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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 760 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia. | There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combina... | Hypercholesterolemia Dyslipidemia | null | 3 | arm 1: ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks arm 2: ABT-335 135mg monotherapy administered orally, once daily for 12 weeks arm 3: Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks intervention 2: ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks intervention 3: Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks | intervention 1: ABT-335 and rosuvastatin calcium intervention 2: ABT-335 intervention 3: rosuvastatin calcium | 168 | 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
Huntsville | Alabama | United States | -86.58594 | 34.7304
Ozark | Alabama | Unit... | 0 | NCT00463606 | |
[
5
] | 289 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo c... | The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the ... | Nausea Extrapyramidal Symptoms | Metoclopramide Nausea Akathisia Emergency department | null | 4 | arm 1: Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes arm 2: Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes arm 3: Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes arm 4: Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously... | [
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: an anti-emetic medication intervention 2: used for prophylaxis against akathisia intervention 3: placebo intervention 4: Metoclopramide 20 mg | intervention 1: metoclopramide 10 mg intervention 2: Diphenhydramine 25 mg intervention 3: Placebo intervention 4: Metoclopramide 20 mg | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 0 | NCT00475306 |
[
4
] | 799 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia. | null | Nocturia | null | 5 | arm 1: Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for ... | [
2,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg intervention 2: Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour b... | intervention 1: desmopressin acetate intervention 2: Placebo | 80 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Beverly Hills | California | United States | -118.40036 | 34.07362
Long Beach... | 0 | NCT00477490 | |
[
0
] | 101 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 3TRIPLE | false | 0ALL | false | Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications a... | Information collected during your office visits:
The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of qu... | Osteoarthritis Post-traumatic; Arthrosis | arthroplasty replacement knee | null | 2 | arm 1: Patients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care. arm 2: Patients in the Corticosteroid group will have the same medications as the Control Group with t... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate intervention 2: bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline | intervention 1: methylprednisolone acetate intervention 2: active comparator | 1 | Lexington | Kentucky | United States | -84.47772 | 37.98869 | 0 | NCT00492973 |
[
3
] | 48 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters. | null | Preterm Infants Parenteral Nutrition n-3 Fatty Acids | n-3 Polyunsaturated Fatty Acids (PUFA) parenteral nutrition preterm infant | null | 2 | arm 1: Lipidem 20 % arm 2: Lipofundin MCT/LCT 20% | [
0,
1
] | 2 | [
0,
0
] | intervention 1: daily i.v. infusion for up to 5 days intervention 2: daily i.v. infusion for up to 5 days | intervention 1: Lipofundin MCT/LCT 20 % intervention 2: Lipidem 20% | 2 | Munich | Bavaria | Germany | 11.57549 | 48.13743
Greifswald | N/A | Germany | 13.40244 | 54.08905 | 0 | NCT00497289 |
[
3
] | 163 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects. | null | Obesity | exenatide obesity diabetes Amylin Lilly | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: subcutaneous injection (5mcg or 10mcg), twice a day intervention 2: subcutaneous injection (equivalent volume to active dose), twice a day | intervention 1: exenatide intervention 2: placebo | 16 | Peoria | Arizona | United States | -112.23738 | 33.5806
Tucson | Arizona | United States | -110.92648 | 32.22174
Santa Ana | California | United States | -117.86783 | 33.74557
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Topeka | Kansas | United States | -95.67804 | 39.04833
Wichita | Kansas | United S... | 0 | NCT00500370 |
[
4
] | 5 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
To determine the risk of bleeding from ASA therapy in thrombocytopenic patients who develop Acute Coronary Syndrome (ACS), and assess its effect on the overall morbidity and mortality in these patients as well as platelet functions. | Aspirin is known to decrease death rate by as much as 50% in patients that suffer from heart attacks. Patients with low platelet count are not given aspirin for fear of an increased risk of bleeding. Researchers want to compare the risks versus the benefits of using aspirin in this patient population.
Participants in ... | Thrombocytopenia Myocardial Infarction | Thrombocytopenia Platelet Function Acute Coronary Syndrome Myocardial Infarction Heart Attack Aspirin | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily | intervention 1: Aspirin | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00501345 |
[
3
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether a phospholipid emulsion is effective in the treatment of chronic endotoxemia in hemodialysis patients. | Over 70% of dialysis patients suffer chronically from severe fatigue and tiredness. A possible inciting factor may be high levels of circulating endotoxin, which is well-established as a potent stimulator of inflammatory cytokine release.
The source of increased endotoxin in dialysis patients remains unclear, with the... | Fatigue End Stage Renal Disease (ESRD) | Fatigue Hemodialysis Endotoxemia Phospholipid Emulsion | null | 2 | arm 1: Dosage of 1.5 mL/kg of Lipidose over a 2-hour period. arm 2: Dosage of 1.5 mL/kg of Placebo over a 2-hour period. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Over the course of 2 weeks, immediately following subject's three (Monday/Wednesday/Friday (M/W/F)) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of Lipidose over a 2-hour period. intervention 2: Over the course of 2 weeks, immediately following subject's ... | intervention 1: Lipidose intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00506454 |
[
3
] | 35 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients. | null | Restless Legs Syndrome | Restless Legs Syndrome | null | 1 | arm 1: Subjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose... | [
0
] | 1 | [
0
] | intervention 1: White film-coated round-shaped tablet | intervention 1: ropinirole controlled release (CR)-RLS | 11 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Hiroshima | N/A | Japan | 132.45 | 34.4
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Osaka | N/A | Japan | 135.50107 | 34.69379
Osaka | N/A | Japan | 135.50107 | 34.69379
Osaka | N/A | Japan | 135... | 0 | NCT00530790 |
[
4
] | 107 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years). | null | Asthma | Symbicort pMDI spacer children | null | 2 | arm 1: Budesonide/formoterol pMDI 40/2.25ug + spacer arm 2: Budesonide/formoterol pMDI 40/2.25 ug | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Budesonide/formoterol pMDI 40/2.25ug + spacer intervention 2: Budesonide/formoterol pMDI 40/2.25 ug | 11 | Budapest | N/A | Hungary | 19.04045 | 47.49835
Debrecen | N/A | Hungary | 21.62444 | 47.53167
Kaposvár | N/A | Hungary | 17.8 | 46.36667
Bialystok | N/A | Poland | 23.16433 | 53.13333
Bydgoszcz | N/A | Poland | 18.00762 | 53.1235
Bytom | N/A | Poland | 18.93282 | 50.34802
Karpacz | N/A | Poland | 15.75594 | 50.77669
Kr... | 0 | NCT00536913 |
[
3
] | 707 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives ... | null | Seasonal Allergic Rhinitis | null | 5 | arm 1: Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily arm 2: MFNS with OXY 3 sprays once daily arm 3: MFNS once daily arm 4: OXY twice daily arm 5: Placebo nasal spray | [
0,
0,
1,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM). intervention 2: MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening. intervention 3: MFNS 2 sprays per no... | intervention 1: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) intervention 2: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) intervention 3: mometasone furoate nasal spray (MFNS) once daily intervention 4: oxymetazoline nasal spray... | 0 | null | 0 | NCT00552110 | |
[
4
] | 97 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed IR compressed tablet... | null | Mood Disorders | Mood disorder | null | 1 | arm 1: Lamictal orally disintegrating tablet (ODT) | [
0
] | 1 | [
0
] | intervention 1: Experimental formulation | intervention 1: Lamotrigine | 18 | San Diego | California | United States | -117.16472 | 32.71571
Santa Ana | California | United States | -117.86783 | 33.74557
Jacksonville | Florida | United States | -81.65565 | 30.33218
Orange City | Florida | United States | -81.29867 | 28.94888
Winter Park | Florida | United States | -81.33924 | 28.6
Marietta | Geo... | 0 | NCT00579982 |
[
3
] | 102 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal. | null | Prostate Cancer | Prostate Cancer Docetaxel 03-076 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Leuprolide LUPRON intervention 2: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p) intervention 3: 70 mg/m2 given on day o1 of each 3 week cycle | intervention 1: GnRh (Leuprolide) intervention 2: Testosterone Gel intervention 3: Docetaxel | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00587431 |
[
0
] | 79 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclof... | Alcohol use is ubiquitous in American society. 83% of Americans have ever consumed alcohol, 51% have in the lst month.
The average American consumes 2.18 gallons of ethanol yearly. Alcohol related morbidity and mortality are staggering problems in the USA. Symptoms of alcohol withdrawal occur because alcohol is a cent... | Alcohol Withdrawal Delirium | Alcohol withdrawal Delirium tremors | null | 2 | arm 1: Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. arm 2: Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours. | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours. intervention 2: Placebo intervention 3: Lorazepam was provided to all subjects (both arms of the study), as indicated by clinical condition. Standard "symptom-triggered dosing" of lorazepam for alcohol withdrawal w... | intervention 1: Baclofen intervention 2: Placebo intervention 3: Lorazepam | 1 | Duluth | Minnesota | United States | -92.10658 | 46.78327 | 0 | NCT00597701 |
[
2,
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 2MALE | false | We propose oral dosing of gastrointestinal permeation enhancement technology \[GIPET\] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men. | The purpose of this study is to test how the body responds to a new oral form of acyline given for seven days and to also look at the safety of oral acyline.
