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
] | 111 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states. | null | Hyponatremia | Hyponatremia | null | 1 | arm 1: Enrolled subjects began treatment with 15 mg tolvaptan QD. A titration between target doses of 15 mg, 30 mg, or 60 mg of trial medication was based on the subject's change in serum sodium concentration and clinical tolerance of the trial medication. | [
0
] | 1 | [
0
] | intervention 1: Once Daily | intervention 1: Tolvaptan | 0 | null | 0 | NCT02449044 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX in subjects having had 2 prior pharmacokinetic assessments with AlphaNine. | Two pharmacokinetic assessments (studies) were carried out in the same subjects during a previous clinical trial. The first pharmacokinetic study (PK1) was performed after a single dose of AlphaNine. The second pharmacokinetic study (PK2) was performed following 26 Weeks of AlphaNine treatment after PK1. To compare Alp... | Hemophilia B | Factor IX (FIX) | null | 1 | arm 1: BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection. | [
0
] | 1 | [
0
] | intervention 1: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg. | intervention 1: BeneFIX | 3 | Pleven | N/A | Bulgaria | 24.61667 | 43.41667
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Varna | N/A | Bulgaria | 27.91667 | 43.21667 | 0 | NCT03091751 |
[
4
] | 564 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension. | null | Essential Hypertension | Essential hypertension High blood pressure | null | 1 | arm 1: Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus am... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 300 mg tablet intervention 2: 5 mg tablet intervention 3: 12.5 mg and 25 mg capsule | intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide | 8 | Houston | Texas | United States | -95.36327 | 29.76328
Belgium | N/A | Belgium | N/A | N/A
Egypt | N/A | Egypt | N/A | N/A
Germany | N/A | Germany | N/A | N/A
Poland | N/A | Poland | N/A | N/A
Slovakia | N/A | Slovakia | N/A | N/A
Spain | N/A | Spain | N/A | N/A
Turkey | N/A | Turkey (Türkiye) | N/A | N/A | 0 | NCT00667719 |
[
2
] | 60 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration). | Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by Smith... | Depressive Disorder | fast condition Paroxetine reference/test healthy volunteers Bioequivalence | null | 2 | arm 1: Reference drug administration followed by test drug administration arm 2: Test drug administration followed by Reference drug administration | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) intervention 2: Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited ... | intervention 1: Test formulation intervention 2: Reference formulation | 1 | Belo Horizonte | Minas Gerais | Brazil | -43.93778 | -19.92083 | 0 | NCT01316926 |
[
4
] | 850 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data. | The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a long-term treatment in transplant recipients. Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled. | Heart Transplantation Liver Transplantation Kidney Transplantation | FK506E Heart Transplantation MR4 Tacrolimus Advagraf Kidney Transplantation Renal Transplantation | null | 1 | arm 1: Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective ... | [
0
] | 1 | [
0
] | intervention 1: oral | intervention 1: FK506E | 105 | Cincinnati | Ohio | United States | -84.51439 | 39.12711
Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Brisbane | Queensland | Australia | 153.02809 | -27.46794
Heidelberg | Victoria | Australia | 145.06667 | -37.75
Melbourne | Victoria | Australia | 144.96332 | -37.814
Innsbruck | N/A | Austria | 11... | 0 | NCT02118896 |
[
3
] | 227 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition. | null | Cachexia | Cachexia, COPD, Chronic Obstructive Pulmonary Disease | null | 3 | arm 1: SUN11031 for injection, low dose, twice daily for 12 weeks arm 2: SUN11031 for injection, higher dose, twice daily for 12 weeks arm 3: Placebo injection, twice daily for 12 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Twice daily subcutaneous injections of placebo for 12 weeks. intervention 2: Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks. intervention 3: Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks. | intervention 1: Placebo comparator intervention 2: SUN11031 20 μg/kg intervention 3: SUN11031 40 μg/kg | 43 | Waterbury | Connecticut | United States | -73.0515 | 41.55815
Clearwater | Florida | United States | -82.8001 | 27.96585
Largo | Florida | United States | -82.78842 | 27.90979
Hagerstown | Maryland | United States | -77.71999 | 39.64176
Missoula | Montana | United States | -113.994 | 46.87215
Papillion | Nebraska | Uni... | 0 | NCT00698828 |
[
4
] | 19 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | null | Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if ora... | Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.
We propose a study to see if oral amiodarone given fo... | Atrial Fibrillation Lung Cancer | Atrial fibrillation Lung cancer Pulmonary resection Post-operative complications | null | 2 | arm 1: Perioperative amiodarone arm 2: Control arm, standard care with no perioperative amiodarone | [
0,
1
] | 2 | [
0,
10
] | intervention 1: Perioperative orally administered intervention 2: Control | intervention 1: Amiodarone intervention 2: Control arm, standard care | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00300495 |
[
2,
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or in peripheral bl... | OBJECTIVES:
Primary
* To determine the maximum tolerated dose (MTD) of clofarabine when administered with low-dose cytarabine and filgrastim (G-CSF) in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS).
