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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
0
] | 59 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body ... | Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K suppleme... | Aging Osteoporosis | Vitamin K metabolism Bone health Metabolism | null | 1 | arm 1: 28 day diet low vitamin K, 28 day diet high vitamin K | [
0
] | 1 | [
0
] | intervention 1: phylloquinone (vitamin K1) 500 mcg daily in third month | intervention 1: Vitamin K | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00336232 |
[
3
] | 157 | RANDOMIZED | FACTORIAL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic Kidney Disease (CKD), not on dialysis, who ... | PROCRIT (Epoetin alfa) is a brand of recombinant human erythropoietin (rHuEPO). Erythropoietin is a hormone produced in the kidney. Its function is to stimulate the production of red blood cells in the bone marrow. Many patients with Chronic Kidney Disease (CKD) do not produce enough erythropoietin and thus develop ane... | Renal Failure , Chronic Anemia | Long Term Care Facilities subcutaneous injections PROCRIT Epoetin alfa Anemia | null | 2 | arm 1: None arm 2: Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs). | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks intervention 2: None | intervention 1: Epoetin Alfa intervention 2: Standard of care | 0 | null | 0 | NCT00337935 |
[
3
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD). | null | Chronic Obstructive Pulmonary Disease (COPD) | null | 2 | arm 1: Arm 1: drug, crossing over to Pbo comparator arm 2: Arm 2: Pbo comparator, crossing over to drug | [
5,
5
] | 2 | [
0,
0
] | intervention 1: fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment. intervention 2: Placebo /inhalation, 2 inhalations bid. 14 Days of treatment. | intervention 1: Fluticasone intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00387036 | |
[
5
] | 39 | NON_RANDOMIZED | FACTORIAL | 0TREATMENT | 0NONE | true | 0ALL | false | This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder. | Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in activities that were once enjoyable, irritability, and sleep problems. Medication therapy, behavioral therapy, and a combination of both th... | Post-Traumatic Stress Disorder | PTSD Trauma Sexual Abuse Sexual Assault | null | 3 | arm 1: Participants assigned to the control condition will receive no treatment arm 2: Participants will receive treatment with sertraline arm 3: Participants will receive cognitive behavioral therapy | [
4,
1,
1
] | 2 | [
0,
5
] | intervention 1: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks intervention 2: CBT consists of sixteen 1-hour sessions during a period of 12 weeks. | intervention 1: Sertraline intervention 2: Cognitive behavioral therapy (CBT) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00391430 |
[
2,
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current therapies target the immune system early in the disea... | RA is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. It occurs when the immune system, which normally defends the body from invading organisms, turns its attack against the membrane lining the joints. RA is commonly managed by DMARDs initiated early in the disease pro... | Rheumatoid Arthritis | Autoimmune disease Biologic response modifiers Disease-modifying antirheumatic drugs (DMARDS) Immune system Rheumatoid arthritis (RA) Rituximab (anti-CD20 monoclonal antibodies) | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.
Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid. | intervention 1: Rituximab | 1 | Denver | Colorado | United States | -104.9847 | 39.73915 | 0 | NCT00396812 |
[
4
] | 109 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period. | null | Blepharospasm | null | 2 | arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: i... | intervention 1: incobotulinumtoxinA (Xeomin) intervention 2: Placebo | 2 | Houston | Texas | United States | -95.36327 | 29.76328
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 | 0 | NCT00406367 | |
[
4
] | 564 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 1FEMALE | true | Science News (October 2004) called vitamin D deficiency a "silent epidemic" in America, with no group unaffected. Using new guidelines of optimal vitamin D levels, more than 90% of African American women now suffer from vitamin D deficiency. Deficiency during pregnancy has profound effects on the developing fetus. Othe... | With avoidance of sunlight exposure due to lifestyle changes and concerns regarding skin cancer and the resultant widespread use of sunscreen, very few Americans are meeting their needs for vitamin D either through skin photosynthesis or dietary intake. A study published by the Centers for Disease Control (CDC) and our... | Vitamin D Deficiency Pregnancy | vitamin D cholecalciferol pregnant women | null | 2 | arm 1: Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. arm 2: Women are randomized to one of 2 treat... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day intervention 2: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 intervention 3: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starti... | intervention 1: cholecalciferol (vitamin D3) intervention 2: cholecalciferol intervention 3: cholecalciferol | 1 | Columbia | South Carolina | United States | -81.03481 | 34.00071 | 0 | NCT00412087 |
[
3
] | 53 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. It was planned to enroll approximately ... | null | Gastric Cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, IV, every 21 days x 6 cycles | intervention 1: pemetrexed intervention 2: cisplatin | 6 | Barnaul | N/A | Russia | 83.7456 | 53.3598
Ivanovo | N/A | Russia | 40.97139 | 56.99719
Kazan' | N/A | Russia | 49.12214 | 55.78874
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Stavropol | N/A | Russia | 41.9734 | 45.0428 | 0 | NCT00415168 | |
[
2,
3
] | 6 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer. | The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial. | Breast Neoplasms | null | 1 | arm 1: sunitinib + exemestane | [
0
] | 2 | [
0,
0
] | intervention 1: 25 mg, oral, daily dosing intervention 2: 37.5 mg, oral, continuous dosing, daily | intervention 1: exemestane intervention 2: sunitinib malate | 3 | Atlanta | Georgia | United States | -84.38798 | 33.749
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884 | 0 | NCT00417885 | |
[
5
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture patients to achieve the optimal therapeutic level. | Low Vitamin D levels can cause faster bone loss and increase the risk of having a fracture. Patients who experience a hip fracture have low levels of Vitamin D. It is not clear how much Vitamin D must be taken in order to reach this optimal level.
Serum 25-hydroxyvitamin D3 (25-OHD) concentrations are the recognized f... | Hip Fracture | Vitamin D Hip fracture Optimal level Deficiency Functional muscle strength | null | 3 | arm 1: 50 000 IU Vitamin D2 arm 2: 100 000 IU Vitamin D2 arm 3: Placebo | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 50 000 IU vitamin D2, one time bolus dose intervention 2: 100 000 IU vitamin D2, one time bolus dose intervention 3: Placebo, 1 time bolus dose | intervention 1: Vitamin D2 intervention 2: Vitamin D2 intervention 3: Placebo | 0 | null | 0 | NCT00424619 |
[
3
] | 4 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remi... | Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytopla... | Churg-Strauss Syndrome | Antineutrophil cytoplasmic antibody associated vasculitis Glomerulonephritis Rituximab | null | 1 | arm 1: 375 mg/m\^2/week for 4 weeks | [
0
] | 2 | [
0,
0
] | intervention 1: Patients received 4 weekly doses of rituximab 375 mg/m\^2. intervention 2: Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months | intervention 1: Rituximab intervention 2: Prednisone | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00424749 |
[
3,
4
] | 255 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration | null | Macular Degeneration Choroidal Neovascularization | Age-related macular degeneration AMD Choroidal neovascularization Verteporfin Ranibizumab | null | 2 | arm 1: Verteporfin (6 mg/m\^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as n... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of the infusion. intervention 2: Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection)... | intervention 1: Verteporfin Photodynamic Therapy intervention 2: Ranibizumab intervention 3: Placebo | 12 | Vienna | N/A | Austria | 16.37208 | 48.20849
Antwerp | N/A | Belgium | 4.40026 | 51.22047
Aalborg | N/A | Denmark | 9.9187 | 57.048
Créteil | N/A | France | 2.46569 | 48.79266
Regensburg | N/A | Germany | 12.10161 | 49.01513
Budapest | N/A | Hungary | 19.04045 | 47.49835
Florence | N/A | Italy | 11.24626 | 43.77925
Rot... | 0 | NCT00433017 |
[
5
] | 151 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment. | null | Major Depressive Disorder Idiopathic Parkinson Disease | null | 1 | arm 1: Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks | [
0
] | 1 | [
0
] | intervention 1: Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks | intervention 1: Duloxetine hydrochloride | 13 | Ancona | N/A | Italy | 13.5103 | 43.60717
Brescia | N/A | Italy | 10.21472 | 45.53558
Catania | N/A | Italy | 15.07041 | 37.49223
Genova | N/A | Italy | 11.87211 | 45.21604
Lido di Camaiore | N/A | Italy | 10.2269 | 43.90012
Messina | N/A | Italy | 15.55256 | 38.19394
Milan | N/A | Italy | 12.59836 | 42.78235
Napoli | ... | 0 | NCT00437125 | |
[
4
] | 180 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or wit... | null | Asthma | null | 2 | arm 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) arm 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks. intervention 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks. | intervention 1: mometasone furoate dry powder inhaler intervention 2: Budesonide DPI | 0 | null | 0 | NCT00442117 | |
[
4
] | 3,002 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis. | Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Sympt... | Thrombosis, Venous | superficial vein thrombosis superficial thrombophlebitis fondaparinux deep vein thrombosis venous thromboembolism treatment thrombosis | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 1 | [
0
] | intervention 1: Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day | intervention 1: Fondaparinux 2.5mg or placebo | 227 | Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Brno | N/A | Czechia | 16.60796 | 49.19522
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Pilsen | N/A | Czechia | 13.37759 | 49.74747
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague... | 0 | NCT00443053 |
[
4
] | 399 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescent... | null | Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension arm 2: Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension intervention 2: Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension | intervention 1: Atomoxetine intervention 2: Other standard therapy for ADHD | 35 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Hoboken | N/A | Belgium | 4.34844 | 51.17611
Leuven | N/A | Belgium | 4.70093 | 50.87959
Amiens | N/A | France | 2.3 | 49.9
Bordeaux | N/A | France | -0.5805 | 44.84044
Lyon | N/A | France | 4.84671 | 45.74846
Montpellier | N/A | France | 3.87635 | 43.61093
Paris | N/A | Fr... | 0 | NCT00447278 | |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with es... | OBJECTIVES:
Primary
* Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol.
