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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
2
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may... | OBJECTIVES:
Primary
* To determine the maximum tolerated dose and toxicity of PEG-interferon alfa-2b and sorafenib tosylate in patients with unresectable or metastatic clear cell renal cell carcinoma.
Secondary
* To determine the progression-free survival of patients treated with this regimen.
* To evaluate, in a p... | Kidney Cancer | clear cell renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer | null | 1 | arm 1: Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks. | [
0
] | 8 | [
2,
0,
6,
6,
6,
10,
10,
10
] | intervention 1: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks. intervention 2: None intervention 3: None intervention 4: None intervention 5: None interventi... | intervention 1: PEG-interferon alfa-2b intervention 2: Sorafenib intervention 3: gene expression analysis intervention 4: polymerase chain reaction intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: flow cytometry intervention 7: immunoenzyme technique intervention 8: laboratory biomarker a... | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00589550 |
[
5
] | 31 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis (PAR). This decrease in sleep fragmentation... | Montelukast is a once daily LRA indicated for the treatment of allergic rhinitis and asthma, which is both safe and effective. Documented improvement in nasal congestion has been showed in patients with both seasonal and perennial allergic rhinitis. As demonstrated in recent publications, we fully anticipate that nasal... | Perennial Allergic Rhinitis | sleep somnolence allergies rhinitis fatigue | null | 2 | arm 1: montelukast 10 mg daily arm 2: Placebo tablet | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 10 mg po each day (compared to placebo for 2 weeks) intervention 2: placebo for 2 weeks | intervention 1: montelukast intervention 2: placebo | 0 | null | 0 | NCT00590772 |
[
4
] | 100 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight | To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able t... | Pain Fever | null | 1 | arm 1: 40 to 75 mg/kg/day every 4 to 6 hours | [
0
] | 1 | [
0
] | intervention 1: Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose | intervention 1: IV Acetaminophen | 14 | Stanford | California | United States | -122.16608 | 37.42411
Wilmington | Delaware | United States | -75.54659 | 39.74595
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038
Ann Arbor | Michigan | United States | -83.74088 | 42.27756... | 0 | NCT00598702 | |
[
2
] | 31 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo. | The Phase 1 clinical study compared the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and Staccato Placebo in 14 subjects with a history of sedative abuse. Subjects who met the inclusion/exclusion criteria received 2 mg of oral alprazolam and matching placebo over 2 sessions. Those who de... | Abuse Liability of Staccato Alprazolam | null | 14 | arm 1: Sequence 1: Q, 1, 2, 7, 3, 6, 4, 5; where Q=Qualifying sessions (2 mg oral alprazolam and placebo in random order), 1=placebo, 2=oral alprazolam 1 mg, 3= oral alprazolam 2 mg, 4= oral alprazolam 4 mg, 5= inhaled alprazolam 0.5 mg, 6= inhaled alprazolam 1 mg, 7= inhaled alprazolam 2 mg arm 2: Sequence Q, 2: 2, 3,... | [
5,
5,
5,
5,
5,
5,
5,
5,
5,
5,
5,
5,
5,
5
] | 9 | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Inhaled Staccato placebo + oral placebo intervention 2: Inhaled Staccato alprazolam 0.5 mg + oral placebo intervention 3: Inhaled Staccato alprazolam 1 mg + oral placebo intervention 4: Inhaled Staccato alprazolam 2 mg + oral placebo intervention 5: Oral alprazolam 1 mg + Inhaled placebo intervention 6:... | intervention 1: Inhaled placebo + oral placebo intervention 2: Inhaled alprazolam 0.5 mg intervention 3: Inhaled alprazolam 1 mg intervention 4: Inhaled alprazolam 2 mg intervention 5: Oral alprazolam 1 mg intervention 6: Oral alprazolam 2 mg intervention 7: Oral alprazolam 4 m intervention 8: Oral alprazolam 2 mg qual... | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00603980 | |
[
0
] | 18 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 2DOUBLE | false | 0ALL | true | This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose... | Omalizumab is a monoclonal antibody directed against Immunoglobulin E (IgE) and is FDA-approved for use in allergic asthma, though its clinical role is not precisely defined. It binds IgE on the same site of the Fc domain as the high affinity IgE receptor (FcεRI), and therefore, blocks the interaction between IgE and m... | Allergic Rhinitis | Basophils Mast Cells IgE IgE receptors omalizumab | null | 2 | arm 1: This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4week... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Dosing is based on IgE level and weight given every 2 or 4 weeks intervention 2: Dosing is based on IgE level and weight given every 2 or 4 weeks | intervention 1: omalizumab intervention 2: placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00604786 |
[
5
] | 10 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compare... | null | Hypokalemia | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
7
] | intervention 1: Hydrochlorothiazide 25 mg a day for 14 days. intervention 2: Licorice candy 32 grams a day for 14 days. | intervention 1: Hydrochlorothiazide intervention 2: Licorice | 1 | Oulu | N/A | Finland | 25.46816 | 65.01236 | 0 | NCT00605202 | |
[
0
] | 2 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension. | null | Treatment Induced Hypertension | null | 2 | arm 1: Minoxidil arm 2: Hydralazine | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week intervention 2: 25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week | intervention 1: Minoxidil intervention 2: Hydralazine | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00607477 | |
[
5
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and... | null | Major Depressive Disorder | cognitive function psychosocial function augmentation treatment refractory depression | null | 1 | arm 1: This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment. | [
5
] | 1 | [
0
] | intervention 1: varied dose (5, 10, 15 mg qd) for 6 wks | intervention 1: Aripiprazole | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00608543 |
[
5
] | 156 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor. | null | Non Small Cell Lung Carcinoma | Carcinoma Non Small Cell Lung EGFR mutation Gefitinib | null | 0 | null | null | 1 | [
0
] | intervention 1: Gefitinib tablet 250mg once daily orally | intervention 1: Gefitinib | 1 | Daegu | N/A | South Korea | 128.59111 | 35.87028 | 0 | NCT00608868 |
[
4
] | 90 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease. | null | Chronic Obstructive Pulmonary Disease | indacaterol chronic obstructive pulmonary disease exercise endurance moderate to severe chronic obstructive pulmonary disease COPD | null | 2 | arm 1: Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. | intervention 1: Indacaterol 300 μg intervention 2: Placebo | 20 | Torrance | California | United States | -118.34063 | 33.83585
Lebanon | New Hampshire | United States | -72.25176 | 43.64229
Brussels | N/A | Belgium | 4.34878 | 50.85045
Gembloux | N/A | Belgium | 4.69889 | 50.56149
Jette | N/A | Belgium | 4.33419 | 50.87309
Liège | N/A | Belgium | 5.56749 | 50.63373
Edmonton | N/A | ... | 0 | NCT00620022 |
[
5
] | 228 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | null | 0ALL | null | This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting | null | Alzheimer's Disease | Alzheimer's disease cholinesterase inhibitor rivastigmine | null | 0 | null | null | 1 | [
0
] | intervention 1: The study treatment was delivered as a patch sizes 5 and 10 cm\^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm\^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increase... | intervention 1: Rivastigmine transdermal patch | 1 | Rueil-Malmaison | N/A | France | 2.18967 | 48.8765 | 0 | NCT00622713 |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | true | The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure. | There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure. | Hypertension | Salt sensitivity of Blood Pressure | null | 4 | arm 1: Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 2: Subject completes a normal s... | [