* To evaluate efficacy as measured by hematologic response rates in patients who are treate... | Myelodysplastic Syndromes | de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes | null | 1 | arm 1: G-CSF 300 μg subcutaneously to begin one day prior to treatment and continued until ANC greater than 1.0 or recovers back to the patients baseline ANC for 3 days in a row subsequent to completion of chemotherapy (SOC) Low-dose Cytarabine 10 mg/m2 subcutaneously daily starting on day 1 for the first 5 consecutive... | [
0
] | 5 | [
2,
0,
0,
6,
3
] | intervention 1: subcutaneously one day prior to treatment intervention 2: single IV dose over 1 hour daily for 5 days intervention 3: subcutaneously daily for 5 days 2-4 hours following the end of the Clofarabine infusion intervention 4: Both standard cytogenetic testing and FISH (fluorescent in situ hybridization) are... | intervention 1: filgrastim intervention 2: clofarabine intervention 3: cytarabine intervention 4: microarray analysis intervention 5: biopsy | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00503880 |
[
3
] | 224 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo. | This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or... | Ulcerative Colitis | null | 3 | arm 1: Matching dose of placebo will be given orally in capsules three times per day for 56 days. arm 2: A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days. arm 3: A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in ... | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day). intervention 2: Matching dose of Placebo intervention 3: HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day). | intervention 1: HMPL-004 low dose intervention 2: Placebo intervention 3: HMPL-004 high dose | 0 | null | 0 | NCT00659802 | |
[
3
] | 155 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension. | null | Hypertension | Blood Pressure Hypertension Resistant Hypertension | null | 5 | arm 1: Following a 2-week placebo run-in period, participants received LCI699 0.25 mg, capsules, orally, twice daily (BID), with or without food for up to 8 weeks. arm 2: Following a 2-week placebo run-in period, participants received LCI699 1 mg, capsules, orally, once daily (QD), with or without food for up to 8 week... | [
0,
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: LCI699 oral capsules intervention 2: Eplerenone oral capsules intervention 3: LCI699-matching placebo oral capsules intervention 4: Eplerenone-matching placebo oral capsules | intervention 1: LCI699 intervention 2: Eplerenone intervention 3: LCI699-matching Placebo intervention 4: Eplerenone-matching Placebo | 38 | Mobile | Alabama | United States | -88.04305 | 30.69436
Sierra Vista | Arizona | United States | -110.30369 | 31.55454
Buena Park | California | United States | -117.99812 | 33.86751
Irvine | California | United States | -117.82311 | 33.66946
Long Beach | California | United States | -118.18923 | 33.76696
Roseville | C... | 0 | NCT00817635 |
[
5
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery. | null | Breast Neoplasms | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Caelyx will be administered intravenously at a dose of 40 mg/m\^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses \>=90 mg). | intervention 1: Caelyx (pegylated liposomal doxorubicin; SCH 200746) | 0 | null | 0 | NCT00604968 | |
[
3
] | 69 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | null | The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothes... | null | MDS Myelodysplastic Syndromes Thrombocytopenia | MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia | null | 5 | arm 1: 500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 2: 750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles arm 3: 750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 4: Placebo weekly via subcutaneous inj... | [
1,
1,
1,
2,
2
] | 4 | [
0,
2,
0,
0
] | intervention 1: Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period. intervention 2: AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle... | intervention 1: Placebo intervention 2: AMG 531 (Romiplostim) intervention 3: Azacitidine intervention 4: Decitabine | 0 | null | 0 | NCT00321711 |
[
4
] | 108 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis. | null | Migraine | null | 3 | arm 1: Treatment Sequence A: rizatriptan, rizatriptan, placebo arm 2: Sequence B: rizatriptan, placebo, rizatriptan arm 3: Sequence C: placebo, rizatriptan, rizatriptan | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack intervention 2: Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack | intervention 1: rizatriptan benzoate intervention 2: Comparator: placebo | 0 | null | 1 | NCT00812006 | |
[
4
] | 517 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: Sitagliptin phosphate (+) metformin hydrochloride arm 2: pioglitazone | [
0,
1
] | 2 | [
0,
0
] | intervention 1: sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period intervention 2: pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period. | intervention 1: sitagliptin phosphate (+) metformin hydrochloride intervention 2: Comparator: pioglitazone | 0 | null | 0 | NCT00532935 | |
[
4
] | 314 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400m... | null | Rheumatoid Arthritis | RA | null | 8 | arm 1: Participants received matching placebo:
* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group) arm 2: Participants received Ocreliz... | [
2,
0,
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Oral or parenteral repeating dose intervention 2: Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).
Ocrelizumab was administered in combination with Methotrexate. intervention 3: ... | intervention 1: Methotrexate intervention 2: Ocrelizumab intervention 3: Placebo | 0 | null | 0 | NCT00673920 |
[
5
] | 50 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD). | Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improve... | Huntington's Disease | null | 2 | arm 1: Memantine 10 mg BID for three months arm 2: Placebo 10 mg BID for three months | [
0,
2
] | 1 | [
0
] | intervention 1: 10 mg BID x 3 months | intervention 1: Memantine | 3 | La Jolla | California | United States | -117.2742 | 32.84727
Kansas City | Kansas | United States | -94.62746 | 39.11417
Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00652457 | |
[
3
] | 394 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated ... | null | Diabetes Mellitus Type 2 | null | 6 | arm 1: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.
During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal toleranc... | [
2,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: po daily for 12 weeks intervention 2: 2.5mg po daily for 12 weeks intervention 3: 5mg po daily for 12 weeks intervention 4: 10mg po daily for 12 weeks intervention 5: 20mg po daily for 12 weeks intervention 6: 40mg po daily for 12 weeks | intervention 1: Placebo intervention 2: RO4998452 intervention 3: RO4998452 intervention 4: RO4998452 intervention 5: RO4998452 intervention 6: RO4998452 | 67 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Palm Springs | California | United States | -116.54529 | 33.8303
Bradenton | Florida | United States | -82.57482 | 27.49893
Jacksonville | Florida | United States | -81.65565 | 30.33218
Atlanta | G... | 0 | NCT00800176 | |
[
5
] | 608 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin | null | Diabetes Mellitus | null | 1 | arm 1: Sitagliptin | [
0
] | 1 | [
0
] | intervention 1: Sitagliptin 100 mg/day - tablet for 24 weeks | intervention 1: sitagliptin phosphate | 0 | null | 1 | NCT00833027 | |
[
3
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine/ cisplatin/ trastuzumab or gemcitabine/ trastuzumab. | Rationale: Previous studies have demonstrated the anti-tumor efficacy of gemcitabine and trastuzumab against metastatic breast cancer when given alone and in combination. Yet, research indicates that the two drugs given together work more effectively than either alone. Laboratory studies testing the combination of tras... | Breast Cancer | metastatic | null | 2 | arm 1: Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of c... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 1000 mg/m2 IV over 30 minutes on Days 1 and 8. intervention 2: 2 mg/kg IV on days 1, 8 and 15. If Trastuzumab has not been administered within the 3 weeks before starting this treatment, the first dose of Trastuzumab given on Cycle 1, Day 1 will be 4 mg/kg followed by 2 mg/kg weekly. intervention 3: 30 ... | intervention 1: Gemcitabine intervention 2: Trastuzumab intervention 3: Cisplatin | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00201760 |