Secondary
* Determine the toxicity of this regimen in these patients.
* Determine the response rate in patients treated with this regim... | Prostate Cancer | adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: Transdermal estradiol given 0.2mg/day for duration of study. intervention 2: Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2 | intervention 1: transdermal estradiol intervention 2: paclitaxel poliglumex | 2 | San Francisco | California | United States | -122.41942 | 37.77493
Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00459810 |
[
3
] | 12 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a residential study that looks at the effects of buprenorphine in persons who abuse but are not dependent on opioids. Animal studies show that very high doses of buprenorphine produce less effects than mid-range doses. This suggests that buprenorphine can be a very safe medication. However, no studies in humans... | Preclinical studies have demonstrated for a variety of measures that buprenorphine has a bell-shaped dose response curve. However, human studies with buprenorphine have not shown such an effect, although controlled studies have generally not tested higher acute doses of buprenorphine. Current clinical recommendations g... | Opioid-related Disorders | Opioid addiction Opioid dependence Buprenorphine | null | 8 | arm 1: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 2: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 3: All partici... | [
0,
0,
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week. intervention 2: Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind intervention 3: Intramuscular; double blind; once per week | intervention 1: Buprenorphine intervention 2: Morphine intervention 3: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00460239 |
[
5
] | 40 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parent... | null | Rheumatoid Arthritis | null | 1 | arm 1: Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15. Participants also received methylprednisolone 100 mg, IV, 30 minutes before the infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, ... | [
0
] | 4 | [
0,
0,
0,
7
] | intervention 1: 1000 mg i.v. on Days 1 and 15 intervention 2: 10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24 intervention 3: ≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24 intervention 4: ≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24 | intervention 1: rituximab intervention 2: Methotrexate intervention 3: Corticosteroid or NSAID intervention 4: Folate | 4 | Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00462345 | |
[
4
] | 298 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis. | null | Parkinson's Disease Psychosis | Parkinson's disease, psychotic disorders | null | 3 | arm 1: Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks arm 2: Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks arm 3: Placebo tablet, once daily by mouth, 6 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg, tablet, once daily by mouth, 6 weeks intervention 2: 40 mg, tablet, once daily by mouth, 6 weeks intervention 3: tablet, once daily by mouth, 6 weeks | intervention 1: Pimavanserin tartrate (ACP-103) intervention 2: Pimavanserin tartrate (ACP-103) intervention 3: Placebo | 78 | Gilbert | Arizona | United States | -111.78903 | 33.35283
Phoenix | Arizona | United States | -112.07404 | 33.44838
Berkeley | California | United States | -122.27275 | 37.87159
Carson | California | United States | -118.28202 | 33.83141
Fountain Valley | California | United States | -117.95367 | 33.70918
Irvine | Cali... | 0 | NCT00477672 |
[
5
] | 82 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis. | null | Osteoporosis | postmenopausal women with primary osteoporosis | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Once daily subcutaneous injection in the abdomen by self administration intervention 2: The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other th... | intervention 1: Full Length Parathyroid Hormone, PTH(1-84) intervention 2: Strontium Ranelate | 1 | Roskilde | N/A | Denmark | 12.08035 | 55.64152 | 0 | NCT00479037 |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingr... | 1\. Background: Cannabis is the most widely used illicit drug in the U.S. According to the 2004 U.S. The 2004 NSDUH estimates there are 3.2 million daily or almost daily marijuana smokers in the United States. Recent reports have estimated that 1.5% of the US population meets DSM-IV diagnostic criteria for cannabis abu... | Marijuana Dependence | Marijuana Addiction Substance Withdrawal Syndrome Clinical Trial Dronabinol Behavioral Therapy Adults Neuroimaging Neuropsychological Testing Neurocognitive Testing Behavioral Probes | null | 2 | arm 1: Dronabinol+ BRENDA therapy arm 2: Placebo+BRENDA therapy | [
1,
2
] | 3 | [
0,
5,
0
] | intervention 1: 10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week intervention 2: weekly therapy sessions for 6 weeks intervention 3: 4 capsules daily for 2 weeks followed by a 1 week taper | intervention 1: Dronabinol intervention 2: BRENDA therapy intervention 3: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00480441 |
[
3
] | 94 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ... | PRIMARY OBJECTIVES:
I. To compare the response rate associated with the combination of vorinostat, carboplatin, paclitaxel versus carboplatin, paclitaxel and placebo for patients with previously untreated, advanced NSCLC.
SECONDARY OBJECTIVES:
I. To determine the time to progression and overall survival for the two ... | Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | null | 2 | arm 1: Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3. arm 2: Patients receive an oral placebo once daily on days 1-14 and pac... | [
0,
1
] | 5 | [
0,
0,
0,
10,
10
] | intervention 1: Given PO intervention 2: Given IV intervention 3: Given IV intervention 4: Given PO intervention 5: Correlative studies | intervention 1: vorinostat intervention 2: paclitaxel intervention 3: carboplatin intervention 4: placebo intervention 5: laboratory biomarker analysis | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 0 | NCT00481078 | |
[
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer. | OBJECTIVES:
Primary
* Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.
Secondary
* Determine the time to PSA recurrence in patients receiving this treatment.
* Determine the time to metastatic disease in patients receiving this t... | Prostate Cancer | adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer | null | 0 | null | null | 1 | [
0
] | intervention 1: Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle. | intervention 1: docetaxel | 2 | Portland | Oregon | United States | -122.67621 | 45.52345
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00482274 |
[
2
] | 47 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).
