phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
5
] | 136 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs). | This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study. | Partial Seizures | Lyrica Epilepsies - Partial | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 150 to 600 mg/day during 21 weeks | intervention 1: Pregabalin | 8 | Mexico | D. F. | Mexico | -98.43784 | 18.88011
Acapulco de Juárez | Guerrero | Mexico | -99.90891 | 16.84942
Morelia | Michoacán | Mexico | -101.18443 | 19.70078
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Aguascalientes | N/A | Mexico | -102.2843 | 21... | 0 | NCT00407797 |
[
3
] | 52 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite the efforts in front-line therapy, second-line protocols have not yet been established in randomized clinical trials for those patient... | null | Gastric Adenocarcinoma Barrett Esophagus | Adenocarcinoma of esophagogastric junction Adenocarcinoma of lower esophagus (Barrett carcinoma) | null | 0 | null | null | 1 | [
0
] | intervention 1: Capsules of 50, 25 or 12,5 mg. Dosage 50 mg, 37.5 mg or 25 mg once daily until progression of disease or untolerable side effects | intervention 1: Sunitinib-Malate | 12 | Heidelberg | Baden-Würtemberg | Germany | 8.69079 | 49.40768
Tübingen | Baden-Würtemberg | Germany | 9.05222 | 48.52266
München | Bavaria | Germany | 13.46314 | 48.69668
Würzburg | Bavaria | Germany | 9.95121 | 49.79391
Cologne | North Rhine-Westphalia | Germany | 6.95 | 50.93333
Essen | North Rhine-Westphalia | German... | 0 | NCT00411151 |
[
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to assess the effects of the treatment combination of the commercially available chemotherapy drugs, docetaxel and liposomal doxorubicin, and a blood thinner Enoxaparin on pancreatic cancer. The main goal of the study is to find out if this combination chemotherapy and enoxaparin increases ... | The objective of the study is to determine the safety and efficacy of the combination of docetaxel and liposomal doxorubicin chemotherapy combined with enoxaparin in patients with advanced pancreatic cancer.
Docetaxel (TAXOTERE) belongs to the group of anticancer drugs called mitotic inhibitors. Liposomal doxorubicin ... | Pancreatic Cancer | Pancreatic Docetaxel Doxorubicin Enoxaparin | null | 1 | arm 1: Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg | [
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Docetaxel intervention 2: Liposomal Doxorubicin intervention 3: Enoxaparin | 1 | Iowa City | Iowa | United States | -91.53017 | 41.66113 | 0 | NCT00426127 |
[
0
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objectives:
1. To determine the feasibility and toxicity of employing purine-analog based conditioning for allogeneic donor stem cell transplantation in patients with severe aplastic anemia (AA).
2. To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy. | Before treatment starts, patients will have their bone marrow checked and will have lung, heart, and kidney tests.
Patients in this study will receive the drugs fludarabine, cyclophosphamide, and antithymocyte globulin by vein through a previously inserted plastic catheter that extends into the large chest vein. Fluda... | Aplastic Anemia | Severe Aplastic Anemia Bone Marrow Failure Stem Cell Transplantation Fludarabine Cyclophosphamide Antithymocyte Globulin SAA ATG Cytoxan Neosar Fludarabine Phosphate Thymoglobulin | null | 1 | arm 1: Fludarabine 30 mg/m\^2/day by vein (IV), Cyclophosphamide IV 300 mg/m\^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 30 mg/m\^2 by vein daily over 30 minutes intervention 2: 300 mg/m\^2 by vein daily over 2 hours intervention 3: 3.75 mg/kg by vein daily over 4 hours | intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Antithymocyte Globulin | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00427336 |
[
4
] | 82 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 1FEMALE | false | The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity.
Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental ... | -Introduction The Polycystic Ovarian Syndrome (PCOS) is a frequent endocrine among women in reproductive ages, with a prevalence of 10%. In 2003, a consensus among the European and American Society of Human Reproduction (ESRHE and ASRM) defined that PCOS is a ovarian disfunction which present at least 2 out of 3 criter... | Polycystic Ovary Syndrome | Polycystic Ovary Syndrome clomiphene citrate Raloxifene | null | 2 | arm 1: Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle arm 2: Use of 100mg of raloxifene during days 5-9 of the menstrual cycle | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 100mg PO on days 5-9 of the menstrual cycle intervention 2: 100mg PO on days 5-9 of the menstrual cycle | intervention 1: clomiphene citrate intervention 2: raloxifene | 1 | Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 | 0 | NCT00427700 |
[
3
] | 41 | NON_RANDOMIZED | null | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens. | null | Breast Neoplasms | null | 1 | arm 1: BIBW 2992 (Afatinib) once daily until progression | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: BIBW 2992 | 12 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Encinitas | California | United States | -117.29198 | 33.03699
Santa Monica | California | United States | -118.49138 | 34.01949
Tampa | Florida | United States | -82.45843 | 27.94752
Boston | Massachusetts | United States | -71.05977 | 42.35843
Chapel Hill |... | 0 | NCT00431067 | |
[
2
] | 28 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given s... | The prevalence of asthma has dramatically increased in many parts of the world. Currently, there is no effective way to prevent development of allergic rhinitis and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly... | Allergy Asthma | Perennial Allergic Rhinitis Asthma Sublingual Immunotherapy (SLIT) | null | 1 | arm 1: Glycerinated German Cockroach Allergenic Extract | [
0
] | 2 | [
0,
0
] | intervention 1: Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum ... | intervention 1: Glycerinated German cockroach allergenic extract intervention 2: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00434421 |
[
4
] | 1,723 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin. | null | Sexual Dysfunctions, Psychological | null | 1 | arm 1: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. | [
0
] | 1 | [
0
] | intervention 1: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily. | intervention 1: Flibanserin | 196 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United Sta... | 0 | NCT00441558 | |
[
3
] | 60 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart). | Varicose veins are extremely common, affecting up to 25% of the western adult population. While in their early stages they are little more than a sometimes-painful aesthetic problem, progression is inevitable and some will progress to more severe and largely irreversible problems of chronic venous insufficiency (CVI) a... | Varicose Veins | PFO Patent Foramen Ovale Right-to-Left Shunt Sclerotherapy | null | 1 | arm 1: Polidocanol (1%) Microfoam (Varisolve) | [
0
] | 2 | [
0,
3
] | intervention 1: Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein. intervention 2: Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries. | intervention 1: Polidocanol (1%) Microfoam (Varisolve) intervention 2: Endovenous Microfoam Occlusion | 7 | Los Angeles | California | United States | -118.24368 | 34.05223
Durham | North Carolina | United States | -78.89862 | 35.99403
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 |... | 0 | NCT00442364 |
[
3
] | 56 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. G... | PRIMARY OBJECTIVES:
I. The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme.
SECONDARY OBJECTIVES:
I. To assess and estimate the toxicities. II. Tumor response rate. III. To estimate 6-mont... | Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor | null | 1 | arm 1: Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study | [
0
] | 3 | [
0,
0,
10
] | intervention 1: 150mg Given orally once daily intervention 2: 400mg Given orally twice daily intervention 3: Correlative studies | intervention 1: erlotinib hydrochloride intervention 2: sorafenib tosylate intervention 3: pharmacological study | 9 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Detroit | Michigan | United ... | 0 | NCT00445588 | |
[
2
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing. | null | Carcinoma | Safety PK Biomarker | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: AG-013736 5mg twice daily \[BID\] | intervention 1: Axitinib (AG-013736) | 1 | Kashiwa | Chiba | Japan | 139.97732 | 35.86224 | 0 | NCT00447005 |
[
3
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influen... | null | Influenza | influenza flu | null | 3 | arm 1: Peramivir 200 mg administered intravenously once daily for 5 days (5 doses) arm 2: Peramivir 400 mg administered intravenously once daily for 5 days (5 doses) arm 3: Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses) | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment intervention 2: Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo su... | intervention 1: Peramivir 200 mg intervention 2: Peramivir 400 mg intervention 3: Oseltamivir | 83 | Mobile | Alabama | United States | -88.04305 | 30.69436
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Orange | California | United States | -117.85311 | 33.78779
Orange | California | United States | -117.85311 | 33.78779
Sacramento | California | United States | -121.4944 | 38.58157
San Jose | California ... | 0 | NCT00453999 |
[
3,
4
] | 420 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | false | The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety | The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.