[
4
] | 1,864 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if n... | Antiretroviral (ARV) treatment regimens consisting of EFV and two NRTIs are the most commonly prescribed regimens for the initial therapy of HIV-infected people in the United States. Such regimens are popular because the drugs are easy to administer, have overall excellent efficacy, and are well tolerated. However, bec... | HIV Infections | Treatment Naive | null | 4 | arm 1: Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks arm 2: Participants will receive EFV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks arm 3: Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks arm 4: Participants will rece... | [
0,
0,
0,
0
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 600 mg abacavir/300 mg lamivudine tablet taken orally daily intervention 2: 300 mg tablet taken orally daily intervention 3: 600 mg tablet taken orally daily intervention 4: 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily intervention 5: 100 mg tablet taken orally dai... | intervention 1: Abacavir/Lamivudine intervention 2: Atazanavir intervention 3: Efavirenz intervention 4: Emtricitabine/Tenofovir disoproxil fumarate intervention 5: Ritonavir intervention 6: Abacavir/Lamivudine placebo intervention 7: Emtricitabine/Tenofovir disoproxil fumarate placebo | 52 | Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.774... | 1 | NCT00118898 |
[
5
] | 305 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus thera... | null | Kidney Transplantation | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1.0-1.5 g oral dose twice daily intervention 2: As prescribed intervention 3: As prescribed intervention 4: As prescribed | intervention 1: mycophenolate mofetil [CellCept] intervention 2: Corticosteroids intervention 3: Calcineurin inhibitors intervention 4: Sirolimus | 36 | Bakersfield | California | United States | -119.01871 | 35.37329
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
Riverside | California | United States | -117.39616 | 33.95335... | 1 | NCT00121810 | |
[
4
] | 1,869 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine. | Patients from 6 feeder trials could be eligible to enter current study CLDT600A2303 ( NCT00142298) if they met inclusion/exclusion criteria. The feeder studies were as follows:
* CLDT600A2302 (NV-02B-007)(NCT00057265), the GLOBE study, was a Phase III, randomized, doubleblind,multi-center, 104-week, pivotal study of t... | Chronic Hepatitis B | null | 1 | arm 1: telbivudine 600 mg p.o. daily for 104 weeks. | [
0
] | 1 | [
0
] | intervention 1: Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regim... | intervention 1: Telbivudine (LdT) | 39 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
Sacramento | California | United States | -121.4944 | 38.58157
San Die... | 0 | NCT00142298 | |
[
4
] | 2,456 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3. | null | Osteoporosis | Osteoporosis, Zoledronic Acid | null | 3 | arm 1: Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment. arm 2: Patients who were treated with Zoled... | [
0,
2,
0
] | 2 | [
0,
0
] | intervention 1: Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion. intervention 2: 100 mL physiologic 0.9% normal saline for intravenous infusion. | intervention 1: Zoledronic Acid intervention 2: Placebo | 31 | Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Beverly Hills | California | United States | -118.40036 | 34.07362
San Diego | California | United States | -117.16472 | 32.71571
Walnut Creek | California | United States | -122.06496 | 37.90631
Lakew... | 0 | NCT00145327 |
[
4
] | 587 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone.
Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the ... | null | Multiple Myeloma | null | 1 | arm 1: Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dos... | [
0
] | 2 | [
0,
0
] | intervention 1: Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles. intervention 2: Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycl... | intervention 1: Lenalidomide intervention 2: Dexamethasone | 5 | South Brisbane | N/A | Australia | 153.02049 | -27.48034
Vienna | Montlearstrasse 37 | Austria | 16.37208 | 48.20849
Dublin | N/A | Ireland | -6.24889 | 53.33306
Salamanca | N/A | Spain | -3.67975 | 40.42972
London | N/A | United Kingdom | -0.12574 | 51.50853 | 1 | NCT00420849 | |
[
5
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis. | The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin. | Psoriasis | Psoriasis | null | 2 | arm 1: Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. arm 2: Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Etanercept 50 mg QW initiated during taper of ciclosporin intervention 2: Randomized to placebo during taper of ciclosporin | intervention 1: Etanercept intervention 2: Placebo | 0 | null | 1 | NCT00581555 |
[
3
] | 59 | RANDOMIZED | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. This study will also characterize the pharmacokinetic profile of DVS SR in children and adole... | null | Depression Major Depressive Disorder | MDD Child Adolescent Pharmacokinetic Outpatient Pediatrics Depressive Disorder Major | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks. | intervention 1: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) | 9 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
North Miami | Florida | United States | -80.18671 | 25.89009
Terre Haute | Indiana | United States | -87.41391 | 39.4667
Wichita | Kansas | United States | -97.33754 | 37.69224
New Orleans | Louisiana | United States | -90.07507 | 29.95465
New York | New Yor... | 1 | NCT00619619 |
[
4
] | 286 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current tradition... | null | Rheumatoid Arthritis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 8mg/kg iv every 4 weeks | intervention 1: Tocilizumab | 81 | Aachen | N/A | Germany | 6.08342 | 50.77664
Bad Abbach | N/A | Germany | 12.04494 | 48.93754
Bad Aibling | N/A | Germany | 12.01055 | 47.8638
Bad Bramstedt | N/A | Germany | 9.88243 | 53.91827
Bad Nauheim | N/A | Germany | 8.73859 | 50.36463
Baden-Baden | N/A | Germany | 8.23975 | 48.7606
Bayreuth | N/A | Germany | 11.... | 1 | NCT00754559 | |
[
4
] | 437 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks. | null | Depressive Disorder, Major | Major Depressive Disorder | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
6
] | intervention 1: 50 mg/day oral tablet for 12 weeks intervention 2: CYP2D6 genotyping at randomization | intervention 1: desvenlafaxine succinate sustained release intervention 2: Genotyping | 0 | null | 1 | NCT00824291 |
[
4
] | 561 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-... | null | Chronic Obstructive Pulmonary Disease | COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease | null | 3 | arm 1: Aclidinium bromide dose, inhaled, for 12 weeks of treatment arm 2: Aclidinium bromide dose, inhaled, for 12 weeks of treatment arm 3: Inhaled placebo for 12 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment intervention 2: Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment intervention 3: Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment | intervention 1: Aclidinium bromide intervention 2: Aclidinium bromide intervention 3: Placebo | 112 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Jasper | Alabama | United States | -87.27751 | 33.83122
Mobile | Alabama | United States | -88.04305 | 30.69436
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States |... | 1 | NCT00891462 |
[
3
] | 62 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating p... | OBJECTIVES:
* Evaluate the overall survival and progression-free survival in patients with stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant paclitaxel and carboplatin.