For enrollment information see the Central Contact informat... | null | Acute Myelogenous Leukemia | Phase I Phase II acute myelogenous leukemia AML cancer | null | 0 | null | null | 1 | [
0
] | intervention 1: intravenous infusion administered on days 1, 2 and 3 | intervention 1: AZD4877 | 4 | Chicago | Illinois | United States | -87.65005 | 41.85003
Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00486265 |
[
3
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS). | null | Myelodysplastic Syndromes Blood Disease Bone Marrow Disease | null | 2 | arm 1: vorinostat 400 mg arm 2: vorinostat 200 mg | [
0,
0
] | 2 | [
0,
0
] | intervention 1: vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles. intervention 2: vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles. | intervention 1: vorinostat intervention 2: vorinostat | 0 | null | 0 | NCT00486720 | |
[
4
] | 226 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of the study is
* Find out if patients receiving Sorafenib will live longer
* Find out if Sorafenib has any effect on patient reported outcomes
* Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their metastases
* Determine the pharmacokinetics (PK) in patients with liver cancer | null | Carcinoma, Hepatocellular | null | 2 | arm 1: Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment. arm 2: ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: multikinase inhibitor; Sorafenib 400 mg (orally) twice daily intervention 2: Matching placebo (orally) twice daily | intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo | 23 | Hefei | Anhui | China | 117.28083 | 31.86389
Guangzhou | Guangdong | China | 113.25 | 23.11667
Guangzhou | Guangdong | China | 113.25 | 23.11667
Wuhan | Hubei | China | 114.26667 | 30.58333
Nanjing | Jiangsu | China | 118.77778 | 32.06167
Nanjing | Jiangsu | China | 118.77778 | 32.06167
Dalian | Liaoning | China | 121.... | 0 | NCT00492752 | |
[
4
] | 1,027 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen. | Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between o... | Ulcerative Colitis | null | 2 | arm 1: an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day) arm 2: an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks intervention 2: Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks | intervention 1: Mesalamine Once-Daily intervention 2: Mesalamine Twice-Daily | 245 | Athens | Alabama | United States | -86.97219 | 34.80243
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Dothan | Alabama | United States | -85.39049 | 31.22323
Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | United ... | 0 | NCT00505778 | |
[
3
] | 28 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation. The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validat... | The Fontan physiology is the end result of staged reconstruction of the heart and the major blood vessels in patients who have a single ventricle. After completion of the reconstruction, the great veins which usually bring blood back to the heart are connected directly to the pulmonary arteries, allowing blood from the... | Hypoplastic Left Heart Syndrome Tricuspid Atresia | Other Single Ventricle Anatomy Hypoplastic Left Heart Syndrome Tricuspid Atresia | null | 2 | arm 1: Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks. arm 2: Placebo will be given for six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three t... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: One 20 mg capsule of sildenafil will be taken by mouth three times-a-day. intervention 2: One placebo capsule will be taken by mouth three times-a-day. | intervention 1: Sildenafil intervention 2: Placebo | 0 | null | 0 | NCT00507819 |
[
3
] | 279 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of... | null | Knee Osteoarthritis | Osteoarthritis Knee CRx-102 prednisolone dipyridamole CombinatoRx WOMAC | null | 5 | arm 1: 2.7 mg prednisolone plus 90 mg dipyridamole
Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 2: 2.7 mg prednisolone plus 180 mg dipyridamole
Subject... | [
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: CRx-102 dose 1 intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 dose 2 intervention 5: CRx-102 dose 3 | intervention 1: CRx-102 (2.7/90) intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 (2.7/180) intervention 5: CRx-102 (2.7/360) | 58 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Chandler | Arizona | United States | -111.84125 | 33.30616
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tuscon | Arizona | United States | N/A | N/A
Little Rock | Arkansas | United States | -92... | 0 | NCT00521989 |
[
5
] | 214 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate... | A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate either in fixed combination (SFC50/500 µg bid) or separately (SAL 50 µg and FP 500 µg bid) via Diskus inhalers on the course of the disease and frequency of exacerbations in subjects with se... | Pulmonary Disease, Chronic Obstructive | Severe and very severe COPD (GOLD stage III / IV) exacerbations health care utilisation Chronic Obstructive Pulmonary Disease (COPD) quality of life compliance salmeterol/fluticasone combination | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: comparator intervention 2: comparator | intervention 1: Salmeterol / Fluticasone (50/500 µg) BID fixed combination intervention 2: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers | 23 | Bruchsal | Baden-Wurttemberg | Germany | 8.59804 | 49.12426
Heidelberg | Baden-Wurttemberg | Germany | 8.69079 | 49.40768
Mannheim | Baden-Wurttemberg | Germany | 8.46694 | 49.4891
Wiesloch | Baden-Wurttemberg | Germany | 8.69846 | 49.29504
Cottbus | Brandenburg | Germany | 14.32888 | 51.75769
Neuruppin | Brandenburg |... | 0 | NCT00527826 |
[
5
] | 178 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy. | null | Hypertension With Metabolic Syndrome | Hypertension Metabolic Syndrome Dual combination therapy Triple combination therapy Aliskiren Direct Renin inhibitor | null | 3 | arm 1: 6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prio... | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to ... | intervention 1: Amlodipine intervention 2: Aliskiren intervention 3: Ramipril | 1 | Cambridge | N/A | United Kingdom | 0.11667 | 52.2 | 0 | NCT00542269 |
[
0
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is as... | We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both a... | Bipolar Depression | Bipolar depression | null | 1 | arm 1: Riluzole 50 mg twice daily for 2 weeks, increased to riluzole 50 mg in the morning and 100 mg in the evening for 1 week if tolerated, with a further increase to riluzole 100 mg twice daily if tolerated for 3 weeks. | [
0
] | 1 | [
0
] | intervention 1: 50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks | intervention 1: Riluzole | 1 | Belmont | Massachusetts | United States | -71.17867 | 42.39593 | 0 | NCT00544544 |
[
0
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | true | Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an... | Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup. | Bacterial Vaginosis | bacterial vaginosis vaginal acidifying gel recurrence | null | 2 | arm 1: Receive metronidazole plus vaginal gel arm 2: Oral Metronidazole antibiotic therapy alone | [
0,
1
] | 2 | [
0,
0
] | intervention 1: placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH. intervention 2: oral metronidazole therapy alone | intervention 1: Vaginal acidifying gel (RepHresh) intervention 2: Metronidazole control | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00545181 |
[
4
] | 513 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure | null | Anemia | null | 2 | arm 1: Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. arm 2: SMC for IDA (as determined by the Investigator) for treating CKD related anemia. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC) | 1 | Norristown | Pennsylvania | United States | -75.3399 | 40.1215 | 0 | NCT00548691 | |
[
4
] | 2,018 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state. | null | Anemia | null | 2 | arm 1: Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) arm 2: Varied as determined by the Investigator | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC) | 1 | Norristown | Pennsylvania | United States | -75.3399 | 40.1215 | 0 | NCT00548860 | |
[
3
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | true | The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis. | null | Endometriosis | Endometriosis Pelvic pain Oral progesterone blocker | null | 3 | arm 1: Placebo once daily arm 2: Proellex 25 mg once daily arm 3: Proellex 50 mg once daily | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 1 capsule daily for 4 months intervention 2: 1 capsule daily for 4 months intervention 3: 2 capsules daily for 4 months | intervention 1: Proellex 25 mg intervention 2: Placebo intervention 3: Proellex 50 mg | 17 | Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Diego | California | United States | -117.16472 | 32.71571
San Ramon | California | United States | -121.97802 | 37.77993
Lake Worth | Florida | United States | -80.07231 | 26.61708
West Palm Beach... | 0 | NCT00556075 |
[
4
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan). | This study is a Phase III, multicenter, randomized, double-blind, parallel, placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the following phases: screening phase (up to 10 days), wash-ou... | Exocrine Pancreatic Insufficiency Chronic Pancreatitis Pancreatectomy | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. intervention 2: Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2... | intervention 1: Viokase® 16 intervention 2: Placebo intervention 3: Proton pump inhibitor (PPI) intervention 4: Omeprazole | 18 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229
Lévis | Quebec | Canada | -71.17793 | 46.80326
Bialystok | N/A | Poland | 23.16433 | 53.13333
Gdansk | N/A | Poland | 18.64912 | 54.35227
Katowice | N/A | Poland | 19.02754 | 50.25841
Krakow | N/A | Poland | 19.93658 | 50.06143
Lodz | N/A | Poland | 19.4739... | 0 | NCT00559364 | |
[
3
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea | null | Blepharitis Meibomianitis Dry Eye | null | 2 | arm 1: COL-101 arm 2: Sugar capsule | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 40mg, once per day for 84 days intervention 2: sugar capsule | intervention 1: COL-101 (doxycycline, USP) capsules intervention 2: placebo | 8 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Naples | Florida | United States | -81.79596 | 26.14234
Louisville | Kentucky | United States | -85.75941 | 38.25424
St Louis | Missouri | United States | -90.19789 | 38.62727
Lynbrook | New York | United States | -73.6718 | 40.65483
Oklahoma City | Oklahoma... | 0 | NCT00560703 | |
[
5
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
The aim of this study is to:
1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of l... | Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.
Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describ... | Osteoarthritis of the Knee | osteoarthritis knee arthroplasty local infiltration analgesia TKA epidural analgesia operation surgery | null | 3 | arm 1: Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine arm 2: Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine arm 3: standard continuous epidural analgesia | [
0,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: intraoperative and 1. postoperative day intervention 2: intraoperative LIA (IV and IA) and continuous EDA intervention 3: intraoperative and 1. postoperative day intervention 4: intraoperative intervention 5: continuous postoperatively intervention 6: continuous postoperatively | intervention 1: ropivacaine intervention 2: adrenaline intervention 3: ketorolac intervention 4: morphine intervention 5: fentanyl intervention 6: bupivacaine | 1 | Rud | N/A | Norway | 11.63333 | 60.43333 | 0 | NCT00562627 |
[
4
] | 426 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | null | The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus. | null | Atrophy Vaginal Diseases | Urogenital atrophy Menopausal symptoms Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy | null | 2 | arm 1: Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. arm 2: Placebo will be taken once daily, in the morning, with food for 52 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food. intervention 2: Dosing wil... | intervention 1: Ospemifene 60 mg intervention 2: Placebo | 0 | null | 0 | NCT00566982 |
[
5
] | 26 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder. | Because the opiate antagonists appear to be effective in the treatment of pathological gambling (PG), it is reasonable to ask whether acamprosate (calcium acetylhomotaurine; Campral), also FDA approved for the treatment of alcoholism, can be used effectively to treat PG. Acamprosate is not an opioid antagonist; rather,... | Pathological Gambling | acamprosate, impulse-control disorders | null | 1 | arm 1: Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses. | [
0
] | 1 | [
0
] | intervention 1: Two 333mg tablets taken three times daily. | intervention 1: acamprosate | 0 | null | 0 | NCT00571103 |
[
5
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | true | We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone. | We performed a 6-week, 4-group, parallel, randomized, double-blind, double-dummy, clinical trial in 60 patients with perennial allergic rhinitis. After an initial screening with an allergy questionnaire and skin puncture testing to confirm an allergic response to a perennial allergen (cat, dog, dust mite, indoor mold),... | Allergic Rhinitis | null | 4 | arm 1: Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm arm 2: Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm arm 3: Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in t... | [
2,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 2 puffs of each nasal spray in each nostril in the pm intervention 2: 2 puffs of each nasal spray in each nostril in the pm intervention 3: 2 puffs of each nasal spray in each nostril in the pm intervention 4: 2 puffs of each nasal spray in each nostril in the pm | intervention 1: Fluticasone furoate intervention 2: Placebo Fluticasone furoate intervention 3: Oxymetazoline intervention 4: Placebo Oxymetazoline | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00584987 | |
[
3
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sensitive GIST releases... | null | Gastrointestinal Stromal Tumors Cancer Brain Solid Tumors | Gastrointestinal stromal tumors Imatinib Peginterferon α-2b Immunotherapy Targeted therapy | null | 1 | arm 1: All participants enrolled in the study. | [
0
] | 2 | [
0,
0
] | intervention 1: Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible. intervention 2: Continue imatinib until progression. | intervention 1: Peginterferon-alpha 2b (PegIFNa2b); intervention 2: Imatinib | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00585221 |
[
0
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes. | Despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (CKD). CKD constitutes one of the highest risk populations for cardiovascular disease. When the creatinine clearance is ≤ 60 ml/min the risk for cardiov... | Chronic Kidney Disease | Kidney Failure, Chronic Renal Insufficiency, Chronic Proteinuria Albuminuria | null | 2 | arm 1: Placebo 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. arm 2: Pioglitazone 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. | [
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Pioglitazone 30 mg daily for 6 months intervention 2: Placebo 30 mg daily for 6 months intervention 3: 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity. | intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Nitroglycerin | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00586261 |
[
3
] | 105 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort. | null | Vulvodynia | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: semi solid, twice weekly, 4 months intervention 2: semi solid, twice weekly for 4 months intervention 3: semi solid, twice weekly for 4 months | intervention 1: Lidocaine/Diphenhydramine intervention 2: lidocaine intervention 3: placebo | 48 | Montgomery | Alabama | United States | -86.29997 | 32.36681
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Searcy | Arkansas | United States | -91.73625 | 35.25064
Dinuba | California | United States | -119.38707 | 36.54328
San Diego | California | U... | 0 | NCT00590590 | |
[
4
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive substance). This resea... | Introduction and aims: Stress and corticosteroid exposure are associated with changes in the human and animal hippocampus. In animals, phenytoin prevents dendritic changes in the hippocampus secondary to corticosterone. We propose to use functional magnetic resonance imaging (fMRI) to explore the effects of 3-days of e... | Healthy | Phenytoin Dilantin Corticosteroid Neuroprotection Mania Cognition Mood Memory Hydrocortisone Healthy Controls MRI hippocampal activation | null | 1 | arm 1: This study has one arm due to a crossover design. All 17 subjects received 4 treatments: placebo then placebo, phenytoin then placebo, placebo then hydrocortisone, and phenytoin then hydrocortisone. Each treatment was randomly assigned and had a unique sequence out of 24 possible sequences. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). intervention 2: Beginning two days prior to the ... | intervention 1: Phenytoin (brand name Dilantin) intervention 2: Hydrocortisone intervention 3: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00591006 |
[
5
] | 176 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabet... | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealt... | [
1,
4
] | 2 | [
0,
0
] | intervention 1: insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER.