The trial is sponsored by Bayer Yakuhin, Ltd. | Dysmenorrhea | Dysmenorrhea Intracyclic bleeding Drospirenone (DRSP) Ethinylestradiol | null | 2 | arm 1: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) arm 2: 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-d... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) intervention 2: 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4... | intervention 1: DRSP 3 mg/EE 20 µg (13 cycles) intervention 2: DRSP 3 mg/EE 30 µg (6 cycles) | 26 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Maebashi | Gunma | Japan | 139.08333 | 36.4
Takasaki | Gunma | Japan | 139.01667 | 36.33333
Kobe | Hyōgo | Japan | 135.183 | 34.6913
Nishinomiya | Hyōgo | Japan | 135.331... | 0 | NCT00461305 |
[
0
] | 100 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas | The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple... | Pleural Effusion Associated With Pulmonary Infection Bacterial Pleural Effusion Other Than Tuberculosis | parapneumonic pleural effusion empyema TPA (Activase, Alteplase) | null | 2 | arm 1: Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted. arm 2: If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days intervention 2: Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days | intervention 1: Alteplase intervention 2: Placebo | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00468104 |
[
2,
3
] | 27 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | RATIONALE: Drugs used in chemotherapy, such as ABT-751, 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 I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with me... | OBJECTIVES:
Primary
* Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients.
Secondary
* Determine the objective response rate (partial a... | Prostate Cancer | adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer | null | 1 | arm 1: Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21.
Phase II: Patients receive ABT-751 twice daily | [
0
] | 1 | [
0
] | intervention 1: Phase I:
Cohort \| Number of Patients \|Dose (mg) ABT-751 (BID)
* -1 \| 3-6 \|100 mg BID
* 1 \| 3-6 \|125 mg BID
* 2 \| 3-6 \|150 mg BID
* 3 \| 3-6 \|175 mg BID
* 4 \| 3-6 \|200 mg BID
Phase II:
Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle | intervention 1: ABT-751 | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00471718 |
[
2
] | 5 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression.
MK-0657 decreases the activity of a brain receptor called NMDA, which the chemica... | Even though there are many antidepressant drugs for clinical use, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatments despite adequate dosage, duration, and compliance. Furthermore, these medications may take weeks to months to achieve their... | Major Depression | NMDA Receptor Depression Treatment Unipolar Depression Treatment Resistant Glutamatergic Depression Major Depression | null | 2 | arm 1: Double-blind crossover administration of placebo then MK-0657 (4-8 mg/day) arm 2: Double-blind crossover administration of MK-0657 (4-8 mg/day) then placebo | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Daily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day) intervention 2: Daily double-blind administration of placebo | intervention 1: MK-0657 intervention 2: Placebo | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00472576 |
[
0
] | 78 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Among patients with stable coronary artery disease (CAD), it is not clear if the pleiotropic effects of cholesterol reduction differ between high-dose simvastatin alone and combined ezetimibe/simvastatin.
The investigators sought to compare the anti-inflammatory and anti-platelet effects of ezetimibe 10 mg / simvastat... | Introduction
Among patients with coronary artery disease (CAD), a robust evidence base supports the beneficial effects of statin therapy on mortality and other adverse cardiovascular outcomes . Recently, two large trials , have demonstrated that compared to standard dose statin therapy, high statin doses reduced Low-d... | Stable Angina | angina atherosclerosis simvastatin ezetimibe inflammation | null | 2 | arm 1: Patients were treated with simvastatin 80 mg for 6 weeks arm 2: Patients were treated with daily Ezetimibe 10 mg / Simvastatin 20 mg for 6 weeks | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Simvastatin 80 mg/day, single dose, for 6 weeks. intervention 2: Ezetimibe 10 mg / Simvastatin 20 mg
Patients were treated with daily Ezetimibe 10 mg / Simvastatin 20 mg for 6 weeks | intervention 1: Simvastatin 80 mg/day for 6 weeks intervention 2: Ezetimibe 10 mg / Simvastatin 20 mg | 1 | São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 | 0 | NCT00474123 |
[
4
] | 150 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone.
This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany.
Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (basel... | null | Relapsed or Refractory Multiple Myeloma | CC-5013 Revlimid Lenalidomide Celgene Multiple Myeloma | null | 1 | arm 1: Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was... | [
0
] | 2 | [
0,
0
] | intervention 1: Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression. intervention 2: Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle ... | intervention 1: Lenalidomide intervention 2: dexamethasone | 48 | Berlin | N/A | Germany | 13.41053 | 52.52437
Bonn | N/A | Germany | 7.09549 | 50.73438
Bonn | N/A | Germany | 7.09549 | 50.73438
Braunschweig | N/A | Germany | 10.52673 | 52.26594
Burg | N/A | Germany | 14.14856 | 51.83448
Chemnitz | N/A | Germany | 12.92922 | 50.8357
Cologne | N/A | Germany | 6.95 | 50.93333
Cologne |... | 0 | NCT00478777 |
[
3
] | 138 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty | This is a phase 2, multicenter, parallel-group, active-control, randomized, double-blind, dose-ranging study conducted to evaluate three dose levels of SKY0402 compared with 150 mg of bupivacaine HCl. | Postoperative Pain | pain postoperative total knee arthroplasty analgesia | null | 2 | arm 1: Bupivacaine HCl (Marcaine 0.25% with epinephrine 1:200,000) arm 2: SKY0402 at various dosage levels. Single administration. | [
1,
5
] | 2 | [
0,
0
] | intervention 1: 150 mg Bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug) | intervention 1: Bupivacaine HCl intervention 2: SKY0402 | 9 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Davis | California | United States | -121.74052 | 38.54491
Laguna Hills | California | United States | -117.71283 | 33.61252
New York | New York | United States | -74.00597 | 40.71427
Columbus | Ohio | United States | -82.99879 | 39.96118
Lubbock | Texas | Uni... | 0 | NCT00485693 |
[
3
] | 73 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued that mixed states were the most common episodes in manic-depressive illness. A mixed state is defined as a person who is experiencing symptoms of both depression and mania.
Currently, a person must have depression plus 3 or m... | We plan on enrolling 25 subjects from each of the four sites. After signing a consent form, subjects will be screened and asked to have a physical and specific safety labs done to make sure they can safely participate in the study. After the screening visit, subjects will be randomly, like a flip of a coin, placed into... | Bipolar Disorder Bipolar Depression Depression | Bipolar Disorder Major Depression Clinical pharmacology Clinical Trial | null | 2 | arm 1: Participants were instructed by a physician to take a study drug daily. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone. Participants were not informed whether they were r... | [
2,
1
] | 2 | [
0,
0
] | intervention 1: ziprasidone, geodon. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks. intervention 2: Placebo, sugar pill arm. Dosing instructions began at 40 mg/day ... | intervention 1: ziprasidone (Geodon) intervention 2: placebo | 4 | Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00490542 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study... | Primary Objective:
To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.
Secondary Objective:
To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Prot... | Prostate Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Sandostatin 30mg intramuscular every 28 days | intervention 1: Sandostatin | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00510224 | |
[
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM) | This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll pat... | Glioblastoma Multiforme | Glioblastoma Multiforme, GBM, RAD001, RAD | null | 4 | arm 1: Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. arm 2: Participants scheduled to undergo salvage surgical resection received a daily oral dose ... | [
0,
0,
0,
1
] | 2 | [
0,
3
] | intervention 1: Tablets taken once a day with a full glass of water. intervention 2: Salvage surgical resection | intervention 1: Everolimus intervention 2: Surgery | 8 | Los Angeles | California | United States | -118.24368 | 34.05223
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Durham | No... | 0 | NCT00515086 |
[
2,
3
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). It is anticipated that ro... | null | Idiopathic Thrombocytopenic Purpura Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura Pediatric Idiopathic Thrombocytopenic Purpura | null | 2 | arm 1: 5 thrombocytopenic (as defined per protocol) subjects arm 2: 15 thrombocytopenic (as defined per protocol) subjects | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. intervention 2: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. | intervention 1: Placebo intervention 2: AMG 531 | 0 | null | 0 | NCT00515203 |
[
5
] | 88 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from basel... | null | Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State | Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 300 mg quetiapine fumarate tablets for oral use.
Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day. | intervention 1: Quetiapine 600mg | 7 | Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
San Pedro Garza García | Nuevo León | Mexico | -100.40651 | 25.6604
San Luis Potosí City | San Luis Potosí | Mexico | -100.97135 | 22.15234
Mérida | Yu... | 0 | NCT00521365 |
[
4
] | 662 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium). | null | Postmenopause | Postmenopausal Symptoms e.g. Hot flushes Sweating episodes Vaginal dryness | null | 2 | arm 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). arm 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle). | [
0,
1
] | 2 | [
0,
0
] | intervention 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). intervention 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle). | intervention 1: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.5mg NETA / 1.0mg E2 (Activella) | 59 | Chandler | Arizona | United States | -111.84125 | 33.30616
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Greenwood Village | Colorado | United States | -104.95081 | 39.61721
Boynton B... | 0 | NCT00522873 |
[
3
] | 166 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies com... | This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' in... | Chronic Hepatitis C | Chronic Hepatitis C Genotype 1 Telaprevir Treatment-naïve VX-950-C208 VX-950-TiDP24-C208 | null | 4 | arm 1: Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets... | [
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Oval tablets containing 375 mg of telaprevir for oral administration. intervention 2: Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe. intervention 3: Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen. interven... | intervention 1: Telaprevir intervention 2: Peg-IFN-alfa-2a intervention 3: Peg-IFN-alfa-2b intervention 4: Ribavirin (RBV) tablet intervention 5: Ribavirin (RBV) capsule | 24 | Vienna | N/A | Austria | 16.37208 | 48.20849
Brussels | N/A | Belgium | 4.34878 | 50.85045
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A | Belgium | 4.70093 | 50.87959
Liège | N/A | Belgium | 5.56749 | 50.63373
Angers | N/A | France | -0.55202 | 47.47156
Clichy | N/A | France | 2.30952 | 48.90018
Grenoble | N/A ... | 0 | NCT00528528 |
[
3
] | 44 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidol... | SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." SCD is caused by an abnormal type of hemoglobin, which is a protein inside red blood cells that carries oxygen. HbSC is a form of SCD that is characterized by the p... | Hemoglobin SC Disease | Sickle Cell Disease Vaso-occlusive Event Painful Crises Acute Chest Syndrome | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
1,
1,
1
] | 3 | [
0,
0,
10
] | intervention 1: HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months) intervention 2: HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months) intervention 3: HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 mo... | intervention 1: Hydroxyurea intervention 2: Magnesium Pidolate intervention 3: Placebo Pills and Placebo Liquid | 19 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Oakland | California | United States | -122.2708 | 37.80437
Sacramento | California | United States | -121.4944 | 38.58157
Aurora | Colorado | United States | -104.83192 | 39.72943
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Georgia | Unit... | 0 | NCT00532883 |
[
5
] | 14 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40. These randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic NSCLC. Patients will be recruited by inv... | null | Carcinoma, Non-Small-Cell Lung | Non-Small Cell Lung Cancer Locally Advanced or Metastatic NSCL Cancer | null | 2 | arm 1: docetaxel arm 2: Gefitinib (IRESSA) | [
1,
0
] | 3 | [
0,
3,
0
] | intervention 1: 250 mg oral intervention 2: performed at screening and every 6 weeks intervention 3: 60mg/m2 intravenous infusion | intervention 1: Gefitinib intervention 2: CT or MRI intervention 3: Docetaxel | 1 | Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 0 | NCT00536107 |
[
5
] | 426 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: Insulin lispro low mixture (1, 2 or 3 daily injections) arm 2: Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro) | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remai... | intervention 1: Insulin lispro low mixture intervention 2: Insulin glargine intervention 3: Insulin lispro | 25 | Daw Park | South Australia | Australia | 138.58407 | -34.98975
East Ringwood | Victoria | Australia | N/A | N/A
Nedlands | Western Australia | Australia | 115.8073 | -31.98184
Belém | N/A | Brazil | -48.50444 | -1.45583
Campinas | N/A | Brazil | -47.06083 | -22.90556
Curitiba | N/A | Brazil | -49.27306 | -25.42778
Fort... | 0 | NCT00548808 | |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary:
* To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.
* To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and imp... | Individuals who have cancer-related malnutrition have also been found to have a higher risk of complications and are less able to tolerate the side effects of conventional therapies such as chemotherapy, radiation, and surgery.
Haelan is a soy-based liquid (beverage). It contains large amount of isoflavones. Isoflavon... | Anorexia Weight Loss Cachexia | Solid Tumors Cancer-Associated Anorexia Weight Loss Haelan Fermented Soy Product Nutrition Cachexia | null | 1 | arm 1: 4 oz Haelan orally twice daily for 8 weeks | [
5
] | 1 | [
0
] | intervention 1: 4 oz orally twice daily for 8 Weeks | intervention 1: Haelan | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00558558 |
[
0
] | 31 | RANDOMIZED | PARALLEL | 6HEALTH_SERVICES_RESEARCH | 2DOUBLE | false | 0ALL | true | Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reporte... | For this pilot study, we hope to recruit a total of 40 subjects, with 20 subjects in the varenicline group, and 20 into the placebo-control group. Assuming significant findings, these data will enable us to estimate a possible effect size for carrying-out a larger study. For preliminary analysis as a prelude to plannin... | Cocaine Dependence Nicotine Dependence | varenicline | null | 2 | arm 1: None arm 2: Placebo is compared to active drug varenicline | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Varenicline up to 2 mg a day intervention 2: Placebo | intervention 1: Varenicline intervention 2: Sugar pill or Placebo | 1 | West Haven | Connecticut | United States | -72.94705 | 41.27065 | 0 | NCT00567320 |
[
2,
3
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving. | The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period. | Alcoholism | N-acetylcysteine Alcoholism Treatment | null | 2 | arm 1: Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. arm 2: Patients will take oral placebo (identical matching placebo) during the study period. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. intervention 2: Patients will take oral placebo (identical matching placebo) during the study period. | intervention 1: N-acetylcysteine intervention 2: Placebo | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00568087 |
[
4
] | 375 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain ... | This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg \[Fioricet\]) for the acute treatment of ... | Migraine Disorders Migraine, Acute | Migraine, acute Migraine Butalbital-containing Combination Medication (BCM) Naproxen sodium Sumatriptan succinate TREXIMET® | null | 6 | arm 1: TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3) arm 2: TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3) arm 3: BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3) arm 4: BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3) arm 5: placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3) ... | [
5,
5,
5,
5,
5,
5
] | 3 | [
0,
0,
0
] | intervention 1: Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg) intervention 2: butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet... | intervention 1: TREXIMET® intervention 2: Butalbital-containing Combination Medications (BCM) intervention 3: placebo | 107 | Chandler | Arizona | United States | -111.84125 | 33.30616
Gilbert | Arizona | United States | -111.78903 | 33.35283
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United... | 0 | NCT00573170 |
[
5
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to ... | null | Non-diabetic Nephropathy With Hypertension | Candesartan Cilexetil Non-diabetic Nephropathy hypertension urine protein creatinine ratio | null | 3 | arm 1: Candesartan Cilexetil arm 2: Candesartan Cilexetil arm 3: Candesartan Cilexetil | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 8 mg oral once daily dose intervention 2: 16 mg oral once daily dose intervention 3: 32 mg oral once daily dose | intervention 1: Candesartan Cilexetil intervention 2: Candesartan Cilexetil intervention 3: Candesartan Cilexetil 32mg | 1 | Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00573430 |
[
2,
3
] | 7 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomiz... | null | Bacteria Infection Respiratory Tract Infections | Ureaplasma Bronchopulmonary dysplasia very low birthweight | null | 2 | arm 1: Early treatment with azithromycin arm 2: Expectant (usual) management | [
0,
4
] | 1 | [
0
] | intervention 1: 10 mg/kg IV per dose given for 10 days | intervention 1: Azithromycin | 1 | Birmingham | Alabama | United States | -86.80249 | 33.52066 | 0 | NCT00599053 |
[
5
] | 24 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 0NONE | false | 0ALL | false | The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of... | The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril dail... | Childhood Obstructive Sleep Apnea Syndrome (OSAS) | null | 2 | arm 1: 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy arm 2: None | [
1,
4
] | 1 | [
0
] | intervention 1: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy | intervention 1: fluticasone furoate | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00603044 | |
[
4
] | 4,008 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients. | Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive. | Obesity | Obesity Weight loss lorcaserin APD356 BLOSSOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena | null | 3 | arm 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening arm 2: Lorcaserin 10 mg tablet each morning and evening arm 3: Matching placebo tablet each morning and evening | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. intervention 2: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. intervention 3: Matching placebo tablet each morning and evening for a duration of 52 weeks. | intervention 1: Lorcaserin 10 mg once daily (QD) intervention 2: Lorcaserin 10 mg twice a day (BID) intervention 3: Matching Placebo | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00603902 |
[
4
] | 252 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | We are performing a prospective, randomized, controlled trial of dopamine versus norepinephrine for septic shock. The trial will enroll patients with suspected or documented site of infection and having 2 out of the three SIRS criteria. Patients will also be receiving standard of care, early-goal directed therapy inclu... | Research Question/Hypothesis: The initial selection of the vasopressor norepinephrine in comparison to dopamine will result in a decrease in mortality for patients in septic shock.
