phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 1,326 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS). | This is a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study includes a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period from Week 1 to 48; and a re-treatment period during Week 49 to 96.
During the initial treatment period (We... | Multiple Sclerosis, Relapsing-Remitting | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks. intervention 2: Cladribine... | intervention 1: Cladribine 5.25 mg/kg intervention 2: Cladribine 3.5 mg/kg intervention 3: Placebo | 0 | null | 1 | NCT00213135 | |
[
5
] | 390 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms. | null | Diabetes Mellitus, Type 2 | null | 3 | arm 1: Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%) arm 2: Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. I... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Insulin glargine administered subcutaneously once daily. intervention 2: Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%) | intervention 1: Insulin Glargine intervention 2: Insulin Glulisine | 1 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079 | 1 | NCT00283049 | |
[
4
] | 365 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise | All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requ... | Diabetes | null | 5 | arm 1: PLUS open-label metformin (as needed as rescue medication) arm 2: PLUS open-label metformin (as needed as rescue medication) arm 3: PLUS open-label metformin (as needed as rescue medication) arm 4: PLUS open-label metformin (as needed as rescue medication) arm 5: PLUS open-label metformin (as needed as rescue me... | [
0,
0,
0,
0,
2
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 5mg QPM, Dail... | intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Placebo intervention 6: metformin | 74 | Columbiana | Alabama | United States | -86.60721 | 33.17817
Haleyville | Alabama | United States | -87.62141 | 34.22649
Mesa | Arizona | United States | -111.82264 | 33.42227
Bakersfield | California | United States | -119.01871 | 35.37329
Burbank | California | United States | -118.30897 | 34.18084
Cudahy | California... | 1 | NCT00316082 | |
[
4
] | 490 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa mainte... | null | Anemia | null | 2 | arm 1: Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa admin... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: As prescribed, iv. intervention 2: 120, 200 or 360 micrograms iv / month, starting dose | intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera] | 88 | Adelaide | N/A | Australia | 138.59863 | -34.92866
Clayton | N/A | Australia | 145.11667 | -37.91667
Gosford | N/A | Australia | 151.34399 | -33.4244
Parkville | N/A | Australia | 144.95 | -37.78333
Woolloongabba | N/A | Australia | 153.03655 | -27.48855
Linz | N/A | Austria | 14.28611 | 48.30639
Vienna | N/A | Austria... | 1 | NCT00394953 | |
[
3
] | 765 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatmen... | The study was conducted in 2 parts.
Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared:
* PegIntron and ribavirin for 48 weeks (Arm 1 - Control)
* PegIntron, ribavirin, and boceprevir for 28 weeks (Arm 2)
* Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron, r... | Chronic Hepatitis C | null | 8 | arm 1: Participants treated with PegIntron (1.5 μg/kg, once weekly \[QW\]) and Ribavirin (800 to 1400 mg/day) for 48 weeks.
Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron (1.5 μg/kg, QW), Ribavirin (800 to 1400 mg/day), and bocep... | [
1,
0,
0,
0,
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 200 mg capsules taken as 800 mg orally three times daily (TID) intervention 2: 1.5 μg/kg subcutaneously (SC) once weekly (QW) intervention 3: 200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily intervention 4: 200 mg capsules in doses of 400 to 1000 mg/day (... | intervention 1: boceprevir (SCH 503034) intervention 2: peginterferon-alfa 2b (PegIntron) intervention 3: ribavirin intervention 4: ribavirin (low-dose) | 0 | null | 1 | NCT00423670 | |
[
4
] | 517 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 millig... | null | Parkinson Disease | null | 3 | arm 1: None arm 2: None arm 3: None | [
5,
5,
2
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo | 76 | Linz | N/A | Austria | 14.28611 | 48.30639
Pardubice | N/A | Czechia | 15.77659 | 50.04075
Prague | N/A | Czechia | 14.42076 | 50.08804
Rakovník | N/A | Czechia | 13.7334 | 50.1037
Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284
Valašské Meziříčí | N/A | Czechia | 17.97113 | 49.47181
Győr | N/A | Hungary | 17... | 1 | NCT00466167 | |
[
4
] | 1,075 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris. | This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female s... | Acne Vulgaris | Acne Vulgaris Adapalene | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks | intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle | 34 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Marina del Rey | California | United States | -118.45371 | 33.98162
San Diego | California | United States | -117.16472 | 32.71571
Vallejo | California | United States | -122.25664 | 38.10409
Denve... | 1 | NCT00598832 |
[
3
] | 808 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials | Dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide, aclidinium bromide monotherapy and formoterol monotherapy | Chronic Obstructive Pulmonary Disease (COPD) | Bronchitis Chronic Emphysema Smokers or ex-Smokers | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
2,
2,
2
] | 2 | [
0,
0
] | intervention 1: once daily intervention 2: once daily | intervention 1: Aclidinium bromide and formoterol intervention 2: Aclidinium bromide and formoterol placebo | 9 | Taichung | N/A | Australia | N/A | N/A
Taipei | N/A | Australia | N/A | N/A
Moscow | N/A | Czechia | N/A | N/A
Saint Petersburg | N/A | Poland | N/A | N/A
St-Petersburg | N/A | Poland | N/A | N/A
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saratov | N/A | Russia | 4... | 1 | NCT00626522 |
[
4
] | 600 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults 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 vortioxetine.
The study enrolled 600 patients. Participants were randomly assigned (by chance, like flip... | Major Depressive Disorder | Major Depressive Disorder Depression Drug Therapy Major Depressive Episode | null | 2 | arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablet, orally, once daily for up to 6 weeks. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Encapsulated immediate-release tablets. intervention 2: Vortioxetine placebo-matching capsules. | intervention 1: Vortioxetine intervention 2: Placebo | 33 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Cerritos | California | United States | -118.06479 | 33.85835
Encino | California | United States | -118.50119 | 34.15917
Fresno | California | United States | -119.77237 | 36.74773
San Diego | California | United States | -117.16472 | 32.71571
Farmington | Co... | 1 | NCT00672958 |
[
3
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | OBJECTIVES:
I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis. | PROTOCOL OUTLINE:
Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. | Osteoporosis | arthritis & connective tissue diseases idiopathic juvenile osteoporosis rare disease | null | 1 | arm 1: Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily. | [
0
] | 1 | [
0
] | intervention 1: Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months. | intervention 1: Alendronate | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00010439 |
[
4
] | 53 | RANDOMIZED | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 2MALE | true | RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.
PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with ... | OBJECTIVES:
* Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
* Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
* Compare markers... | Osteoporosis Prostate Cancer | osteoporosis stage III prostate cancer stage IV prostate cancer | null | 2 | arm 1: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. arm 2: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. | [
0,
1
] | 3 | [
7,
0,
0
] | intervention 1: Given orally intervention 2: Given orally intervention 3: Given IV | intervention 1: cholecalciferol intervention 2: calcium gluconate intervention 3: zoledronic acid | 3 | Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00058188 |
[
3
] | 70 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block... | OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide.