* Estimate the perce... | Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma fallopian tube cancer peritoneal cavity cancer | null | 1 | arm 1: neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel) | [
0
] | 3 | [
0,
0,
3
] | intervention 1: pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles intervention 2: pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles intervention 3... | intervention 1: carboplatin intervention 2: paclitaxel intervention 3: debulking surgery | 0 | null | 0 | NCT00008138 |
[
3
] | 50 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will examine the safety and effectiveness of treating adrenocortical cancer with combination chemotherapy using doxorubicin, vincristine, and etoposide in addition to the drugs mitotane and tariquidar and, when possible, surgery. Adrenocortical cancer cells have a large amount of a protein called P-glycoprot... | Adrenocortical cancer (ACC) is a rare tumor that is optimally treated with surgical resection. However, many patients present with unresectable disease and relapses are common after surgical resection creating a need for more effective systemic therapies. Several investigators have reported responses to a variety of ch... | Adrenal Cortex Neoplasms | P-glycoprotein Inhibition Drug Resistance Reversal Pharmacodynamics Molecular Target Endocrine Cancer Adrenocortical Cancer ACC Adrenocortical Tumor | null | 1 | arm 1: Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.
Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m\^2 continuous intravenous infusion doxorubicin o... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: XR9576 (Tariquidar) | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00071058 |
[
4
] | 124 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder. | The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatm... | Obsessive-Compulsive Disorder | Child Adolescent | null | 3 | arm 1: Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist. arm 2: Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of t... | [
0,
0,
1
] | 3 | [
0,
5,
5
] | intervention 1: Participants are maintained on their optimized dose of SRI for OCD symptoms (see "Other Names" section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat ind... | intervention 1: Serotonin reuptake inhibitors management intervention 2: Cognitive behavioral therapy by a psychologist intervention 3: Instructional cognitive behavioral therapy by a psychiatrist | 3 | Durham | North Carolina | United States | -78.89862 | 35.99403
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Providence | Rhode Island | United States | -71.41283 | 41.82399 | 0 | NCT00074815 |
[
2,
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. This phase I/II t... | PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) of R115777 administered concurrently with radiation therapy to pediatric patients with non-disseminated, diffuse, intrinsic brainstem gliomas who are not receiving enzyme-inducing anti-convulsant drugs (EIACD).
II. To assess the efficacy of R115777 t... | Untreated Childhood Brain Stem Glioma | null | 1 | arm 1: PHASE I: Patients undergo radiotherapy 5 days a week for 6 weeks. Beginning 0-2 days before radiotherapy, patients receive oral tipifarnib twice daily until the completion of radiotherapy. Beginning 2 weeks after the completion of radiotherapy, patients receive oral tipifarnib twice daily in weeks 1-3. Treatment... | [
0
] | 2 | [
4,
0
] | intervention 1: Undergo radiotherapy intervention 2: Given orally | intervention 1: radiation therapy intervention 2: tipifarnib | 1 | Memphis | Tennessee | United States | -90.04898 | 35.14953 | 0 | NCT00079339 | |
[
4
] | 115 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance. | Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepre... | Parkinson Disease Depression | Parkinson disease depression Parkinson's disease paroxetine venlafaxine antidepressant | null | 3 | arm 1: Paroxetine and venlafaxine will be compared to placebo over 12 weeks. arm 2: Paroxetine and venlafaxine will be compared to placebo over 12 weeks. arm 3: Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | [
1,
1,
2
] | 3 | [
0,
0,
10
] | intervention 1: Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 ... | intervention 1: paroxetine intervention 2: venlafaxine intervention 3: placebo | 18 | San Francisco | California | United States | -122.41942 | 37.77493
Gainesville | Florida | United States | -82.32483 | 29.65163
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Georgia | United States | -84.38798 | 33.749
Lexington | Kentucky | United States | -84.47772 | 37.98869
Baltimore | Maryland |... | 0 | NCT00086190 |
[
3
] | 175 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir/ritonavir (LPV/r) will also be studied.
S... | A single dose of nevirapine (SD-NVP) given to an HIV infected pregnant woman in labor followed by a single dose to her infant had been shown to be a simple and effective means of reducing mother-to-child transmission (MTCT) of HIV among women who had not received antiretroviral (ART) during pregnancy. However, developm... | HIV Infections | HIV Seronegativity Treatment Naive Pregnancy Perinatal Transmission Vertical Transmission Mother-To-Child Transmission MTCT | null | 3 | arm 1: NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and BID for 7 days postpartum, ddI 250 mg orally daily (if body weight \<60 kg) or 400 mg orally twice daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum,... | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: once daily intervention 2: twice daily intervention 3: single-dose at the onset of labor intervention 4: twice daily | intervention 1: Didanosine, enteric-coated intervention 2: Lopinavir/ritonavir intervention 3: Nevirapine intervention 4: Zidovudine | 7 | Saimai | Bangkok | Thailand | N/A | N/A
Bangkok | Bangkoknoi | Thailand | 100.50144 | 13.75398
Chanthaburi | N/A | Thailand | 102.10447 | 12.60961
Chiang Mai | N/A | Thailand | 98.98468 | 18.79038
Chiangrai | N/A | Thailand | N/A | N/A
Chon Buri | N/A | Thailand | 100.98345 | 13.3622
Phayao | N/A | Thailand | 99.87883 ... | 0 | NCT00109590 |
[
4
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will determine the effects of omega-3 fatty acid (FA) augmentation of sertraline on depression and cardiac endpoints after myocardial infarction (MI). | BACKGROUND:
Depression is a risk factor for morbidity and mortality following an acute MI and unstable angina. Two recent studies (sertraline versus placebo and sertraline plus cognitive therapy versus usual care) reported only modest reductions in depression following an acute MI or unstable angina, and many treated ... | Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Sertraline (50 mgs) plus omega-3 (2 grams) intervention 2: Sertraline (50 mgs) plus corn oil (2 grams) (placebo) | intervention 1: Sertraline/omega-3 intervention 2: Sertraline/Corn Oil | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00116857 | |
[
3,
4
] | 57 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.