Acyline temporarily blocks the production of the hormone testosterone in healthy men. It has been tested in over 100 men in an injection form. This study will be... | Healthy | Male Contraception Acyline | null | 0 | null | null | 1 | [
0
] | intervention 1: 20 mg GIPET enhanced oral dose, daily for 7-days | intervention 1: Acyline | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00603187 |
[
4
] | 82 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza. | null | Influenza | Influenza Subjects with uncomplicated acute influenza | Prot_SAP_000.pdf:
CLINICAL STUDY PROTOCOL
Protocol No. BCX1812-311
IND No. 76,350
A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-
CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF
INTRAMUSCULAR PERAMIVIR IN SUBJECTS WITH UNCOMPLICATED ACUTE
INFLUENZA
THE IMPROVE 1 STUDY
(IntraMuscular Pe... | 2 | arm 1: Placebo intramuscular injection arm 2: Single intramuscular injection of 300mg peramivir | [
2,
0
] | 2 | [
0,
0
] | intervention 1: To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza. intervention 2: Single intramuscular injection | intervention 1: Peramivir intervention 2: Placebo | 96 | Millbrook | Alabama | United States | -86.36192 | 32.47986
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Phoenix | Arizona | United States | -112.07404 | 33.44838
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Mountain Home | Arkansas ... | 0 | NCT00610935 |
[
3
] | 126 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | null | The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II. | null | Atrophy Vaginal Diseases | Menopausal symptoms Urogenital atrophy Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy | null | 4 | arm 1: Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks arm 2: Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks arm 3: Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks arm... | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12). intervention 2: 1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, ... | intervention 1: Placebo intervention 2: Ospemifene 5 mg intervention 3: Ospemifene 15 mg intervention 4: Ospemifene 30 mg | 0 | null | 0 | NCT00630539 |
[
0
] | 20 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several ph... | null | Smoking | null | 2 | arm 1: 50 mg cycloserine arm 2: Matched placebo | [
0,
3
] | 2 | [
0,
0
] | intervention 1: 50 mg Cycloserine given in two separate experimental sessions separated by approximately one week. intervention 2: Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week. | intervention 1: Cycloserine intervention 2: Placebo | 1 | West Haven | Connecticut | United States | -72.94705 | 41.27065 | 0 | NCT00633256 | |
[
0
] | 57 | RANDOMIZED | CROSSOVER | 1PREVENTION | 2DOUBLE | true | 0ALL | false | Question #1: Will glycine ameliorate cognitive deficits? Hypothesis #1: Based on positive findings conducted with glycine and milacemide, a glycine prodrug, in schizophrenia and dementia, we expect that glycine will ameliorate cognitive deficits.
Question #2: Will alcoholic patients show enhanced endocrinal effects to... | The purpose of this study is to investigate the interaction between glycine and D-cycloserine in alcoholic patients and healthy subjects. Preclinical studies have shown that compounds acting at the glycine site of the N-methyl-D-aspartate (NMDA) receptor complex, such as glycine, may reverse the effects of ethanol on t... | Alcohol Dependence | Alcohol Dependence, Alcoholism, Glycine, D-Cycloserine | null | 2 | arm 1: Alcohol dependent patients will receive 4 interventions arm 2: Healthy subjects will receive 4 interventions | [
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Test days will involve administration of D-Cycloserine in the morning in pill form then 4 hours later a 30 minute infusion of Glycine. intervention 2: Placebo intervention 3: None intervention 4: None | intervention 1: D-Cycloserine PO and Glycine IV intervention 2: Placebo D-Cycloserine PO and placebo Glycine IV intervention 3: Placebo D-Cycloserine PO and Glycine IV intervention 4: D-Cycloserine PO and placebo Glycine IV | 1 | West Haven | Connecticut | United States | -72.94705 | 41.27065 | 0 | NCT00635102 |
[
2
] | 38 | RANDOMIZED | SINGLE_GROUP | null | 4QUADRUPLE | true | 0ALL | false | The product is being tested to see if exposure to light causes toxic reactions on the skin. | null | Healthy | wound healing phototoxicity Healthy Subjects | null | 3 | arm 1: Drug arm 2: Placebo comparator arm 3: Subjects serve as own controls. | [
0,
2,
4
] | 2 | [
0,
0
] | intervention 1: 20mg under Finn chambers intervention 2: 20mg under Finn chambers | intervention 1: Xenaderm intervention 2: Placebo | 0 | null | 0 | NCT00644917 |
[
5
] | 23 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | A single center, double blind, randomized, placebo controlled, two-treatments, two-period crossover study conducted in adult smokers. | The main objective of this study is to use blood oxygen level-dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) in abstinent smokers to directly evaluate the effect of the 4 milligrams (mg) nicotine lozenge on brain activation associated with visual attention. The experimental task featured 3 conditions: 1.... | Smoking | nicotine therapy fMRI/EEG replacement | null | 2 | arm 1: Nicotine lozenge containing 4 mg of nicotine to be placed in mouth and suck to dissolution. arm 2: Placebo lozenge to be placed in mouth and suck to dissolution. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Nicotine lozenge containing 4 mg of nicotine intervention 2: Placebo lozenge | intervention 1: Nicotine intervention 2: Placebo | 0 | null | 0 | NCT00657020 |
[
3
] | 40 | RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 2DOUBLE | true | 0ALL | false | To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial to determine whether treatment with a statin improves muscle microvascular blood flow. | To characterise features of the metabolic syndrome, including body fat, insulin sensitivity, and liver fat together with muscle micorvascular blood flow.
To undertake a randomised controlled trial of atorvastatin 40 mg. o.d for 6 months to determine whether any of the above measures change with treatment. | Metabolic Syndrome | metabolic syndrome Volunteers recruited from the community | null | 2 | arm 1: Active arm atorvastatin 40 mg. o.d. arm 2: Placebo arm dummy pill | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 40 m.g. o.d. tablets for 6 months intervention 2: Placebo | intervention 1: atorvastatin intervention 2: placebo | 0 | null | 0 | NCT00666029 |
[
5
] | 114 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | true | The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream. | Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other anesthetic medications prior to venipuncture. However, the time for the anesthetic to take affect is approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine 4% topical anesthetic cream (LMX4), which has... | Pain Anxiety | pediatric patients pain anxiety topical anesthetic randomized control trial | null | 2 | arm 1: This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick. arm 2: This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture intervention 2: A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture | intervention 1: 4% lidocaine topical anesthetic cream intervention 2: Placebo cream | 1 | Allentown | Pennsylvania | United States | -75.49018 | 40.60843 | 0 | NCT00676364 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting. | Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit. | Actinic Keratosis | null | 2 | arm 1: Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. arm 2: Subjects were randomized to appl... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. intervention 2: over th... | intervention 1: Biafine intervention 2: Polysporin | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00695578 | |
[
2
] | 26 | RANDOMIZED | CROSSOVER | 6HEALTH_SERVICES_RESEARCH | 2DOUBLE | true | 2MALE | false | The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidase PH20 (rHuPH20).
T... | null | Diabetes Mellitus | rHuPH20 Hyaluronidase Insulin | null | 4 | arm 1: Humalog first, then Humalog + recombinant human hyaluronidase PH20 (rHuPH20)
A single subcutaneous (SC) injection of 20 units (U) Humalog on Day 1 of the study, followed by a single SC injection of 20 U Humalog + 300 U rHuPH20 after a washout period of at least 6 days arm 2: Humalog + recombinant human hyaluron... | [
1,
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Humalog intervention 2: Humulin-R intervention 3: Recombinant human hyaluronidase PH20 (rHuPH20) | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00705536 |
[
5
] | 25 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 1SINGLE | true | 1FEMALE | false | A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers. | At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the r... | Acne Vulgaris | acne irritation objective sensory methods | null | 1 | arm 1: Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model) | [
0
] | 2 | [
0,
0
] | intervention 1: adapalene gel 0.3% topically applied daily in a split-face model for two weeks intervention 2: Tretinoin 0.1% topically applied daily in a split face model for two weeks | intervention 1: Adapalene Gel intervention 2: Tretinoin Gel | 1 | Broomall | Pennsylvania | United States | -75.35658 | 39.9815 | 0 | NCT00714714 |
[
3
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the efficacy of bortezomib in combination with melphalan and prednisone to achieve complete responses for patients with previously untreated multiple myeloma compared to an historical control group. This trial will also evaluate the safety and toxicity of this regimen as well as e... | Based on the need to improve front-line therapy for patients less likely to undergo transplant, the promising recent in vitro and clinical work on melphalan and bortezomib, we propose a prospective trial with bortezomib added to standard melphalan and prednisone therapy for previously untreated patients with multiple m... | Multiple Myeloma | Multiple myeloma | null | 1 | arm 1: Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach ... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Bortezomib intervention 2: Melphalan intervention 3: Prednisone | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00734149 |
[
5
] | 4 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials. | null | Systemic Lupus Erythematosus | null | 2 | arm 1: Arm 1: Drug arm 2: Arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: simvastatin 20mg daily at nights for 12 weeks. Tablets intervention 2: placebo daily at nights for 12 weeks. Tablets | intervention 1: simvastatin intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00739050 | |
[
3
] | 27 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease. | null | Reflux Episodes | GERD transient lower esophageal sphincter relaxations (TLESRs) reflux | null | 2 | arm 1: AZD3355 arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 65 mg capsules, oral, 3 single doses intervention 2: capsules, oral, 3 single doses | intervention 1: AZD3355 intervention 2: Placebo | 0 | null | 0 | NCT00743444 |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy.