Secondary I. Determine the response rate in patients treated with this regimen. II. Determine the toxicity of this regimen in these... | Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma Stage IV Ovarian Cancer | null | 1 | arm 1: Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 3 | [
2,
0,
10
] | intervention 1: Given IV intervention 2: Given PO intervention 3: Correlative studies | intervention 1: Bevacizumab intervention 2: Cyclophosphamide intervention 3: Laboratory Biomarker Analysis | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 0 | NCT00072566 | |
[
2,
3
] | 174 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can... | null | Breast Neoplasms | metastatic breast cancer | null | 2 | arm 1: Docetaxel + Placebo arm 2: Docetaxel + AG-013736 | [
5,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 5 mg twice daily \[bid\] continuous dosing intervention 2: Standard of care drug administration intervention 3: 5mg twice daily \[bid\] continuous dosing intervention 4: Standard of care drug administration | intervention 1: Placebo intervention 2: Docetaxel intervention 3: AG-013736 (axitinib) intervention 4: Docetaxel | 54 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Berkeley | California | United States | -122.27275 | 37.87159
Montebello | California | United States | -118.10535 | 34.00946
Monterey Park | California | United States | -118.12285 | 34.06251
San Francisco... | 0 | NCT00076024 |
[
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the safety and effectiveness of combination therapy with peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people with HCV alone. Peginterferon alpha-2a is a compound that... | Hepatitis C infection occurs in one-third of all HIV-infected individuals. Liver disease has become more significant among patients coinfected with HIV and HCV. Several studies have shown that coinfected individuals develop earlier and more severe liver disease. Pegylated interferon alpha with ribavirin has become the ... | Hepatitis C HIV Infections | Pegasys Ribavirin Early Virological Response Hepatitis C HIV | null | 2 | arm 1: Pegylated interferon alfa -2a STANDARD DOSE Pegasys 180ug/week arm 2: Double dose pegylated interferon with weight based Ribavirin | [
1,
0
] | 2 | [
0,
0
] | intervention 1: pegylated interferon alfa -2a 180ug/twice weekly and weight based ribavirin for 4 weeks then pegylated interferon alfa -2a 180ug/ weekly for the remainder of the treatment intervention 2: pegylated interferon alfa -2a 180ug weekly and weight based ribavirin for duration of the treatment | intervention 1: Double dose pegylated interferon with weight based Ribavirin intervention 2: standard dose pegylated interferon alfa -2a and ribavirin | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00085917 |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in... | OBJECTIVES:
Primary
* Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan.
Secondary
* Determine the duration of response in patients treated with this regimen.
* Determine the tolerance to and toxicity of this regimen... | Bladder Cancer | transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer stage IV bladder cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: gemcitabine hydrochloride intervention 2: irinotecan hydrochloride | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00089128 |
[
3
] | 23 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | This randomized phase II trial studies how well celecoxib works in preventing multiple myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing ... | PRIMARY OJBECTIVES:
I. Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in patients with monoclonal gammopathy of undetermined significance or smoldering myeloma.
SECONDARY OBJECTIVES:
I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these ... | Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Smoldering Multiple Myeloma | null | 2 | arm 1: Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. arm 2: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. | [
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies | intervention 1: celecoxib intervention 2: placebo intervention 3: laboratory biomarker analysis | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00099047 | |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer. | OBJECTIVES:
Primary
* Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.
Secondary
* Determine the safety and tolerability of this drug in these patients.
OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats eve... | Head and Neck Cancer | thyroid gland medullary carcinoma recurrent thyroid cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: irinotecan hydrochloride | 2 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00100828 |
[
3
] | 10 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease. | Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood... | Pulmonary Disease, Chronic Obstructive Emphysema | Chronic Obstructive Pulmonary Disease Emphysema Phosphodiesterase inhibitors Sildenafil Exercise testing Quality of life | null | 2 | arm 1: Sildenafil first, followed by washout, followed by placebo arm 2: Placebo first, followed by washout, followed by Sildenafil | [
1,
2
] | 2 | [
0,
0
] | intervention 1: sildenafil citrate 25 mg by mouth thrice daily (po tid) intervention 2: 25 mg po tid | intervention 1: sildenafil citrate intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00104637 |
[
4
] | 602 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer. | The following abbreviations were used in the Adverse Event section:
* international normalized ratio (inr)
* Common Terminology Criteria for Adverse Events (ctcae)
* Not Otherwise Specified (nos)
* Gastrointestinal (gi)
* Central nervous system (cns)
* Absolute Neutrophil Count (anc)
* Alanine aminotransferase (ALT)
*... | Carcinoma, Hepatocellular | Liver Cancer Cancer | null | 2 | arm 1: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continue... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. intervention 2: Sorafenib-matching placebo tablet... | intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo | 178 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
San Francisco |... | 0 | NCT00105443 |
[
5
] | 131 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 2MALE | true | The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy. | The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy. | Erectile Dysfunction Prostate Cancer | Treatment effectiveness Treatment efficacy Investigational, Therapies Immunosuppressant Erectile dysfunction Prostatectomy | null | 2 | arm 1: Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up. arm 2: Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral intervention 2: oral | intervention 1: Tacrolimus intervention 2: Placebo | 6 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Cleveland | Ohio | United States | -81.69541 | 41.4995
Nashville | Tennessee | United States | -86.78444 | 36.16589
Houston | Texas | United S... | 0 | NCT00106392 |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) i... | Purpose: The primary objective of this study is to determine the safety and estimate the efficacy of etanercept for the treatment of hidradenitis suppurativa. The secondary objective of this study is to determine the impact of etanercept treatment of hidradenitis suppurativa on skin related quality of life.
Duration:
... | Hidradenitis Suppurativa | clinical trial; efficacy; etanercept; hidradenitis suppurativa; quality of life; safety; tnf | null | 1 | arm 1: Open-label treatment with etanercept 50 mg/week subcutaneous injection | [
0
] | 1 | [
0
] | intervention 1: etanercept 50 mg/week subcutaneous injection | intervention 1: etanercept | 0 | null | 0 | NCT00107991 |
[
3
] | 16 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who have failed on therapy with azacytidine, the current standard of therapy. | Methylation is a change that occurs to Deoxyribonucleic acid (DNA) that affects gene usage in human cells. Abnormal methylation is very common in leukemias, which is a related disease to MDS. Decitabine is a new drug that blocks DNA methylation. Researchers want to find out if blocking methylation will help control MDS... | Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia | Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Azacytidine Failure Decitabine | null | 1 | arm 1: 20 mg/m2 by vein (IV) over 1 hour daily x 5 days. | [
0
] | 1 | [
0
] | intervention 1: 20 mg/m2 IV over 1 hour daily x 5 days. | intervention 1: Decitabine | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00113321 |
[
3
] | 183 | RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lu... | null | Systemic Lupus Erythematosus | SLE | null | 3 | arm 1: Double Blind Period arm 2: Double Blind Period arm 3: Open Label | [
1,
2,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months intervention 2: Injectable, intravenous, 0 mg, every 28 days, 12 months intervention 3: Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months intervention 4: Injectable, intravenous, 10 mg/kg, every 28 days | intervention 1: Abatacept intervention 2: Placebo intervention 3: Prednisone intervention 4: Abatacept | 52 | Tucson | Arizona | United States | -110.92648 | 32.22174
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Chicago | Il... | 0 | NCT00119678 |
[
5
] | 1,091 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving p... | null | Atopic Dermatitis | Atopic, dermatitis, asthma, children, modification Atopic dermatitis/atopy | null | 2 | arm 1: Pimecrolimus arm 2: Corticosteroid | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Pimecrolimus cream 1 % intervention 2: conventional corticosteroid-based treatment | intervention 1: Pimecrolimus intervention 2: Corticosteroid | 36 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Fayetteville | Arkansas | United States | -94.15743 | 36.06258
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Mission Viejo | California | United States | -117.672 | 33.60002
Orange | California | United States | -117.85311 | 33.78779
Redwood City ... | 0 | NCT00124709 |
[
4
] | 143 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma. | null | Multiple Myeloma Stage I | Multiple Myeloma Stage I Zoledronic acid Progression | null | 2 | arm 1: Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily. arm 2: No treatment with study medication. | [
0,
4
] | 2 | [
0,
7
] | intervention 1: Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance \> 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated... | intervention 1: Zoledronic acid intervention 2: Calcium / Vitamin D | 1 | Berlin | N/A | Germany | 13.41053 | 52.52437 | 0 | NCT00171925 |
[
4
] | 475 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | true | This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three week... | null | Breast Cancer Breast Neoplasms Cancer of the Breast | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression intervention 2: 75 mg/m2, intravenous (IV), every 21 days until disease progression intervention 3: 1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression | intervention 1: gemcitabine intervention 2: docetaxel intervention 3: capecitabine | 65 | Glendale | Arizona | United States | -112.18599 | 33.53865
Fort Smith | Arkansas | United States | -94.39855 | 35.38592
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Springdale | Arkansas | United States | -94.12881 | 36.18674
Berkeley | Calif... | 0 | NCT00191152 | |
[
2
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body. | null | Advanced Solid Tumors Neoplasms | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression intervention 2: rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2 | intervention 1: ixabepilone intervention 2: Rifampin | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00207090 | |
[
3
] | 61 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010). | null | Macular Degeneration | Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 1 drop per dosed eye per protocol. | intervention 1: pegaptanib sodium | 12 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Urayasu | Chiba | Japan | 139.90055 | 35.65879
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Fukushima | Fukushima | Japan | 140.46667 | 37.75
Maebashi | Gunma | Japan | 139.08333 | 36.4
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
Kyoto | Kyoto | Japan | 135.75385 | 3... | 0 | NCT00239928 |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether treatment with valganciclovir decreases T cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV) co-infection, potentially improving immune responses to antiretroviral therapy. | null | HIV Infections Cytomegalovirus Infections | HIV CMV T Cell activation Valganciclovir | null | 2 | arm 1: 900mg PO qd arm 2: 900mg PO qd | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. intervention 2: Placebo designed to resemble Valganciclovir | intervention 1: Valganciclovir intervention 2: Placebo | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00264290 |
[
3
] | 6 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment. | 852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability | Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia | Leukemia Lymphoma Myeloma Hematology 852A IRM Oncology | null | 1 | arm 1: Patients receiving at least one dose of 852A. | [
0
] | 1 | [
0
] | intervention 1: Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2. | intervention 1: 852A | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00276159 |
[
3,
4
] | 114 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms. | The DOMINO study is a randomized, double-blind, multi-center, futility study of minocycline in patients with HD. Subjects will be randomized (3:1) to one of the two study arms: (1) the group that receives active minocycline (100 mg po b.i.d.), and (2) the group that receives placebo. Subjects will be enrolled over an a... | Huntington Disease | Study of Minocycline in Huntington's Disease | null | 2 | arm 1: Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration. arm 2: Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (\~ 8 hours apart) intervention 2: Matching placebo 1 capsule twice daily, 18 months treatment duration. | intervention 1: minocycline intervention 2: Matching placebo | 12 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Englewood | Colorado | United States | -104.98776 | 39.64777
Gainesville | Florida | United States | -82.32483 | 29.65163
Tampa | Florida | United States | -82.45843 | 27.94752
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts ... | 0 | NCT00277355 |
[
2
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available. | null | Cancer: Solid Tumors | Cancer, solid tumors | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available. | intervention 1: E7080 | 1 | Tokyo | Tokyo | Japan | 139.69171 | 35.6895 | 0 | NCT00280397 |
[
4
] | 35 | null | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that pres... | null | Clinically Isolated Syndrome | null | 2 | arm 1: None arm 2: None | [
0,
5
] | 2 | [
0,
10
] | intervention 1: 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks intervention 2: No treatment for 96 weeks | intervention 1: Rebif® intervention 2: No Treatment | 1 | Windsor, Barrie, Hamilton, Mississauga | Ontario | Canada | N/A | N/A | 0 | NCT00287079 | |
[
4
] | 344 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary... | This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403 milligrams or placebo equivalent administered... | Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis Lung Pirfenidone InterMune | null | 2 | arm 1: 2403 mg/day pirfenidone dose group. arm 2: Placebo equivalent. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study. intervention 2: Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study. | intervention 1: Pirfenidone intervention 2: Placebo | 1 | Brisbane | California | United States | -122.39997 | 37.68077 | 0 | NCT00287729 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck. | Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well... | Head and Neck Cancer | head and neck cancer | null | 1 | arm 1: pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles | [
0
] | 1 | [
0
] | intervention 1: 500 mg/m2 IV every 3 weeks for 6 cycles | intervention 1: Pemetrexed | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00293579 |
[
4
] | 746 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial is conducted in North America (the United States of America (USA) and Mexico).
The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (we... | null | Diabetes Diabetes Mellitus, Type 2 | null | 4 | arm 1: Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195). arm 2: Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-lab... | [
0,
0,
1,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: 1.8 mg for s.c. (under the skin) injection intervention 2: 8 mg capsule intervention 3: 1.2 mg for s.c. (under the skin) injection intervention 4: Glimepiride placebo, 8mg capsule intervention 5: Liraglutide placebo, 200 mcl intervention 6: Liraglutide placebo, 300 mcl | intervention 1: liraglutide intervention 2: glimepiride intervention 3: liraglutide intervention 4: placebo intervention 5: placebo intervention 6: placebo | 117 | Concord | California | United States | -122.03107 | 37.97798
Escondido | California | United States | -117.08642 | 33.11921
Fullerton | California | United States | -117.92534 | 33.87029
Inglewood | California | United States | -118.35313 | 33.96168
Mission Viejo | California | United States | -117.672 | 33.60002
Orang... | 0 | NCT00294723 | |
[
3
] | 41 | NA | SINGLE_GROUP | 0TREATMENT | 1SINGLE | false | 0ALL | null | Background:
* CD4+ cells are white blood cells that regulate the immune system by controlling the strength and quality of the immune response.
* CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses.
* RFT-5-dgA is an immunotoxin (substance that kills specific cells in the immune system) tha... | Background:
* RFT5-dgA is an immunotoxin comprised of the IL-2Ra-specific murine IgG1 antibody RFT5 linked to deglycosylated ricin A chain (dgA) via the sterically hindered heterobifunctional disulfide linker SMPT (4-succinimidyl-oxycarbonyl-a-methyl-a-(2-pyridyldithio)-toluene).
* RFT5-dgA is a recombinant immunotoxi... | Metastatic Melanoma | Clinical Response Stage IV Melanoma Immunotoxin T Regulatory Cells CD25+ Cells Metastatic Melanoma | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: RFT5pdgA | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00314093 |
[
4
] | 1,091 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial period... | null | Diabetes Diabetes Mellitus, Type 2 | null | 5 | arm 1: Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 2: Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 3: Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 4: Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo arm 5: Glim... | [
0,
0,
0,
1,
1
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 0.6 mg for s.c. (under the skin) injection. intervention 2: 1.5-2.0 g tablets intervention 3: 4 mg tablets intervention 4: Glimepiride placebo 1 mg and 2 mg tablets intervention 5: Liraglutide placebo 1-3 mL for s.c. (under the skin) injection intervention 6: 1.2 mg for s.c. (under the skin) injection i... | intervention 1: liraglutide intervention 2: metformin intervention 3: glimepiride intervention 4: placebo intervention 5: placebo intervention 6: liraglutide intervention 7: liraglutide | 190 | Ciudad Autonoma de Bs As | N/A | Argentina | N/A | N/A
Ciudad Autónoma de Bs As | N/A | Argentina | N/A | N/A
Ciudad Autónoma de BsAs | N/A | Argentina | N/A | N/A
Junín | N/A | Argentina | -60.94644 | -34.59391
Broadmeadow | New South Wales | Australia | 151.72849 | -32.92371
Penrith | New South Wales | Australia | 15... | 0 | NCT00318461 | |
[
0
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes neces... | This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal failure requiring hemodialysis or patients with creatinine... | Immunosuppression | Liver transplantation mycophenolate mofetil gastrointestinal adverse effects | null | 2 | arm 1: Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days arm 2: Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Myfortic 360mg or 720 mg BID for 90 days intervention 2: CellCept 500mg or 1000mg BID for 90 days | intervention 1: Myfortic intervention 2: CellCept | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00336817 |
[
0
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it is enteric-coated). Our hypothesis is that... | This is a prospective, single center, open-label, safety and tolerability study on the use of Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) attributable to CellCept are eligible to enter the study... | Immunosuppression | Liver transplantation mycophenolate mofetil gastrointestinal adverse effects | null | 1 | arm 1: All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days. | [
0
] | 1 | [
0
] | intervention 1: Myfortic 360mg or 720 mg BID for 90 days. | intervention 1: Myfortic | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00336895 |
[
4
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each ... | null | Colorectal Cancer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: As prescribed intervention 3: 5mg/kg iv on day 1 of each 2 week cycle intervention 4: As prescribed | intervention 1: bevacizumab [Avastin] intervention 2: XELOX intervention 3: bevacizumab [Avastin] intervention 4: FOLFOX-4 | 7 | Box Hill | N/A | Australia | 145.12545 | -37.81887
Fitzroy | N/A | Australia | 144.97833 | -37.79839
Sydney | N/A | Australia | 151.20732 | -33.86785
Brampton | Ontario | Canada | -79.76633 | 43.68341
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Toronto | Ontario | Canada | -79.39864 | 43.70643
Christchurch | N/A... | 0 | NCT00349336 | |
[
4
] | 226 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved. | The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase. | Epilepsy, Partial | epilepsy lamotrigine Lamictal monotherapy | null | 2 | arm 1: 300 mg/day treatment arm 2: 250 mg/day treatment | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 300 mg/day intervention 2: 250 mg/day | intervention 1: lamotrigine, 300 mg/day intervention 2: lamotrigine, 250 mg/day | 103 | Alabaster | Alabama | United States | -86.81638 | 33.24428
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
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | Unite... | 0 | NCT00355082 |
[
4
] | 599 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodef... | null | Human Immunodeficiency Virus Infections | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: LPV/r 800/200 mg once-daily (QD) tablet intervention 2: LPV/r 400/100 mg twice-daily (BID) tablet | intervention 1: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) intervention 2: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) | 1 | Abbott Park | Illinois | United States | N/A | N/A | 0 | NCT00358917 | |
[
5
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience. | This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in patients with bipolar disorder. Our hypotheses are:
1. Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety... | Generalized Anxiety Disorder Bipolar Disorder | Bipolar Disorder Generalized Anxiety Disorder Double-blind Placebo-controlled Ziprasidone | null | 2 | arm 1: Ziprasidone will be dosed on a twice daily (BID) basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day, for 8 weeks. This time period reflects the rapid onset of effect seen in studies of atypical antipsychotics, but allows time for a potentially longer respo... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks. intervention 2: Placebo administered daily for 8 weeks | intervention 1: Ziprasidone intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00374543 |
[
4
] | 26 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits th... | null | Follicular Lymphoma Lymphoma, Follicular | null | 2 | arm 1: Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin). arm 2: Participants will receive standard R-CVP. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin intervention 2: Standard R-CVP | intervention 1: Zevalin Therapeutic Regimen intervention 2: R-CVP | 6 | Jacksonville | Florida | United States | -81.65565 | 30.33218
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Marietta | Georgia | United States | -84.54993 | 33.9526
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
Nashville | Tenne... | 0 | NCT00384111 | |
[
3
] | 106 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | true | The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that g... | This is a 2-part, open-label (all people know the identity of the intervention) multicenter (when more than 1 hospital or medical school team work on a medical research study), Phase 2 study to evaluate the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with m... | Cancer, Prostate | Cancer Prostate IL-6 Mitoxantrone Metastatic prostate cancer | null | 3 | arm 1: In Part 1, mitoxantrone 12 milligram per square meter (mg/m\^2) will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab 6 mg/kilogram (mg/... | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Mitoxantrone 12 mg/m\^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) intervention 2: Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks u... | intervention 1: Mitoxantrone intervention 2: Siltuximab intervention 3: Prednisone | 34 | Norwalk | Connecticut | United States | -73.4079 | 41.1176
Port Saint Lucie | Florida | United States | -80.35033 | 27.29393
Atlanta | Georgia | United States | -84.38798 | 33.749
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Baltimore | Maryland | United States | -76.61219 | 39.29038
St Louis | Missour... | 0 | NCT00385827 |
[
3
] | 12 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Background:
The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can grow unchecked.
In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53) can be measured in the tumor.
Objectives To determine whether advanced cancers that overexpress p53 can... | Background:
Human peripheral blood lymphocytes (PBL's) can be engineered to express alpha T-cell receptor that recognizes an human leukocyte antigen serotype witin HLA-A A serotype group) HLA-A2. 1 restricted epitope derived from the p53 protein.
We constructed a single retroviral vector that contains both alpha and ... | Anti-p53 TCR-Gene | Tumor Regression In Vivo Cell Survival Toxicity Profile Metastatic Renal Cell Cancer Cancer Metastatic Cancer | null | 2 | arm 1: Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes). arm 2: None | [
0,
0
] | 5 | [
2,
2,
2,
0,
0
] | intervention 1: Peripheral blood lymphocytes are harvested by lymphapheresis and engineered to express a T cell receptor that binds to P53. intervention 2: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days intervention 3: Beginning on day 1 or 2, administered subcutaneously at a dose of 5 mcg/k... | intervention 1: anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes intervention 2: aldesleukin intervention 3: filgrastim intervention 4: cyclophosphamide intervention 5: fludarabine phosphate | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00393029 |
[
3
] | 16 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.
The secondary objectives were to further assess efficacy and safety of Aflib... | The study consisted of:
* A 30-day screening phase prior to Day 1
* Day 1 registration and pre-treatment paracentesis
* Aflibercept administration within 1-day of registration
* Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
* A 60-day post-treatment follow-up phase... | Ovarian Neoplasms | Ovarian cancer malignant ascites angiogenesis angiogenesis inhibition VEGF-Trap fusion recombinant protein | null | 1 | arm 1: Participants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met | [
0
] | 1 | [
0
] | intervention 1: 4.0 mg/kg administered intravenously (IV) once every 2 weeks | intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | 3 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Milan | N/A | Italy | 12.59836 | 42.78235
Bromma | N/A | Sweden | 17.94 | 59.34 | 0 | NCT00396591 |
[
3
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of ... | null | Idiopathic Parkinson's Disease | null | 2 | arm 1: Intracerebral administration of CERE-120 arm 2: Sham Neurosurgery | [
0,
3
] | 2 | [
0,
3
] | intervention 1: CERE-120 5.4 x 10\^11 vg intervention 2: Bilateral partial thickness burr holes placed, no intraparenchymal injections | intervention 1: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) intervention 2: Sham Surgery | 9 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Francisco | California | United States | -122.41942 | 37.77493
Chicago | Illinois | United States | -87.65005 | 41.85003
New York | New York | United States | -74.00597 | 40.71427
Durham | North Carolina | United States | -78.89862 | 35.99403
Cleveland | O... | 0 | NCT00400634 | |
[
5
] | 80 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to:
Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of ... | Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing t... | Atrial Fibrillation Esophagectomy | Amiodarone Atrial fibrillation Surgical procedures, thoracic | null | 2 | arm 1: Intravenous amiodarone arm 2: Control | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Intravenous amiodarone continuous infusion x 4 days intervention 2: No amiodarone | intervention 1: Amiodarone intervention 2: Control | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00420017 |
[
4
] | 722 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. I... | null | Asthma | Glucocorticosteroids Dry Powder Inhaler Bronchodilator Metered-Dose Inhaler | null | 2 | arm 1: Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. arm 2: Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID | [
0,
1
] | 2 | [
0,
0
] | intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. intervention 2: Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks. | intervention 1: Mometasone furoate/formoterol (MF/F) MDI intervention 2: Fluticasone propionate/salmeterol (F/SC) DPI | 0 | null | 0 | NCT00424008 |
[
3
] | 66 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag ... | null | Purpura, Thrombocytopaenic, Idiopathic | idiopathic thrombocytopenic purpura ITP thrombocytopenia platelets | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: experimental | intervention 1: eltrombopag | 3 | Hanover | Lower Saxony | Germany | 9.73322 | 52.37052
Berlin | State of Berlin | Germany | 13.41053 | 52.52437
Moscow | N/A | Russia | 37.61556 | 55.75222 | 0 | NCT00424177 |
[
4
] | 336 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis. | null | Menopause Postmenopausal Vaginal Atrophy | null | 1 | arm 1: One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks | [
0
] | 1 | [
0
] | intervention 1: Tablets, administered intravaginally twice weekly | intervention 1: estradiol, 10 mcg | 42 | Brno | N/A | Czechia | 16.60796 | 49.19522
Brno | N/A | Czechia | 16.60796 | 49.19522
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Århus N | N/A | Denmark | N/A | N/A
Glostrup Municipality | N/A | Denmark | 12.40377 | 55.6666
Her... | 0 | NCT00431132 | |
[
5
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable C... | null | Cystic Fibrosis | Lung disease CF Pulmozyme | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 2.5 mg inhalation dose twice daily for 14±2 days intervention 2: 2.5 mg inhalation dose twice daily for 14±2 days | intervention 1: Dornase alfa intervention 2: placebo | 40 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
Sacramento | California | United States | -121.4944 | 38.58157
Ventura... | 0 | NCT00434278 |
[
3,
4
] | 282 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require ... | Aerosolized beta-2 agonist therapy is anticipated to diminish the formation of lung edema, enhance clearance of lung edema and decrease pulmonary inflammation in patients with acute lung injury. Because beta-2 agonists have been shown to reduce permeability induced lung injury, it is anticipated that the severity of lu... | Respiratory Distress Syndrome, Adult | Acute Lung Injury Acute Respiratory Distress Syndrome Albuterol Aerosolized Critical Care Ventilator | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 3 | [
0,
3,
0
] | intervention 1: Albuterol sulfate, USP, solution for inhalation will be diluted as follows:
* The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution.
* The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution.
A high-efficiency small volume jet nebulizer ... | intervention 1: Albuterol Sulfate intervention 2: Mini-Bronchoalveolar Lavage (BAL) intervention 3: Placebo | 40 | Fresno | California | United States | -119.77237 | 36.74773
Sacramento | California | United States | -121.4944 | 38.58157
San Francisco | California | United States | -122.41942 | 37.77493
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Denver... | 0 | NCT00434993 |
[
5
] | 265 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | null | 0ALL | null | To evaluate the potential effects of artemether- lumefantrine on the auditory function | null | Malaria Falciparum | Malaria hearing co-artemether auditory Plasmodium falciparum marsh fever Plasmodium infections remittent fever paludism artemether artemisinins benflumetol lumefantrine | null | 3 | arm 1: Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight. arm 2: Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body wei... | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Artesunate-mefloquine intervention 2: Atovaquone-proguanil intervention 3: Artemether-lumefantrine | 1 | Tumaco | N/A | Colombia | -78.79275 | 1.79112 | 0 | NCT00444106 |
[
4
] | 735 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks. | This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial. | Vasomotor Symptoms Hot Flashes | Vasomotor symptom relief Postmenopausal women Severe to Moderate Vasomotor symptoms | null | 4 | arm 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally... | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 3: One tablet \[17β-estradiol (E2 0.... | intervention 1: 0.5mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 3: Estradiol (E2 0.3mg) intervention 4: Placebo | 76 | Mobile | Alabama | United States | -88.04305 | 30.69436
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United S... | 0 | NCT00446199 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection | null | Herpes Simplex | Infants, Herpes simplex infection | null | 1 | arm 1: Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. | [
0
] | 1 | [
0
] | intervention 1: Administered orally as a single individualized dose between 25-200 mg based on body weight. | intervention 1: famciclovir | 6 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Chicago | Illinois | United States | -87.65005 | 41.85003
Detroit | Michigan | United States | -83.04575 | 42.33143
Omaha | Nebraska | United States | -95.94043 | 41.25626
Cleveland | Ohio | United States | -81.69541 | 41.4995
Dallas | Texas | United States | ... | 0 | NCT00448227 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Sunitinib 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.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatmen... | OBJECTIVES:
Primary
* Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.
Secondary
* Determine the safety of this drug in these patients.
* Determine the time to tumor response and duration of tumor response in patients treated with this drug.
OUTLINE: T... | Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor | recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor ovarian choriocarcinoma ovarian immature teratoma ovarian mature teratoma recurrent malignant testicular germ cell tumor testicular choriocarcinoma testicular seminoma testicular yolk sac tumor ovarian dysgerminoma ovarian embryonal carcinoma ovarian yo... | null | 1 | arm 1: The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks) | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: sunitinib malate | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00453310 |
[
0
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis.
The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient.
The primary outcome variable between the two strate... | This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.
Power calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or... | Perforated Appendicitis | appendicitis, perforation, abscess, treatment | null | 2 | arm 1: 5 days of IV antibiotics after appendectomy arm 2: home on oral antibiotics to complete 7 days of treatment when tolerating PO's | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing) intervention 2: Augmentin 40mg/kg BID when tolerating POs to complete 7 days total | intervention 1: 5 days of IV antibiotics (ceftriaxone and metronidazole) intervention 2: Home with oral antibiotics when eating (ampicillin/clavulanic acid) | 1 | Kansas City | Missouri | United States | -94.57857 | 39.09973 | 0 | NCT00462020 |
[
3
] | 230 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed. | The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg... | Fibromyalgia Syndrome | Fibromyalgia Syndrome Rotigotine Neupro | null | 3 | arm 1: Placebo arm 2: 4 mg/24 hrs arm 3: 8 mg/24 hrs | [
2,
0,
0
] | 3 | [
0,
0,
10
] | intervention 1: Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch) intervention 2: Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches) intervention 3: Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appear... | intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo | 35 | Mobile | Alabama | United States | -88.04305 | 30.69436
Mesa | Arizona | United States | -111.82264 | 33.42227
Peoria | Arizona | United States | -112.23738 | 33.5806
Santa Ana | California | United States | -117.86783 | 33.74557
Cromwell | Connecticut | United States | -72.64537 | 41.5951
DeLand | Florida | United Sta... | 0 | NCT00464737 |
[
3
] | 147 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.
Catamenial epilepsy... | null | Partial Epilepsy Catamenial Epilepsy | Partial onset seizures Complex-partial seizures Anticonvulsant Partial seizures Catamenial epilepsy | null | 2 | arm 1: active study drug arm 2: placebo | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Oral suspension 200-500 mg 3x/day intervention 2: non-active placebo | intervention 1: Ganaxolone intervention 2: Placebo | 27 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Aurora | Col... | 0 | NCT00465517 |
[
3
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to... | OBJECTIVES:
Primary
* Determine the time to progression in patients with unresectable or metastatic colorectal cancer treated with cetuximab and celecoxib.
Secondary
* Determine the response rate, median survival, and 1-year survival rate of patients treated with this regimen.
* Determine the toxicity profile of th... | Colorectal Cancer | recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer | null | 1 | arm 1: None | [
0
] | 6 | [
2,
0,
6,
10,
10,
10
] | intervention 1: 400 mg/m2 iv week 1, then 250 mg/m2 weekly thereafter, starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol. intervention 2: 200 mg po BID starting on day 1 and continuing until progressive disease, excessive toxici... | intervention 1: cetuximab intervention 2: celecoxib intervention 3: proteomic profiling intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis intervention 6: mass spectrometry | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00466505 |
[
5
] | 265 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease | null | Alzheimer's Disease | memantine Alzheimer's Disease communication | null | 2 | arm 1: Memantine 20mg (10mg twice daily) oral administration for 12 weeks arm 2: Placebo oral administration twice daily for 12 weeks | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Memantine 20mg (10mg twice daily) oral administration for 12 weeks intervention 2: Placebo oral administration twice daily for 12 weeks | intervention 1: Memantine intervention 2: placebo | 25 | East Gosford | New South Wales | Australia | 151.35338 | -33.43874
Hornsby | New South Wales | Australia | 151.09931 | -33.70244
Kogarah | New South Wales | Australia | 151.13564 | -33.9681
Newcastle | New South Wales | Australia | 151.7801 | -32.92953
Randwick | New South Wales | Australia | 151.24895 | -33.91439
Cher... | 0 | NCT00469456 |
[
5
] | 228 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine. | null | Attention Deficit Hyperactivity Disorder | null | 1 | arm 1: 0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks. | [
0
] | 1 | [
0
] | intervention 1: atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks. | intervention 1: Atomoxetine | 8 | Beijing | N/A | China | 116.39723 | 39.9075
Shanghai | N/A | China | 121.45806 | 31.22222
Pusan | N/A | South Korea | 128.3681 | 36.3809
Seoul | N/A | South Korea | 126.9784 | 37.566
Neihu Taipei | N/A | Taiwan | N/A | N/A
Niao Sung Hsiang | N/A | Taiwan | N/A | N/A
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taoyuan ... | 0 | NCT00471354 | |
[
2,
3
] | 54 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of s... | This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine ... | Prostatic Neoplasms | Abiraterone acetate CB7630 Prostatic neoplasms Hormone refractory prostate cancer Castration resistant prostate cancer Castration refractory prostate cancer | null | 1 | arm 1: Abiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD. intervention 2: Abiraterone acetate MTD orally for 12 cycles (28 day each). intervention 3: Dexamethasone 0.5 mg orally will be given (If participants have... | intervention 1: Abiraterone acetate intervention 2: Abiraterone acetate MTD intervention 3: Dexamethasone | 1 | Sutton | N/A | United Kingdom | -0.2 | 51.35 | 0 | NCT00473512 |
[
4
] | 79 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | null | Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
Secondary :
1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation re... | null | Renal Transplant | null | 0 | null | null | 1 | [
0
] | intervention 1: (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level. | intervention 1: Sirolimus (Rapamune®) | 9 | Deagu | N/A | South Korea | N/A | N/A
Deagu | N/A | South Korea | N/A | N/A
Pusan | N/A | South Korea | 128.3681 | 36.3809
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A |... | 0 | NCT00478608 | |
[
3
] | 397 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning ... | null | Overactive Bladder Detrusor Overactivity | null | 2 | arm 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks arm 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks intervention 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks | intervention 1: Vardenafil HCl (Levitra, BAY38-9456) intervention 2: Placebo | 55 | Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Brantford | Ontario | Canada | -80.26636 | 43.1334
Kitchener | Ontario | Canada | -80.5112 | 43.42537
Montreal | Quebec | Canada | -73.58781 | 45.50884
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Prague | N/A |... | 0 | NCT00478881 | |
[
4
] | 539 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of... | null | Early Parkinson Disease (Early PD) | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo | 95 | Gilbert | Arizona | United States | -111.78903 | 33.35283
Sun City | Arizona | United States | -112.27182 | 33.59754
La Jolla | California | United States | -117.2742 | 32.84727
Oxnard | California | United States | -119.17705 | 34.1975
Danbury | Connecticut | United States | -73.45401 | 41.39482
Boca Raton | Florida |... | 0 | NCT00479401 | |
[
4
] | 310 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium. | null | Mixed Dyslipidemia | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 2: Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-wee... | intervention 1: ABT-335 intervention 2: rosuvastatin calcium intervention 3: simvastatin intervention 4: atorvastatin calcium | 1 | Abbott Park | Illinois | United States | N/A | N/A | 0 | NCT00491530 | |
[
2
] | 75 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is ... | A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever | Pain Fever | null | 2 | arm 1: Intravenous Acetaminophen administered 15 milligrams/kilogram (mg/kg) every 8 hours (q8h) or every 6 hours (q6h) based age of subject arm 2: Intravenous Acetaminophen administered 12.5 milligrams/kilogram (mg/kg) every 6 hours (q6h) or every 4 hours (q4h) | [
0,
0
] | 2 | [
0,
0
] | intervention 1: This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen... | intervention 1: IV Acetaminophen intervention 2: IV Acetaminophen | 5 | Stanford | California | United States | -122.16608 | 37.42411
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Durham | North Carolina | United States | -78.89862 | 35.99403
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00493246 | |
[
3
] | 185 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia. | Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared... | Pneumonia Bacterial Pneumonia Ventilator-Associated Pneumonia Infections, Nosocomial | Pneumonia Lung Infection Bacterial Infection Hospital-Acquired Infection Ventilator Infection Antibiotic Therapy | null | 1 | arm 1: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days | [
0
] | 1 | [
0
] | intervention 1: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days | intervention 1: doripenem | 40 | Palm Springs | California | United States | -116.54529 | 33.8303
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Jacksonville | Florida | United States | -81.65565 | ... | 0 | NCT00502801 |
[
3
] | 200 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objectives:
1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose adjusted to yield a blood drug level with a median daily area under the plasma concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given intravenously over three hours once daily for fo... | Patients who agree to the optional pharmacology procedures #1 will initially receive a therapeutic test dose of busulfan to test the blood levels over time; this information will be used to determine the subsequent high-dose busulfan doses. Patients who do not agree to the optional pharmacology procedure will receive a... | Leukemia | Acute Myeloid Leukemia Myelodysplastic Syndromes Busulfan Busulfex Myleran Fludarabine Fludarabine Phosphate Fludara | null | 1 | arm 1: Once a day for four days, Busulfan 130 mg/m\^2 through intravenous catheter over 3 hours immediately after Fludarabine 40 mg/m\^2 over 1 hour. | [
0
] | 2 | [
0,
0
] | intervention 1: 130 mg/m\^2 injected through the intravenous catheter over three hours, once a day, for four days, starting immediately after Fludarabine. intervention 2: 40 mg/m\^2 through a central venous catheter over one hour, once a day, for four days. | intervention 1: Busulfan intervention 2: Fludarabine | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00502905 |
[
3
] | 146 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either... | This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), multicenter study that will evaluate the safety and tolerability of doripenem (an antibiotic used to treat infections) in patients with ventilator-associated pneumonia (VAP) or complicated intra... | Pneumonia, Ventilator-Associated Pneumonia, Bacterial Pneumonia Abdominal Abscess Bacterial Infections | Doripenem Imipenem Cilastatin Vancomycin DORIBAX, DORIPREX, FINIBAX, DURAPTA, PRIMAXIN, Anti Bacterial Agents Ileus Hospitalized Fever | null | 4 | arm 1: Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion arm 2: Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients wi... | [
0,
1,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion intervention 2: Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion intervention 3: 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associate... | intervention 1: Imipenem/cilastatin intervention 2: Imipenem/cilastatin intervention 3: Doripenem intervention 4: Doripenem | 0 | null | 0 | NCT00515034 |
[
3
] | 53 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against HIV-1 strains including those resistant to currently available antiretroviral drugs. The purpose of this study is to assess the effectiveness of raltegravir in further reducing viral load in HIV infected patients that have alrea... | Although ART has reduced the morbidity and mortality from HIV-1 infection, most individuals who stop ART experience rapid viral rebound. Effective ART can suppress viral load to less than 50 copies/ml; however, current treatment regimens cannot completely eliminate the infection. The primary purpose of this study was t... | HIV Infections | Treatment Experienced | null | 2 | arm 1: 400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks arm 2: Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add ... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 400 mg tablet taken orally twice daily intervention 2: 400 mg placebo tablet taken orally twice daily | intervention 1: Raltegravir (MK-0518) intervention 2: Placebo | 20 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Palo Alto | California | United States | -122.14302 | 37.44188