The study was terminated when all ongoing participants had been treated for at least 5 years. | Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.
The data include data from the participants who participated in both the main study (FE200486 CS... | Prostate Cancer | Prostate Cancer Androgen ablation therapy | null | 2 | arm 1: Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. arm 2: Participants who completed the CS14 study in the Degarelix 80 mg (20 mg... | [
0,
0
] | 1 | [
0
] | intervention 1: Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study. | intervention 1: Degarelix | 22 | Homewood | Alabama | United States | -86.80082 | 33.47177
Anaheim | California | United States | -117.9145 | 33.83529
Tarzana | California | United States | -118.55397 | 34.17334
Torrance | California | United States | -118.34063 | 33.83585
Denver | Colorado | United States | -104.9847 | 39.73915
Aventura | Florida | U... | 0 | NCT00117286 |
[
2
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Neurologic complications secondary to cerebrovascular damage are prevalent in children with sickle cell disease. These patients experience both clinically overt cerebrovascular accidents and "silent infarctions" demonstrated by magnetic resonance imaging (MRI). They are also at risk for neurocognitive abnormalities.We ... | The trial's primary objective is to evaluate the safety and tolerability of daily low-dose aspirin in children with sickle cell disease. The secondary objectives are to assess (1) The feasibility of recruiting children with Hgb SS and Hgb S Beta-0 Thalassemia to an aspirin trial, (2) The level of compliance with aspiri... | Sickle Cell Disease | sickle cell disease hemoglobin SS disease hemoglobin S Beta-0 Thalassemia silent infarction in sickle cell disease overt stroke in sickle cell disease aspirin transcranial Doppler ultrasound neurocognitive testing | null | 1 | arm 1: One-arm study | [
0
] | 1 | [
0
] | intervention 1: 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months. | intervention 1: aspirin | 0 | null | 0 | NCT00178464 |
[
2,
3
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find ou... | Organ transplantation is a common procedure in hospitals, but organ rejection and serious side effects are potential problems for the patient. Mycophenolate mofetil, sirolimus, and tacrolimus are drugs used to decrease immune system activity in people who have received organ transplants so that the new organ will not b... | Kidney Transplantation Kidney Disease Kidney Failure | kidney kidney transplant kidney transplantation transplant transplantation renal renal transplant renal transplantation kidney disease chronic renal failure kidney failure | null | 2 | arm 1: Kidney transplantation, followed by immunotherapy given along with kidney donor Donor bone Bone marrow Marrow stem cell Cells (DBMCs) infusions arm 2: Kidney transplantation, followed by immunotherapy | [
0,
1
] | 6 | [
0,
0,
0,
0,
3,
3
] | intervention 1: Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4 intervention 2: Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study intervention 3: Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or en... | intervention 1: Alemtuzumab intervention 2: Mycophenolate mofetil intervention 3: Sirolimus intervention 4: Tacrolimus intervention 5: Donor bone marrow stem cell infusion intervention 6: Kidney transplant | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00183248 |
[
3
] | 147 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carbopl... | null | Breast Cancer | null | 3 | arm 1: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles. arm 2: gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.
carboplatin: Area Under the Curve (AUC) 2.5, IV, ever... | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles intervention 2: 150 mg/m2, IV, every 14 days x 8 cycles intervention 3: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles intervention 4: 50 mg/m2, IV, every 14 days x 8 cycles | intervention 1: gemcitabine intervention 2: paclitaxel intervention 3: carboplatin intervention 4: cisplatin | 18 | Santo André | N/A | Brazil | -46.53833 | -23.66389
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Beijing | N/A | China | 116.39723 | 39.9075
Hangzhou | N/A | China | 120.16142 | 30.29365
Nanjing | N/A | China | 118.77778 | 32.06167
Wuhan | N/A | China | 114.26667 | 30.58333
Delhi | N/A | India | 77.23149 | 28.65195
K... | 0 | NCT00191854 | |
[
3
] | 49 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated. | null | Non Small Cell Lung Cancer | null | 1 | arm 1: Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles.
Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. | [
0
] | 3 | [
0,
0,
4
] | intervention 1: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) intervention 2: 80 mg/m2, IV, every 21 days x 5 cycles intervention 3: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5 | intervention 1: gemcitabine intervention 2: cisplatin intervention 3: radiation | 8 | Aalst | N/A | Belgium | 4.0355 | 50.93604
Charleroi | N/A | Belgium | 4.44448 | 50.41136
Gilly | N/A | Belgium | 4.4789 | 50.42449
Haine-St.- Paul | N/A | Belgium | N/A | N/A
Herentals | N/A | Belgium | 4.83248 | 51.17655
Mechelen | N/A | Belgium | 4.47762 | 51.02574
Ottignies | N/A | Belgium | 4.56679 | 50.66535
Turnh... | 0 | NCT00192036 | |
[
3
] | 102 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resista... | Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
* Liposomal Doxorubicin
* Docetaxel
For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be e... | Breast Cancer | Breast Cancer | null | 2 | arm 1: Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days. arm 2: Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Liposomal Doxorubicin intervention 2: Docetaxel | intervention 1: Liposomal Doxorubicin intervention 2: Docetaxel | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00193037 |
[
3
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to determine in patients with Non Small Cell Lung Cancer refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy. | While EGFR inhibitors have demonstrated activity against NSCLC \[their integration into first-line therapy in combination with standard agents has yielded disappointing results\]. There are many potential reasons for the disappointing results in these first-line studies \[ A single-arm Phase I trial of cetuximab in com... | Non-small Cell Lung Cancer | Non-small cell lung cancer | null | 2 | arm 1: Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. arm 2: Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Peme... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Cetuximab intervention 2: Pemetrexed | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00203931 |
[
3
] | 120 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan will increase the blood levels of markers responsible for repair of the vessel wall, reduce oxidation and inflammation, improve the function of t... | Atherosclerosis or 'hardening of the arteries' is a process that ultimately leads to the development of heart attacks, strokes, poor circulation, and death. Millions of Americans are affected by this progressive disease of the arteries. Researchers have tried to understand the very complex processes that lead to harden... | Carotid Artery Diseases Atherosclerosis | Angiotensin receptor blockade Oxidative stress Endothelial dysfunction | null | 2 | arm 1: Valsartan titrated up to 320 mg orally daily arm 2: Patients received a placebo instead of Valsartan | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Valsartan was titrated to a target dose of 320 mg orally daily intervention 2: A matched placebo pill will be given orally daily. | intervention 1: Valsartan intervention 2: Placebo | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00208767 |
[
3,
4
] | 137 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | true | This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.