Study Design/Source Population:
This trial is a single-center, prospective, randomized, open-label comparison of dopamine versus norepine... | Septic Shock | sepsis septic shock | null | 2 | arm 1: Patients that get Dopamine as an infusion for hypotension arm 2: Patients that get norepinephrine as an infusion for hypotension | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Dopamine 5-20 mcg/kg/min to pre-determined max of 20 intervention 2: Norepinephrine 5-20 mcg/min, to a pre-determined max of 20 | intervention 1: Dopamine intervention 2: Norepinephrine | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00604019 |
[
2
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib. | The primary objectives of this trial include:
* To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.
* To define the dosage-limiting toxicities (DLT) of this combination.
* To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with a... | Metastatic Solid Tumor | null | 1 | arm 1: All subjects receive treatment with intravenous topotecan and oral erlotinib. | [
0
] | 2 | [
0,
0
] | intervention 1: All subjects receive treatment with intravenous topotecan and oral erlotinib. intervention 2: All subjects receive treatment with intravenous topotecan and oral erlotinib. | intervention 1: Topotecan intervention 2: Erlotinib | 1 | Memphis | Tennessee | United States | -90.04898 | 35.14953 | 0 | NCT00611468 | |
[
5
] | 1,139 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | Trachoma is a disease of poverty, which in the hyperendemic areas affects all individuals by the time they are two years old. Active disease is concentrated in children and occurs sporadically in adults. Infection is more widespread. It is anticipated that 25% of the children will be blinded by this disease if they liv... | Population
We will take advantage of the ongoing work in the ten villages currently being studied in Kornaka West. They have never had mass treatment with azithromycin, and the baseline trachoma and infection rates are greater than 20%. The final survey for that current study will occur in January, 2008. Within villag... | Trachoma Chlamydia Trachomatis | Trachoma Chlamydia trachomatis | null | 2 | arm 1: Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive an initial treatment with 1 gm oral dose of Azithromycin; receive a second 1 gm oral dose of Azithromycin at... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children \> 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given 30 days apart; at Day 0 \& Day 30 for a total of 2 doses. intervention 2: 1 gm Azithromycin orally, provided as... | intervention 1: Azithromcyin intervention 2: Azithromycin | 2 | San Francisco | California | United States | -122.41942 | 37.77493
Niamey | N/A | Niger | 2.1098 | 13.51366 | 0 | NCT00618449 |
[
2,
3
] | 171 | RANDOMIZED | FACTORIAL | 1PREVENTION | 1SINGLE | true | 1FEMALE | false | Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to develop a new alternative treatment that include a dietary supplement (green tea extract) and a mind-body exercise (Tai Chi) for lessening bone loss in postmenopausal women with low bone mass. A combination of dietary supplement an... | This is a 24-week, randomized, and placebo-controlled intervention trial to investigate the effects of green tea polyphenols (GTP) and Tai Chi (TC) on relevant primary and secondary endpoints in postmenopausal women with osteopenia. Women at least 2 years after menopause, with osteopenia, will be recruited primarily fr... | Osteoporosis | postmenopausal, bone, dietary supplement, mind-body exercise | null | 4 | arm 1: 24 weeks of placebo. arm 2: 24 weeks of green tea polyphenols arm 3: 24 weeks of placebo plus Tai Chi exercise. arm 4: 24 weeks of green tea polyphenols plus Tai Chi exercise. | [
2,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 500 mg medicinal starch pills daily intervention 2: 500 mg green tea polyphenols daily intervention 3: 500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks intervention 4: 500 mg GTP daily plus TC exercise (3x/week) for 24 weeks | intervention 1: Placebo intervention 2: Green Tea Polyphenols (GTP) intervention 3: Placebo+Tai Chi (TC) intervention 4: GTP+TC | 1 | Lubbock | Texas | United States | -101.85517 | 33.57786 | 0 | NCT00625391 |
[
0
] | 8 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 1SINGLE | false | 0ALL | true | Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medic... | Cystic fibrosis (CF) is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States (70,000 worldwide). The lungs of a person with cystic fibrosis often contain thick sticky mucus that can clog the lungs and lead to life-threatening lung infections. ... | Cystic Fibrosis | cystic fibrosis surfactant aerosol inhaled drug inhaled antibiotic | null | 2 | arm 1: Subjects inhaled calfactant then isotonic saline arm 2: Subjects inhaled isotonic saline then calfactant | [
0,
0
] | 2 | [
0,
0
] | intervention 1: single inhaled dose by nebulizer intervention 2: single inhaled dose by nebulizer | intervention 1: calfactant intervention 2: isotonic saline | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00628134 |
[
2
] | 20 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze. | null | Osteosarcoma Leukemia Lymphoma | high dose methotrexate Voraxaze leucovorin delayed elimination methotrexate toxicity rescue renal insufficiency | null | 2 | arm 1: High-dose methotrexate, leucovorin, and Voraxaze arm 2: High-dose methotrexate and leucovorin without Voraxaze (glucarpidase) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: single intravenous dose intervention 2: standard of care, leucovorin every 6 hours | intervention 1: glucarpidase, high-dose methotrexate, leucovorin intervention 2: high-dose methotrexate, leucovorin | 25 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Palo Al... | 0 | NCT00634504 |
[
4
] | 994 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy... | null | Type 2 Diabetes | null | 3 | arm 1: Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg) arm 2: Dapagliflozin (5 mg) arm 3: Metformin XR (500 mg up to 2000 mg) | [
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, Once daily, 24 weeks intervention 2: Tablets, Oral, Once daily, 24 weeks | intervention 1: Dapagliflozin intervention 2: Metformin XR | 99 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Haleyville | Alabama | United States | -87.62141 | 34.22649
Tempe | Arizona | United States | -111.90931 | 33.41477
Concord | California | United States | -122.03107 | 37.97798
Fountain Valley | California | United States | -117.95367 | 33.70918
Fresno | Calif... | 0 | NCT00643851 | |
[
0
] | 11 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | true | 0ALL | false | This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hai... | This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA... | Healthy | Healthy Volunteers | null | 2 | arm 1: 4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo arm 2: 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Placebo capsule daily for 4 weeks intervention 2: 160 mg/day orally for 4 weeks | intervention 1: Fenofibrate capsule daily for 4 weeks intervention 2: Fenofibrate | 1 | Gainesville | Florida | United States | -82.32483 | 29.65163 | 0 | NCT00644592 |
[
3
] | 14 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Aldesleukin may stimulate the natural kil... | OBJECTIVES:
Primary
* To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell product following a preparative regimen comprising cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary per... | Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor fallopian tube cancer peritoneal cavity cancer | null | 2 | arm 1: This group includes patients that received all chemotherapy, infusion of natural killer (NK) cells and total body irradiation per protocol.