San Francisco | California | United States | -122.41942 | 37.77493
Torrance | California | United States | -118.34063 | 33.83585
Aurora | Colorado | United States | -104.83192 | 39.72943
Chicago | ... | 0 | NCT00515827 |
[
5
] | 201 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia. | Currently, treatment of acute symptoms in schizophrenia is less than ideal, up to one-third of patients with schizophrenia do not respond to current treatments, and poor drug tolerability can decrease a patient's ability to remain on treatment. Paliperidone ER doses in the range of 3 mg/day to 12 mg/day have been appro... | Schizophrenia | Schizophrenia | null | 3 | arm 1: Paliperidone ER 1.5 mg tablet once daily for 6 weeks arm 2: Paliperidone ER 6 mg tablet once daily for 6 weeks arm 3: Placebo Once daily for 6 weeks | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 1.5 mg tablet once daily for 6 weeks intervention 2: Once daily for 6 weeks intervention 3: 6 mg tablet once daily for 6 weeks | intervention 1: Paliperidone ER intervention 2: Placebo intervention 3: Paliperidone ER | 20 | Cerritos | California | United States | -118.06479 | 33.85835
Torrance | California | United States | -118.34063 | 33.83585
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Bradenton | Florida | United States | -82.57482 | 27.49893
Leesburg | Florida | United States | -81.87786 | 28.81082
A... | 0 | NCT00524043 |
[
4
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a common and serious lung condition that usually requires hospitalization. Dexamethasone is a medication that may decrease hospitalization time for people with ACS, but it may also bring about new sickle cell pain. This study will ev... | SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." ACS is a life-threatening, lung-related complication of SCD that can lower the level of oxygen in the blood. Repeat occurrences of ACS can cause lung damage. It is ... | Anemia, Sickle Cell | Sickle Cell Disease ACS Acute Chest Syndrome Hgb SS Hgb Sβ0 Dexamethasone | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Individuals meeting entry criteria will be randomized to receive dexamethasone 0.3 mg/kg (12 mg maximum single dose). The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapere... | intervention 1: Dexamethasone intervention 2: Placebo | 6 | Sacramento | California | United States | -121.4944 | 38.58157
Louisville | Kentucky | United States | -85.75941 | 38.25424
Boston | Massachusetts | United States | -71.05977 | 42.35843
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
... | 0 | NCT00530270 |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:
* Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
* Part 2 whose main ob... | null | Lung Cancer | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression intervention 2: 500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle intervention 3: 75 mg/m², IV, every 21 days, for each 21-day cycle intervention 4: po, QD | intervention 1: enzastaurin intervention 2: pemetrexed intervention 3: cisplatin intervention 4: placebo | 12 | Leuven | N/A | Belgium | 4.70093 | 50.87959
Gauting | N/A | Germany | 11.37703 | 48.06919
GroBhansdorf | N/A | Germany | N/A | N/A
Hamburg | N/A | Germany | 9.99302 | 53.55073
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Bergamo | N/A | Italy | 9.66721 | 45.69601
Catania | N/A | Italy | 15.07041 | 37.49223
Padua | N... | 0 | NCT00538681 | |
[
4
] | 535 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%.
Secondary objectives of t... | This is a multi-centre, comparative, randomised, open-label, parallel-group study of the efficacy and safety of a 3-day regimen of a fixed combination of PA (3:1) versus AL in the treatment of acute uncomplicated Plasmodium falciparum mono-infection. The study population will include 534 patients, comprising male and f... | Malaria | Falciparum malaria pediatric Coartem artesunate lumefantrine pyronaridine Pyramax | null | 2 | arm 1: Oral pyronaridine/artesunate (PA, 60:20mg granules) once a day for 3 consecutive days (Days 0, 1, and 2).
Posology based on body weight ranges. arm 2: Oral artemether/lumefantrine (AL, 20:120mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2).
Posology based on body weight ranges. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: The strength of the granule formulation is 60:20 mg pyronaridine artesunate per sachet. Depending on their body weight, patients will receive between 1 to 3 pyronaridine artesunate sachets per day, for 3 consecutive days The actual dose-range covered by this regimen is 7.0:2.3 mg/kg to 13.3:4.4 mg/kg py... | intervention 1: pyronaridine artesunate intervention 2: arthemeter lumefantrine | 8 | Ouagadougou | N/A | Burkina Faso | -1.53388 | 12.36566
Abidjan | N/A | Côte d’Ivoire | -4.00167 | 5.35444
Kinshasa | N/A | Democratic Republic of the Congo | 15.31357 | -4.32758
Lambaréné | N/A | Gabon | 10.24055 | -0.7001
Siaya | N/A | Kenya | 34.28806 | 0.0607
Bamako | N/A | Mali | -7.97522 | 12.60915
Maputo | N/A | ... | 0 | NCT00541385 |
[
3
] | 4 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers | Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments. | Venous Ulcers | Nitric Oxide Venous Leg Ulcers | null | 3 | arm 1: Standard of care - dressings and sustained compression only arm 2: 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound arm 3: 200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound | [
4,
0,
0
] | 2 | [
0,
0
] | intervention 1: 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound intervention 2: 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound | intervention 1: Nitric Oxide - same dose 6 wks intervention 2: Nitric Oxide modified treatment | 1 | Richmond | Virginia | United States | -77.46026 | 37.55376 | 0 | NCT00545298 |
[
5
] | 781 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg ... | null | Post-Menopausal Osteoporosis | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day). intervention 2: 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 150... | intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] | 39 | Gainesville | Georgia | United States | -83.82407 | 34.29788
St Louis | Missouri | United States | -90.19789 | 38.62727
Omaha | Nebraska | United States | -95.94043 | 41.25626
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Fargo | North Dakota | United States | -96.7898 | 46.87719
Madison | Wisconsin |... | 0 | NCT00551174 | |
[
3
] | 260 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy | The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvas... | Hyperlipidemia | LDL hepatic fat | null | 8 | arm 1: Placebo arm 2: 2.5 mg AEGR-733 arm 3: 5 mg AEGR-733 arm 4: 7.5 mg AEGR-733 arm 5: 10 mg AEGR-733 arm 6: 5 mg AEGR-733 + 20 mg atorvastatin arm 7: 5 mg AEGR-733 + 145 mg fenofibrate arm 8: 5 mg AEGR-733 + 10 mg ezetimibe | [
2,
1,
1,
1,
1,
1,
1,
1
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 3 capsules each evening for each 4-week period intervention 2: 3 capsules each evening for each 4-week period intervention 3: 3 capsules each evening for each 4-week period intervention 4: 3 capsules each evening for each 4-week period intervention 5: 3 capsules each evening for each 4-week period inter... | intervention 1: AEGR-733 intervention 2: placebo intervention 3: AEGR-733 intervention 4: AEGR-733 intervention 5: AEGR-733 intervention 6: AEGR-733 and atorvastatin intervention 7: AEGR-733 and fenofibrate intervention 8: AEGR-733 and ezetimibe | 15 | San Diego | California | United States | -117.16472 | 32.71571
Santa Rosa | California | United States | -122.71443 | 38.44047
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Chicago | Illinois | United States | -87.65005 | 41.85003
Iowa City | Iowa | United States | -91.53017 | 41.66113
L... | 0 | NCT00559962 |
[
5
] | 208 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study evaluated the safety and efficacy of 10 cm\^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm\^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of pati... | null | Alzheimer's Disease | Alzheimer's Disease Rivastigmine Patch | null | 1 | arm 1: For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Rivastigmine 5 and 10 cm^2 patch | 1 | Munich | N/A | Germany | 11.57549 | 48.13743 | 0 | NCT00561392 |
[
4
] | 153 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) | null | Attention Deficit Hyperactivity Disorder | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period intervention 2: Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period intervention... | intervention 1: Atomoxetine Hydrochloride intervention 2: Atomoxetine hydrochloride intervention 3: Atomoxetine hydrochloride | 3 | Bucheon-si | N/A | South Korea | 126.78306 | 37.49889
Incheon | N/A | South Korea | 126.70515 | 37.45646
Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00568685 | |
[
2,
3
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine abs... | null | Methamphetamine Dependence, Treatment Seeking | methamphetamine, crystal, treatment | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 2 gr/day (333 mg, TID) intervention 2: matching placebo | intervention 1: Acamprosate intervention 2: placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00571922 |
[
4