The study was terminated when all ongoing participants had been treated for at least 5 years (in... | Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).
The data include data from the participants who participated in both the main study (FE200486 CS12... | Prostate Cancer | Prostate Cancer Androgen ablation therapy | null | 3 | arm 1: Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL). arm 2: Participants who completed the CS12 study in the Degarelix 120 mg arm continued th... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study. | intervention 1: Degarelix | 34 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A | Belgium | 4.70093 | 50.87959
Berlin | N/A | Germany | 13.41053 | 52.52437
Mannheim | N/A | Germany | 8.46694 | 49.4891
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Győr |... | 0 | NCT00215683 |
[
3
] | 35 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the safety of alemtuzumab after kidney transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and to avoid steroids and chronic use of calcineurin inhibitors in pediatric renal transplant recipients 1 to 20 years of age. | Kidney transplantation is widely considered to be the treatment of choice for children with End Stage Renal Disease (ESRD). Improvements in surgical techniques, donor selection, and immunosuppression practices, as well as the enhanced experience of specialized pediatric transplant teams, have all led to marked improvem... | Kidney Failure, Chronic Kidney Transplantation Immunosuppression | End stage renal disease Kidney transplantation Renal transplantation Kidney failure Pediatric renal transplant recipients Alemtuzumab Campath Mycophenolate mofetil MMF CellCept Tacrolimus Prograf Sirolimus Rapamycin | null | 1 | arm 1: In this open-label, single-arm trial , participants will be administered a 0.3 mg/kg dose of alemtuzumab (Campath) intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants will then receive a maintenance immunosuppressive regimen of tacrolimus and mycophenolate ... | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose. intervention 2: Admi... | intervention 1: Alemtuzumab intervention 2: Tacrolimus intervention 3: Mycophenolate mofetil intervention 4: Sirolimus | 4 | San Francisco | California | United States | -122.41942 | 37.77493
Boston | Massachusetts | United States | -71.05977 | 42.35843
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00240994 |
[
3
] | 87 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise. With fewer insulin producing cells blood glu... | The study is a randomized, two-arm, trial in which 2/3 of participants will receive the study drug, while the remaining 1/3 will receive a placebo (a pretend medicine that does nothing). The group you are assigned to is decided by chance (as by the toss of a coin or drawing straws). Neither you nor your doctor will be ... | Type 1 Diabetes Mellitus | Newly diagnosed type 1 diabetes New Onset type 1 diabetes Preservation of insulin secretion Type 1 diabetes Juvenile Onset Diabetes Insulin Dependent Diabetes T1D | null | 2 | arm 1: Participants will receive active rituximab (anti-CD20 monoclonal antibody) as an intravenous infusion, with 4 administrations at weeks 0, 1, 2, and 3 at a dose of 375mg/m2 arm 2: Participants will receive placebo given as an intravenous infusion with 4 administrations at weeks 0, 1, 2, and 3. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: Placebo intravenous infusion | intervention 1: Anti-CD20 (rituximab) intervention 2: Placebo Comparator | 16 | Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Stanford | California | United States | -122.16608 | 37.42411
Aurora | Colorado | United States | -104.83192 | 39.72943
Gainesville | Florida | United States | -82.32483 | 29.65163
Miami |... | 0 | NCT00279305 |
[
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensiv... | Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other... | Carcinoma, Small Cell Lung Cancer | Extensive stage Relapsed | null | 1 | arm 1: Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. | [
0
] | 1 | [
0
] | intervention 1: 320mg/m2 every 21 days as a 15-20 minute infusion | intervention 1: Vinflunine | 3 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00284154 |
[
3
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose is to assess the response of subjects to etanercept (as compared to placebo) in treating the physical signs of mucosal and cutaneous lichen planus. The investigators also wish to assess the effect of etanercept on disease-related itching, pain, and serious adverse events in patients with lichen planus. | Lichen planus affects up to 1% of the worldwide population. Recent estimates suggest approximately 0.44% of the US population suffers from this disease. Oral or genital involvement occurs in 60-70% of patients, and it may be the sole manifestation of disease in 20-30% of patients.
Lichen planus is a mucocutaneous diso... | Lichen Planus | null | 2 | arm 1: patients receive normal saline injection twice weekly for weeks 1-12 arm 2: patients receive etanercept injection twice weekly for weeks 1-12. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: etanercept 50 mg twice weekly for 12 weeks intervention 2: None | intervention 1: Etanercept intervention 2: Placebo | 12 | Stanford | California | United States | -122.16608 | 37.42411
Atlanta | Georgia | United States | -84.38798 | 33.749
Louisville | Kentucky | United States | -85.75941 | 38.25424
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Ann Arbor | Michigan... | 0 | NCT00285779 | |
[
3
] | 61 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evalua... | Eligible patients will receive treatment with carboplatin and topotecan.
Topotecan 4mg/m2 IV on days 1, 8.
Carboplatin AUC=5 IV day 1 only .
\- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.) | Carcinoma, Small Cell | Lung Cancer Carcinoma, Small Cell | null | 1 | arm 1: Topotecan 4mg/m2 IV on days 1, 8.
Carboplatin AUC=5 IV day 1 only .
\- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.) | [
0
] | 2 | [
0,
0
] | intervention 1: Topotecan 4mg/m2 IV on days 1, 8. intervention 2: Carboplatin AUC=5 IV day 1 only . | intervention 1: Topotecan intervention 2: carboplatin | 16 | Anniston | Alabama | United States | -85.83163 | 33.65983
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Fort Myers | Florida | United States | -81.84059 | 26.62168
Lakeland | Florida | United States | -81.9498 | 28.03947
Gainesville | Georgia | United States | -83.82407 | 34.29788
Bowling Green | Kentucky ... | 0 | NCT00305942 |
[
4
] | 850 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled c... | null | Asthma | Persistent Asthma EXTRA Xolair Difficult Breathing | null | 2 | arm 1: The subcutaneous dose of Xolair administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a... | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP. intervention 2: Placebo was administered by sub... | intervention 1: omalizumab (Xolair) intervention 2: placebo intervention 3: corticosteroids intervention 4: long-acting beta-agonists | 0 | null | 0 | NCT00314574 |
[
3
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks.
Secondary Objectives are to compare the safety and tolerability p... | null | Advanced Breast Cancer | oncology cancer breast cancer | null | 2 | arm 1: ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks arm 2: ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 3.6 mg intramuscular depot injection given every 4 weeks intervention 2: 10.8 mg intramuscular depot injection given every 12 weeks | intervention 1: Goserelin acetate intervention 2: Goserelin acetate | 14 | Prague | N/A | Czechia | 14.42076 | 50.08804
Arkhangelsk | N/A | Russia | 40.55291 | 64.54717
Belgorod | N/A | Russia | 36.58015 | 50.61074
Kaliningarad | N/A | Russia | N/A | N/A
Kazan, Tatarstan | N/A | Russia | N/A | N/A
Moscow | N/A | Russia | 37.61556 | 55.75222
Ryazan | N/A | Russia | 39.6916 | 54.6269
Saint Pete... | 0 | NCT00322348 |
[
3
] | 62 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer | null | Non Small Cell Lung Cancer | null | 1 | arm 1: Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. | [
0
] | 2 | [
0,
0
] | intervention 1: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles intervention 2: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles | intervention 1: pemetrexed intervention 2: carboplatin | 7 | Bobigny | N/A | France | 2.45012 | 48.90982
Brest | N/A | France | -4.48628 | 48.39029
Caen | N/A | France | -0.35912 | 49.18585
Le Mans | N/A | France | 0.20251 | 48.0021
Lille | N/A | France | 3.05858 | 50.63297
Nantes | N/A | France | -1.55336 | 47.21725
Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 | 0 | NCT00350792 | |
[
3
] | 31 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
1\. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater.
Secondary objectives include determining the toxicity, time-to-treatment failu... | Oxaliplatin is a chemotherapy drug designed to destroy cancer cells by interfering with DNA function, which is necessary for growth of new cells.
Capecitabine is a chemotherapy drug designed to destroy cancer cells by interfering with cell division, which is important to the growth of cancer.
You will receive 14 days... | Gastrointestinal Cancer | Gastrointestinal Cancer Small Bowel Cancer Ampulla of Vater Capecitabine Xeloda Oxaliplatin Eloxatin | null | 1 | arm 1: Intravenous Oxaliplatin 130 mg/m\^2, Day 1 + Oral Capecitabine 750 mg/m\^2 twice daily Days 1-14. | [
0
] | 2 | [
0,
0
] | intervention 1: Oral capecitabine 750 mg/m\^2 twice daily (total daily dose 1500 mg/m\^2) on Days 1-14 in 21 Day Cycle. intervention 2: 130 mg/m\^2 by vein Day 1 over 2 hours in 21 Day Cycle | intervention 1: Capecitabine intervention 2: Oxaliplatin | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00354887 |
[
3
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate:
* How bevacizumab, given with chemotherapy before surgery, and then bevacizum... | Initial trials of neoadjuvant chemotherapy administered for locally advanced tumors, including those in breast cancer, demonstrated therapy could induce sufficient tumor regression to allow for the resection of otherwise unresectable tumors. Subsequent demonstration of the equivalence of lumpectomy to mastectomy in pat... | Breast Cancer | NSABP Doxorubicin Cyclophosphamide Bevacizumab Capecitabine Docetaxel Breast cancer Locally advanced Neoadjuvant Locally advanced breast cancer | null | 1 | arm 1: None | [
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles intervention 2: 60 mg/m\^2 IV every 21 days x 4 cycles intervention 3: 600 mg/m\^2 IV every 21 days x 4 cycles intervention 4: F... | intervention 1: Bevacizumab intervention 2: Doxorubicin intervention 3: Cyclophosphamide intervention 4: Capecitabine intervention 5: Docetaxel | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00365417 |
[
5
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | The purpose of this study is to determine whether Lansoprazole 30mg taken twice daily is effective in the treatment of laryngitis due to gastroesophageal reflux. | The investigators propose to study the effect of Lansoprazole 30 mg bid therapy vs. placebo in patients who present with symptoms characteristic of reflux laryngitis. The efficacy of Lansoprazole 30 mg bid in healing and improving reflux laryngitis will be determined. For the purpose of this study, healed reflux laryng... | Laryngopharyngeal Reflux | Gastroesophageal reflux Laryngitis Hoarseness Dysphonia Proton pump inhibitor | null | 2 | arm 1: Lansoprazole 30 mg Twice Daily arm 2: placebo | [
0,
2
] | 2 | [
0,
7
] | intervention 1: Lansoprazole 30mg twice daily intervention 2: placebo twice daily | intervention 1: Lansoprazole intervention 2: Sugar pill | 3 | Detroit | Michigan | United States | -83.04575 | 42.33143
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00369265 |
[
3
] | 136 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment. | null | Metastatic Breast Cancer | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Ixabepilone,16 mg/m\^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if wel... | intervention 1: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg intervention 2: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg intervention 3: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg | 25 | Burbank | California | United States | -118.30897 | 34.18084
La Verne | California | United States | -117.76784 | 34.10084
San Francisco | California | United States | -122.41942 | 37.77493
Iowa City | Iowa | United States | -91.53017 | 41.66113
Columbia | Missouri | United States | -92.33407 | 38.95171
New York | New ... | 0 | NCT00370552 | |
[
3
] | 81 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study. | Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th... | Chronic Renal Failure Chronic Kidney Disease Anemia | anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to ... | intervention 1: peginesatide | 9 | Pine Bluff | Arkansas | United States | -92.0032 | 34.22843
Mountain View | California | United States | -122.08385 | 37.38605
Lauderdale Lakes | Florida | United States | -80.20838 | 26.16647
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Shreveport | Louisiana | United States | -93.75018 | 32.52515
D... | 0 | NCT00372489 |
[
4
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib f... | The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial. | Gastrointestinal Stromal Tumor | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 37.5 mg daily intervention 2: 800mg daily | intervention 1: sunitinib malate intervention 2: imatinib mesylate | 25 | Detroit | Michigan | United States | -83.04575 | 42.33143
Farmington Hills | Michigan | United States | -83.37716 | 42.48531
City of Saint Peters | Missouri | United States | -90.62651 | 38.80033
Creve Coeur | Missouri | United States | -90.42262 | 38.66089
St Louis | Missouri | United States | -90.19789 | 38.62727
Phi... | 0 | NCT00372567 | |
[
5
] | 360 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis | null | Chronic Kidney Disease End Stage Renal Disease Coronary Artery Calcification Vascular Calcification Calcification Cardiovascular Disease Chronic Renal Failure Hyperparathyroidism Kidney Disease Nephrology Secondary Hyperparathyroidism | calcification vascular calcification coronary vascular calcification chronic kidney disease end stage renal disease dialysis | null | 1 | arm 1: Standard of care, without use of cinacalcet. | [
1
] | 1 | [
0
] | intervention 1: Low dose vitamin D with cinacalcet | intervention 1: cinacalcet | 0 | null | 0 | NCT00379899 |
[
5
] | 33 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC). | null | Non-small Cell Lung Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity\* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.