0.5% hydrocortisone, si... | This study will last up to 16 weeks, with a total of 5 visits to the clinic (Baseline visit, Week 4, 8, 12, and 16 ), excluding the Screening Visit.
Screening Visit/Baseline Visit:
Patients will read and be explained the informed consent. Patients who agree to participate will sign the informed consent and a copy wil... | Keloid Hypertrophic Scar Cicatrix, Hypertrophic | Keloid Hypertrophic scar Hydrocortisone, silicone, vitamin E lotion HSE Onion extract gel OE Cetearyl alcohol lotion CEA | null | 3 | arm 1: 0.5% hydrocortisone, silicone, vitamin E lotion arm 2: Onion extract gel arm 3: Cetearyl alcohol lotion | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 0.5% hydrocortisone, silicone, vitamin E lotion will be applied topically to cover the selected scar twice daily for 16 weeks. The lesion will be cleansed with soap and water and dried thoroughly. The medication will be applied with a brush and allow it to dry for one minute before contact with clothing... | intervention 1: 0.5% hydrocortisone, silicone, vitamin E lotion intervention 2: Onion extract gel intervention 3: Cetearyl alcohol lotion | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00754247 |
[
3
] | 10 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study. | The objectives of this trial are:
* To generate additional information about the overall safety profile,
* To generate safety information of hepatically or renally impaired patients, as appropriate, and
* To generate safety information when patients are also taking concomitant medications and/or therapies without tria... | Acute Myelogenous Leukemia Myelodysplastic Syndrome | Acute Myelogenous Leukemia Myelodysplastic Syndrome Dacogen Decitabine | null | 1 | arm 1: Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks. | [
0
] | 1 | [
0
] | intervention 1: Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts). | intervention 1: Decitabine | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00760084 |
[
3,
4
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol will be stratified into two subgroups accordi... | The rationale for using chemotherapy in combination with Rituximab:
Since Rituximab is an anti-B cell therapy, in order to improve the rate of durable responses beyond the 32% (18 of 57) seen with Rituximab alone, it seems appropriate to combine it with a therapy that would also target T cells and/or macrophages. Our ... | Immune Thrombocytopenic Purpura | Pts w/ Chronic ITP who have fail/relap after Rituxan rx | null | 2 | arm 1: 'Standard Dose of Rituximab administered with C, V, P (CVP)'
Interventions: Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses at standard rates and use of premedication. The schedule will be to give the first rituximab infusion 5 days (± 3 days) prior to first admini... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 'Rituximab, Cyclophosphamide, Vincristine, Prednisone interventions are as follows: Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. However, the schedule of the infusions will be different than the usual one: Rather than administrating the 4 doses once wee... | intervention 1: Rituxan, Cyclophosphamide, Vincristine, Prednisone intervention 2: Higher Dose of Rituximab | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00774202 |
[
0
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | true | The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical ... | null | Abortion, Induced Pain | Local anesthesia Paracervical Intracervical Abortion Pain Local anesthesia for elective first trimester abortion | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 3 | [
3,
3,
0
] | intervention 1: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inse... | intervention 1: Paracervical block intervention 2: Intracervical intervention 3: Buffered Lidocaine, vasopressin, sodium bicarbonate | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00816751 |
[
0
] | 40 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | true | 1FEMALE | false | The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women. | Many contraceptive methods are currently available. However, about 50% of all pregnancies in the world are not planned, most of them occurring in developing countries. Long-lasting reversible contraceptives such as the etonogestrel implant represent an option for the reduction of unwanted pregnancies, especially among ... | Breastfeeding Contraception | Adverse Effects Etonogestrel Postpartum period Contraception Hemostasis Metabolism | null | 2 | arm 1: Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is compounded by 68mg of etonogestrel, 3years of duration. arm 2: At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, ... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum) intervention 2: 150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery | intervention 1: etonogestrel implant intervention 2: depot medroxyprogesterone acetate | 1 | Ribeirão Preto | São Paulo | Brazil | -47.81028 | -21.1775 | 0 | NCT00828542 |
[
0
] | 34 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The investigators' primary specific aims are to demonstrate that:
1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.
2. Shikani intubation of pediatric patients is e... | null | Intubation,Endotracheal | Pediatric | null | 2 | arm 1: Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg arm 2: Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. | [
2,
1
] | 2 | [
0,
0
] | intervention 1: One intravenous dose: 0.2mg/kg/dose intervention 2: One Intravenous dose | intervention 1: Cisatracurium intervention 2: Normal saline | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00912990 |
[
2
] | 54 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions.... | This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions.... | Healthy | healthy pharmacokinetics therapeutic equivalency fenofibric acid | null | 3 | arm 1: 1 x 35 mg tablet administered after an overnight fast of at least 10 hours arm 2: 3 x 35 mg tablets administered after an overnight fast of at least 10 hours arm 3: 1 x 105 mg tablet administered after an overnight fast of at least 10 hours | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 1 x 35 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 3 x 35 mg tablets administered after an overnight fast of at least 10 hours intervention 3: 105 mg tablet administered after an overnight fast of at least 10 hours | intervention 1: Fenofibric Acid 35 mg Tablet intervention 2: Fenofibric Acid 35 mg Tablet intervention 3: Fenofibric Acid 105 mg Tablet | 0 | null | 0 | NCT00961259 |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is:
* To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.