0,
0,
2,
2
] | 2 | [
0,
10
] | intervention 1: Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet intervention 2: Placebo pill taken twice per day on each day of the diet | intervention 1: celecoxib (Celebrex) intervention 2: Placebo | 1 | Newark | Delaware | United States | -75.74966 | 39.68372 | 0 | NCT00624559 |
[
5
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair | null | Asthma | Asthma allergen challenge bronchoprovocation Methacholine challenge serum Immunoglobulin E Nitric Oxide skin prick test | null | 4 | arm 1: Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. arm 2: Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants re... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection; intervention 2: Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position. | intervention 1: Xolair intervention 2: Placebo | 6 | Berlin | N/A | Germany | 13.41053 | 52.52437
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Munich | N/A | Germany | 11.57549 | 48.13743
Groningen | N/A | Netherlands | 6.56667 | 53.21917
Bloemfontein | N/A | South Africa | 26.214 | -29.12107
Durban | N/A | South Africa | 31.0292 | -29.8579 | 0 | NCT00624832 |
[
4
] | 441 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin. | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin arm 2: Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner intervention 2: Tablets, 500 - 2000 mg, once, twice or three times daily intervention 3: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection b... | intervention 1: biphasic insulin aspart 30 intervention 2: metformin intervention 3: biphasic insulin aspart 50 | 1 | Beijing | Beijing Municipality | China | 116.39723 | 39.9075 | 0 | NCT00627445 | |
[
3
] | 324 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-b... | null | Type 2 Diabetes | insulin resistance | null | 4 | arm 1: Teneligliptin 10 mg, orally, once daily arm 2: Teneligliptin 20 mg, orally, once daily arm 3: Teneligliptin 40 mg, orally, once daily arm 4: Teneligliptin placebo-matching tablets, orally, once daily | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Teneligliptin 10mg intervention 2: Teneligliptin 20 mg intervention 3: Teneligliptin 40 mg intervention 4: Placebo | 1 | Takikawa-shi | Hokkaido | Japan | N/A | N/A | 0 | NCT00628212 |
[
3
] | 262 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants. | null | Diabetes Mellitus Type 2 | null | 4 | arm 1: LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks arm 2: LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks arm 3: LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for ... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: LY2189265 intervention 2: Placebo | 34 | Peoria | Arizona | United States | -112.23738 | 33.5806
Anaheim | California | United States | -117.9145 | 33.83529
Lancaster | California | United States | -118.13674 | 34.69804
Northridge | California | United States | -118.53675 | 34.22834
Palm Springs | California | United States | -116.54529 | 33.8303
South Miami ... | 0 | NCT00630825 | |
[
3
] | 146 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks. | null | Diabetes Mellitus, Type 2 | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks). intervention 2: Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-... | intervention 1: MK-0893 intervention 2: Sitagliptin intervention 3: Metformin intervention 4: Placebo for MK-0893 intervention 5: Placebo for Sitagliptin intervention 6: Placebo for Metformin | 0 | null | 0 | NCT00631488 | |
[
4
] | 362 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching place... | null | Erectile Dysfunction | Erectile Dysfunction | null | 2 | arm 1: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. arm 2: Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT) intervention 2: Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet | intervention 1: Vardenafil ODT (STAXYN, BAY38-9456) intervention 2: Placebo | 47 | Antwerp | N/A | Belgium | 4.40026 | 51.22047
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Genk | N/A | Belgium | 5.50082 | 50.965
Ghent | N/A | Belgium | 3.71667 | 51.05
Liège | N/A | Belgium | 5.56749 | 50.63373
Lille | ... | 0 | NCT00631969 |
[
3
] | 35 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dos... | null | Diabetes Mellitus Coronary Artery Disease | null | 2 | arm 1: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. arm 2: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose. intervention 2: Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose. | intervention 1: prasugrel intervention 2: Clopidogrel | 4 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Worcester | Massachusetts | United States | -71.80229 | 42.26259
New York | New York | United States | -74.00597 | 40.71427
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 0 | NCT00642174 | |
[
3
] | 451 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes. | Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin sec... | Diabetes Mellitus, Type II Diabetes Mellitus, Non Insulin Dependent | Type 2 diabetes mellitus Metformin Hemoglobin A1c | null | 7 | arm 1: Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). arm 2: Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the eve... | [
0,
0,
0,
0,
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks. intervention 2: One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. intervention 3: One matching plac... | intervention 1: Canagliflozin (JNJ-28431754) intervention 2: Sitagliptin intervention 3: Placebo | 78 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mesa | Arizona | United States | -111.82264 | 33.42227
Tucson | Arizona | United States | -110.92648 | 32.22174
Encinitas | California | United States | -117.29198 | 33.03699
Lincoln | California | United States | -121.29301 | 38.89156
Los Angeles | California... | 0 | NCT00642278 |
[
0
] | 37 | RANDOMIZED | CROSSOVER | null | 0NONE | false | 0ALL | false | The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge. | During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine labo... | Asthma | formoterol methacholine challenge | null | 2 | arm 1: a single dose of 24 mcg of formoterol arm 2: a single dose of 12 mcg of formoterol | [
1,
1
] | 3 | [
0,
0,
1
] | intervention 1: a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler) intervention 2: a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler) intervention 3: subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose | intervention 1: formoterol intervention 2: formoterol intervention 3: Dry Powder Inhaler (Twisthaler) | 1 | Gainesville | Florida | United States | -82.32483 | 29.65163 | 0 | NCT00643578 |
[
3
] | 55 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. | The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will ... | Hyperphosphatemia End-stage Renal Disease | ESRD end-stage renal disease end stage renal disease hemodialysis dialysis kidney failure renal failure kidney renal phosphate binder phosphorus | null | 1 | arm 1: All patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels. | [
0
] | 1 | [
0
] | intervention 1: ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study. | intervention 1: ferric citrate | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00648167 |
[
3
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well as reducing the severity and frequency of symptoms of orthostatic hypotension in these patients. The efficacy of droxidopa in ameliorating ... | This is a phase II, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of droxidopa in HD patients with intradialytic hypotension. The study will be conducted in up to 15 centers, with a sufficient number of patients enrolled to allow 75 patients to be randomized into 3... | Intradialytic Hypotension | null | 3 | arm 1: Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with Placebo) arm 2: Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) arm 3: Placebo (3 capsules with mannitol substituted for droxidopa) | [
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: Capsules containing 200 mg droxidopa intervention 2: Capsules with mannitol substituted for droxidopa | intervention 1: Droxidopa intervention 2: Placebo | 1 | Medford | Oregon | United States | -122.87559 | 42.32652 | 0 | NCT00657046 | |
[
4
] | 10 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time. | Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessa... | Multiple Myeloma | null | 2 | arm 1: Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months arm 2: monitor myeloma parameters every 3-6 months | [
1,
4
] | 1 | [
0
] | intervention 1: Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks | intervention 1: Bortezomib | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00657553 | |
[
4
] | 614 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | We will evaluate the efficacy of PN400 and an active comparator in patients that have Osteoarthritis of the knee. | 3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales. | Osteoarthritis | null | 3 | arm 1: PN400: 500 mg naproxen/20 mg esomeprazole arm 2: Celecoxib 200 mg arm 3: sugar pill | [
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets | intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00664560 | |
[
4
] | 610 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee. | 3-Month study in subjects 50 years and older with osteoarthritis of the knee. Assessments Western Ontario and McMaster Universities (WOMAC) pain and function and patient global assessment scales. | Osteoarthritis | null | 3 | arm 1: PN400: 500 mg naproxen/20 mg esomeprazole bid arm 2: Celecoxib 200 mg arm 3: sugar pill | [
0,
1,
2
] | 4 | [
0,
0,
10,
0
] | intervention 1: 500 mg naproxen/20 mg esomeprazole bid intervention 2: 200 mg celecoxib qd intervention 3: sugar pill bid intervention 4: Antacid Tablets | intervention 1: PN 400 (VIMOVO) intervention 2: celebrex intervention 3: Placebo intervention 4: Rescue Antacid | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00665431 | |
[
5
] | 728 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan | null | Hypertension | Hypertension adults Valsartan + Amlodipine Angiotensin Receptor Blockers | null | 2 | arm 1: Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titrat... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: valsartan and amlodipine intervention 2: valsartan and amlodipine | 1 | Metairie | Louisiana | United States | -90.15285 | 29.98409 | 0 | NCT00666536 |
[
0
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | true | 0ALL | true | The purpose of this study is to determine the function of an enzyme that breaks down drugs and helps the removal of drugs from your body. This enzyme is called cytochrome P450 2C19 and is located in your liver. Exposure to other medications or variations in genes that you have inherited from your parents, may speed up ... | The goal of this study is to develop a quick and reliable method that will diagnose hepatic CYP2C19 function and could be used routinely in clinical practice. Specifically, we propose to test pantoprazole - 13C as a probe for determining CYP2C19 phenotype. Pantoprazole, 5-(difluoromethoxy)-2-\[\[(3,4-dimethoxy-2-pyridy... | Healthy | CYP2C19 Pantoprazole Genotype Pharmacokinetics Metabolism | null | 3 | arm 1: CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19\*1/\*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test. arm 2: CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (\*2 and \*3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test. arm 3: Homozygous fo... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: \[13C\]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes | intervention 1: [13C]Pantoprazole | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00668902 |
[
2
] | 44 | RANDOMIZED | FACTORIAL | null | 0NONE | false | 0ALL | true | Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to mo... | null | Scoliosis | dexmedetomidine neuromonitoring spine procedures safe dose 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring 3effect of dexmedetomidine on somatosensory evoked potential... | null | 5 | arm 1: Dexmedetomidine low infusion, Propofol low infusion arm 2: Dexmedetomidine high infusion, Propofol low infusion arm 3: Dexmedetomidine high infusion, Propofol high infusion arm 4: Dexmedetomidine intermediate infusion, Propofol intermediate infusion arm 5: Dexmedetomidine low infusion, Propofol high infusion | [
1,
1,
1,
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M intervention 2: Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M intervention 3: Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M intervention 4: Dexmedetomidine loading dose 1.1 MCG/KG.Pr... | intervention 1: low dexmedetomidine, low propofol intervention 2: high dexmedetomidine, low propofol intervention 3: Dexmedetomidine intervention 4: Dexmedetomidin intervention 5: Dexmedetomidine | 1 | Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 0 | NCT00671931 |
[
3
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide... | null | Melanoma | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: * Temozolomide: 200mg/m\^2, daily, PO, days 1-4
* Vinblastine: 1.5mg/m\^2, daily, IV, days 1-4
* Cisplatin: 20mg/m\^2, daily IV, days 1-4
* IL (interleukin)-2: - 18 milli-International unit (MIU)/m\^2, IVCI (intravenous continual infusion), day 1
* 9 MIU/m\^2, IVCI, day 2
* 4.5 MIU/m\^2, IVCI, days 3 \&... | intervention 1: Concurrent decrescendo biochemotherapy regimen intervention 2: Low-dose Temozolomide plus Sorafenib | 0 | null | 0 | NCT00673361 | |
[
3
] | 106 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible... | For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pan... | Congenital Hyperinsulinism Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy CHI PHHI | Congenital Hyperinsulinism Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy CHI PHHI F-DOPA L-fluoro-dihydroxyphenylalanine | null | 1 | arm 1: Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery. | [
0
] | 2 | [
0,
4
] | intervention 1: 0.08-0.16 mCi/kg once intervention 2: None | intervention 1: F-DOPA intervention 2: PET scan | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00674440 |
[
3
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients | null | Restless Legs Syndrome | pregabalin, RLS, efficacy, safety | null | 6 | arm 1: Placebo arm 2: investigational treatment arm 3: investigational treatment arm 4: investigational treatment arm 5: investigational treatment arm 6: investigational treatment | [
2,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks intervention 2: 50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 3: 100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 4: 150 mg (capsule) per day, 1 - 3 hours before bedti... | intervention 1: placebo intervention 2: Pregabalin intervention 3: Pregabalin intervention 4: Pregabalin intervention 5: Pregabalin intervention 6: Pregabalin | 25 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Diego | California | United States | -117.16472 | 32.71571
Santa Monica | California | United States | -118.49138 | 34.01949
Aurora | Colorado | United States | -104.83192 | 39.72943
Brandon | F... | 0 | NCT00676403 |
[
5
] | 33 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in pati... | This will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. Eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) Formoterol --\> Formoter... | Pulmonary Disease, Chronic Obstructive Chronic Bronchitis Pulmonary Emphysema | Pulmonary Disease, Chronic Obstructive Tiotropium Formoterol Bronchodilator Agents Exercise Tolerance Randomized Controlled Trial [Publication Type] COPD | null | 2 | arm 1: Formoterol plus Placebo (Tiotropium) arm 2: Formoterol plus Tiotropium | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Formoterol 12mcg-capsules (2x/d) + Placebo (Tiotropium) (1x/d). Double-blind medication will be dispensed in HandiHalers and Aerolisers during 2 weeks. intervention 2: Formoterol 12mcg-capsule (2x/dia) + Tiotropium 18mcg-capsule (1x/d). Double-blind medication will be dispensed in HandiHalers and Aeroli... | intervention 1: Formoterol plus Placebo (Tiotropium) intervention 2: Formoterol plus Tiotropium | 1 | São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 | 0 | NCT00680056 |
[
4
] | 572 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a capacity to respond to Sativex. | This 19 week, multicentre study was conducted in two phases. Phase A was a preliminary, single-blind four week treatment period to identify subjects with a capacity to respond to Sativex; eligible, consenting subjects entered a seven day screening period prior to returning to the study centre to begin a four week singl... | Spasticity Multiple Sclerosis | Spasticity Multiple Sclerosis | null | 2 | arm 1: Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.
Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours arm 2: Contai... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg) intervention 2: containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.... | intervention 1: Sativex® intervention 2: Placebo | 1 | Cliftonville | Northampton | United Kingdom | -5.93333 | 54.61667 | 0 | NCT00681538 |
[
2
] | 200 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This study is to evaluate the oral tolerability of a nicotine prototype | null | Healthy Volunteer Smokers | Nicotine Tolerability NRT | null | 2 | arm 1: Marketed nicotine replacement therapy product arm 2: Nicotine prototype | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Marketed nicotine replacement therapy formulation intervention 2: Nicotine prototype | intervention 1: Nicotine intervention 2: Nicotine | 0 | null | 0 | NCT00682461 |
[
0
] | 24 | RANDOMIZED | CROSSOVER | 6HEALTH_SERVICES_RESEARCH | 1SINGLE | true | 0ALL | true | The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor. | To test the hypothesis that the administration of the NO donor isosorbide dinitrate,but not the phosphodiesterase inhibitor sildenafil, will attenuate stimulated vascular t-PA release whereas both agents will improve glucose uptake. | Obesity | Bradykinin Obesity Nitric Oxide Donor tissue type plasminogen activator isosorbide dinitrate phosphodiesterase inhibitor Renin-Angiotensin Aldosterone System Fibrinolysis Angiotensin converting enzyme | null | 4 | arm 1: Bradykinin (Clinalfa AG, Läufelfingen, Switzerland) arm 2: N-monomethyl-L-arginine (L-NMMA, NO synthase inhibitor; Bachem, Torrance, CA) arm 3: Isosorbide (NO donor) arm 4: Sildenafil (phosphodiesterase type 5 (PDE5) inhibitor | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Graded doses of bradykinin (Clinalfa AG, Läufelfingen, Switzerland) will be infused at 50, 100, and 200ng/min. Each dose will be infused for 5 minutes and FBF will measured during the last 2 minutes of infusion. Arterial and venous blood samples will be obtained for measurement of net t-PA release after... | intervention 1: Control (bradykinin) intervention 2: L-NMMA + bradykinin intervention 3: Isosorbide + L-NMMA + bradykinin intervention 4: Sildenafil + L-NMMA + bradykinin | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00685945 |
[
5
] | 393 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen. | null | Hypertension | null | 2 | arm 1: Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. arm 2: Patients were treated with atenolol/amlodipine 50/5 mg... | [
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None | intervention 1: Valsartan/amlodipine 80/5 mg tablets intervention 2: Amlodipine 5 mg capsules intervention 3: Amlodipine 10 mg capsules intervention 4: Atenolol 50 mg tablets intervention 5: Atenolol 100 mg tablets | 1 | Rueil-Malmaison | N/A | France | 2.18967 | 48.8765 | 0 | NCT00687973 | |
[
5
] | 24 | RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 2DOUBLE | false | 0ALL | true | A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo | null | Crohn's Disease | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6 intervention 2: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6 | intervention 1: infliximab intervention 2: placebo | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00688636 | |
[
0
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine the efficacy of Pegfilgrastim in the mobilization of autologous peripheral blood stem cells (PBSCs), defined as cell yield ≥ 3 x 10e6 CD34+/kg and to assess the costs related to Pegfilgrastim use in the mobilization of autologous PBSCs. Also to determine the side effects of Peg... | null | Hematologic Malignancies | null | 1 | arm 1: All eligible patients will receive chemotherapy and one dose of Pegfilgrastim | [
0
] | 1 | [
0
] | intervention 1: Pegfilgrastim: Sub Cutaneous, 6 mg on Day 3 of chemotherapy regimen or as otherwise indicated by chemotherapy regimen (ie., 24 hours after completion of chemotherapy). | intervention 1: Pegfilgrastim | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 0 | NCT00689884 | |
[
5
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis | null | Seasonal Allergic Rhinitis | Rhinitis Seasonal Allergic Rhinitis allergies | null | 2 | arm 1: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily arm 2: Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily intervention 2: Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily | intervention 1: Olopatadine HCL Nasal Spray, 0.6% intervention 2: Fluticasone Propionate Nasal Spray, 50 mcg | 1 | Sacramento | California | United States | -121.4944 | 38.58157 | 0 | NCT00691665 |
[
3
] | 125 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses. | null | Fibromyalgia | null | 3 | arm 1: In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. arm 2: In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. arm 3: In the first stage, subjects were randomly assigned to re... | [
2,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Desvenlafaxine Sustained Release (DVS SR) intervention 2: Lyrica® (Pregabalin) intervention 3: Placebo | 27 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Roseville | California | United States | -121.28801 | 38.75212
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Santa Ana | California | United States | -117.86783 | 33.74557
Walnut Cr... | 0 | NCT00696787 | |
[
4
] | 36 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with Sativex®. | This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term... | Spasticity Multiple Sclerosis | Spasticity Multiple Sclerosis | null | 2 | arm 1: Sativex arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: containing delta-9-tetrahydrocannabinol (THC)(27 mg/ml):cannabidiol (CBD)(25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief intervention 2: Contains no active drug and is delivered in 100 micro... | intervention 1: Sativex intervention 2: Placebo | 1 | Gorleston-on-Sea | Norfolk | United Kingdom | 1.73069 | 52.57301 | 0 | NCT00702468 |
[
3
] | 157 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | true | This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability. | DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP0... | Osteoporosis | Osteoporosis 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3 Vitamin D Bone Density Conservation Agents Bone Regeneration | null | 3 | arm 1: None arm 2: 220 ng arm 3: 440 ng | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: oral, once daily intervention 2: oral, once daily | intervention 1: Placebo intervention 2: DP001 | 9 | Upland | California | United States | -117.64839 | 34.09751
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Bethesda | Maryland | United States | -77.10026 | 38.98067
Omaha | Nebraska | United States | -95.94043 | 41.25626
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Mineola | New York... | 0 | NCT00715676 |
[
3
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy. | null | Soft Tissue Sarcoma | Soft Tissue Sarcoma CC-4047 Pomalidomide | null | 1 | arm 1: 7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Pomalidomide | 3 | Santa Monica | California | United States | -118.49138 | 34.01949
Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768
Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00717522 |
[
3
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide... | The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection ... | ST-Elevation Myocardial Infarction | eptifibatide Integrilin ST-Elevation Myocardial Infarction Acute Myocardial Infarction | null | 2 | arm 1: Intracoronary injection of eptifibatide arm 2: Intra-coronary injection of normal saline. | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Intra-coronary injection, weight based, of eptifibatide. intervention 2: Intra-coronary injection, based on weight, of eptifibatide intervention 3: Intra-coronary injection, weight based, of normal saline. | intervention 1: eptifibatide intervention 2: eptifibatide intervention 3: normal saline | 3 | Ormond Beach | Florida | United States | -81.05589 | 29.28581
Rochester | Michigan | United States | -83.13382 | 42.68059
Mansfield | Ohio | United States | -82.51545 | 40.75839 | 0 | NCT00719914 |
[
3
] | 81 | null | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.
The s... | Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study. | Major Depressive Disorder | depression combination | null | 1 | arm 1: BCI-024 and BCI-049 | [
0
] | 1 | [
0
] | intervention 1: BCI-024 and BCI-049 once a day at bedtime for 6 weeks | intervention 1: Combination Product: BCI-024 + BCI-049 | 9 | Garden Grove | California | United States | -117.94145 | 33.77391
San Diego | California | United States | -117.16472 | 32.71571
Altanta | Georgia | United States | N/A | N/A
Rockville | Maryland | United States | -77.15276 | 39.084
Beachwood | Ohio | United States | -81.50873 | 41.4645
Philadelphia | Pennsylvania | Un... | 0 | NCT00731653 |
[
4
] | 106 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The Electronic Device - The RebiSmart™ is an electronic injection device that is being studied for the delivery of Merck Serono's Rebif® New Formulation. The RebiSmart™ device is a stand-alone hand-held device with internal power supply. It is used for subcutaneous (under the skin) injections with single-use sterile di... | null | Multiple Sclerosis | Multiple Sclerosis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: RNF 44 mg, 3 times a week by subcutaneous injection. | intervention 1: Rebif® New Formulation (RNF) using RebiSmartTM | 6 | Rockland | Massachusetts | United States | -70.91616 | 42.13066
Ontario, British Columbia, Quebec | N/A | Canada | -71.21454 | 46.81228
Hamburg, Ulm, Berlin, Erbach | N/A | Germany | N/A | N/A
Chieti & Roma | Italy | Italy | N/A | N/A
Barcelona & Madrid | Spain | Spain | N/A | N/A
Sweden | N/A | Sweden | N/A | N/A | 0 | NCT00735007 |
[
2,
3
] | 20 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objectives:
The primary objectives of this study are as follows:
• To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non small cell lung cancer (NSCLC).