\*Toxicity acceptable if none of ... | intervention 1: pemetrexed | 2 | Taichung | N/A | Taiwan | 120.6839 | 24.1469
Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 0 | NCT00380718 | |
[
3
] | 36 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease... | This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days (Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be evaluated prior to each cycle and % fetal hemoglobin ... | Prostate Cancer | null | 1 | arm 1: azacitidine for injectable suspension | [
0
] | 1 | [
0
] | intervention 1: Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles. | intervention 1: azacitidine for injectable suspension | 13 | Denver | Colorado | United States | -104.9847 | 39.73915
Ocoee | Florida | United States | -81.54396 | 28.56917
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Albany | New York | United States | -73.75623 | 42.65258
Cary | North Carolina | Unite... | 0 | NCT00384839 | |
[
5
] | 407 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin. | null | Diabetic Neuropathy, Painful | null | 3 | arm 1: Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \& Germany) or 150 mg BID (Canada), PO for 10 weeks. arm 2: Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg Q... | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Duloxetine (DLX) once daily (QD), orally (PO) intervention 2: Pregabalin (PGB) orally (PO) intervention 3: Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study) | intervention 1: duloxetine hydrochloride intervention 2: pregabalin intervention 3: gabapentin | 9 | Torrance | California | United States | -118.34063 | 33.83585
Cromwell | Connecticut | United States | -72.64537 | 41.5951
Staten Island | New York | United States | -74.13986 | 40.56233
Greenville | North Carolina | United States | -77.36635 | 35.61266
Midvale | Utah | United States | -111.89994 | 40.61106
Bochum | N/... | 0 | NCT00385671 | |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases. | OBJECTIVES:
Primary
* Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.
Secondary
* Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using the PSA Working Group Criteria, in patients trea... | Metastatic Cancer Pain Prostate Cancer | Tandutinib MLN518 CT53518 pain adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer bone metastases hormone-based castration | null | 1 | arm 1: 500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases. Tandutinib (MLN518) previously known as CT53518. | [
0
] | 1 | [
0
] | intervention 1: 500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle. | intervention 1: Tandutinib | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00390468 |
[
4
] | 293 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in t... | Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in t... | Sepsis | sepsis prevention mineral supplementation | null | 2 | arm 1: metoclopramide, zinc, selenium, and glutamine arm 2: saline, sterile water, whey protein | [
0,
2
] | 8 | [
0,
0,
7,
0,
10,
10,
10,
7
] | intervention 1: 0.2 mg/kg/dose IV every 12 hours intervention 2: one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants \< or equal to one year of age, and 20 mg/day elemental zinc for patients \> 1 year of age) intervention 3: one enteral dose daily of glutamine 0.3 gm/kg/day intervention 4: one... | intervention 1: Metoclopramide intervention 2: Zinc intervention 3: Glutamine intervention 4: Selenium intervention 5: saline intervention 6: sterile water intervention 7: selenium intervention 8: whey-protein | 7 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Detroit | Michigan | United States | -83.04575 | 4... | 0 | NCT00395161 |
[
4
] | 451 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied. | null | Crohn's Disease | null | 3 | arm 1: 4 arms for induction period
2 arms for maintenance period arm 2: 4 arms for induction period
2 arms for maintenance period arm 3: 1 arm for open-label extension phase | [
0,
2,
5
] | 3 | [
0,
0,
0
] | intervention 1: Dextrose 5% in water, intravenous (IV).
Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57;
3 mg/kg on days IP-1, IP-15,IP-29, IP-57;
\~10 mg/kg on days IP-1, IP-15,IP-29, IP-57,
or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57.
Induction Period 3 months
Maintenance Peri... | intervention 1: abatacept intervention 2: placebo intervention 3: abatacept | 101 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Gainesville | Florida | United States | -82.32483 | 29.65163
Jacksonville | Florida | United States | -81.65565 | 30.33218
Winter Pa... | 0 | NCT00406653 | |
[
3
] | 16 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | In this study the influence of zonisamide administration over a 13 week period on alcohol consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of zonisamide given to subjects will be slowly increased over a period of several weeks. They will receive a full dose over a 5 week period. This wil... | null | Alcoholism | Zonisamide Alcoholism Alcohol | null | 1 | arm 1: In open-label non-placebo controlled trial subjects are treatment with zonisamide 400 mg during the maintenance phase of this study | [
0
] | 1 | [
0
] | intervention 1: Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily. | intervention 1: Zonisamide | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00406692 |
[
5
] | 370 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxet... | null | Major Depressive Disorder | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either... | intervention 1: duloxetine hydrochloride intervention 2: placebo | 33 | Pasadena | California | United States | -118.14452 | 34.14778
Sherman Oaks | California | United States | -118.44925 | 34.15112
Hamden | Connecticut | United States | -72.89677 | 41.39593
Coral Springs | