanjing | N/A | China | 118.77778 | 32.06167
Shanghai | N/A | China | 121.45806 | 31.22222
Suozhou | N/A | China | N/A | N/A
Wuhan | N/A | China | 114.26667 | 30.58333
Barranquilla Atlant... | 1 | NCT00391222 |
[
5
] | 1,175 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection o... | null | Hepatitis C, Chronic | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 180 µg sc weekly for 48 weeks intervention 2: 1200 mg po daily for 48 weeks intervention 3: 360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks intervention 4: 1400-1600 mg po daily for 48 weeks | intervention 1: peginterferon alfa-2a intervention 2: Ribavirin intervention 3: peginterferon alfa-2a intervention 4: Ribavirin | 184 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Anchorage | Alaska | United States | -149.90028 | 61.21806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Fresno | California | United States | -119.77237 | 36.74773
La Jolla | California | ... | 1 | NCT00394277 | |
[
4
] | 352 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV. | null | HIV Infection | treatment experienced | null | 2 | arm 1: Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir ) arm 2: Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir) | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment intervention 2: KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment. intervention 3: MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) ... | intervention 1: MK0518 (raltegravir) intervention 2: Comparator: KALETRA™ (lopinavir (+) ritonavir ) intervention 3: Comparator: placebo intervention 4: Comparator: placebo | 0 | null | 1 | NCT00443703 |
[
3
] | 278 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic... | The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 mg/day to 1400 mg/day based on subject body weight, with both drugs administered in combination with peginterferon alfa-2b to therapy-n... | Chronic Hepatitis C | Phase 2b Dose-Ranging Study | null | 4 | arm 1: Oral taribavirin tablet 20 mg/kg/day (Actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) arm 2: Oral taribavirin tablet 25 mg/kg/day (Actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk) ... | [
0,
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week f... | intervention 1: Taribavirin intervention 2: Taribavirin intervention 3: Taribavirin intervention 4: Ribavirin | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 1 | NCT00446134 |
[
3
] | 207 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel ... | null | Opioid Induced Constipation (OIC) | NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar | null | 2 | arm 1: Placebo arm 2: NKTR-118 | [
2,
0
] | 2 | [
0,
0
] | intervention 1: placebo, oral, once daily (QD) intervention 2: 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD) | intervention 1: placebo intervention 2: NKTR-118 | 33 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Pinson | Alabama | United States | -86.68332 | 33.68899
Tucson | Arizona | United States | -110.92648 | 32.22174
Laguna Hills | California | United States | -117.71283 | 33.61252
San Diego | California | United States | -117.16472 | 32.71571
Littleton | Colorad... | 1 | NCT00600119 |
[
5
] | 6,586 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. | null | Non-Small Cell Lung Cancer | null | 1 | arm 1: Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason. | [
0
] | 1 | [
0
] | intervention 1: Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. | intervention 1: Erlotinib | 543 | Tirana | N/A | Albania | 19.81866 | 41.32744
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
... | 0 | NCT00949910 | |
[
2,
3
] | 108 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing them or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that... | OBJECTIVES:
* Determine the safety of paclitaxel and ifosfamide followed by carboplatin and etoposide with stem cell support in patients with unfavorable germ cell tumors with unfavorable prognostic factors and resistance to cisplatin.
* Determine the efficacy of this regimen as salvage therapy in these patients.
* Es... | Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor | recurrent malignant testicular germ cell tumor recurrent ovarian germ cell tumor extragonadal germ cell tumor | null | 1 | arm 1: The design of this trial is a phase I/II trial of sequential accelerated chemotherapy cycles with taxol/ifosfamide and carboplatin/etoposide administered with G-CSF and PBSC support. | [
0
] | 6 | [
2,
0,
0,
0,
0,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None | intervention 1: filgrastim intervention 2: carboplatin intervention 3: etoposide intervention 4: ifosfamide intervention 5: paclitaxel intervention 6: peripheral blood stem cell transplantation | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00002558 |
[
3
] | 16 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | null | Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: For patients: dystonia rating sca... | Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: dystonia rating scales (TWISTRS) | Focal Dystonia | Writer's Cramp Calcium Channel Antagonists Torticollis Chemodenervation | null | 1 | arm 1: cervical dsytonia patinets | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Amlodipine plus Botulinum toxin | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00015457 |
[
3
] | 36 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the ... | Hepatitis C infection occurs in one-third of all HIV-infected individuals. Liver disease has become more clinically significant among patients coinfected with HIV and HCV. Several studies have shown that coinfected individuals develop earlier and severe liver disease. Interferon with ribavirin has become the therapy of... | Hepatitis C HIV Infections | Liver Disease Virologic Response Immune Mechanisms Cirrhosis Eradication HIV Hepatitis C | null | 1 | arm 1: Weekly Injection of peginterferon alfa-2b and weight based ribavirin (1-1.2g/day) for 48 weeks | [
0
] | 2 | [
0,
0
] | intervention 1: Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously intervention 2: Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks. | intervention 1: Peginterferon alfa-2b intervention 2: Ribavirin | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00018031 |
[
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The ... | OBJECTIVES:
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant
Chronic Graft-versus-Host Disease Matched Related patie... | Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms | recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblas... | null | 1 | arm 1: This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction. | [
0
] | 6 | [
2,
0,
0,
0,
3,
3
] | intervention 1: Consenting individuals will receive pretransplant immunosuppressive cytoreduction, which will consist of 4 days of Campath-1H, 5 days of fludarabine, and two days of melphalan. All therapy should be completed approximately 24-36 hours before administration of the primary allograft.
Campath-1H (20mg/dos... | intervention 1: alemtuzumab intervention 2: cyclosporine intervention 3: fludarabine phosphate intervention 4: melphalan intervention 5: allogeneic bone marrow transplantation intervention 6: peripheral blood stem cell transplantation | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00027560 |
[
3
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to ... | OBJECTIVES:
* Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
* Determine the objective response rate and overall survival of patients treated with these regimens.
* Determine the incidence of thromboem... | Pancreatic Cancer | adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer | null | 2 | arm 1: bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference. arm 2: rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over ... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: rhuMAB-VEGF intervention 2: docetaxel | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00066677 |
[
3
] | 46 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | BAY 43-9006 (Sorafenib) is an experimental cancer drug produced by Bayer Health Care Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This study will investigate its effect on prostate cancer and its side effects. Researchers expect to enroll a maximum of 46 men with prostate cancer f... | BAY 43-9006 (Sorafenib) is a potent inhibitor of wild-type and mutant b-Raf and c-Raf kinase isoforms in vitro. In addition, this agent also inhibits p38, c-kit, vascular endothelial growth factor receptor 2 (VEGFR-2) and platelet-derived growth factor receptor beta (PDGFR-beta) affecting tumor growth as well as possib... | Prostate Cancer | Hormone-Refractory Proteomics Angiogenesis VEGFR Prostate Cancer Metastatic Prostate Cancer | Prot_000.pdf:
1
NCI Protocol #:
CC Protocol #: 04-C-0262 (Version I)
CTEP # 6594
A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer
Principal Investigator:
William L. Dahut, M.D., MOB/CCR/NCI
Protocol chairperson:
William L. Dahut, M.D., ... | 2 | arm 1: The first stage was to rule out the probability of 4 month progression free survival.
Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles. arm 2: Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second st... | [
0,
0
] | 1 | [
0
] | intervention 1: 400 mg BAY 43-9006 orally twice daily in 28 day cycles. | intervention 1: BAY 43-9006 | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00090545 |
[
3,
4
] | 190 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Maraviroc (UK-427,857), a selective and reversible CCR5 co-receptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients in the United States, maraviroc (UK-427,857) is approved for use as part of combinati... | (i) Subjects remained on their assigned therapy for 48 weeks, unless the subject was discontinued early for protocol-defined treatment failure or other reasons such as adverse event, loss to follow-up, withdrawal of consent, or death.
(ii) If a subject met the criteria for treatment failure or discontinued for another... | HIV Infections | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: OBT (3-6 drugs based on treatment history and resistance testing) intervention 2: maraviroc (UK-427,857) 150 mg taken once daily intervention 3: OBT (3-6 drugs based on treatment history and resistance testing) intervention 4: maraviroc (UK-427,857) 150 mg taken twice daily intervention 5: OBT (3-6 drug... | intervention 1: Optimized Background Therapy (OBT) intervention 2: maraviroc (UK-427,857) intervention 3: Optimized Background Therapy (OBT) intervention 4: maraviroc (UK-427,857) intervention 5: Optimized Background Therapy (OBT) | 77 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Beverly Hills | California | United States | -118.40036 | 34.07362
Fountain Valley | California | United States | -117.95367 | 33.70918
Hayward | California | United States | -122.0808 | 37.66882
Los An... | 0 | NCT00098748 | |
[
0
] | 56 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth facto... | This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Seco... | AIDS HIV Infections | HIV lipodystrophy growth hormone visceral fat IGF-I Treatment Experienced | null | 2 | arm 1: recombinant human growth hormone subcutaneously once a day arm 2: placebo subcutaneously once a day | [
1,
2
] | 2 | [
0,
0
] | intervention 1: growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months intervention 2: placebo subcutaneously once a day, 18 months | intervention 1: recombinant human growth hormone intervention 2: placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00100698 |
[
3
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce tumor size and prolong survival in patients with metastatic melanoma (melanoma that has spread beyond the original tumor site). It will also examine the toxicity and blood effects of Revlimid.
Patients 18 years of age and older... | Background:
* Patients with stage IV ocular melanoma have very few available treatment options and an overall poor prognosis.
* Pre-clinical and early clinical evidence suggest that lenalidomide has activity against solid tumors.
* This trial is designed to evaluate the safety and efficacy of two different doses of a ... | Melanoma | Response Rate Toxicity Progression-Free Survival Overall Survival Pharmacokinetic Ocular Melanoma | null | 2 | arm 1: oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks arm 2: oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks | [
0,
0
] | 1 | [
0
] | intervention 1: oral dose (1 capsule) 25 mg per day 7 days a week for cohort 1 oral dose (1 capsule) 5 mg per day 7 days a week for cohort 2 | intervention 1: Revlimid | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00109005 |
[
0
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated. | There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also infl... | Atherosclerosis | atherosclerosis inflammation statins PET carotid ultrasonography | null | 2 | arm 1: Patients with FDG-positive plaque who received simvastatin and diet therapy arm 2: Patients FDG-positive plaque who received diet therapy alone | [
0,
4
] | 1 | [
0
] | intervention 1: simvastatin 5-10 mg/day | intervention 1: simvastatin | 1 | Kurume | N/A | Japan | 130.51667 | 33.31667 | 0 | NCT00114504 |
[
3
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims include evaluating changes in myocardial iron burden ... | DESIGN NARRATIVE:
Participants will be randomized to 1 year of treatment with L1/DFO combination therapy or DFO monotherapy. At baseline, 6 months, and 1 year on therapy, cardiac function will be assessed by MRI measurement of left ventricular ejection fraction (LVEF), T2\*, Holter monitoring, and electrocardiography.... | Cardiovascular Diseases Heart Diseases Beta-Thalassemia | null | 2 | arm 1: Deferoxamine (DFO) and deferiprone (L1) combination therapy arm 2: Deferoxamine (DFO) monotherapy | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Deferoxamine will be given daily for 12-24h/day 7 days a week either subcutaneous or intravenous at up to 50-60 mg/kg/day. intervention 2: The dose of L1, 75mg/kg in three divided oral doses, is the maximum dose at which toxicity has been tested in prospective trials | intervention 1: Deferoxamine intervention 2: Deferiprone (L1) | 6 | Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | P... | 0 | NCT00115349 | |
[
3
] | 435 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xelod... | null | Colorectal Cancer | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: 850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle intervention 2: 130 mg/m\^2 IV on Day 1 of each 3-week cycle intervention 3: 7.5 mg/kg IV on Day 1 of each 3-week cycle intervention 4: 1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle intervention 5: 85 mg/m\^2 IV on Day 1 of each 2-week cycle in... | intervention 1: capecitabine intervention 2: Oxaliplatin intervention 3: bevacizumab intervention 4: capecitabine intervention 5: Oxaliplatin intervention 6: bevacizumab | 0 | null | 0 | NCT00118755 | |
[
3
] | 27 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do not have the disease. This may be the reason why children and teenagers with sickle cell anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens that do not have the disease.
This study is b... | 1. The study will compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months.
2. The study investigates the effect of oral glutamine and placebo on body composition in children with SCA by ... | Anemia, Sickle Cell | Hemoglobin S Disease Sickle Cell Anemia | null | 2 | arm 1: Glutamine arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 0.6 gm/kg of oral glutamine per day, in two doses for one year. intervention 2: Placebo | intervention 1: Glutamine intervention 2: Placebo | 1 | Memphis | Tennessee | United States | -90.04898 | 35.14953 | 0 | NCT00131508 |
[
4
] | 147 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections.