• To evaluate the efficacy of th... | This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID (twice daily) on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the firs... | Non Small Cell Lung Cancer Lung Cancer | Lung Cancer Advanced Lung Cancer NSCLC | null | 3 | arm 1: 100 mg BID ABT-751 orally for 7 days. Carboplatin AUC 4.5 once every 21 days. arm 2: 125 mg BID ABT-751orally for 7 days. Carboplatin AUC 4.5 or 6 once every 21 days. arm 3: 150 mg BID ABT-751orally for 7 days. Carboplatin AUC 6 once every 21 days. | [
0,
0,
0
] | 1 | [
0
] | intervention 1: This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the fi... | intervention 1: ABT-751 and Carboplatin | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 0 | NCT00735878 |
[
4
] | 321 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chron... | This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend tr... | Pain | Chronic pain Acetoaminophen Tramadol Osteoarthritis of the knee Low back pain | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets). intervention 2: ... | intervention 1: Tramadol Hydrochloride Plus Acetaminophen (Open-Label) intervention 2: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) intervention 3: Placebo (Double-Blind) | 20 | Aichi | N/A | Japan | 130.62158 | 32.51879
Amagasaki | N/A | Japan | 135.41667 | 34.71667
Chiba | N/A | Japan | 140.11667 | 35.6
Edogawa City | N/A | Japan | 139.87308 | 35.69225
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukushima | N/A | Japan | 140.46667 | 37.75
Iruma | N/A | Japan | 139.368 | 35.818
Kagoshima | N/A |... | 0 | NCT00736853 |
[
3
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psori... | null | Psoriasis Vulgaris | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Once daily application intervention 2: Twice daily application intervention 3: Twice daily application | intervention 1: LEO 19123 Cream (calcipotriol plus LEO 80122) intervention 2: Dovonex® cream intervention 3: Cream vehicle | 1 | Barrie | Ontario | Canada | -79.66634 | 44.40011 | 0 | NCT00764751 | |
[
5
] | 180 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 2MALE | true | Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males.
The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill.
Approximately 170 healthy adult males will be assigned by ... | null | Human Volunteer | Spermatogenesis in Healthy Males | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 1 mg/kg extended release minocycline HCL, once daily for 84 days. intervention 2: placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days. | intervention 1: minocycline extended release intervention 2: Placebo | 10 | Tarzana | California | United States | -118.55397 | 34.17334
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Lawrenceville | New Jersey | United States | -74.7296 | 40.29733
Great Neck | New York | United States | -73.72846 | 40.80066
Purchase | New York | United States | -73.71457 | 41.04093
Cincinnati ... | 0 | NCT00765336 |
[
2,
3
] | 27 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin. | Although aspirin has been a stalwart treatment in the prevention and treatment of myocardial infarction and stroke, it does not have its expected effects in a significant proportion of the population. This phenomenon has been termed "aspirin resistance". Omega-3 fatty acid supplementation has been associated with a red... | Increased Drug Resistance | aspirin omega 3 fatty acids Lovaza myocardial infarction aspirin resistance cardiovascular disease | null | 4 | arm 1: First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin arm 2: First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo arm 3: First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then p... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
10
] | intervention 1: Aspirin 81mg tablet intervention 2: Lovaza 4 grams intervention 3: Lovaza 4 grams plus aspirin 81 mg intervention 4: Capsule resembling fish oil and a tablet resembling aspirin | intervention 1: Aspirin intervention 2: Lovaza intervention 3: Both Aspirin and Lovaza intervention 4: Placebo | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00771914 |
[
0
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | true | This study is a split face, paired-comparison, pilot study of 10 subjects. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from the clinic, as well as advertising and from previous Institut... | Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface,... | Acne Vulgaris | Acne | null | 2 | arm 1: Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to left side of the face. arm 2: Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to right side of the face. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily. intervention 2: Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily. | intervention 1: Topical benzoyl peroxide 10.0% cream - Formulation 1 intervention 2: Topical benzoyl peroxide 10.0% cream - Formulation 2 | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00787943 |
[
3
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin. | Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information. | Phase 1 Pharmacodynamic Study | null | 4 | arm 1: Intervention: Oral rsCT tablet given once 4 hours after evening meal. arm 2: Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal arm 3: Intervention: Oral rsCT tablet given once 2 hours after evening meal. arm 4: Intervention: Part 2 Open label. Fortical (rsCT) ... | [
0,
2,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit ... | intervention 1: Oral rsCT tablet intervention 2: Oral Placebo Tablet intervention 3: Oral rsCT tablet intervention 4: Fortical (rsCT) nasal spray | 1 | Springfield | Missouri | United States | -93.29824 | 37.21533 | 0 | NCT00803686 | |
[
5
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augment... | null | Dehydration | dehydration fluid therapy hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rHuPH20 | null | 9 | arm 1: subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with Tegaderm arm 2: subcutaneous administration of a s... | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution | intervention 1: hylenex-facilitated subcutaneous Lactated Ringer's infusion | 2 | Lincoln | Nebraska | United States | -96.66696 | 40.8
Neptune City | New Jersey | United States | -74.02792 | 40.20011 | 0 | NCT00807885 |
[
4
] | 150 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general e... | null | Postoperative Nausea and Vomiting | Postoperative Nausea and Vomiting palonosetron pediatric | null | 2 | arm 1: Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg) arm 2: Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg) | [
0,
0
] | 2 | [
0,
0
] | intervention 1: palonosetron IV 1 mcg/kg intervention 2: palonosetron 3mcg/kg IV | intervention 1: palonosetron intervention 2: palonosetron | 13 | Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
Cherkassy | N/A | Ukraine | 32.05738 | 49.44452
Dnipropetrovsk | N/A | Ukrain... | 0 | NCT00828295 |
[
5
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to assess the safety, efficacy and tolerability of Clobetasol propionate foam in subjects with chronic dermatitis. | The study is being conducted in order to obtain safety, efficacy and tolerability data for Clobetasol propionate foam in the treatment of chronic dermatitis. The subjects must have mild to moderate disease based on the Investigator's assessment at baseline. | Hand Dermatosis | Dermatosis, Dermatitis, Dry skin, Irritated skin | null | 1 | arm 1: All subjects receive clobetasol propionate | [
0
] | 1 | [
0
] | intervention 1: Clobetasol propionate. The study product will be applied topically twice a day (morning and evening) for 14 days of treatment. | intervention 1: clobetasol propionate | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 0 | NCT00828464 |
[
3
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers | The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In thes... | Venous Stasis Ulcers | Venous Stasis Ulcers venous insufficiency leg ulcers Thymosin Beta 4 Laminin-5 | null | 2 | arm 1: There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once ... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 g... | intervention 1: Thymosin Beta 4 intervention 2: Placebo | 8 | Bologna | N/A | Italy | 11.33875 | 44.49381
Naples | N/A | Italy | 14.26811 | 40.85216
Padua | N/A | Italy | 11.88586 | 45.40797
Padua | N/A | Italy | 11.88586 | 45.40797
Rome | N/A | Italy | 12.51133 | 41.89193
Lublin | N/A | Poland | 22.56667 | 51.25
Szczecin | N/A | Poland | 14.55302 | 53.42894
Wroclaw | N/A | Polan... | 0 | NCT00832091 |
[
5
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris. | To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed. | Acne | Acne Vulgaris Acne | null | 2 | arm 1: Clindamycin and benzoyl peroxide gel arm 2: Clindamycin and tretinoin gel | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks intervention 2: Clindamycin and tretinoin gel once a day for 12 weeks. | intervention 1: Duac intervention 2: Ziana gel | 2 | Louisville | Kentucky | United States | -85.75941 | 38.25424
Mason | Ohio | United States | -84.30994 | 39.36006 | 0 | NCT00841776 |
[
0