1\. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m\... | [
0,
0
] | 6 | [
2,
0,
0,
4,
2,
2
] | intervention 1: All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion. intervention 2: 60 mg/m\^2 on Days 4 and 5 preceding natural killer cell infusion. intervention 3: 25 mg/m\^2 on Days 6 through 2 ... | intervention 1: Allopurinol intervention 2: Cyclophosphamide intervention 3: Fludarabine phosphate intervention 4: total-body irradiation intervention 5: Allogeneic natural killer cells intervention 6: Aldesleukin | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00652899 |
[
4
] | 153 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB. | null | Overactive Bladder | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks | intervention 1: fesoterodine fumarate | 12 | Inegeku, Chibashi | Chiba | Japan | 140.11667 | 35.6
Akashi-shi | Hyōgo | Japan | N/A | N/A
Amagasaki-shi | Hyōgo | Japan | N/A | N/A
Chuou-ku, Koube-shi | Hyōgo | Japan | 135.183 | 34.6913
Kaibara-cho, Tanba-shi | Hyōgo | Japan | N/A | N/A
Nishinomiya-shi | Hyōgo | Japan | N/A | N/A
Kawasakishi | Kanagawa | Japan | N/... | 0 | NCT00658684 | |
[
0
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed... | null | Bipolar Disorder Metabolic Syndrome | bipolar disorder sedation overweight Abilify medication | null | 1 | arm 1: Aripiprazole | [
0
] | 1 | [
0
] | intervention 1: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be chan... | intervention 1: Aripiprazole | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00665444 |
[
3
] | 230 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance do... | null | Idiopathic Restless Legs Syndrome | SPM 962 rotigotine Idiopathic Restless Legs Syndrome RLS | null | 4 | arm 1: inactive placebo arm 2: 2.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets arm 3: 4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet arm 4: 6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 m... | [
2,
0,
0,
0
] | 1 | [
0
] | intervention 1: transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks | intervention 1: SPM 962 | 8 | Chubu Region | N/A | Japan | N/A | N/A
Chugoku Region | N/A | Japan | N/A | N/A
Hokkaido Region | N/A | Japan | N/A | N/A
Kanto Region | N/A | Japan | N/A | N/A
Kinki Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A
Shikoku Region | N/A | Japan | N/A | N/A
Tohoku Region | N/A | Japan | N/A | N/A | 0 | NCT00666965 |
[
4
] | 440 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Sub... | The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.
Treatment: Subject... | Helicobacter Infections | H. Pylori Quadruple therapy Eradication rate Multinational trial Resistance to antibiotics Subjects with confirmed Helicobacter Pylori infection | null | 2 | arm 1: Triple therapy, given for 7 days at a dose of omeprazole 20 mg twice daily, amoxicillin 500 mg 2 capsules twice daily, and clarithromycin 500 mg 1 tablet twice daily arm 2: OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, a... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID intervention 2: Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules Q... | intervention 1: Omeprazole, amoxicillin, clarithromycin intervention 2: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole | 1 | Bath | N/A | United Kingdom | -2.36172 | 51.3751 | 0 | NCT00669955 |
[
4
] | 528 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy dat... | null | Benign Prostatic Hypertrophy | Cetrorelix BPH | null | 1 | arm 1: Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26. | [
0
] | 1 | [
0
] | intervention 1: Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2, | intervention 1: Cetrorelix Pamoate | 69 | Homewood | Alabama | United States | -86.80082 | 33.47177
Huntsville | Alabama | United States | -86.58594 | 34.7304
Laguna Hills | California | United States | -117.71283 | 33.61252
Newport Beach | California | United States | -117.92895 | 33.61891
Sacramento | California | United States | -121.4944 | 38.58157
San Die... | 0 | NCT00670306 |
[
0
] | 14 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | The purpose of this study is to evaluate the effects of insulin resistance on brain function in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior to and following 4-month treatment with Metformin. Additionally, brain function in women with PCOS will be compared to the brain activi... | The pathogenesis of Polycystic Ovary Syndrome (PCOS), a reproductive and metabolic disorder, is associated with insulin resistance. The effects of insulin resistance on cognition, mood, opioid system and reproductive function in PCOS affected women are investigated in the current study. The identification of reversible... | Polycystic Ovary Syndrome | Polycystic Ovary Syndrome Insulin resistance Metformin Brain function | null | 2 | arm 1: Control subjects will have 5 visits (screening, oral glucose tolerance test (OGTT), neuropsychological testing, functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) as they will receive no treatment and will not have repeat studies. The baseline values obtained from the control sub... | [
4,
0
] | 1 | [
0
] | intervention 1: Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg twice daily (BID), adding a dose after lunch. On the third week, the dose will be increased to 500 mg three times dail... | intervention 1: Metformin | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00670800 |
[
0
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease | The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This stud... | End-Stage Renal Disease | Endstage renal disease Vitamin D Monocyte function | null | 1 | arm 1: Cholecalciferol (Vitamin D) | [
0
] | 1 | [
0
] | intervention 1: 50,000 Units PO Twice weekly for 8 weeks | intervention 1: Cholecalciferol | 0 | null | 0 | NCT00677534 |
[
3
] | 114 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production. | Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th... | Anemia Chronic Renal Failure Chronic Kidney Disease | anemia chronic kidney disease CKD chronic renal failure CRF erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). intervention 2: Participants received pegi... | intervention 1: peginesatide intervention 2: peginesatide intervention 3: Epoetin Alfa | 11 | Irkutsk | N/A | Russia | 104.29585 | 52.29795
Krasnodar | N/A | Russia | 38.97603 | 45.04484
Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668
Moscow | N/A | Russia | 37.61556 | 55.75222
Nizhny Novgorod | N/A | Russia | 44.00205 | 56.32867
Omsk | N/A | Russia | 73.36859 | 54.99244
Petrozavodsk | N/A | Russia | 34.34691 ... | 0 | NCT00680043 |
[
3
] | 10 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 1FEMALE | true | PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period. | The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period. | Uterine Fibroids | Uterine fibroids Fibroids | null | 3 | arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Lupron Depot | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Proellex 25 mg, 1 capsule daily for 4 months intervention 2: Proellex 50 mg, 2 capsules daily for 4 months intervention 3: Lupron 3.75 mg monthly intramuscular injections for 4 months | intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Lupron Depot | 4 | Sarasota | Florida | United States | -82.53065 | 27.33643
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Mexico City | Federal District | Mexico | -99.12766 | 19.42847 | 0 | NCT00683917 |
[
5
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents. | Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patient... | Type 2 Diabetes Mellitus | Glargine Type 2 diabetes Basal insulin | null | 3 | arm 1: Insulin glargine injected subcutaneously once daily at bedtime arm 2: Insulin glargine injected subcutaneously once daily in the morning arm 3: NPH insulin injected subcutaneously once daily at bedtime | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL) intervention 2: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL) intervention 3: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses ... | intervention 1: 1- Insulin glargine QHS intervention 2: 2 - Insulin glargine QAM intervention 3: 3 - NPH insulin QHS | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00686712 |
[
5
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone. | Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily... | Type 2 Diabetes Mellitus | Glargine Type 2 diabetes Basal insulin | null | 2 | arm 1: Insulin glargine injected at bedtime arm 2: NPH insulin injected twice-daily, before breakfast and at bedtime | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Insulin glargine at bedtime substituting for NPH insulin at bedtime intervention 2: Addition of morning NPH to bedtime NPH | intervention 1: Insulin glargine at bedtime instead of NPH intervention 2: NPH twice-daily | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00687453 |
[
3