If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insul... | intervention 1: insulin aspart intervention 2: insulin detemir | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00591227 | |
[
3
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex... | RRP and its surgeries usually involves the vocal cords or other regions of the larynx, thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This technique provides a less traumatic alternative to ... | Laryngeal Papilloma | Papilloma pulsed dye laser Celebrex voice | null | 2 | arm 1: endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects arm 2: once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 s... | [
0,
1
] | 3 | [
0,
1,
3
] | intervention 1: oral taking of Celebrex (100 mg, BID) for 9 months intervention 2: once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J intervention 3: once-time surgery to remove laryngeal papilloma | intervention 1: Celebrex intervention 2: PDL intervention 3: CO2 laser or microsurgery | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00592319 |
[
3
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will test the combination of clofarabine, cytarabine, and thymoglobulin as a non-myeloablative conditioning regimen for patients with myelodysplastic syndromes or acute myeloid leukemia undergoing allogeneic stem cell transplant. | Current reduced intensity conditioning regimens have been able to decrease TRM (treatment related mortality) but suffer from increased rates of disease relapse. Disease burden at transplantation, as measured by percent myeloblasts, predicts relapse. Current regimens employ fludarabine and busulfan with various adjutant... | Myelodysplastic Syndromes Acute Myeloid Leukemia | Conditioning regimens Stem Cell Transplantation Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation Nonmyeloablative conditioning Clofarabine Cytarabine Anti-thymocyte globulin | null | 1 | arm 1: * Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplan... | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Clofarabine intervention 2: Cytarabine intervention 3: Thymoglobulin intervention 4: Stem cell infusion | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00593645 |
[
4
] | 165 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control. | null | Type 2 Diabetes Mellitus | diabetes exenatide metformin thiazolidinedione Byetta Amylin Lilly | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID) intervention 2: subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day | intervention 1: exenatide intervention 2: placebo | 25 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Concord | California | United States | -122.03107 | 37.97798
Fresno | California | United States | -119.77237 | 36.74773
Denver | Colorado | United States | -104.9847 | 39.73915
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Mogadore | Ohio | Unite... | 0 | NCT00603239 |
[
4
] | 71 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-week... | null | Anemia | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: As prescribed intervention 2: 120, 200 or 360 micrograms sc 4-weekly (starting dose) | intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera] | 21 | Alicante | Alicante | Spain | -0.48149 | 38.34517
Badajoz | Badajoz | Spain | -6.97061 | 38.87789
Badalona | Barcelona | Spain | 2.24741 | 41.45004
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
L'Hospitalet de Llo... | 0 | NCT00605345 | |
[
5
] | 21 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump. | Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin v... | Type 2 Diabetes Insulin Resistance | Type 2 diabetes Insulin Resistance Continuous Subcutaneous Insulin Infusion U-500 Insulin Omnipod | null | 1 | arm 1: All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens. | [
0
] | 1 | [
0
] | intervention 1: U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs | intervention 1: U-500 Insulin delivered by Omnipod (disposable insulin pump) | 1 | Asheville | North Carolina | United States | -82.55402 | 35.60095 | 0 | NCT00606034 |
[
2
] | 34 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a dose-finding study; therefore, there is no hypothesis testing | null | Neoplasms | null | 2 | arm 1: Schedule A (CP-870,893 administration schedule) arm 2: Schedule B (CP-870,893 administration schedule) | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg) intervention 2: P... | intervention 1: Paclitaxel + Carboplatin + CP-870,893 intervention 2: Paclitaxel + Carboplatin + CP-870,893 | 4 | Los Angeles | California | United States | -118.24368 | 34.05223
Santa Monica | California | United States | -118.49138 | 34.01949
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00607048 | |
[
3
] | 13 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH). | An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine for the treatment of autoimmune hepatitis (AIH).
Patients with histologically confirmed chronic hepatitis who fulfill criteria established by the Internati... | Autoimmune Hepatitis | Autoimmune hepatitis Chronic active hepatitis | null | 2 | arm 1: LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg) arm 2: Azathioprine tablets(50mg)+ prednisone tablets(5mg) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6. intervention 2: Azathiop... | intervention 1: LCP-Tacro (tacrolimus) intervention 2: Azathioprine | 12 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Jacksonville | Florida | United States | -81.65565 | 30.33218
Chicago | Illinois | United States | -87.65005 | 41.85003
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Rochester | Minnesota | United States | -92.4699 | 44.02163
New York | New York... | 0 | NCT00608894 |
[
3
] | 70 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis. | null | Severe Sepsis | Sepsis septic shock Systemic Inflammatory Response Syndrome | null | 6 | arm 1: AZD9773: single infusion of 50 units/kg arm 2: AZD9773: single infusion of 250 units/kg arm 3: AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs arm 4: AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs arm 5: AZD9773: loading infusion... | [
0,
0,
0,
0,
0,
2
] | 2 | [
0,
10
] | intervention 1: intravenous infusions intervention 2: Placebo | intervention 1: AZD9773 (CytoFab) intervention 2: Placebo | 26 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Newark | Delaware | United States | -75.74966 | 39.68372
Bay Pines | Florida | United States | -82.77816 | 27.81419
Miami | Florida | United States | -80.19366 | 25.77427
Chicago | Illinois | United States | -87.65005 | 41.85003
Oak Park | Illinois | United St... | 0 | NCT00615017 |
[
3
] | 96 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia. | The primary purpose of study PXN110527 was to investigate the efficacy of a high (3600mg/day) dose versus a low (1200mg/day) dose of GEn in subjects with post-herpetic neuralgia (PHN) who have a history of an inadequate response to gabapentin treatment. The study is a cross-over design. Prior to screening subjects are ... | Neuralgia, Postherpetic | Post-herpetic neuralgia(PHN) Neuropathic pain | null | 2 | arm 1: gabapentin enacarbil 1200mg/day, 4 weeks treatment in either the first or second treatment period arm 2: gabapentin enacarbil 3600mg/day, 4 weeks treatment in either the first or second treatment period | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1200mg/day gabapentin enacarbil intervention 2: 3600mg/day gabapentin enacarbil | intervention 1: GEn 1200mg/day intervention 2: GEn 3600mg/day | 53 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Oxnard | California | United States | -119.17705 | 34.1975
Roseville | California | United States | -121.28801 | 38.75212
San Francisco | California | United States | -122.41942 | 37.77493
Bradenton | Florida | United States | -82.57482 | 27.49893
Chipley | Flor... | 0 | NCT00617461 |
[
5
] | 1,060 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 0ALL | false | The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY® | null | Cardiovascular Disease | DEFINITY Safety Survelliance | null | 1 | arm 1: Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography | [
5
] | 1 | [
0
] | intervention 1: DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert | intervention 1: DEFINITY® | 16 | San Diego | California | United States | -117.16472 | 32.71571
Newark | Delaware | United States | -75.74966 | 39.68372
Chicago | Illinois | United States | -87.65005 | 41.85003
Auburn | Maine | United States | -70.23117 | 44.09785
Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483
Kansas City | Missour... | 0 | NCT00625365 |
[
4