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment, developmental disability and autism. Minocycline is an antibiotic that has recently been used to treat the mouse model for Fragile X, and was found to reverse the structural abnormalities that are seen their brain cells. The purpose ... | Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment and is also associated with a range of learning disabilities, neurological problems, such as seizures, and behavioural difficulties. For many individuals with FXS, behavioral difficulties result in severe problems within the family an... | Fragile X Syndrome | Clinical Drug Trial | null | 1 | arm 1: open label treatment with minocycline low or high dose, 50 mg or 100 mg PO (by mouth) BID (twice a day), added to existing medication regimen for 8 weeks | [
0
] | 1 | [
0
] | intervention 1: 50-100 mg PO BID for 8 weeks with an option for a 1 year extension. | intervention 1: Minocycline | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00858689 |
[
2
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantitie... | null | Type 2 Diabetes | null | 1 | arm 1: MK-0941 | [
0
] | 1 | [
0
] | intervention 1: A single dose of 40 mg of \[14C\]MK-0941 (160 µCi), taken orally as eight 5-mg capsules | intervention 1: MK-0941 | 0 | null | 0 | NCT00912002 | |
[
2
] | 18 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic profile of cladribine, especially in terms of extent of absorption of cladribine since pH-modifying drug may potentially affect the stability of cladribine and thereby its bioavailability | null | Multiple Sclerosis | null | 2 | arm 1: Subjects will receive a single dose of cladribine10 milligram (mg) orally on Day 1. After a wash out period of 10-25 days, subjects will receive pantoprazole 40 mg orally for 2 consecutive days. On Day 2 of the pantoprazole administration, a single dose of cladribine 10 mg will be administered orally 3 hours aft... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days. intervention 2: Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period. | intervention 1: Cladribine intervention 2: Pantoprazole | 0 | null | 0 | NCT00938366 | |
[
3
] | 567 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with post-herpetic neuralgia. | null | Postherpetic Neuralgia | pain herpetic neuralgia | null | 6 | arm 1: ESL 400 mg twice-daily arm 2: ESL 800 mg once-daily arm 3: ESL 600 mg twice daily arm 4: ESL 1200 mg once daily arm 5: ESL 800 mg twice daily arm 6: placebo | [
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Scored tablets intervention 2: oral route | intervention 1: Eslicarbazepine acetate intervention 2: Placebo | 0 | null | 0 | NCT00981227 |
[
4
] | 317 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets. intervention 2: Patients will rece... | intervention 1: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d. intervention 2: Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d. intervention 3: Metformin | 0 | null | 0 | NCT01028391 | |
[
0
] | 86 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To demonstrate that a focused Emergency Department (ED) intervention for uncontrolled hyperglycemia enables safe and effective glycemic management and reduces emergency room re-visits. We assessed hypoglycemia BG \< 60mg/dL; change in mean blood glucose and A1C, and ED revisits for hyperglycemia. | Patients with BG \> 200mg/dL presenting to an urban tertiary care hospital ED were enrolled in a 4 week prospective intervention with historic self-controls. Subjects returned at 12-72 hours, 2 and 4 weeks. Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each v... | Type 2 Diabetes Mellitus | Type 2 diabetes mellitus Uncontrolled hyperglycemia Emergency Department | null | 1 | arm 1: All enrolled patients received the intervention. There was no comparative arm. The analysis was done as pre and post. | [
5
] | 2 | [
0,
5
] | intervention 1: Diabetes medications (including sulfonylureas, metformin and/or insulin) were initiated and/or adjusted at each visit using the intervention algorithm per presenting blood glucose and prior diabetes medications. intervention 2: Survival skills DSME based upon current JCAHO and ADA joint recommendations ... | intervention 1: Antihyperglycemic medication guideline for management of uncontrolled hyperglycemia presenting to the ED using metformin, sulfonylurea and/or insulin intervention 2: Diabetes survival skills self-management education | 1 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT01033773 |
[
3
] | 387 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an ina... | This study is a multicenter (more than 1 site), placebo-controlled (compared to placebo), randomized (participants assigned study drug by chance), double-blind (neither the participant nor the physician know the assigned study drug), parallel-group comparison (comparison for each group at the same time) study. The stud... | Migraine | Topiramate Migraine | null | 3 | arm 1: In titration period, topiramate 25 milligram (mg) tablet will be given once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21;... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: In the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 week... | intervention 1: Topiramate intervention 2: Placebo | 29 | Bunkyō City | N/A | Japan | 139.4217 | 35.5331
Chitose | N/A | Japan | 141.65222 | 42.81944
Hachiōji | N/A | Japan | 139.32389 | 35.65583
Iruma | N/A | Japan | 139.368 | 35.818
Isehara | N/A | Japan | 139.31019 | 35.39932
Kagoshima | N/A | Japan | 130.55 | 31.56667
Kamogawa | N/A | Japan | 140.1003 | 35.0969
Kitakyushu... | 0 | NCT01081795 |
[
2
] | 55 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state. | Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain. | Healthy | Healthy subjects Opioid Healthy volunteers | null | 2 | arm 1: Reformulated OXY 10 mg (Totowa) x 1 dose arm 2: Reformulated OXY 10 mg (Wilson) x 1 dose | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state. intervention 2: Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state. | intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl) | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT01101308 |
[
0
] | 39 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. .
Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on... | null | Asthma Placebo Effects | null | 3 | arm 1: albuterol arm 2: placebo arm 3: placebo | [
1,
2,
2
] | 3 | [
0,
0,
3
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: albuterol intervention 2: placebo inhaler intervention 3: placebo acupuncture | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT01143688 | |
[
4
] | 36 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 1FEMALE | false | To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels. | To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels. | Preterm Birth | Preterm birth, prevention, progesterone, oral | null | 2 | arm 1: Oral Micronized Progesterone arm 2: Identical Placebo Tablet | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks intervention 2: Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks | intervention 1: oral micronized progesterone intervention 2: Identical Placebo tablet | 1 | Dayton | Ohio | United States | -84.19161 | 39.75895 | 0 | NCT01180296 |
[
3
] | 45 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | true | 0ALL | null | The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures. | The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provid... | Dental Anesthesia Efficacy | null | 2 | arm 1: 3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril arm 2: .5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg. intervention 2: Each subject received both an injection along with 3 sprays of isotonic salin... | intervention 1: 3% tetracaine HCL with 0.05% oxymetazoline HCL intervention 2: Lidocaine Injection | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT01302483 | |
[
5
] | 544 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | Background:
* While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi... | Sample size
Decisions were based on the following:
1. Number of patients with erythema migrans treated with doxycycline and cefuroxime axetil was determined assuming no difference in treatment outcome will be detected (non-inferiority testing).
2. The decision for a larger sample sizes than needed for 1. was done wit... | Erythema Migrans Post-Lyme Disease Symptoms | erythema migrans doxycycline cefuroxime axetil post-Lyme disease symptoms background symptoms in general population | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 100 mg bid; 15 days intervention 2: 500 mg bid; 15 days | intervention 1: doxycycline intervention 2: cefuroxime axetil | 2 | Ljubljana | N/A | Slovenia | 14.50513 | 46.05108
Ljubljana | N/A | Slovenia | 14.50513 | 46.05108 | 0 | NCT01518192 |
[
5
] | 71 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections (\[IPFI\]; lung diseases caused by fungal infection). | This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of itraconazole sequential therapy in participants with IPFI. The study duration will be 4 to ... | Pulmonary Fungal Infection | Invasive Pulmonary Fungal Infection Itraconazole | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks. | intervention 1: Itraconazole | 0 | null | 0 | NCT01823289 |
[
2
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 2MALE | false | The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites. | Methodology:
Single-centre, open-label, parallel group, non-randomised multiple-dose 7-day study in 12 healthy elderly and 12 healthy younger male subjects.
Duration of treatment:
Each subject participated in the study for approximately 6 weeks. Participation included a screening evaluation within 28 days before inp... | Parkinson Disease | Opicapone BIAL | null | 2 | arm 1: BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. arm 2: BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. | [
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: BIA 9-1067 | 1 | Rueil | Malmaison | France | 1.87938 | 49.047 | 0 | NCT02092168 |
[
3
] | 2 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease. | Inclusion Criteria:
1. Diagnosis of idiopathic Parkinson's disease.
2. Age \> 40 years.
3. willingness and ability to comply with the study requirements and give informed consent. | Parkinson's Disease | Parkinson's disease PD dyskinesia treatment motor complications | null | 2 | arm 1: subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. arm 2: subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: sildenafil 50mg BID for 2 weeks intervention 2: None | intervention 1: sildenafil intervention 2: Placebo | 1 | Loma Linda | California | United States | -117.26115 | 34.04835 | 0 | NCT02162979 |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 2MALE | false | To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 100/25) | Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least 14 days. On each treatment period, after completion of pre-dose assessments, BIA 9-1067/Placebo was to be administered concomitantly with ... | Parkinson's Disease (PD) | Parkinson's disease (PD) BIA 9-1067 Opicapone | null | 4 | arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.) arm 2: Period 1: BIA 9... | [
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: Controlled-release levodopa/carbidopa 100/25 mg | intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Sinemet® CR 100/25 | 1 | Mount Royal | Quebec | Canada | -73.64918 | 45.51675 | 0 | NCT02169453 |
[
5
] | 27 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety... | Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.
Phase 2 - All remaining subjects received Iloprost as a continuous treatment.
The study was designed for an enrollment of 2... | Pulmonary Hypertension | pulmonary hypertension | null | 2 | arm 1: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.
A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosol... | [
0,
0
] | 1 | [
0
] | intervention 1: A 20 mcg dose of Iloprost will be given initially. | intervention 1: Inhaled Iloprost | 0 | null | 0 | NCT02170519 |
[
3
] | 55 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma. | OBJECTIVES:
* Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC.
* Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients.
* Determine the safety profile of this drug in these patients.
* Determine the... | Brain and Central Nervous System Tumors | adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma | null | 1 | arm 1: Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
Drug Poly-ICLC | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: poly ICLC | 8 | Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Ho... | 0 | NCT00058123 |
[
3
] | 99 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN). | null | Neuralgia, Postherpetic | monoclonal antibody | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 50 mcg/kg intervention 2: 200 mcg/kg intervention 3: placebo | intervention 1: RN624 intervention 2: RN624 intervention 3: Placebo | 31 | Anniston | Alabama | United States | -85.83163 | 33.65983
Anniston | Alabama | United States | -85.83163 | 33.65983
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Atlantis | Florida | United States | -80.10088 | 26.5909
Clearwater | Florida | ... | 0 | NCT00568321 |
[
3
] | 334 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol. | null | Hypercholesterolemia | null | 4 | arm 1: 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks arm 2: 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks arm 3: 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvasta... | [
0,
1,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: MK-6213 160 mg for 4 weeks. intervention 2: atorvastatin calcium 20mg for 4 weeks. intervention 3: None intervention 4: None | intervention 1: MK-6213 intervention 2: Atorvastatin calcium intervention 3: Placebo for MK-6312 160 mg intervention 4: Placebo for Atorvastatin 20 mg | 0 | null | 0 | NCT00687271 | |
[
0
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 9OTHER | 1SINGLE | true | 0ALL | true | The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. | The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays. | Chronic Sinusitis | Nasal Spray Nasal Drop Intranasal Medication | null | 2 | arm 1: This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses. arm 2: This arm will contain subjects who will place two drops of a nasal contrast solution... | [
0,
0
] | 3 | [
4,
0,
0
] | intervention 1: Subjects will undergo a Xoran miniCAT scan of their sinuses intervention 2: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml. intervention 3: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each no... | intervention 1: Sinus CT Scan intervention 2: Omnipaque 240 Contrast Solution intervention 3: Omnipaque 240 mg I/mL | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00626366 |
[
4
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the st... | null | Epilepsy | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg; \>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reach... | intervention 1: Zonisamide intervention 2: Placebo | 73 | Chatswood | New South Wales | Australia | 151.18333 | -33.8
Randwick | New South Wales | Australia | 151.24895 | -33.91439
Heidelburg | Victoria | Australia | N/A | N/A
Melbourne | Victoria | Australia | 144.96332 | -37.814
Melbourne | N/A | Australia | 144.96332 | -37.814
Split | HR | Croatia | 16.43915 | 43.50891
Zag... | 0 | NCT00692003 | |
[
3
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale. | null | Akathisia, Drug-Induced Antipsychotic Agents Movement Disorders | Antipsychotic Agents | null | 4 | arm 1: Preladenant 25 mg every 12 hours for 13 days arm 2: Placebo every 12 hours for 13 days arm 3: Preladenant 25 mg every 12 hours for 13 days arm 4: Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site) | [
0,
2,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Preladenant, one 25 mg capsule, administered orally every 12 hours intervention 2: Matching placebo capsule administered orally every 12 hours intervention 3: Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue... | intervention 1: Preladenant intervention 2: Placebo intervention 3: Anticholinergic agents or propanolol intervention 4: Haloperidol | 0 | null | 0 | NCT00693472 |
[
3
] | 38 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease. | null | Dry Eye Disease | null | 1 | arm 1: bromfenac ophthalmic solution 0.06% bilaterally twice a day | [
0
] | 1 | [
0
] | intervention 1: bromfenac ophthalmic solution 0.06% bilaterally twice a day | intervention 1: bromfenac ophthalmic solution 0.06% | 1 | Irvine | California | United States | -117.82311 | 33.66946 | 0 | NCT00758784 | |
[
3
] | 107 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848. | null | Atherosclerosis | SB-480848 Dyslipidaemia | null | 4 | arm 1: Matched Placebo arm 2: SB480848 40mg/day arm 3: SB480848 80mg/day arm 4: SB480848 160mg/day | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1 tablet once a day intervention 2: 1 tablet once a day intervention 3: 1 tablet once a day intervention 4: 1 tablet once a day | intervention 1: SB480848 40mg EC Tablet intervention 2: SB480848 80mg EC Tablet intervention 3: SB480848 160mg EC Tablet intervention 4: SB480848 Placebo Tablet | 7 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Tokyo | N/A | Japan | 139.69171 | 35.6895
Tokyo | N/A | Japan | 139.69171 | 35.6895
Tokyo | N/A | Japan | 139.69171 | 35.6895
Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00734032 |
[
2
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted. | null | Overactive Bladder | null | 4 | arm 1: Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo arm 2: Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd) arm 3: Part II, Sequence 1: study drug crossing over to placebo arm 4: Part II, Sequence 2: placebo crossing over to study drug | [
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose tolterodine tartrate 4 mg capsule intervention 2: Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: placebo to t... | intervention 1: tolterodine tartrate intervention 2: Comparator: Placebo to tolterodine tartrate | 0 | null | 0 | NCT00768521 | |
[
3
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures. | This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an... | Opioid-induced Constipation | null | 2 | arm 1: Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. arm 2: Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon th... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. intervention 2: Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. | intervention 1: Methylnaltrexone bromide intervention 2: Placebo | 1 | Tarrytown | New York | United States | -73.85875 | 41.07621 | 0 | NCT00640146 | |
[
4
] | 116 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs). | null | Digital Ulcers | digital ulcers systemic sclerosis finger ulcers bosentan open label | null | 1 | arm 1: Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter | [
0
] | 2 | [
0,
0
] | intervention 1: Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose) intervention 2: Bosentan 125-mg oral tablets administered b.i.d. (target dose) | intervention 1: Bosentan 62.5 mg intervention 2: Bosentan 125 mg | 0 | null | 0 | NCT00319696 |
[
4
] | 1,068 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants. | null | Migraine | null | 2 | arm 1: Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medicat... | [
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: One capsule taken orally at onset of migraine intervention 2: One tablet taken orally at onset of migraine intervention 3: One tablet taken orally at onset of migraine intervention 4: One capsule taken orally at onset of migraine intervention 5: One tablet taken orally at onset of migraine intervention ... | intervention 1: Telcagepant 300 mg soft gel capsules intervention 2: Telcagepant 280 mg tablets intervention 3: Rizatriptan 10 mg tablets intervention 4: Placebo to telcagepant capsules intervention 5: Placebo to telcagepant tablets intervention 6: Placebo to rizatriptan tablets | 0 | null | 0 | NCT00443209 | |
[
0
] | 1,496 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.
This study tests whether RS... | A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-2) | Alzheimer's Disease | apolipoprotein E Alzheimer's disease cognition rosiglitazone adjunctive therapy | null | 3 | arm 1: Rosiglitazone Extended Release 2mg OD arm 2: Rosiglitazone Extended Release 8mg OD arm 3: Placebo | [
0,
0,
2
] | 4 | [
0,
0,
10,
10
] | intervention 1: Rosiglitazone Extended Release 2mg OD intervention 2: Rosiglitazone Extended Release 8mg OD intervention 3: Placebo intervention 4: Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the d... | intervention 1: Rosiglitazone Extended Release 2mg intervention 2: Rosiglitazone Extended Release 8mg intervention 3: Placebo intervention 4: Donepezil | 249 | Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | Californi... | 1 | NCT00348309 |
[
3
] | 63 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imati... | OBJECTIVES:
I. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.
II. Determine the objective response rate of patients treated with this drug. III. Determine the safety ... | Gastrointestinal Stromal Tumor | null | 1 | arm 1: Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks ... | [
0
] | 2 | [
3,
0
] | intervention 1: Undergo surgical resection intervention 2: Given orally | intervention 1: Conventional Surgery intervention 2: Imatinib Mesylate | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00028002 | |
[
3,
4
] | 64 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficien... | Adrenal insufficiency is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving replacement therapy with hydrocortisone or cortisone aceta... | Adrenal Insufficiency | Adrenal insufficiency Primary adrenal insufficiency Addison's disease Hydrocortisone Modified release | null | 2 | arm 1: Test drug: hydrocortisone (modified release), oral tablet, available as 20 mg and 5 mg.
The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state arm 2: Reference drug: hydrocortisone, oral tablet, 10 mg. The reference drug was administered orally thrice daily (at 8 AM... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial intervention 2: The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered ... | intervention 1: hydrocortisone (modified release), oral tablet 20 and 5 mg intervention 2: Hydrocortisone, oral tablet, 10 mg | 0 | null | 0 | NCT00915343 |
[
3
] | 53 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 2MALE | false | The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy. | Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after o... | Postoperative Pain Inguinal Hernia | Herniorrhaphy Inguinal Hernia Repair Postoperative pain | null | 2 | arm 1: Two, 5x5cm bupivacaine collagen sponges implanted during surgery arm 2: Placebo collagen sponge implanted during surgery | [
0,
2
] | 2 | [
0,
0
] | intervention 1: collagen; Bupivacaine hydrocholoride intervention 2: collagen | intervention 1: Bupivacaine Collagen Sponge intervention 2: placebo collagen sponge | 1 | Anaheim | California | United States | -117.9145 | 33.83529 | 0 | NCT00626886 |
[
3
] | 401 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese ... | Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender.
Baseline measurements for t... | Obesity Overweight Body Weight | null | 2 | arm 1: SCH 497079, administered orally, once daily arm 2: Placebo capsules, administered orally, once daily | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 100 mg capsule administered orally intervention 2: Placebo capsules matching SCH 497079 administered orally | intervention 1: SCH 497079 intervention 2: Placebo | 0 | null | 0 | NCT00642993 | |
[
3
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Critically injured patients endure a period of hypermetabolism/catabolism after being resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor wound healing, susceptibility to infection and long hospital stays. While there have been some data to suggest that hypermetabolism can be amelio... | null | Trauma | null | 2 | arm 1: None arm 2: None | [
0,
4
] | 1 | [
0
] | intervention 1: None | intervention 1: Propranolol | 1 | Denver | Colorado | United States | -104.9847 | 39.73915 | 0 | NCT00356187 | |
[
3
] | 333 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV. | Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV. This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone. PEG-IFN and ribavirin are used in standard treatment of... | HIV Infections Hepatitis C Liver Disease | Treatment Experienced | null | 3 | arm 1: At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA \>=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks. arm 2... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: 180 mcg PEG-IFN subcutaneously intervention 2: One tablet or capsule containing ribavirin 200 mg | intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin | 37 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
San Diego | California | United States | -117.16472 | 32.71571
San ... | 1 | NCT00078403 |
[
4
] | 3,182 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104) | null | Obesity | Obesity Weight loss lorcaserin APD356 BLOOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena | null | 2 | arm 1: Lorcaserin 10 mg tablet each morning and evening arm 2: Matching placebo tablet each morning and evening | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks. intervention 2: Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks. | intervention 1: Lorcaserin 10 mg BID intervention 2: Matching Placebo BID | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00395135 |
[
4
] | 807 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder. | The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is t... | Depressive Disorder, Major | major depressive disorder MDD depression | null | 4 | arm 1: DVS SR 50mg/day arm 2: DVS SR 100mg/day arm 3: DVS SR 200mg/day arm 4: Paroxetine 20mg/day | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper intervention 2: 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper | intervention 1: DVS SR intervention 2: Paroxetine | 43 | Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Guangdong Province | N/A | China | N/A | N/A
Hunan Province | N/A | China | N/A | N/A
Jiangsu Province | N/A | China | N/A | N/A
Shanghai | N/A | China | 121.45806 | 31.22222
Shanghai | N/A | China | 121.45806 | 31.22222
Shanxi Prov... | 1 | NCT00445679 |
[
3
] | 125 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy. | null | Sleep Apnea, Obstructive Hypopnea Syndrome Excessive Daytime Sleepiness | null | 6 | arm 1: Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil arm 2: Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249 arm 3: Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo arm 4: Arm 4: Tre... | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment period... | intervention 1: Comparator: MK0249 intervention 2: Comparator: placebo intervention 3: Comparator: modafinil | 0 | null | 1 | NCT00620659 | |
[
4
] | 781 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder. | Participants in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.
Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week t... | Generalized Anxiety Disorder | Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy | null | 5 | arm 1: Placebo-matching capsules, orally, once daily for up to 9 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 3: Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by pla... | [
2,
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Placebo-matching capsules intervention 2: Encapsulated vortioxetine immediate release tablets intervention 3: Overencapsulated duloxetine capsules | intervention 1: Placebo intervention 2: Vortioxetine intervention 3: Duloxetine | 66 | Anaheim | California | United States | -117.9145 | 33.83529
Beverly Hills | California | United States | -118.40036 | 34.07362
Fresno | California | United States | -119.77237 | 36.74773
Los Angeles | California | United States | -118.24368 | 34.05223
Oceanside | California | United States | -117.37948 | 33.19587
San D... | 1 | NCT00730691 |
[
4
] | 271 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy. | null | Urinary Tract Infection | null | 2 | arm 1: ertapenem sodium arm 2: ceftriaxone sodium | [
0,
1
] | 2 | [
0,
0
] | intervention 1: a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed) intervention 2: a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to ora... | intervention 1: ertapenem sodium (MK0826) intervention 2: Comparator: ceftriaxone sodium | 0 | null | 1 | NCT01014013 |
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