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone. | Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters \[testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)\] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equival... | Hypogonadism | testosterone male hypogonadism low testosterone | null | 1 | arm 1: Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T a... | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. intervention 2: Two capsules each containing 100 mg T as TU and 100 m... | intervention 1: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) intervention 2: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose) intervention 3: Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food) intervention 4: Ora... | 4 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00695110 |
[
4
] | 56 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-... | Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-... | Uterine Fibroids Anemia | Uterine fibroids Anemia | null | 3 | arm 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months arm 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months arm 3: Placebo, 2 capsules daily for 3 months | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months | intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo | 30 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Col... | 0 | NCT00702702 |
[
3
] | 3 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to k... | OBJECTIVES:
Primary
* Determine if the administration of anti-p53 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes, high-dose aldesleukin, and adenovirus p53 dendritic cell (DC) vaccine after a nonmyeloablative, but lymphoid-depleting, preparative regimen will result in clinical tumor regression in ... | Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific | recurrent renal cell cancer stage IV renal cell cancer recurrent melanoma stage IV melanoma unspecified adult solid tumor, protocol specific | null | 2 | arm 1: Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2) arm 2: Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) +... | [
0,
0
] | 6 | [
2,
2,
2,
2,
0,
0
] | intervention 1: Intravenous (IV) aldesleukin 720,000 IU/kg every 8 hours for a maximum of 15 doses. intervention 2: Intravenous (IV) anti-p53 TCR transduced PBL will be administered at a a dose of 1 x 10\^8 cells to 5 x 10\^10 cells. intervention 3: Ad-p53 DC vaccine, up to 2 x 10\^8 ad-p53 DCs per dose will be adminis... | intervention 1: aldesleukin intervention 2: anti-p53 T-cell receptor-transduced peripheral blood lymphocytes intervention 3: autologous dendritic cell-adenovirus p53 vaccine intervention 4: filgrastim intervention 5: cyclophosphamide intervention 6: fludarabine phosphate | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00704938 |
[
2
] | 46 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established. | This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. ... | Cancer | cancer advanced cancer solid tumors CGC-11047 PG-11047 | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks). | intervention 1: PG-11047 | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00705653 |
[
3
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. | The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Te... | Secondary Hypogonadism | Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH) Secondary hypogonadism Semen volume Sperm count Sperm motility | null | 3 | arm 1: 1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period arm 2: Testim 1% Gel applied topically for 6 months arm 3: 1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone | [
0,
1,
0
] | 2 | [
0,
0
] | intervention 1: 25 mg Androxal capsules, 1 capsule daily for 6 months intervention 2: Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months | intervention 1: 25 mg Androxal intervention 2: Testim 1% | 2 | New York | New York | United States | -74.00597 | 40.71427
Purchase | New York | United States | -73.71457 | 41.04093 | 0 | NCT00706719 |
[
5
] | 231 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks. | null | Glaucoma Ocular Hypertension | Ocular surface health OSDI TFBUT Glaucoma Ocular hypertension Corneal staining | null | 2 | arm 1: One drop self-administered in the study eye(s) once daily at night for 12 weeks arm 2: One drop self-administered in the study eye(s) once daily at night for 12 weeks | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for... | intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®) | 0 | null | 0 | NCT00708422 |
[
4
] | 64 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment ... | null | Pulmonary Arterial Hypertension | Ventavis iloprost inhaled treatment pulmonary arterial hypertension | null | 2 | arm 1: Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 arm 2: Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc intervention 2: Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc | intervention 1: iloprost (5 µg) intervention 2: placebo | 0 | null | 0 | NCT00709956 |
[
4
] | 160 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection. | CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalatio... | Cystic Fibrosis Lung Infection Pseudomonas Aeruginosa | cystic fibrosis pseudomonas aeruginosa lung infection CFQ-R inhaled antibiotic aztreonam lysine | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: AZLI 75 mg three times daily (TID) intervention 2: Placebo three times daily (TID) | 40 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Oakland | California | United States | -122.2708 | 37.80437
Orange | California |... | 0 | NCT00712166 |
[
3
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to improve cholesterol and ... | Objectives Summary
\* To investigate whether the progressive addition of a fibrate and niacin to baseline statin therapy will improve apolipoprotein A-I kinetics, postprandial lipidemia, and postabsorptive lipoproteins and metabolism in adult men and women with atherogenic dyslipidemia.
Major Efficacy Aims
* Objecti... | Dyslipidemia | Low HDL cholesterol High triglycerides niacin fibrate | null | 3 | arm 1: atorvastatin 10 mg/day by mouth for a total duration of 4 weeks arm 2: ABT335 135 mg/day by mouth added to atorvastatin for a total duration of at least 8 arm 3: ER niacin titrated up to 2 g/day with aspirin 325 mg/day by mouth added to atorvastatin and ABT335 for 10 weeks | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg QD for 4 weeks intervention 2: 135 mg QD added to atorvastatin for 8 weeks intervention 3: 2000 mg QD added to atorvastatin and ABT335 for 10 weeks | intervention 1: Atorvastatin intervention 2: ABT335 intervention 3: ER Niacin | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00728910 |
[
4
] | 919 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | null | The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity. | null | Atrophy Vaginal Diseases | Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms Vaginal atrophy Urogenital atrophy | null | 2 | arm 1: Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. arm 2: Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All s... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed intervention 2: oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lub... | intervention 1: Ospemifene 60 mg intervention 2: Placebo | 0 | null | 0 | NCT00729469 |
[
3
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to both healthy volunteers and to COPD patients before. This study will assess a new formulation of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less likely to deteriorate in its container, it ... | null | Pulmonary Disease, Chronic Obstructive | Chronic Obstructive Pulmonary Disease (COPD) Magnesium stearate GSK573719 | null | 1 | arm 1: 7 day repeat dose | [
0
] | 1 | [
0
] | intervention 1: 7 day repeat dose | intervention 1: GSK573719 | 7 | Reading | Berkshire | United Kingdom | -0.97113 | 51.45625
Buckshaw Village, Chorley | Lancashire | United Kingdom | -2.61667 | 53.65
Waterloo, Liverpool | Merseyside | United Kingdom | N/A | N/A
Clydebank, Glasgow | N/A | United Kingdom | N/A | N/A
Edgbaston, Birmingham | N/A | United Kingdom | N/A | N/A
Llanishen | N... | 0 | NCT00732472 |
[
5
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long.
There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied ... | See brief summary | Postoperative Pain | Day surgery Hallux Valgus Pain Analgesics | null | 2 | arm 1: Active study drug:
Etoricoxib 90 mg once daily arm 2: Tramadol 100 mg slow release twice daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 90 mg once daily intervention 2: 100 mg twice daily | intervention 1: etoricoxib intervention 2: tramadol | 1 | Stockholm | N/A | Sweden | 18.06871 | 59.32938 | 0 | NCT00733421 |
[
4
] | 77 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed. | Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study... | Uterine Fibroids | Uterine Fibroids | null | 3 | arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: oral daily dose of placebo | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months intervention 2: Two 25 mg mg capsules of Proellex® orally daily for up to four months intervention 3: Two placebo capsules orally daily for up to four months | intervention 1: Proellex intervention 2: Proellex intervention 3: Placebo | 15 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Boynton Beach | Florida |... | 0 | NCT00735553 |
[
4
] | 560 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder. | The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.