S... | null | Possible Fungal Infection | Neutropenia Fever of unknown origin Empirical treatment Voriconazole | null | 2 | arm 1: Voriconazole starts within 18 hours of onset of fever intravenously with a loading dose of 6 mg/kg q12h for the first two doses followed by 4 mg/kg q12h (maintenance dose). Switched to oral treatment (200 mg BID) is possible after at least four days. Treatment will be ended if the patient is afebrile (\< 38.0 °C... | [
0,
5
] | 2 | [
0,
0
] | intervention 1: voriconazole, early treatment intervention 2: voriconazole, deferred treatment | intervention 1: voriconazole (Vfend) intervention 2: voriconazole (Vfend) | 28 | Augsburg | N/A | Germany | 10.89851 | 48.37154
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Bielefeld | N/A | Germany | 8.53333 | 52.03333
Bremen | N/A | Germany | 8.80717 | 53.07582
Chemnitz | N/A | Germany | 12.92922 | 50.8357
C... | 0 | NCT00150345 |
[
3
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances \[TBARS\], and aminothiol leve... | Individuals with a high cholesterol level, diabetes or metabolic syndrome (collection of abnormalities such as high blood pressure, high triglyceride levels \[fat\], obesity, high blood glucose level) have an increased risk of developing a hardening of the arteries and heart disease.
A group of medications called stat... | Diabetes Mellitus Metabolic Syndrome X Hypercholesterolemia | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 12 Weeks of Oral Atorvastatin 10 mg therapy. intervention 2: 12 Weeks of Oral Pravastatin 80 mg therapy. | intervention 1: Atorvastatin intervention 2: Pravastatin | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00166036 | |
[
4
] | 57 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. | null | Fetal Growth Retardation | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years | intervention 1: Genotonorm (Somatropin) | 22 | Amiens | N/A | France | 2.3 | 49.9
Angers | N/A | France | -0.55202 | 47.47156
Besançon | N/A | France | 6.01815 | 47.24878
Bordeaux | N/A | France | -0.5805 | 44.84044
Bron | N/A | France | 4.91303 | 45.73865
Caen | N/A | France | -0.35912 | 49.18585
Dunkirk | N/A | France | 2.37681 | 51.0344
Lille | N/A | France | 3.... | 0 | NCT00174252 | |
[
5
] | 30 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in t... | Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 (IC50=30nM), and adrenergic receptors.
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of p... | Bipolar Disorder Mania | children bipolar disorder quetiapine preschoolers | null | 1 | arm 1: 2.5 - 5.0mg/kg PO BID quetiapine
Other Names:
Seroquel | [
0
] | 1 | [
0
] | intervention 1: 2.5 - 5.0mg/kg PO BID quetiapine | intervention 1: quetiapine | 0 | null | 0 | NCT00181883 |
[
5
] | 86 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression. | Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depressio... | Bipolar Disorder Depression | Lamotrigine Divalproex Antidepressant | null | 2 | arm 1: Participants will take active lamotrigine and active divalproex ER arm 2: Participants will take active lamotrigine and placebo | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. ... | intervention 1: Lamotrigine intervention 2: Divalproex (DIV) ER intervention 3: Placebo | 0 | null | 0 | NCT00183469 |
[
5
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset.
We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age ... | Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye incr... | Glaucoma | Latanoprost Glaucoma Intraocular pressure | null | 1 | arm 1: All participants will be taking Latanoprost; This study compares efficacy within age groups. | [
5
] | 1 | [
0
] | intervention 1: Latanoprost 0.005% ophthalmic solution QHS 8 weeks | intervention 1: Latanoprost 0.005% | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00224289 |
[
4
] | 112 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded s... | XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms. | Brain Edema Brain Tumor | peritumoral brain edema edema malignant brain tumor astrocytoma brain tumor dexamethasone Decadron | null | 1 | arm 1: All patients will receive hCRF (XERECEPT) 2mg/day | [
0
] | 1 | [
0
] | intervention 1: 2mg/day | intervention 1: hCRF [XERECEPT (corticorelin acetate injection)] | 32 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Newport Beach | California | United States | -117.92895 | 33.61891
Palo Alto | California | United States | -122.14302 | 37.44188
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Aurora... | 0 | NCT00226655 |
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