] | 181 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled. | null | Type 2 Diabetes | diabetes exenatide LY2148568 Byetta Lilly Amylin | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: subcutaneous injection, 5mcg, twice a day intervention 2: subcutaneous injection, 10mcg, twice a day intervention 3: subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day | intervention 1: exenatide intervention 2: exenatide intervention 3: placebo | 12 | Chiba | N/A | Japan | 140.11667 | 35.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukushima | N/A | Japan | 140.46667 | 37.75
Hyōgo | N/A | Japan | 144.43333 | 43.36667
Ibaraki | N/A | Japan | 135.56828 | 34.81641
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kumamoto | N/A | Japan | 130.69181 | 32.80589
Kyoto | N/A | Ja... | 0 | NCT00577824 |
[
4
] | 2,388 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis. | null | Seasonal Allergic Rhinitis | allergic rhinitis allergies seasonal allergies | null | 4 | arm 1: Olopatadine HCl 0.6% 1 spray per nostril twice daily arm 2: Vehicle 1 spray per nostril twice daily arm 3: Olopatadine HCl 0.6% 2 sprays per nostril twice daily arm 4: Vehicle 2 sprays per nostril twice daily | [
0,
2,
0,
2
] | 2 | [
0,
0
] | intervention 1: Olopatadine HCl 1 or 2 sprays per nostril twice daily intervention 2: Vehicle 1 or 2 sprays per nostril twice daily | intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Vehicle | 1 | Kenilworth | Illinois | United States | -87.71756 | 42.08586 | 0 | NCT00578929 |
[
0
] | 15 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 1SINGLE | true | 0ALL | false | Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/p... | • All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can... | Burn | null | 2 | arm 1: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change arm 2: receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change intervention 2: .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change | intervention 1: Instilled 1% Lidocaine intervention 2: Placebo (0.9% Normal Saline) | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00585325 | |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients. | This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease. | Parkinson's Disease | Parkinson's disease time to "on" delayed on | null | 2 | arm 1: Parcopa at equivalent dosage to subjects current stable dose arm 2: Carbidopa-levodopa (Sinemet)at subjects current stable dose | [
0,
1
] | 2 | [
0,
0
] | intervention 1: at subjects current stable dose of comparator intervention 2: at subjects current stable dose | intervention 1: Parcopa intervention 2: carbidopa-levodopa (Sinemet) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00590122 |
[
3
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis. | null | Liver Cirrhosis | conivaptan Liver Cirrhosis Hypertension, Portal | null | 3 | arm 1: Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours arm 2: Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours arm 3: Placebo continuous intravenous infusion over 6.5 hours | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: IV intervention 2: IV | intervention 1: conivaptan intervention 2: Placebo | 1 | Barcelona | N/A | Spain | 2.15899 | 41.38879 | 0 | NCT00592475 |
[
4
] | 217 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease. | This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease. | Early-Stage Parkinson's Disease | Rotigotine | null | 1 | arm 1: Rotigotine | [
0
] | 1 | [
0
] | intervention 1: Rotigotine trans-dermal patches:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
Optimal dosing:
During the first year:
The maximum Rotigotine dose allowed is 6 mg/24 hours.
After the first year: allowed dose increase of Rotigotine up to a maximum of 1... | intervention 1: Rotigotine | 42 | Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Fountain Valley | California | United States | -117.95367 | 33.70918
Fresno | California | United States | -119.77237 | 36.74773
Los Angeles | Califo... | 0 | NCT00594165 |
[
0
] | 11 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 3TRIPLE | true | 0ALL | false | Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biol... | null | Healthy | sleep performance night shift Ramelteon Healthy Individuals | null | 2 | arm 1: Ramelteon 8 mg will be given once prior to a 2-hour nap arm 2: Placebo will be given once prior to a 2-hour nap | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ramelteon 8 mg tablet by mouth x 1 dose intervention 2: placebo identical in appearance to active experimental drug x 1 dose | intervention 1: Ramelteon intervention 2: placebo | 0 | null | 0 | NCT00595075 |
[
4
] | 213 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients. | • To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients
Secondary Objectives:
* To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment
* To compare the safe... | Acute Pain Fever | Acute pain Fever IV Acetaminophen Analgesic | null | 3 | arm 1: 1 g q6h IV Acetaminophen arm 2: 650 mg q4h IV Acetaminophen arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen. | [
0,
0,
5
] | 1 | [
0
] | intervention 1: Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing ace... | intervention 1: IV Acetaminophen | 14 | Arcadia | California | United States | -118.03534 | 34.13973
Glendale | California | United States | -118.25508 | 34.14251
Laguna Hills | California | United States | -117.71283 | 33.61252
Pasadena | California | United States | -118.14452 | 34.14778
Pasadena | California | United States | -118.14452 | 34.14778
Santa B... | 0 | NCT00598559 |
[
2
] | 53 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were teste... | Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study. | Colorectal Neoplasms Neoplasms | advanced solid tumors, colorectal cancer, sunitinib (SUTENT), FOLFOX | null | 1 | arm 1: SU011248 \[sunitinib\] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX... | [
0
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 2: 50 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 3: 50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2) intervention 4: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 5: 50 mg sunitinib + modifie... | intervention 1: sunitinib + FOLFOX intervention 2: sunitinib + FOLFOX intervention 3: sunitinib + FOLFOX intervention 4: sunitinib + FOLFOX intervention 5: sunitinib + FOLFOX intervention 6: sunitinib + FOLFOX intervention 7: sunitinib + FOLFOX | 3 | Aurora | Colorado | United States | -104.83192 | 39.72943
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00599924 |
[
3
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial. | null | Diabetes | Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks intervention 2: Oral placebo capsules, once daily, 28 weeks | intervention 1: Phentermine/Topiramate intervention 2: Placebo | 9 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Spring Valley | California | United States | -116.99892 | 32.74477
Walnut Creek | California | United States | -122.06496 | 37.9... | 0 | NCT00600067 |
[
3
] | 622 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to determine if the investigational drug is effective and safe in individuals with asthma. | A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persi... | Asthma | Adolescents Adults Pharmacokinetics Asthma GW685698X Pharmacogenetics | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: GW685698X intervention 2: placebo | intervention 1: GW685698X intervention 2: placebo | 155 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fort Smith | Arkansas | United States | -94.39855 | 35.38592
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | California | United States | -119.77237 | 36.74773
Granada Hills | California | United States | -118.52314 | 34.26472
Huntington B... | 0 | NCT00603278 |
[
4
] | 272 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persisten... | null | Asthma COPD | null | 1 | arm 1: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. | [
0
] | 1 | [
0
] | intervention 1: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period. | intervention 1: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) | 0 | null | 0 | NCT00604500 | |
[
3
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.
The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy. | null | Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin | null | 3 | arm 1: 12 weekly doses of 1.5 mg CJC-1134-PC arm 2: 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC arm 3: 12 weekly doses of placebo | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: 1.5 or 2.0 mg CJC-1134-PC intervention 2: Placebo | intervention 1: CJC-1134-PC intervention 2: Placebo | 1 | Montreal | Quebec | Canada | -73.58781 | 45.50884 | 0 | NCT00638716 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD). | Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exclude subjects with sleepdisordered breathing. The following evening, subjects underwent another polysomnogram, followed ... | Parkinson Disease | excessive daytime somnolence Parkinson disease sleep disturbance | null | 1 | arm 1: sodium oxybate 4.5 to 9.0 gms per night | [
0
] | 1 | [
0
] | intervention 1: 4.5 to 9.0 grams per night | intervention 1: sodium oxybate | 0 | null | 0 | NCT00641186 |
[
5
] | 328 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension | null | Essential Hypertension | Essential Hypertension | null | 2 | arm 1: Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. arm 2: Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily i... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Aliskiren supplied in 150 mg and 300 mg tablets. intervention 2: Placebo to Aliskiren matching 150 and 300 mg tablets | intervention 1: Aliskiren intervention 2: Placebo to Aliskiren | 3 | Zanesville | Ohio | United States | -82.01319 | 39.94035
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Valencia | N/A | Spain | -0.37966 | 39.47391 | 0 | NCT00654875 |
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