The study enrolled 560 patients. Participants were randomly assigned (b... | Major Depressive Disorder | Depression Depressive Disorder Mood Disorder Mental Disorder Melancholia, Involutional Paraphrenia, Involutional Drug Therapy | null | 4 | arm 1: Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 4: Vortioxetine placebo-matching capsules, orally, once daily for ... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Encapsulated immediate-release vortioxetine tablets intervention 2: Vortioxetine placebo-matching capsules | intervention 1: Vortioxetine intervention 2: Placebo | 48 | Elizabeth Vale | N/A | Australia | 138.66819 | -34.74857
Southport | N/A | Australia | 153.39796 | -27.96724
Litoměřice | N/A | Czechia | 14.1318 | 50.53348
Lnáře | N/A | Czechia | 13.78406 | 49.4579
Prague | N/A | Czechia | 14.42076 | 50.08804
Bully-les-Mines | N/A | France | 2.72703 | 50.4438
Marseille | N/A | France... | 0 | NCT00735709 |
[
4
] | 175 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated. | Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed month... | Uterine Fibroids | Uterine Fibroids | null | 2 | arm 1: Proellex 25 mg once daily arm 2: Proellex 50 mg once daily | [
1,
1
] | 2 | [
0,
0
] | intervention 1: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle intervention 2: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle | intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg | 25 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Beverly Hills | California | United States | -118.40036 | 34.07362
San Diego | California | United States | -117.16472 | 32.71571
Sarasota | Florida | United States | -82.53065 | 27.33643
Atlanta ... | 0 | NCT00737282 |
[
5
] | 20 | RANDOMIZED | PARALLEL | null | 0NONE | false | 0ALL | false | Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wr... | Abstract:
Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate if infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to ... | Arthroplasty, Replacement, Hip | Skin preparation Skin marking site marking Site identification | null | 2 | arm 1: Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA) arm 2: Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, ... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Skin preparation of the surgical site per label of the product. The area for surgery will be prepared for 30 seconds intervention 2: Skin preparation of the surgical site per product labeling. The area will be painted with the solution. | intervention 1: CHG 2% w/v and IPA 70% v/v intervention 2: Iodophor 0.7% and IPA 74% w/w | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00739583 |
[
5
] | 598 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin ... | null | Type 2 Diabetes | diabetes type 2 | null | 2 | arm 1: titrated arm 2: Non-titrated | [
0,
0
] | 1 | [
0
] | intervention 1: Oral | intervention 1: Rosuvastatin | 84 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Red Deer | Alberta | Canada | -113.802 | 52.26682
Spruce Grove | Alberta | Canada | -113.91874 | 53.53344
St. Albert | Alberta | Canada | -113.63533 | 53.63344
Chilliwack | British Columbia | Canada | -121.95257 | 49.... | 0 | NCT00747149 |
[
5
] | 110 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal. | null | Smoking Cessation | nicotine withdrawal, smoking cessation, varenicline | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days) intervention 2: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days) | intervention 1: varenicline intervention 2: placebo | 2 | Austin | Texas | United States | -97.74306 | 30.26715
San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00749944 |
[
5
] | 51 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | true | 0ALL | false | Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days. | null | Dry Eye Syndromes | null | 2 | arm 1: Carboxymethylcellulose and Glycerin arm 2: Polyethylene glycol 400 | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1 drop in both eyes as needed for 7 days' intervention 2: 1 drop in both eyes as needed for 7 days | intervention 1: Lubricant Eye Drops (Optive™) intervention 2: Lubricating Eye Drops (blink® Tears) | 1 | Chevy Chase | Maryland | United States | -77.07115 | 39.00287 | 0 | NCT00756678 | |
[
3
] | 56 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action). | null | Cystic Fibrosis | cystic fibrosis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 60 mg, oral tablet, twice daily for 28 days intervention 2: Match placebo to 60 mg, oral tablet, twice daily for 28 days | intervention 1: AZD9668 intervention 2: AZD9668 Placebo equivalent | 14 | Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Hamburg | N/A | Germany | 9.99302 | 53.55073
Kiel | N/A | Germany | 10.13489 | 54.32133
Leipzig | N/A | Germany | 12.37129 | 51.33962
München | N/A | Germany | 13.31243 | 51.60698
Rabka-Zdrój | N/A | Poland | 19.96654 | 49.60889
Warsaw | N/A | Poland | 21.01178 | 52.2297... | 0 | NCT00757848 |
[
3,
4
] | 77 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo. | The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient a... | Varicose Veins | Varicose Veins | null | 2 | arm 1: Varisolve (polidocanol endovenous mircofoam) arm 2: Agitated saline | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2) intervention 2: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session | intervention 1: Varisolve (Polidocanol Endovenous Microfoam) intervention 2: Agitated Saline | 5 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
New York | New York | United States | -74.00597 | 40.71427
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Bellevue | Washington | United States | -122.20068 | 47.61038 | 0 | NCT00758420 |
[
4
] | 33 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | true | To test effectiveness of dentifrice in maintaining periodontal health. | null | Periodontal Disease | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period. intervention 2: subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period. | intervention 1: Triclosan, Fluoride intervention 2: Fluoride | 1 | Queensland | N/A | Australia | N/A | N/A | 0 | NCT00763256 | |
[
4
] | 1,191 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension. | null | Hypertension | aliskiren antihypertensive hypertension renin inhibitor moderate-severe hypertension | null | 4 | arm 1: Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 ... | [
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 150 and 300 mg tablets intervention 2: 5 and 10 mg capsules intervention 3: 12.5 and 25 mg capsules intervention 4: tablet intervention 5: capsules | intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide (HCTZ) intervention 4: Placebo intervention 5: Placebo | 12 | Denver | Colorado | United States | -104.9847 | 39.73915
Sydney | N/A | Australia | 151.20732 | -33.86785
Ottawa | N/A | Canada | -75.69812 | 45.41117
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Berlin | N/A | Germany | 13.41053 | 52.52437
Jerusalem | N/A | Israel | 35.21633 | 31.76904
Rome | N/A | Italy | 12.5113... | 0 | NCT00765674 |
[
4
] | 633 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Respon... | null | Chronic Constipation | Constipation Chronic Constipation Linaclotide | null | 3 | arm 1: Linaclotide 290 micrograms arm 2: Linaclotide 145 micrograms arm 3: Matching placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 2: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 3: Oral, once daily each morning at least 30 minutes before breakfast for the dur... | intervention 1: Linaclotide 290 micrograms intervention 2: Linaclotide 145 micrograms intervention 3: Placebo | 108 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Chandler | Arizona | United States | -111.84125 | 33.30616
Mesa | Arizona | United States | -111.82264 | 33.42227
Peoria | Arizona | United S... | 0 | NCT00765882 |
[
5
] | 256 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 m... | null | Essential Hypertension ( Mild to Moderate) | Essential Hypertension ( mild to moderate) | null | 1 | arm 1: All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Aliskiren 150 or 300 mg intervention 2: Hydrochlorothiazide 12.5 or 25 mg intervention 3: Amlodipine 5 or 10 mg | intervention 1: Aliskiren intervention 2: Hydrochlorothiazide intervention 3: Amlodipine | 4 | Paris | N/A | France | 2.3488 | 48.85341
Budapest | N/A | Hungary | 19.04045 | 47.49835
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bratislava | N/A | Slovakia | 17.10674 | 48.14816 | 0 | NCT00765947 |
[
4
] | 1,727 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore. | null | Herpes Labialis | null | 2 | arm 1: Acyclovir Lauriad 50mg arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 50 mg muco-adhesive buccal tablets, single application on the gum intervention 2: 50 mg muco-adhesive buccal tablets, single application on the gum | intervention 1: Acyclovir Lauriad intervention 2: Placebo | 53 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tucson | Arizona | United States | -110.92648 | 32.22174
San Francisco | California | United States | -122.41942 | 37.77493
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Meridian | Idaho | United States | -116.39151 | 43.61211
Springfield | Mi... | 0 | NCT00769314 | |
[
4
] | 8 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily. | Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-... | Uterine Fibroids Anemia | Uterine fibroids Anemia | null | 3 | arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months | intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo | 7 | Toluca | Estado de Mexico C.P. | Mexico | -99.65324 | 19.28786
Mexico City | Federal District | Mexico | -99.12766 | 19.42847
Mexico City | Federal District | Mexico | -99.12766 | 19.42847
Mexico City | Federal District | Mexico | -99.12766 | 19.42847
San Miguel de Allende | Guanajuato | Mexico | -100.74389 | 20.91528
... | 0 | NCT00785356 |
[
5
] | 207 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication. | null | Hypertension | nebivolol Bystolic® Hypertension blood pressure withdrawal | null | 2 | arm 1: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration arm 2: Matching placebo tablets, oral administration | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration intervention 2: Matching placebo tablets, oral administration | intervention 1: Nebivolol intervention 2: Placebo | 26 | Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Bradenton | Florida | United States | -82.57482 | 27.49893
Brooksville | Florida | United States | -82.38991 | 28.55554
DeLand | Florida |... | 0 | NCT00785512 |
[
4
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart).