* To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients. | Epidemiological evidence indicates that metabolic syndrome (MS) is a strong predisposing condition for atherosclerosis. Elevation of plasma low-density lipoprotein (LDL) cholesterol(LDL-C) concentration is the most important risk factor for atherosclerosis; however, LDL-C elevation is not a criterion for metabolic synd... | Metabolic Syndrome | Metabolic Syndrome LDL subfraction L5 The reduction of LDL in patients with Metabolic Syndrome The prevalence of L5 in patients with Metabolic Syndrome The reduction of L5 in patients with Metabolic Syndrome | null | 4 | arm 1: Randomly chosen participants will receive ezetimibe 10mg daily for 3 months. arm 2: Randomly chosen participants will receive Simvastatin 20mg daily for 3 months. arm 3: Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months. arm 4: Randomly chosen participants will receive Placebo tab 1 da... | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Simvastatin 20mg daily for 3 months. intervention 2: Vytorin 20/10mg daily for 3 months. intervention 3: Placebo one tablet daily times 3 months. intervention 4: Ezetimibe 10mg daily for 3 months. | intervention 1: Simvastatin intervention 2: Vytorin intervention 3: Placebo intervention 4: Ezetimibe | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00988364 |
[
5
] | 162 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination | null | Sleep | Naproxen sodium Diphenhydramine Drugs, Investigational | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
1,
0,
1,
1,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. intervention 2: Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. intervention 3: One dose of naproxen sodium 2... | intervention 1: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg intervention 2: Naproxen Sodium 440 mg (BAYH6689) intervention 3: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg intervention 4: Naproxen Sodium 220 mg (BAYH6689) intervention 5: DPH 50mg intervention 6: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT01118273 |
[
4
] | 301 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 0ALL | null | The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy. | null | Renal Failure | contras-induced nephropathy | null | 2 | arm 1: hydration with sodium bicarbonate arm 2: hydration with saline 1ml/Kg/h for 6 hours | [
0,
1
] | 2 | [
0,
0
] | intervention 1: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours intervention 2: hydration with saline 1ml/Kg/h for 6 hours | intervention 1: sodium bicarbonate intervention 2: saline | 1 | Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 | 0 | NCT01172353 |
[
4
] | 332 | null | null | null | null | null | 0ALL | null | To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in flu... | null | Dry Eye | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: 3% DE-089 ophthalmic solution intervention 2: 0.1% sodium hyaluronate ophthalmic solution | 1 | Osaka | Osaka | Japan | 135.50107 | 34.69379 | 0 | NCT01240382 | |
[
3
] | 123 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 1FEMALE | false | Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs). | The primary objective was to evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3 consecutive cycles of administration of each tr... | Ovulation Suppression | contraception pregnancy prevention | null | 3 | arm 1: Drug intervention with levonorgestrel and ethinyl estradiol : AG200-15 a transdermal contraceptive system containing 2.60 mg of levonorgestrel and 2.30 mg of ethinyl estradiol. arm 2: Drug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levon... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: pregnancy prevention | intervention 1: levonorgestrel and ethinyl estradiol | 11 | Tucson | Arizona | United States | -110.92648 | 32.22174
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Tampa | Florida | United States | -82.45843 | 27.94752
Sandy Springs | Georgia ... | 0 | NCT01250210 |
[
2
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned. Subjects were to b... | Tissue factor (TF) is a transmembrane glycoprotein that acts as the principal initiator of the extrinsic coagulation pathway. TF is a key mediator between the immune system and coagulation and is the principal activator of coagulation. The TF-FVIIa complex activates FX and FIX, resulting in the cleavage of prothrombin ... | Sepsis Acute Lung Injury Acute Respiratory Distress Syndrome | Sepsis Acute Lung Injury Acute Respiratory Distress Syndrome ALI/ARDS Lung Disease | Prot_SAP_000.pdf:
CONFIDENTIAL
The Safety, Pharmacokinetics, and Pharmacodynamic Effects of TNX-
832 (Sunol-cH36) in Subjects with Acute Lung Injury/Acute
Respiratory Distress Syndrome
TNX-832
Active Ingredient: TNX-832 (Sunol c-H36)
Indication: Acute Lung Injury/Acute Respiratory Distress Syndrome
Study TNX-832.20... | 2 | arm 1: Anti-tissue factor antibody arm 2: Placebo control | [
0,
2
] | 2 | [
2,
0
] | intervention 1: Single intravenous dose of TNX-832 at 0.06, 0.08 or 0.10 mg/kg intervention 2: Single intravenous dose of saline control | intervention 1: TNX-832 intervention 2: Placebo | 7 | Miami | Florida | United States | -80.19366 | 25.77427
Boston | Massachusetts | United States | -71.05977 | 42.35843
St Louis | Missouri | United States | -90.19789 | 38.62727
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Akron | Ohio | United States | -81.51901 | 41.08144
Houston | Texas | Unit... | 0 | NCT01438853 |
[
3
] | 38 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progress... | null | Non-Hodgkin's Lymphoma | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse | intervention 1: rituximab [MabThera/Rituxan] | 11 | Cologne | N/A | Germany | 6.95 | 50.93333
Erlangen | N/A | Germany | 11.00783 | 49.59099
Göttingen | N/A | Germany | 9.93228 | 51.53443
Grenzach-Wyhlen | N/A | Germany | 7.68333 | 47.55
Hanover | N/A | Germany | 9.73322 | 52.37052
Homburg/saar | N/A | Germany | N/A | N/A
München | N/A | Germany | 13.31243 | 51.60698
Mü... | 0 | NCT01998893 | |
[
3
] | 6 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression. | null | Gastric Cancer | null | 1 | arm 1: Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit | [
0
] | 1 | [
0
] | intervention 1: 4 mg/kg initial dose, followed by 2 mg/kg | intervention 1: Trastuzumab | 12 | Vienna | N/A | Austria | 16.37208 | 48.20849
Dresden | N/A | Germany | 13.73832 | 51.05089
Erlangen | N/A | Germany | 11.00783 | 49.59099
Essen | N/A | Germany | 7.01228 | 51.45657
Grenzach-Wyhlen | N/A | Germany | 7.68333 | 47.55
Halle | N/A | Germany | 11.97947 | 51.48158
Kassel | N/A | Germany | 9.5 | 51.31667
Kiel ... | 0 | NCT02005484 | |
[
3
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The objectives of this study are:
* To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:
1. Contrast sensitivity
2. Low contrast visual acuity
3. Wavefront aberrometry
4. Subjective questionnaire
* To assess the safety of ophthalmic phentolamine mesylate | Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day. | Decrease in Night Vision Disturbance; Vision, Loss | Night Vision Disturbances NVD Glare Halos Starbursts Nyxol | null | 2 | arm 1: 1 drop in each eye (QD) for one day. arm 2: 1 drop in each eye (QD) for one day. | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Topical Sterile Ophthalmic Solution intervention 2: Topical Sterile Ophthalmic Solution | intervention 1: Phentolamine Mesylate Ophthalmic Solution 1% intervention 2: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) | 1 | Lynbrook | New York | United States | -73.6718 | 40.65483 | 0 | NCT04004507 |
[
4
] | 374 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams \[mg\] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair o... | null | Ileus | POI Hernia Ventral Wall Hernia Repair Post Operative Ileus | null | 3 | arm 1: Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (define... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: MOA-728 will be administered per the dose and schedule specified in the arm. intervention 2: Placebo matching to MOA-728 will be administered per the schedule specified in the arm. | intervention 1: MOA-728 intervention 2: Placebo | 106 | Benton | Arkansas | United States | -92.58683 | 34.56454
Colton | California | United States | -117.31365 | 34.0739
Laguna Hills | California | United States | -117.71283 | 33.61252
Loma Linda | California | United States | -117.26115 | 34.04835
Long Beach | California | United States | -118.18923 | 33.76696
Los Angele... | 0 | NCT00528970 |
[
3
] | 6 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy be... | OBJECTIVES:
* Determine the immunogenicity of vaccine therapy comprising synthetic ovarian cancer-associated peptides administered with a synthetic tetanus toxoid helper peptide emulsified in Montanide ISA-51 before or after paclitaxel and carboplatin in patients with stage III-IV ovarian epithelial, primary peritonea... | Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer | fallopian tube cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer primary peritoneal cavity cancer | null | 2 | arm 1: Patients in group one will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin in week 1. Treatment may repeat every 3 weeks for up to four courses. They will then undergo surgery to remove as much of the tumor as possible. Within 2 weeks after surgery, patients will receive an injection of th... | [
0,
0
] | 5 | [
2,
2,
0,
0,
3
] | intervention 1: Given intradermally or subcutaneously intervention 2: Given intradermally or subcutaneously intervention 3: Given IV intervention 4: Given IV intervention 5: Patients undergo primary optimal cytoreductive surgery | intervention 1: MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine intervention 2: tetanus toxoid helper peptide intervention 3: carboplatin intervention 4: paclitaxel intervention 5: conventional surgery | 1 | Charlottesville | Virginia | United States | -78.47668 | 38.02931 | 0 | NCT00373217 |
[
2
] | 60 | RANDOMIZED | CROSSOVER | 9OTHER | 4QUADRUPLE | true | 0ALL | false | ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation. | The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation | Healthy | TQT study CP-690 550 | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Single dose 100 mg (5 x 20 mg tablets) intervention 2: Single dose placebo tablets (5 tablets) intervention 3: Single dose Avelox 400 mg tablet | intervention 1: CP-690,550 intervention 2: Placebo intervention 3: Moxifloxacin | 2 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Singapore | N/A | Singapore | 103.85007 | 1.28967 | 0 | NCT01743677 |
[
3
] | 287 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis. | null | Osteoarthritis OA Knee Pain Arthritis | Monoclonal antibody | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 50 mcg/kg | intervention 1: RN624 (PF-04383119) | 36 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Anaheim | California | United States | -117.9145 | 33.83529
National City | Califo... | 0 | NCT00399490 |
[
4
] | 419 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia. | Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been ... | Insomnia | Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders | null | 3 | arm 1: Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening. arm 2: Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on D... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name corn starch), magnesium stearate, and lactose monohydrate. int... | intervention 1: Esmirtazapine intervention 2: Placebo | 0 | null | 0 | NCT00506389 |
[
3
] | 334 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM | null | Diabetes Mellitus, Type 2 | Pioglitazone HbA1c Diabetes mellitus | null | 3 | arm 1: GSK189075 arm 2: Placebo arm 3: pioglitazone (active control) | [
0,
2,
5
] | 3 | [
0,
0,
10
] | intervention 1: Experimental Drug intervention 2: Active Control intervention 3: Placebo Comparator | intervention 1: GSK189075 intervention 2: pioglitazone intervention 3: Placebo | 136 | Mesa | Arizona | United States | -111.82264 | 33.42227
Hollywood | Florida | United States | -80.14949 | 26.0112
Miami | Florida | United States | -80.19366 | 25.77427
Saint Cloud | Florida | United States | -81.28118 | 28.2489
Sunset | Louisiana | United States | -92.06845 | 30.41131
Oxon Hill | Maryland | United Stat... | 0 | NCT00500331 |
[
4
] | 354 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents | null | Diabetes Mellitus Type 2 | Type 2 diabetes melllitus | null | 2 | arm 1: Inhaled insulin plus oral therapy arm 2: Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Addition of inhaled insulin to pre-existing oral diabetes therapy. intervention 2: Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators | intervention 1: Inhaled Insulin (Exubera) intervention 2: Standard of Care | 64 | Coquitlam | British Columbia | Canada | -122.78217 | 49.2846
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Bathurst | New Brunswick | Canada | -65.65112 | 47.61814
London | Ontario | Canada | -81.23304 | 42.98339
Orillia | Ontario | Canada | -79.42068 | 44.60868
Charlottetown | Prince Edward Island | Canada | -63.... | 0 | NCT00282971 |
[
3
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study was conducted to test the safety and tolerability of afegostat tartrate in participants with type 1 Gaucher disease already receiving enzyme replacement therapy. | This was a Phase 2, open-label study in participants with Gaucher disease, a lysosomal storage disorder. Afegostat tartrate (also known as AT2101 or isofagomine tartrate) is designed to act as a pharmacological chaperone by selectively binding to misfolded β-glucocerebrosidase (GCase) and helping it fold correctly, int... | Gaucher Disease, Type 1 Type 1 Gaucher Disease Gaucher Disease | afegostat tartrate isofagomine tartrate AT2101 Amicus Therapeutics | null | 4 | arm 1: Afegostat tartrate was administered orally during the 4-week treatment period. arm 2: Afegostat tartrate was administered orally once per day during the 4-week treatment period. arm 3: Afegostat tartrate was administered orally once every 4 days during the 4-week treatment period. arm 4: Afegostat tartrate was a... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Afegostat tartrate | 10 | San Francisco | California | United States | -122.41942 | 37.77493
Coral Springs | Florida | United States | -80.2706 | 26.27119
Decatur | Georgia | United States | -84.29631 | 33.77483
Iowa City | Iowa | United States | -91.53017 | 41.66113
New York | New York | United States | -74.00597 | 40.71427
Cincinnati | Ohio |... | 0 | NCT00433147 |
[
2,
3
] | 66 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aque... | Cystic fibrosis is a genetic disease resulting from mutations in a 230 kb gene on chromosome 7 known as the cystic fibrosis transmembrane conductance regulator (CFTR). Study subjects with CF manifest pathological changes in a variety of organs that express CFTR. The lungs are frequently affected, the sequelae being chr... | Cystic Fibrosis | Cystic Fibrosis Respiratory Infections Pulmonary Cystic Fibrosis CFTR | null | 4 | arm 1: Subjects in this cohort will receive 280 mg of ARIKACE™ arm 2: Subjects in this arm of cohort 1 will receive matching placebo arm 3: Subjects in this cohort will receive 560 mg of ARIKACE™ arm 4: Subjects in this arm of cohort 2 will receive matching placebo | [
0,
2,
0,
2
] | 2 | [
0,
0
] | intervention 1: Study start date is before Jan 18, 2017. intervention 2: Study start date is before Jan 18, 2017. | intervention 1: ARIKACE™ intervention 2: Placebo | 11 | Leuven | N/A | Belgium | 4.70093 | 50.87959
Budapest | N/A | Hungary | 19.04045 | 47.49835
Kaposvár | N/A | Hungary | 17.8 | 46.36667
Skopje | N/A | North Macedonia | 21.43141 | 41.99646
Rabka-Zdrój | N/A | Poland | 19.96654 | 49.60889
Warsaw | N/A | Poland | 21.01178 | 52.22977
Belgrade | N/A | Serbia | 20.46513 | 44.... | 0 | NCT00777296 |
[
3
] | 28 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo. | null | Painful Bladder Syndrome Interstitial Cystitis Bladder Pain Syndrome | bladder pain urgency frequency | null | 2 | arm 1: Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2 arm 2: URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2 | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week. intervention 2: Liquid formulation without active URG101 drug components | intervention 1: URG101 intervention 2: Placebo | 6 | Glendora | California | United States | -117.86534 | 34.13612
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Cartersville | Georgia | United States | -84.80231 | 34.16533
San Ant... | 0 | NCT00517868 |
[
4
] | 524 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen. | null | Post-Operative Ileus (POI) | null | 3 | arm 1: Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was disch... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm. | intervention 1: Methylnaltrexone intervention 2: Placebo | 1 | Tarrytown | New York | United States | -73.85875 | 41.07621 | 0 | NCT00401375 | |
[
3
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purp... | In this study, participants with CF due to a nonsense mutation will be treated with a new investigational drug called ataluren. Evaluation procedures (history, physical examination, blood and urine tests to assess organ function, electrocardiogram \[ECG\], chest x-ray, and CF-specific tests) to determine if a participa... | Cystic Fibrosis | Cystic fibrosis Nonsense mutation Premature stop codon | null | 2 | arm 1: During Cycle 1, participants will receive ataluren at 4 mg/kg in the morning, 4 mg/kg at midday, and 8 mg/kg in the evening for 14 days, followed by a 14-day follow-up period without treatment. Then, the participants will crossover to the other ataluren dose regimen (ataluren 10, 10, and 20 mg/kg) for Cycle 2. a... | [
0,
0
] | 1 | [
0
] | intervention 1: Ataluren will be provided as a vanilla-flavored powder to be mixed with water, milk, or apple juice. Participants are to receive a total of 42 doses of ataluren during each cycle, for a total of 84 doses of ataluren in both cycles. | intervention 1: Ataluren | 3 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Leuven | N/A | Belgium | 4.70093 | 50.87959
Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00458341 |
[
4
] | 752 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of... | null | Breast Cancer Metastases | Metastatic Breast Cancer | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity
Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity intervention 2: Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21... | intervention 1: Ixabepilone + Capecitabine intervention 2: Capecitabine | 127 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Francisco | California | United States | -122.41942 | 37.77493
Vallejo | California | United States | -122.25664 | 38.10409
Denver | Colorado | United States | -104.9847 | 39.73915
Hartford | Connecticut | United States | -72.68509 | 41.76371
Washington ... | 1 | NCT00080301 |
[
4
] | 1,221 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this tr... | null | Cancer Breast Cancer | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle intervention 2: Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle | intervention 1: Ixabepilone + Capecitabine intervention 2: Capecitabine | 186 | Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Corona | California | United States | -117.56644 | 33.87529
Hartford | Connecticut | United States | -72.68509 | 41.76371
Plantation | Florida | United States | -80.23184 | 26.13421
Boise | Idaho ... | 1 | NCT00082433 | |
[
4
] | 200 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms. | 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 | 2 | arm 1: Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. arm 2: Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking | [
0,
2
] | 2 | [
0,
0
] | intervention 1: hCRF ; open-label dexamethasone that the patient is currently taking intervention 2: placebo hCRF 2mg/day and open-label dexamethasone that they are taking | intervention 1: hCRF intervention 2: placebo hCRF | 34 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fresno | California | United States | -119.77237 | 36.74773
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... | 1 | NCT00088166 |
[
3
] | 61 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment. | null | Carcinoma, Renal Cell | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol | intervention 1: Sunitinib | 11 | Duarte | California | United States | -117.97729 | 34.13945
Pasadena | California | United States | -118.14452 | 34.14778
San Francisco | California | United States | -122.41942 | 37.77493
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Ma... | 1 | NCT00089648 | |
[
4
] | 4,628 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).
To assess that dronedarone is well tolerated in this population. | This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be include... | Atrial Fibrillation Atrial Flutter | Mortality, Hospitalization | null | 2 | arm 1: Dronedarone 400mg tablets twice daily (bid) arm 2: matching placebo tablets | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral administration (tablets) intervention 2: oral administration (tablets) | intervention 1: dronedarone (SR33589) intervention 2: placebo | 37 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
New South Wales | N/A | Australia | N/A | N/A
Vienna | N/A | Austria | 16.37208 | 48.20849
Diegem | N/A | Belgium | 4.43354 | 50.89727
Laval | N/A | Canada | -73.692 | 45.56995
Santiago | N/A | Chile |... | 1 | NCT00174785 |
[
3
] | 69 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine. | Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007. | Acute Myeloid Leukemia | acute myelogenous leukemia acute myeloid leukemia clolar evoltra clofarabine untreated acute leukemia adult acute leukemia | null | 1 | arm 1: Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: clofarabine | 15 | Dublin | N/A | Ireland | -6.24889 | 53.33306
Bologna | N/A | Italy | 11.33875 | 44.49381
Rome | N/A | Italy | 12.51133 | 41.89193
Belfast | Northern Ireland | United Kingdom | -5.92541 | 54.59682
Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369
Birmingham | N/A | United Kingdom | -1.89983 | 52.48142
Cardiff | N/A ... | 1 | NCT00924443 |
[
3
] | 42 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will determine the safety and effectiveness of a combination of the immune-suppressing drugs antithymocyte globulin (ATG) and cyclosporine for treating myelodysplasia, a disorder of low blood cell counts. It will: evaluate whether this drug combination can increase blood counts in patients and reduce their n... | Participants will be admitted to the NIH Clinical Center for the first 10 to 14 days of treatment and will then continue therapy on an outpatient basis. They will undergo the following tests and procedures:
* Placement of central line-An intravenous (IV) catheter (flexible tube inserted into a vein) is placed in a lar... | Myelodysplastic Syndrome | MDS Immunosuppression ATG Cyclosporine Myelodysplastic Syndrome | null | 1 | arm 1: Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper sch... | [
0
] | 2 | [
0,
0
] | intervention 1: Antithymocyte globulin (ATG) intravenous infusion: 40mg/kg/day. Infusion over 6 hours on day 1-4. intervention 2: Cyclosporine (CsA) intravenous infusion: 5mg/kg. Infusion on day 14 administered twice a day. | intervention 1: Antithymocyte globulin intervention 2: Cyclosporine | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00005937 |
[
4
] | 488 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | null | This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders. | Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the effi... | Anxiety Disorders Social Phobia Generalized Anxiety Disorder | Phobic Disorders Anxiety, Separation | null | 4 | arm 1: Participants received sertraline for 12 weeks. arm 2: Participants received cognitive behavioral therapy for 12 weeks arm 3: Participants received both sertraline and CBT for 12 weeks. arm 4: Participants received a placebo pill for 12 weeks. | [
1,
1,
1,
2
] | 3 | [
0,
5,
0
] | intervention 1: Participants were treated with sertraline. intervention 2: Participants received CBT. intervention 3: Participants were treated with a placebo pill. | intervention 1: Sertraline (SRT) intervention 2: Cognitive Behavioral Therapy (CBT) intervention 3: Placebo | 6 | Los Angeles | California | United States | -118.24368 | 34.05223
Baltimore | Maryland | United States | -76.61219 | 39.29038
New York | New York | United States | -74.00597 | 40.71427
Durham | North Carolina | United States | -78.89862 | 35.99403
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsb... | 0 | NCT00052078 |
[
2,
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This phase I/II trial studies the best dose of suramin when given together with paclitaxel in treating women with stage IIIB-IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of paclitaxel by making tumor... | PRIMARY OBJECTIVES:
I. Determine the dose of suramin in combination with paclitaxel (TXT) that results in suramin plasma concentrations approaching 10-50 uM over the duration, when TXT in the plasma is at therapeutically significant levels, in women with stage IIIB or IV breast cancer. (Phase I) II. Determine the obje... | Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IV Breast Cancer | null | 1 | arm 1: PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dos... | [
0
] | 3 | [
0,
0,
10
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies | intervention 1: suramin intervention 2: paclitaxel intervention 3: pharmacological study | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00054028 | |
[
3
] | 28 | null | null | 0TREATMENT | 0NONE | false | 0ALL | null | Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis, and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity, type 2 diabetes, and insulin resistance. At present, there are no approved treatments for NASH patients, but an experimental approach has... | Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple fatty liver (steatosis) to steatosis with inflammation and necrosis to cirrhosis, that occurs in persons who drink little or no alcohol. Nonalcoholic steatohepatitis (NASH) represents the more severe end of this spectrum and ... | Hepatitis | Insulin Obesity Fatty Liver Diabetes Cirrhosis Metformin Insulin Resistance Nonalcoholic Steatohepatitis Hepatitis NASH | null | 0 | null | null | 1 | [
0
] | intervention 1: After complete medical evaluation and liver biopsy, patients who qualified for therapy were started on metformin in an initial dose of 500 mg once daily. After 2 weeks, the dose was increased to 500 mg twice daily and after 4 weeks to the full dose of 1000 mg twice daily. Subsequent dose reductions were... | intervention 1: Metformin | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00063232 |
[
3
] | 7 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phas... | OBJECTIVES:
Primary
* Determine the event-free and relapse-free survival of children with initially unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC) before definitive local control.
Secondary
* Determ... | Sarcoma | childhood fibrosarcoma nonmetastatic childhood soft tissue sarcoma | null | 2 | arm 1: Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and... | [
0,
0
] | 8 | [
2,
0,
0,
0,
0,
3,
2,
2
] | intervention 1: Given Slow intravenous (IV) push over 1-5 minutes, dose \< 1yr 0.025 mg/kg \> or = 1 yr 0.045 mg/kg (max dose 2.5 mg) on days 1,22,43 and 64 intervention 2: Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64. intervention 3: Given IV over 1 hour, dose 3.3 mg/kg in normal saline (NS) 10 cc/kg... | intervention 1: dactinomycin intervention 2: cyclophosphamide intervention 3: etoposide intervention 4: ifosfamide intervention 5: vincristine sulfate intervention 6: Conventional Surgery intervention 7: MESNA (mercaptoethane sulfonate) intervention 8: Filgrastim | 74 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Downey | California | United States | -118.13257 | 33.94001
Loma Linda | California | United States | -117.26115 | 34.04835
Long Beach | California | United States | -118.18923 | 33.76696
Sacramento |... | 0 | NCT00072280 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy a... | OBJECTIVES:
Primary
* Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin, high-dose melphalan, and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma... | Breast Cancer | recurrent breast cancer stage IV breast cancer | null | 1 | arm 1: None | [
0
] | 9 | [
2,
2,
2,
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 7: None intervention 8: None intervention 9: None | intervention 1: anti-thymocyte globulin intervention 2: filgrastim intervention 3: graft-versus-tumor induction therapy intervention 4: therapeutic allogeneic lymphocytes intervention 5: cyclosporine intervention 6: fludarabine phosphate intervention 7: melphalan intervention 8: methotrexate intervention 9: peripheral ... | 1 | La Jolla | California | United States | -117.2742 | 32.84727 | 0 | NCT00074269 |
[
4
] | 628 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the ... | This study was designed to provide one year efficacy and safety data for subcutaneous (SC) omalizumab, compared to placebo in children (6 to \< 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to National Heart, Lung and Blood Institute (NHLBI) step 3 or... | Asthma | allergic asthma atopic omalizumab immunoglobulin E IgE anti-IgE | null | 2 | arm 1: Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was... | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on... | intervention 1: Omalizumab intervention 2: Placebo intervention 3: Fluticasone | 56 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Huntington Beach | California | United States | -117.99923 | 33.6603
Huntington Beach | California | United States | -117.99923 | 33.660... | 0 | NCT00079937 |
[
3
] | 138 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer. | null | Neoplasms, Breast | lapatinib advanced metastatic breast cancer GW572016 ErbB2 | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Lapatinib | 31 | Hollywood | Florida | United States | -80.14949 | 26.0112
Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694
Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694
Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694
Pokfulam | N/A | Hong Kong | N/A | N/A
Delhi | N/A | India... | 0 | NCT00089999 |
[
3
] | 197 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied. | null | Chronic Myelogenous Leukemia | Chronic myelogenous leukemia (CML): Accelerated phase | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure | intervention 1: Dasatinib | 70 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anaheim | California | United States | -117.9145 | 33.83529
Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Vallejo | California | United States | -122.25664 | 38.10409
Jacksonville... | 0 | NCT00101647 |
[
3
] | 124 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may h... | null | Chronic Myeloid Leukemia Blast Crisis | Myeloid blast phase Chronic Myeloid Leukemia (CML) | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure. | intervention 1: Dasatinib | 62 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anaheim | California | United States | -117.9145 | 33.83529
Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Vallejo | California | United States | -122.25664 | 38.10409
Denver | Col... | 0 | NCT00101816 |
[
3
] | 150 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d. | null | Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia | Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia | null | 2 | arm 1: Active Comparator arm 2: Active Comparator | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks intervention 2: Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks | intervention 1: Dasatinib intervention 2: Imatinib | 131 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anaheim | California | United States | -117.9145 | 33.83529
Bakersfield | California | United States | -119.01871 | 35.37329
Fullerton | California | United States | -117.92534 | 33.87029
Loma Linda | California | United States | -117.26115 | 34.04835
Los Ange... | 0 | NCT00103844 |
[
4
] | 349 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | false | 0ALL | false | The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a p... | null | Major Depressive Disorder | Single or recurrent non-psychotic episode of Major Depressive Disorder | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks intervention 2: Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks | intervention 1: Aripiprazole+ ADT intervention 2: Placebo+ ADT | 34 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Coral Springs | Florida | United States | -80.2706 | 26.27119
Augusta | Georgia | United States | -81.97484 | 33.47097
... | 0 | NCT00105196 |
[
2
] | 48 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors. | null | Cancer Refractory Solid Tumor | null | 2 | arm 1: 1-12 years old arm 2: 13-18 years old | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days. intervention 2: Intravenous (IV) cetuximab 75 - 250 mg/m2 dependi... | intervention 1: Cetuximab + Irinotecan intervention 2: Cetuximab + Irinotecan | 9 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Denver | Colorado | United States | -104.9847 | 39.73915
Gainesville | Florida | United States | -82.32483 | 29.65163
Atlanta | Georgia | United States | -84.38798 | 33.749
Baltimore | Maryland | United St... | 0 | NCT00110357 | |
[
3
] | 101 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III o... | null | Cancer Melanoma | null | 2 | arm 1: Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered activ... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21 intervention 2: Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21 intervention 3: Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1 | intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo intervention 3: Dacarbazine | 14 | Tucson | Arizona | United States | -110.92648 | 32.22174
Aurora | Colorado | United States | -104.83192 | 39.72943
Lakeland | Florida | United States | -81.9498 | 28.03947
Park Ridge | Illinois | United States | -87.84062 | 42.01114
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | ... | 0 | NCT00110994 | |
[
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well sorafenib works in treating patients with progressive regional or metastatic cancer of the urothelium. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. | PRIMARY OBJECTIVES:
I. To evaluate the 4-month progression-free survival rate, response rate and toxicity of BAY 43-9006 in patients with progressing regional or metastatic transitional cell carcinoma (or mixed histologies containing a component of TCC) of the urothelium who have progressed on one and only one prior s... | Adenocarcinoma of the Bladder Distal Urethral Cancer Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Regional Transitional Cell Cancer of the Renal Pelvis and ... | null | 1 | arm 1: Patients receive oral sorafenib twice daily on days 1-56. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
10
] | intervention 1: Given PO intervention 2: Optional correlative studies | intervention 1: sorafenib tosylate intervention 2: laboratory biomarker analysis | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00112905 | |
[
2,
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has on cells in the body will also be studied. | This is a phase Ib/II, single-center, open-label study designed to assess the safety, tolerability, pharmacokinetics, and biologic efficacy of ABT-510 (thrombospondin). Participants will be patients with incurable head and neck cancer.
Patients will begin at a fixed dose level of thrombospondin subcutaneously twice da... | Head and Neck Cancer | Head and Neck Cancer Thrombospondin Analogue ABT-510 Antiangiogenic agent Lung Skin Thyroid | null | 1 | arm 1: Fixed dose level of thrombospondin 100 mg subcutaneously twice daily. | [
0
] | 1 | [
0
] | intervention 1: 100 mg subcutaneously twice daily | intervention 1: ABT-510 | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00113334 |
[
4
] | 18 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Study Question: In premature infants with apnea and/or bradycardia attributed to gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and motility agents), compared to placebo, reduce the frequency of apnea and bradycardia?
Background: Many clinicians believe that apnea and bradycardi... | Study Question: In premature infants with apnea and/or bradycardia attributed to GERD, does treatment with H2 blockers and prokinetic agents, compared to placebo, reduce the frequency of apnea and bradycardia?
Background: The incidence of gastroesophageal reflux (GER) has been reported in as many as 50% of healthy ter... | Gastroesophageal Reflux | null | 2 | arm 1: 3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.
All study medication administered via nipple or orogastric (OG) tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs.... | [
5,
5
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Metaclopramide intervention 2: Ranitidine intervention 3: placebo | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00131248 | |
[
4
] | 336 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension | Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titr... | Hypertension | safety and tolerability study hypertension beta-blockers | null | 2 | arm 1: Nebivolol arm 2: Metoprolol | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. intervention 2: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks. | intervention 1: Nebivolol (NEB) intervention 2: Metoprolol (MET) | 1 | Morgantown | West Virginia | United States | -79.9559 | 39.62953 | 0 | NCT00142584 |
[
3
] | 114 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females. | PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the ran... | Polycystic Ovary Syndrome | Polycystic Ovary Syndrome (PCOS) Anovulation Elevated Testosterone | null | 2 | arm 1: Metformin arm 2: Placebo | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet). intervention 2: Placebo intervention 3: A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight ov... | intervention 1: Metformin intervention 2: Placebo intervention 3: Lifestyle Intervention | 1 | Hershey | Pennsylvania | United States | -76.65025 | 40.28592 | 0 | NCT00151411 |
[
2
] | 21 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function. | null | HIV Infections Hepatic Impairment | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Capsule or Tablet, Oral, once daily for 2 days intervention 2: Capsule or Tablet, Oral, once daily for 2 days intervention 3: Capsule or Tablet, Oral, once daily for 2 days intervention 4: Capsule or Tablet, Oral, once daily for 2 days | intervention 1: efavirenz containing antiretroviral regimen intervention 2: efavirenz containing antiretroviral regimen intervention 3: efavirenz containing antiretroviral regimen intervention 4: efavirenz containing antiretroviral regimen | 4 | Baltimore | Maryland | United States | -76.61219 | 39.29038
San Antonio | Texas | United States | -98.49363 | 29.42412
Richmond | Virginia | United States | -77.46026 | 37.55376
Milan | N/A | Italy | 12.59836 | 42.78235 | 0 | NCT00162097 | |
[
3
] | 28 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer | null | Colonic Neoplasms | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles. | intervention 1: Enzastaurin HCl | 3 | Odense | N/A | Denmark | 10.38831 | 55.39594
Vejle | N/A | Denmark | 9.5357 | 55.70927
Uppsala | N/A | Sweden | 17.63889 | 59.85882 | 0 | NCT00192114 | |
[
2,
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Netherton syndrome is a genetic condition that can result in abnormal skin functioning. People with this condition often have red and scaling skin; sparse or short hair; and problems with absorption of medicines or chemicals that are applied to the skin. If these chemicals are absorbed at a high level, they may cause h... | Patients with Netherton syndrome, a rare genodermatosis, manifest a chronic, eczematous dermatitis with erythema and scaling that is often recalcitrant to conventional therapy with emollients and topical corticosteroids. These patients display an altered epidermal barrier with increased permeability to topical agents a... | Netherton Syndrome | null | 1 | arm 1: Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome: | [
0
] | 1 | [
0
] | intervention 1: Open label single arm | intervention 1: Pimecrolimus 1% Cream | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00208026 | |
[
4
] | 63 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 2MALE | true | Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced ... | OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, 2 arm study.
The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned. After stratification based on the patient's age, performance status, and severity of me... | Metastatic Prostate Cancer | null | 2 | arm 1: Daily oral risedronate combined with androgen deprivation arm 2: daily oral placebo combined with androgen deprivation | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Daily oral risedronate combined with androgen deprivation intervention 2: Daily oral placebo combined with androgen deprivation | intervention 1: Risedronate intervention 2: Placebo | 45 | La Mesa | California | United States | -117.02308 | 32.76783
San Bernardino | California | United States | -117.28977 | 34.10834
New Britain | Connecticut | United States | -72.77954 | 41.66121
Tampa | Florida | United States | -82.45843 | 27.94752
Galesburg | Illinois | United States | -90.37124 | 40.94782
Peoria | Il... | 0 | NCT00216060 | |
[
4
] | 243 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurre... | OUTLINE: This is a multi-center study.
* Cisplatin 50 mg/m2 d1, 8, 29, 36
* Etoposide 50 mg/m2/day d1-5, 29-33
* Radiation 5940 cGy (180 cGy/day)
Patients with CR, PR, SD Randomized to either:Docetaxel75 mg/m2 q3wk X 3 cycles
or Observation Only
Performance Status: ECOG 0 or 1
Life Expectancy: Not specified
Hemat... | Non-Small Cell Lung Cancer | Non-Small Cell Lung Cancer | null | 3 | arm 1: Prior to randomization patients received Cisplatin 50 mg/m\^2 days 1,8,29,36 + Etoposide 50 mg/m\^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm. arm 2: Docetaxel 75 mg/m\^2 q3wk X 3 cycles.... | [
5,
1,
4
] | 4 | [
0,
0,
4,
0
] | intervention 1: Cisplatin 50 mg/m2 day 1, 8, 29, 36 intervention 2: Etoposide 50 mg/m2, days 1-5, 29-33 intervention 3: Radiation 5940 cGy (180 cGy/day) intervention 4: docetaxel 75mg/m2 q3wk x 3 cycles | intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiation intervention 4: Docetaxel | 15 | Galesburg | Illinois | United States | -90.37124 | 40.94782
Elkhart | Indiana | United States | -85.97667 | 41.68199
Evansville | Indiana | United States | -87.55585 | 37.97476
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Goshen | Indiana | United States | -85.83444 | 41.58227
Indianapolis | Indiana | Uni... | 0 | NCT00216125 |
[
5
] | 134 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS). | null | Renal Transplant | QoL GI Side Effects MPA | null | 2 | arm 1: 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening. arm 2: Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Enteric-Coated Mycophenolate Sodium (EC-MPS) intervention 2: Mycophenolate Mofetil (MMF) | 1 | Nottingham | N/A | United Kingdom | -1.15047 | 52.9536 | 0 | NCT00239005 |
[
3
] | 185 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in individuals with ALS for a possible future phase III study. | Amyotrophic lateral sclerosis (ALS) is a progressive and devastating neurodegenerative disorder. Available treatment for ALS remains scarce. Oxidative stress and mitochondrial dysfunction have been implicated in the pathophysiology of ALS. Oxidative stress refers to the effects of cell-damaging reactive oxygen species,... | Amyotrophic Lateral Sclerosis Lou Gehrig's Disease | amyotrophic lateral sclerosis ALS Lou Gehrig's disease CoQ10 coenzyme Q10 antioxidants free radicals mitochondrial dysfunction | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
2,
0
] | 2 | [
0,
0
] | intervention 1: antioxidant and mitochondrial cofactor, given in capsules three times daily intervention 2: Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily | intervention 1: coenzyme Q10 intervention 2: Placebo | 19 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Francisco | California | United States | -122.41942 | 37.77493
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
New Haven | Connecticut | United States | -72.92816 | 41.30815
Chic... | 0 | NCT00243932 |
[
4
] | 255 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactiv... | The primary objective of this study is to evaluate whether OROS MPH (Concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study will involve an estimated 2... | ADHD Smoking | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 1... | intervention 1: Osmotic-Release Methylphenidate intervention 2: Placebo | 6 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751
Rochester | Minnesota | United States | -92.4699 | 44.02163
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Columbus | Ohio | United States | -82.99879 | 39.96118
Portland | Oregon | Uni... | 0 | NCT00253747 | |
[
3,
4
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will be utilized to treat ... | Approximately 60 alcohol dependent individuals who are drinking heavily up until 72 hours, or less, prior to study participation will be randomized to receive either flumazenil (intravenously)on two successive days and gabapentin (orally)for 39 days or their matching placebos. They also will receive hydroxyzine and vit... | Alcohol Dependence | Alcoholism Alcohol Dependence Alcohol Withdrawal Treatment Pharmacotherapy | null | 2 | arm 1: 2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39. arm 2: 20 mg Saline infused slowly over 20 minutes. Placebo 1... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2 mg flumazenil for infusion given slowly over 20 minutes given day 1 and day 2 gabapentin 300 mg increasing to 1200 mg over 4 days and continuing to day 30. Gabapentin 900 mg Day 31 to Day 33 gabapentin 600 mg Day 34 to 36 and gabapentin 300 mg Day 37 to 39. intervention 2: 20 mg Saline infused slowly ... | intervention 1: Flumazenil and Gabapentin intervention 2: Placebo | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00262639 |
[
3
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how... | OBJECTIVES:
* Determine the objective response rate and toxicity in patients with androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride and docetaxel.
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by docet... | Prostate Cancer | adenocarcinoma of the prostate stage IV prostate cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. intervention 2: IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 cou... | intervention 1: docetaxel intervention 2: gemcitabine hydrochloride | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00276549 |
[
3
] | 200 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) after the transplant may help destroy any r... | OBJECTIVES:
Primary
* Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of patients with high-risk hematologic malignancies.
* Compare survival, disease-free survival (DFS), response rate, and toxicity rates in these patients wi... | Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Unusual Cancers of Childhood | adult acute lymphoblastic leukemia in remission L1 adult acute lymphoblastic leukemia L2 adult acute lymphoblastic leukemia L3 adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic m... | null | 8 | arm 1: None arm 2: None arm 3: On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosi... | [
1,
1,
1,
1,
1,
1,
1,
1
] | 17 | [
2,
2,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
3,
3,
4
] | intervention 1: Intravenous, 1.5 mg/kg of body weight daily for 7 to 14 days The first dose should be administered over a minimum of 6 hours and over at least 4 hours on subsequent doses through a high-flow vein. intervention 2: Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7... | intervention 1: anti-thymocyte globulin intervention 2: filgrastim intervention 3: busulfan intervention 4: carmustine intervention 5: cyclophosphamide intervention 6: cyclosporine intervention 7: cytarabine intervention 8: etoposide intervention 9: fludarabine phosphate intervention 10: melphalan intervention 11: meth... | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00281879 |
[
3
] | 66 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will determine whether the experimental drug LY686017 can reduce a person's desire for alcohol. A brain chemical called Substance P acts at places in the brain called NK1 receptors. Substance P is released in response to stress and gives rise to behaviors that are thought to represent anxiety. LY686017 block... | Background:
Alcoholism is a chronic relapsing disorder characterized by cycles of intoxication interspersed with phases of withdrawal and abstinence. Co-morbidity with depression and anxiety disorders is high. Even in absence of independent psychiatric co-morbidity, anxiety symptoms are almost invariably present durin... | Alcohol Dependence Alcoholism | Anxiety Alcohol Dependence Alcoholism | null | 2 | arm 1: Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis. arm 2: Subjects received placebo orally on a daily basis | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 50 mg administered orally on a daily basis intervention 2: Administered on a daily basis | intervention 1: LY686017 intervention 2: Placebo | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00310427 |
[
5
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures. | null | Pain, Postoperative | preemptive analgesia paracervical block vaginal hysterectomy | null | 2 | arm 1: Active preemptive local analgesia. arm 2: Placebo for preemptive local analgesia. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection. intervention 2: 20 ml normal saline injection. | intervention 1: bupivacaine and epinephrine intervention 2: Placebo | 1 | Scottsdale | Arizona | United States | -111.89903 | 33.50921 | 0 | NCT00318292 |
[
5
] | 92 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir di... | This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.
Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:
* A. Truvada (... | HIV Infections | HIV 1 Infection | null | 4 | arm 1: Truvada once daily with continuation of the current NNRTI or PI at randomization arm 2: Maintain baseline regimen arm 3: Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2) arm 4: Truvada once daily with NNRTI or PI (all participants who recei... | [
0,
1,
0,
0
] | 2 | [
0,
0
] | intervention 1: Truvada + NNRTI or PI. intervention 2: Maintain baseline regimen | intervention 1: Truvada intervention 2: Current HAART regimen | 1 | Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00323492 |
[
4
] | 1,554 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus. | Over the past 30 years, the prevalence of diabetes has increased dramatically throughout the world due to population growth, aging, urbanization, increasing obesity, and physical inactivity. The total number of people with type 2 diabetes mellitus is projected to rise from 171 million in 2000 to 366 million in 2030. Th... | Type 2 Diabetes Mellitus | Diabetes Mellitus, Type 2 Drug Therapy Diabetes Mellitus, Non Insulin Dependent Glucose Intolerance Hyperglycemia | null | 12 | arm 1: Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. arm 2: Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. arm 3: Alogliptin 25 mg, tablets, oral... | [
2,
0,
0,
1,
0,
0,
1,
0,
0,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Alogliptin tablets. intervention 2: Alogliptin placebo-matching tablets. intervention 3: Pioglitazone tablets. intervention 4: Pioglitazone placebo-matching tablets. | intervention 1: Alogliptin intervention 2: Alogliptin placebo intervention 3: Pioglitazone intervention 4: Pioglitazone placebo | 90 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Columbiana | Alabama | United States | -86.60721 | 33.17817
Huntsville | Alabama | United States | -86.58594 | 34.7304
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Searcy | Arkansas | U... | 0 | NCT00328627 |
[
4
] | 547 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | null | to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue | null | Diabetes Mellitus, Type 2 | null | 3 | arm 1: Technosphere Insulin arm 2: Metformin \& Secretagogues arm 3: Technosphere \& Metformin | [
0,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Inhalation, 15U/30U, prandial intervention 2: Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations. intervention 3: Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets | intervention 1: Technosphere Insulin intervention 2: Metformin & Secretagogues intervention 3: Technosphere Insulin & Metformin | 120 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Chula Vista | California | United States | -117.0842 | 32.64005
Denver | Colorado | ... | 0 | NCT00332488 | |
[
3
] | 43 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | true | The purpose of this study is to compare the amount of acetylcholine release after a single injection of clonidine in normal volunteers and individuals with neuropathic pain. | This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).
The way that nerve fibers carry pain information to the brain is thought to change after surgery and in cases of chronic pain. F... | Pain | pain, chronic pain acetylcholine clonidine a2-adrenergic agonists alpha2-adrenergic agonists | null | 2 | arm 1: Chronic Pain Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injectio... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid) intervention 2: Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid) | intervention 1: clonidine intervention 2: clonidine | 2 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00350532 |
[
3,
4
] | 163 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosigli... | null | Type 2 Diabetes | null | 4 | arm 1: 20 mg arm 2: 10 mg arm 3: 20 mg arm 4: None | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, once daily, up to 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, up to 12 weeks | intervention 1: Dapagliflozin intervention 2: Placebo | 23 | Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Fresno | California | United States | -119.77237 | 36.74773
Greenbrae | California | United States | -122.5247 | 37.94854
Jacksonville | Florida | United States | -81.65565 | 30.33218
Roswell | Georgia | United States | -84.36159 | 34.02316
Indianapolis | India... | 0 | NCT00357370 |
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