] | 24 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the most debilitating variants of psoriasis which very often interferes with daily activities and with the ability to work. This type of psoriasis is very difficult to treat as topicals have difficulty penetrating the thick epiderm... | A total of 24 patients with non-pustular palmoplantar psoriasis affecting at least 10% of the combined palms and soles area and with a modified palmoplantar pustulosis area severity index (m-PPPASI) of at least 8 will be recruited. Patients will be randomized (1:1) to receive either infliximab 5 mg/kg or placebo (norma... | Palmoplantar Psoriasis | Palmoplantar psoriasis Infliximab | null | 2 | arm 1: Placebo at weeks 0, 2, 6 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period. arm 2: Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20. intervention 2: Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at ... | intervention 1: Placebo intervention 2: Infliximab | 5 | London | Ontario | Canada | -81.23304 | 42.98339
Markham | Ontario | Canada | -79.2663 | 43.86682
Laval | Quebec | Canada | -73.692 | 45.56995
Montreal | Quebec | Canada | -73.58781 | 45.50884
Québec | Quebec | Canada | -71.21454 | 46.81228 | 0 | NCT00629772 |
[
5
] | 273 | RANDOMIZED | PARALLEL | 9OTHER | 0NONE | true | 1FEMALE | false | The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among f... | For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitud... | Birth Control Compliance | Contraception, Compliance, Acceptability | null | 2 | arm 1: Contraceptive vaginal ring (NuvaRing) arm 2: Oral contraceptive pill (Ortho Tri-cyclen Lo) | [
1,
1
] | 2 | [
0,
1
] | intervention 1: Low dose oral contraceptive intervention 2: Contraceptive vaginal ring | intervention 1: Ortho Tri-cyclen Lo intervention 2: NuvaRing | 3 | Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00635570 |
[
4
] | 514 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared. | null | Type 2 Diabetes Mellitus | diabetes exenatide once weekly Byetta sitagliptin Januvia thiazolidinedione Amylin Lilly Pioglitazone | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: subcutaneous injection, 2.0mg, once a week intervention 2: oral tablet, 100mg, once a day intervention 3: oral tablet, 45mg, once a day intervention 4: oral tablet, once a day intervention 5: subcutaneous injection, once a week | intervention 1: exenatide once weekly intervention 2: sitagliptin intervention 3: pioglitazone intervention 4: placebo tablet intervention 5: placebo once weekly | 62 | Peoria | Arizona | United States | -112.23738 | 33.5806
Artesia | California | United States | -118.08312 | 33.86585
Concord | California | United States | -122.03107 | 37.97798
Encino | California | United States | -118.50119 | 34.15917
Greenbrae | California | United States | -122.5247 | 37.94854
La Mesa | California... | 0 | NCT00637273 |
[
5
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms. | null | Dysphonia | horseness | null | 2 | arm 1: Lansoprazole and dietary control arm 2: Dietary control and placebo | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Lansoprazole 30 mg taken by mouth daily for 3 months intervention 2: placebo taken by mouth daily for 3 months | intervention 1: Lansoprazole intervention 2: Placebo | 1 | Kansas City | Kansas | United States | -94.62746 | 39.11417 | 0 | NCT00637416 |
[
4
] | 782 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an oint... | null | Psoriasis Vulgaris | null | 3 | arm 1: Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks arm 2: Tacalcitol once daily for up to 8 weeks arm 3: Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Once daily application for up to 8 weeks intervention 2: Once daily application for up to 8 weeks intervention 3: Once daily application for up to 8 weeks | intervention 1: Calcipotriol plus hydrocortisone ointment vehicle intervention 2: Tacalcitol Ointment intervention 3: Calcipotriol plus hydrocortisone ointment | 3 | Waterloo | Ontario | Canada | -80.51639 | 43.4668
Nice | N/A | France | 7.26608 | 43.70313
Dundee | N/A | United Kingdom | -2.97489 | 56.46913 | 0 | NCT00640822 | |
[
4
] | 188 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 o... | null | Anemia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 120, 200 or 360 micrograms iv monthly (starting dose) | intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] | 24 | Brno | N/A | Czechia | 16.60796 | 49.19522
Český Krumlov | N/A | Czechia | 14.31521 | 48.81091
Děčín | N/A | Czechia | 14.21478 | 50.78215
Havířov | N/A | Czechia | 18.43688 | 49.77984
Hradec Králové | N/A | Czechia | 15.83277 | 50.20923
Jihlava | N/A | Czechia | 15.59124 | 49.3961
Karlovy Vary | N/A | Czechia | 12.871... | 0 | NCT00642850 | |
[
4
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers. | null | Hypertension | Hypertension Blood pressure Nebivolol Bystolic (TM) Metoprolol ER (TM) | null | 2 | arm 1: Nebivolol arm 2: Metoprolol ER (TM) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: nebivolol 10mg, 20mg, 40mg daily dosage, oral administration intervention 2: Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration | intervention 1: Nebivolol intervention 2: Metoprolol ER (TM) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00648895 |
[
3
] | 201 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Arge... | null | Rheumatoid Arthritis | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: multiple dose, single schedule intervention 2: matching placebo | intervention 1: ARRY-438162, MEK inhibitor; oral intervention 2: Placebo; oral | 35 | Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
San Juan | N/A | Argentina | -68.52568 | -31.53726
San Miguel de Tucumán | N/A | Argent... | 0 | NCT00650767 | |
[
5
] | 173 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia. | null | Hypercholesterolemia | null | 1 | arm 1: Patients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks | [
0
] | 1 | [
0
] | intervention 1: Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks. | intervention 1: ezetimibe (+) simvastatin | 0 | null | 0 | NCT00654628 | |
[
3
] | 52 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung. | Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breat... | Acute Lung Injury | Acute lung injury Lung resection | null | 2 | arm 1: Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively arm 2: Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively | [
0,
2
] | 2 | [
0,
0
] | intervention 1: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively intervention 2: 0.9% saline 1 litre intravenous over 12 hours pre-operatively | intervention 1: N-acetylcysteine intervention 2: 0.9% saline | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00655928 |
[
5
] | 468 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF). | The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone). | Infertility | Infertility In vitro fertilization Embryo transfer Crinone Intramuscular Progesterone Progesterone support | null | 2 | arm 1: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. arm 2: Progesterone-50 mg ... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. intervention 2: P... | intervention 1: Crinone 8% Vaginal Gel intervention 2: Intramuscular Progesterone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00656201 |
[
4
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment. | The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hem... | Neuromuscular Blockade | null | 1 | arm 1: IV single bolus dose of 4.0 mg/kg sugammadex | [
0
] | 2 | [
0,
0
] | intervention 1: At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered. intervention 2: After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered | intervention 1: sugammadex intervention 2: Rocuronium | 0 | null | 0 | NCT00656799 | |
[
4
] | 186 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. | In patients with primary melanoma and breast cancer, lymph node status is often a strong predictor of outcome and influences the course of treatment a patient may follow after surgery. In an effort to reduce the morbidity and costs of detection of lymph node metastases, surgical oncologists have developed a method by w... | Breast Cancer Melanoma | breast cancer lymph nodes melanoma surgery | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Breast Cancer: Intradermal admin of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site OR periareolar administration of Lymphoseek: Inject 0.2-.04 mL in multiple divided doses at the margin of the areola OR subare... | intervention 1: Lymphoseek | 15 | Alexander City | Alabama | United States | -85.95385 | 32.94401
Birmingham | Alabama | United States | -86.80249 | 33.52066
La Jolla | California | United States | -117.2742 | 32.84727
Laguna Hills | California | United States | -117.71283 | 33.61252
Sacramento | California | United States | -121.4944 | 38.58157
Santa ... | 0 | NCT00671918 |
[
5
] | 376 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Man... | null | Acute Mania in Bipolar Disorder | Acute Mania Bipolar Disorder Quetiapine Fumarate Lithium | null | 2 | arm 1: Quetiapine Fumarate - tablets arm 2: Quetiapine Fumarate - tablets and Lithium | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator.
Tablets intervention 2: Oral treatment, twice daily. 250 mg/day to 2000mg/day from ... | intervention 1: Quetiapine Fumarate intervention 2: Lithium | 16 | Beijing | Beijing Municipality | China | 116.39723 | 39.9075
Guangzhou | Guangdong | China | 113.25 | 23.11667
Baoding | Hebei | China | 115.46246 | 38.87288
Shijiazhuang | Hebei | China | 114.47861 | 38.04139
Daqing | Heilongjiang | China | 125.0 | 46.58333
Xinxiang | Henan | China | 113.80151 | 35.19033
Wuhan | Hubei... | 0 | NCT00672490 |
[
5
] | 530 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some ... | null | Fibromyalgia | null | 2 | arm 1: 60-120 mg, oral, every day, 12 weeks arm 2: oral, daily, 12 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase). intervention 2: oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment) | intervention 1: duloxetine hydrochloride intervention 2: placebo | 46 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
Cromwell | Connecticut | United States | -72.64537 | 41.5951
Danbury | Connect... | 0 | NCT00673452 | |
[
3
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The study will also work to assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and NSF. | Nephrogenic systemic fibrosis (NSF) is a recently described, extremely debilitating and painful condition that affects individuals with renal failure. Recent reports suggest an association between gadolinium exposure during magnetic resonance (MR) studies and the subsequent development of NSF in patients with chronic r... | Nephrogenic Systemic Fibrosis | Treatment Chronic kidney disease Fibrosing disorders Imatinib mesylate | null | 1 | arm 1: Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia. | [
0
] | 1 | [
0
] | intervention 1: 400 mg p.o. daily for 4 months. Dosage was reduced to 200 mg if participants develop gastrointestinal intolerance or alopecia. | intervention 1: Imatinib mesylate | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00677092 |
[
4
] | 934 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 w... | null | Hypercholesterolemia | HMG-CoA LDL-C CHD | null | 3 | arm 1: Rosuvastatin 5mg qd arm 2: Rosuvastatin 10mg qd arm 3: Atorvastatin 10mg qd | [
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Capsule/Tablet, oral, qd, 6 or 12 weeks intervention 2: Capsule/Tablet, 10mg, oral, qd, 6 weeks | intervention 1: Rosuvastatin intervention 2: Atorvastatin | 6 | Wuhan | Hubei | China | 114.26667 | 30.58333
Changsha | Hunan | China | 112.97087 | 28.19874
Shenyang | Liaoning | China | 123.43278 | 41.79222
Beijing | N/A | China | 116.39723 | 39.9075
Shanghai | N/A | China | 121.45806 | 31.22222
Tianjin | N/A | China | 117.17667 | 39.14222 | 0 | NCT00683618 |
[
0
] | 60 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 1SINGLE | true | 0ALL | false | This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder proble... | This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University, Pennsylvania State University, Memorial Health University Medical Center, and Temple University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal disease as confirmed by initial screening using a ... | Healthy | CCK infusion Gallbladder ejection fraction Normal volunteers | null | 6 | arm 1: CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg 60 minutes, with at least 2 days between each infusion arm 2: CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg 30 minutes, with at least 2 days ... | [
1,
1,
1,
1,
1,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes intervention 2: Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes intervention 3: Drug will be given over 30 min infusion, followed by 15 ... | intervention 1: Experimental Sequence ABC intervention 2: Experimental Sequence ACB intervention 3: Experimental Sequence BAC intervention 4: Experimental Sequence BCA intervention 5: Experimental Sequence CAB intervention 6: Experimental Sequence CBA | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00685477 |
[
4
] | 243 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two inv... | This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris" | Acne | Acne | null | 2 | arm 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily arm 2: Vehicle Gel once daily | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical Gel to the face, once daily in the evening for 24 weeks. intervention 2: Topical Gel to the face, once daily in the evening for 24 weeks. | intervention 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel intervention 2: Vehicle Gel | 33 | San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Longmont | Colorado | United States | -105.10193 | 40.16721
Miami | Florida | United States | -80.19366 | 25.77427
Snellville | Georgia | United States | -84.01991 | 33.85733
Chicago | Illinois | Unit... | 0 | NCT00687908 |
[
0
] | 31 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 0ALL | null | We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether t... | null | Substance Withdrawal Syndrome | null | 2 | arm 1: Placebo - sugar pill arm 2: Ondansetron | [
2,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Ondansetron and Placebo crossover | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00695864 | |
[
4
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain. | This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BE... | Respiratory Depression | Chronic Pain Ventilatory Response to Hypercapnia (VRH) | null | 1 | arm 1: BEMA Fentanyl | [
0
] | 1 | [
0
] | intervention 1: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily | intervention 1: BEMA Fentanyl | 0 | null | 0 | NCT00696137 |
[
5
] | 242 | null | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression. | null | Depressive Disorder, Major | null | 1 | arm 1: Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during ... | [
0
] | 1 | [
0
] | intervention 1: Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.
Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more. | intervention 1: Duloxetine | 2 | Guri-si | N/A | South Korea | 127.1394 | 37.5986
Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00696774 | |
[
5
] | 63 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and ... | This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and ... | Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia Dutasteride Tamsulosin | null | 1 | arm 1: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.
Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 ... | [
0
] | 1 | [
0
] | intervention 1: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. | intervention 1: Tamsulosin | 1 | Evansville | Indiana | United States | -87.55585 | 37.97476 | 0 | NCT00701779 |
[
4
] | 155 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess s... | null | Hypogonadism | null | 1 | arm 1: Participants received Testosterone Metered Dose (MD)-Lotion for 120 days. Participants started by receiving 3.0 mL (60 mg) of 2% Testosterone MD-Lotion, and based upon restoration to eugonadal levels, may have had their dose of testosterone adjusted upwards or downwards on Days 45 and 90.
Doses could be titrate... | [
0
] | 1 | [
0
] | intervention 1: 30 mg to 120 mg administered topically once daily for 120 days | intervention 1: Testosterone MD-Lotion | 27 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tuscon | Arizona | United States | N/A | N/A
Burbank | California | United States | -118.30897 | 34.18084
Torrance | California | United States | -118.34063 | 33.83585
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
New Britain | Connecticu... | 0 | NCT00702650 | |
[
5
] | 432 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco. | null | Tobacco Use Cessation | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period. intervention 2: Subjects will be up-titrated during the first wee... | intervention 1: Varenicline Tartrate intervention 2: Placebo | 16 | Florø | N/A | Norway | 5.0328 | 61.59957
Hafrsfjord | N/A | Norway | N/A | N/A
Hamar | N/A | Norway | 11.06798 | 60.7945
Hønefoss | N/A | Norway | 10.25647 | 60.16804
Oslo | N/A | Norway | 10.74609 | 59.91273
Rådal | N/A | Norway | 5.34554 | 60.31063
Trondheim | N/A | Norway | 10.39506 | 63.43049
Gothenburg | N/A | Swe... | 0 | NCT00717093 | |
[
3
] | 15 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma | null | Asthma | Bronchodilator | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets. intervention 2: 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose. intervention 3: 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose intervention 4: 1200mg, 2 x 600mg t... | intervention 1: PF-04191834 intervention 2: PF-04191834 intervention 3: PF-04191834 intervention 4: zileuton intervention 5: Placebo | 4 | Baltimore | Maryland | United States | -76.61219 | 39.29038
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00723021 |
[
4
] | 376 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia | null | Schizophrenia | Intramuscular ziprasidone, agitation, efficacy and safety | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days. intervention 2: The haloperidol group will receive an initi... | intervention 1: Intramuscular ziprasidone mesylate intervention 2: Intramuscular haloperidol | 9 | Baoding | Hebei | China | 115.46246 | 38.87288
Wuhan | Hubei | China | 114.26667 | 30.58333
Kunming | Yunnan | China | 102.71833 | 25.03889
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Changsha | N/A | China | 112.97087 | 28.19874
Guangzhou | N/A | China | 113.25 | 23.11667
Na... | 0 | NCT00723606 |
[
4
] | 530 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activatio... | Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 ... | Migraine Disorders | null | 2 | arm 1: NP101 - sumatriptan iontophoretic transdermal patch arm 2: Placebo iontophoretic transdermal patch | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Sumatriptan iontophoretic transdermal patch intervention 2: NP101 Placebo iontophoretic transdermal patch | intervention 1: NP101 - Sumatriptan iontophoretic transdermal patch intervention 2: Placebo | 34 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Newport Beach | California | United States | -117.92895 | 33.61891
San Francisco | California | United States | -122.41942 | 37.77493
Santa Monica | California | United States | -118.49138 | 34.01949
... | 0 | NCT00724815 | |
[
3
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration. | null | Age Related Macular Degeneration Choroidal Neovascularization Macular Edema | choroidal neovascularization macular degeneration macular edema intravitreal bevacizumab vegf verteporfin PDT | null | 2 | arm 1: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence \[300mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. arm 2: Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\] follo... | [
0,
0
] | 3 | [
0,
1,
1
] | intervention 1: Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. intervention 2: Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\]. intervention 3: Patients will receive combination verteporfin with photodynamic therapy... | intervention 1: Bevacizumab intervention 2: verteporfin photodynamic therapy reduced fluence intervention 3: verteporfin photodynamic therapy standardfluence | 2 | Bakersfield | California | United States | -119.01871 | 35.37329
Santa Barbara | California | United States | -119.69819 | 34.42083 | 0 | NCT00729846 |
[
4
] | 650 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 0ALL | true | The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. | ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance... | ERCP Pancreatic Diseases Bile Duct Diseases | ERCP Drotaverine hydrochloride Hyoscine-N-butylbromide | null | 2 | arm 1: Drotaverine hydrochloride arm 2: Hyoscine-N-butylbromide | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP intervention 2: Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP. | intervention 1: Drotaverine hydrochloride intervention 2: Hyoscine-N-butylbromide | 4 | Fuzhou | N/A | China | 119.30611 | 26.06139
Hangzhou | N/A | China | 120.16142 | 30.29365
Harbin | N/A | China | 126.65 | 45.75
Shanghai | N/A | China | 121.45806 | 31.22222 | 0 | NCT00731198 |
[
4
] | 511 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.
External ge... | null | Genital Warts | external genital warts perianal warts condylomata acuminata human papilloma virus HPV types 6 and 11 | null | 3 | arm 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks arm 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. arm 3: Placebo cream applied daily to wart areas for up to 8 weeks. | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks. intervention 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks intervention 3: Placebo cream applied daily to wart areas for up to 8 weeks | intervention 1: 2.5% imiquimod cream intervention 2: 3.75% imiquimod cream intervention 3: Placebo cream | 43 | Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Carmichael | California | United States | -121.32828 | 38.61713
Chico | California | United States | -121.83748 | 39.72849
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Denver... | 0 | NCT00735462 |
[
3
] | 285 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subj... | This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multi-center study comparing the efficacy, safety and tolerability of CX157 60mg TID and placebo. This study will be conducted at approximately 12 investigative sites in the US.
Subjects with suspected Major Depressive Disorder (MDD) and... | Major Depressive Disorder | MDD | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Six capsules administered three times a day for six weeks. intervention 2: Six capsules administered three times a day for six weeks. | intervention 1: CX157 (TriRima) intervention 2: Placebo | 14 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Beverly Hills | California | United States | -118.40036 | 34.07362
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Winter Park | Florida | United States | -81.33924 | 28.6
Oakbrook Terrace | Illinois | United States | -87.96451 | ... | 0 | NCT00739908 |
[
5
] | 33 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 3TRIPLE | false | 0ALL | false | The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA. | null | Peripheral Arterial Occlusive Disease | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution intervention 2: ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow st... | intervention 1: VISIPAQUE 270 intervention 2: Isovue 250 | 0 | null | 0 | NCT00740207 | |
[
4
] | 301 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders. | The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.
The study enrolled 301 patients. Participants were randomly assigned (by chance, like flipping... | Generalized Anxiety Disorder | Generalized Anxiety Disorder Anxiety Disorders Drug Therapy | null | 2 | arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Encapsulated vortioxetine immediate-release tablets. intervention 2: Vortioxetine placebo-matching capsules | intervention 1: Vortioxetine intervention 2: Placebo | 38 | Tallinn | N/A | Estonia | 24.75353 | 59.43696
Viljandi | N/A | Estonia | 25.59 | 58.36389
Bad Saarow | N/A | Germany | 14.06667 | 52.28333
Berlin | N/A | Germany | 13.41053 | 52.52437
Bochum | N/A | Germany | 7.21648 | 51.48165
Hüttenberg | N/A | Germany | 8.62189 | 50.51453
Rodgau | N/A | Germany | 8.88588 | 50.02627
... | 0 | NCT00744627 |
[
0
] | 3 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 0ALL | true | Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovasc... | With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effec... | Carotid Artery Disease | null | 1 | arm 1: Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma | [
0
] | 1 | [
0
] | intervention 1: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks. | intervention 1: Simvastatin | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00746603 | |
[
4
] | 136 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance. | Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-assoc... | Restless Legs Syndrome Restless Legs Syndrome (RLS) | PSG Restless Legs Syndrome gabapentin enacarbil XP13512 GSK1838262 sleep disturbance RLS polysomnography | null | 2 | arm 1: GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2 arm 2: Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2 | [
5,
5
] | 2 | [
0,
0
] | intervention 1: GSK1838262 extended release tablets intervention 2: Placebo | intervention 1: GSK1838262 Extended Release Tablets intervention 2: Placebo | 24 | Jasper | Alabama | United States | -87.27751 | 33.83122
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Hallandale | Florida | United States | -80.14838 | 25.9812
Atlanta | Georgia | United States | -84.38798 | 33.749
Macon | Georgia | United... | 0 | NCT00748098 |
[
3
] | 2 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and myocardial efficiency in patients with heart failure and to confirm that the unique preclinical pharmacological profile of CK- 1827452 is subs... | null | Heart Failure | null | 2 | arm 1: 0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 arm 2: ≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 | [
0,
0
] | 2 | [
0,
0
] | intervention 1: I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr intervention 2: I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr | intervention 1: CK-1827452 intervention 2: CK-1827452 | 3 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00748579 | |
[
5
] | 131 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo. | Large amounts of VAT (adipose tissue surrounding the viscera of the organs), is known to be associated with increased risk of heart disease and diabetes. Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat. The purpose of this study is to to determine if a 24... | Obesity Overweight | overweight, orlistat, body composition | null | 2 | arm 1: Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day arm 2: Placebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Weight loss treatment intervention 2: Inactive | intervention 1: Orlistat intervention 2: Placebo | 3 | Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Durham | North Carolina | United States | -78.89862 | 35.99403
Gothenburg | West Gothland | Sweden | 11.96679 | 57.70716 | 0 | NCT00752726 |
[
3
] | 368 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids. | null | Asthma | Asthma | null | 4 | arm 1: AZD1981 50 mg Twice Daily (Bid) arm 2: Placebo arm 3: AZD1981 400 mg Twice Daily (Bid) arm 4: AZD1981 1000 mg Twice Daily (Bid) | [
0,
2,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oral tablet, 50 mg twice daily intervention 2: Oral tablet, 400 mg twice daily intervention 3: Oral tablet, 1000 mg twice daily intervention 4: None | intervention 1: AZD1981 intervention 2: AZD1981 intervention 3: AZD1981 intervention 4: Placebo | 21 | Buenos Aires | Argentina | Argentina | -58.37723 | -34.61315
Quilmes | Buenos Aires | Argentina | -58.25454 | -34.72065
Santa Fe | Santa Fe Province | Argentina | -60.70868 | -31.64881
San Miguel de Tucumán | Tucumán Province | Argentina | -65.21051 | -26.81601
Porto Alegre | Brasil | Brazil | -51.23019 | -30.03283
Rio... | 0 | NCT00758589 |
[
5
] | 86 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure. | null | Glaucoma | Glaucoma | null | 2 | arm 1: Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. arm 2: Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months. | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: One drop three times a day in both eyes for 3 months intervention 2: One drop three times a day in both eyes for 3 months intervention 3: One drop once a day in both eyes for 3 months | intervention 1: Brinzolamide 1% ophthalmic solution (Azopt) intervention 2: Placebo eye drops intervention 3: Latanoprost 0.005% ophthalmic solution (Xalatan) | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00759941 |
[
5
] | 8 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | true | The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated... | Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the ge... | Coronary Artery Disease | null | 1 | arm 1: Compare to baseline | [
5
] | 1 | [
0
] | intervention 1: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously | intervention 1: dipyridamole | 1 | Farmington | Connecticut | United States | -72.83204 | 41.71982 | 0 | NCT00763009 | |
[
4
] | 401 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain. | null | Chronic Low Back Pain | null | 2 | arm 1: Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment arm 2: Patients received placebo by mouth once daily for 12 weeks of double-blind treatment | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 60 mg orally once daily for 12 weeks intervention 2: Placebo once daily orally for 12 weeks | intervention 1: Duloxetine intervention 2: Placebo | 26 | Chandler | Arizona | United States | -111.84125 | 33.30616
Cromwell | Connecticut | United States | -72.64537 | 41.5951
DeLand | Florida | United States | -81.30312 | 29.02832
Jacksonville | Florida | United States | -81.65565 | 30.33218
Brighton | Massachusetts | United States | -71.15644 | 42.3501
Oklahoma City | Okl... | 0 | NCT00767806 |
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