Current interventions... | null | ST Segment Elevation Acute Myocardial Infarction | acute myocardial infarction | null | 2 | arm 1: Anakinra 100 mg given daily by subcutaneous injection for 14 days arm 2: 0.67 ml of NaCl 0.9% solution | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 100 mg daily subcutaneous injection for 14 days intervention 2: 0.67 ml of NaCl 0.9% subcutaneously daily for 14 days | intervention 1: Anakinra intervention 2: Placebo | 1 | Richmond | Virginia | United States | -77.46026 | 37.55376 | 0 | NCT00789724 |
[
4
] | 646 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction. | null | Erectile Dysfunction | ED Erectile Dysfunction Dysfunction Erectile | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 30 minutes orally prior to initiation of sexual activity intervention 2: 30 minutes orally prior to initiation of sexual activity intervention 3: 30 minutes orally prior to initiation of sexual activity intervention 4: 30 minutes orally prior to initiation of sexual activity | intervention 1: placebo intervention 2: avanafil intervention 3: avanafil intervention 4: avanafil | 41 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Homewood | Alabama | United States | -86.80082 | 33.47177
Tucson | Arizona | United States | -110.92648 | 32.22174
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
San Diego | Califor... | 0 | NCT00790751 |
[
5
] | 9 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 2DOUBLE | false | 0ALL | false | A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy | null | Inflammation | null | 2 | arm 1: Ketorolac 0.4% arm 2: Mineral Oil Emollient | [
1,
1
] | 2 | [
0,
0
] | intervention 1: One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days intervention 2: One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation | intervention 1: Ketorolac 0.4% intervention 2: Lubricating Eye Drop | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00791323 | |
[
3
] | 200 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide. | null | Acute Gout | Acute flares Gout Anti-interleukin-1β monoclonal antibody Colchicine Triamcinolone acetonide | null | 6 | arm 1: Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended t... | [
0,
0,
0,
0,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. intervention 2: Randomized patients received one... | intervention 1: Canakinumab intervention 2: Canakinumab intervention 3: Canakinumab intervention 4: Canakinumab intervention 5: Canakinumab intervention 6: Triamcinolone acetonide | 75 | Anniston | Alabama | United States | -85.83163 | 33.65983
Birmingham | Alabama | United States | -86.80249 | 33.52066
Buena Park | California | United States | -117.99812 | 33.86751
Oakland | California | United States | -122.2708 | 37.80437
San Diego | California | United States | -117.16472 | 32.71571
West Covina | C... | 0 | NCT00798369 |
[
2
] | 105 | RANDOMIZED | PARALLEL | 5SCREENING | 0NONE | false | 0ALL | false | This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery. | null | Cataract Extraction | Bioavailability | null | 3 | arm 1: Besifloxacin ophthalmic suspension arm 2: Vigamox (moxifloxacin ophthalmic solution, 0.5%) arm 3: Zymar (gatifloxacin ophthalmic solution, 0.3%) | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. intervention 2: Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. intervention 3: Instill gatifloxacin study medication in... | intervention 1: Besifloxacin hydrochloride intervention 2: moxifloxacin hydrochloride intervention 3: gatifloxacin | 1 | Rockville Centre | New York | United States | -73.64124 | 40.65871 | 0 | NCT00824070 |
[
3
] | 366 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting. | This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry... | Migraine Headache | Migraine headache Loxapine Staccato | null | 3 | arm 1: Inhaled Staccato Placebo (0 mg) arm 2: Inhaled Staccato Loxapine 1.25 mg, single dose arm 3: Inhaled Staccato Loxapine 2.5 mg, single dose | [
2,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Inhaled Staccato Loxapine 1.25 mg, single dose intervention 3: Inhaled Staccato Loxapine 1.25 mg, single dose | intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 1.25 mg intervention 3: Inhaled Loxapine 2.5 mg | 3 | Springfield | Missouri | United States | -93.29824 | 37.21533
Mount Vernon | New York | United States | -73.83708 | 40.9126
East Providence | Rhode Island | United States | -71.37005 | 41.81371 | 0 | NCT00825500 |
[
5
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear. | null | Atopic Dermatitis | null | 2 | arm 1: EpiCeram Skin Barrier Emulsion arm 2: Desonide Cream 0.05% | [
1,
1
] | 2 | [
1,
0
] | intervention 1: topical cream, twice daily, 6 weeks intervention 2: topical cream, twice daily, 6 weeks | intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Desonide Cream 0.05% | 5 | Denver | Colorado | United States | -104.9847 | 39.73915
Chicago | Illinois | United States | -87.65005 | 41.85003
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00828412 | |
[
5
] | 163 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris | null | Acne Vulgaris | null | 2 | arm 1: Dapsone gel 5% and Tretinoin gel 0.025% arm 2: Tretinoin gel 0.025% | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks intervention 2: Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks | intervention 1: Dapsone; Tretinoin intervention 2: Tretinoin | 1 | Strongsville | Ohio | United States | -81.83569 | 41.3145 | 0 | NCT00835198 | |
[
4
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF). | Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate ur... | Hyponatremia Acute Decompensated Heart Failure | hyponatremia euvolemic hyponatremia hypervolemic hyponatremia acute decompensated heart failure conivaptan Vaprisol | null | 2 | arm 1: Matching loading dose and continuous intravenous infusion for 48 hours arm 2: 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Premix bag intervention 2: Premix bag | intervention 1: conivaptan intervention 2: placebo | 4 | Hyderabaad | N/A | India | N/A | N/A
Karnāl | N/A | India | 76.98448 | 29.69197
New Delhi | N/A | India | 77.2148 | 28.62137
New Delhi | N/A | India | 77.2148 | 28.62137 | 0 | NCT00843986 |
[
3
] | 14 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo. | null | Type 2 Diabetes Mellitus | null | 3 | arm 1: MK8245 arm 2: MK8245 arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily.
Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. intervention 2: All patients will receive placebo ... | intervention 1: MK8245 5 mg (twice a day) b.i.d. intervention 2: MK8245 50 mg b.i.d. intervention 3: Placebo | 0 | null | 0 | NCT00846391 | |
[
5
] | 34 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis. | This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study. | Plaque-Type Psoriasis | Psoriasis | null | 2 | arm 1: Olux-E (clobetasol propionate 0.05%) foam arm 2: Clobex (clobetasol propionate 0.05%) lotion. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15. intervention 2: Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elb... | intervention 1: Olux-E Foam intervention 2: Clobex lotion | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00852761 |
[
3
] | 349 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis. | null | Kidney Failure, Chronic | Chronic Kidney Disease Phosphate Binder Phosphate Hyperphosphatemia | null | 7 | arm 1: Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. arm 2: Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. arm 3: Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. arm 4: Genz-644470 7.2 g/day tablets dosed orally TID with meals... | [
2,
0,
0,
0,
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Placebo intervention 2: Genz-644470 intervention 3: Sevelamer carbonate | 53 | Alexander City | Alabama | United States | -85.95385 | 32.94401
Birmingham | Alabama | United States | -86.80249 | 33.52066
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Bakersfield | California | United States | -119.01871 | 35.37329
Los Angeles | California | United States | -118.24368 | 34.05223
Param... | 0 | NCT00853242 |
[
4
] | 71 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed. | Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study... | Uterine Fibroids | Uterine Fibroids | null | 3 | arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: Placebo treatment | [
1,
1,
2
] | 2 | [
0,
10
] | intervention 1: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo intervention 2: Placebo | intervention 1: Proellex intervention 2: placebo | 17 | Anaheim | California | United States | -117.9145 | 33.83529
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Miami | Florida | United States | -80.19366 | 25.77427
West Palm ... | 0 | NCT00853567 |
[
5
] | 443 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension. | null | Hypertension | Hypertension African Americans Aliskiren Amlodipine Systolic blood pressure Diastolic blood pressure Stage II Combination | null | 2 | arm 1: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg arm 2: Amlodipine 5mg titrated to 10 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg intervention 2: Amlodipine 5 mg titrated to 10mg | intervention 1: Aliskiren/Amlodipine intervention 2: Amlodipine | 9 | Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Oxon Hill | Maryland | United States | -76.9897 | 38.80345
Detroit | Michigan | United States | -83.04575 | 42.33143
Trenton | New Jersey | United States | -74.74294 | 40.21705
Brooklyn | New York | Uni... | 0 | NCT00853957 |
[
4
] | 172 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | Study of T-PRED(TM) Compared to Pred Forte(R) | This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in t... | Cataract | null | 2 | arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate | [
0,
1
] | 2 | [
0,
0
] | intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution | intervention 1: T-Pred intervention 2: Pred Forte | 1 | Irvine | California | United States | -117.82311 | 33.66946 | 0 | NCT00854061 |
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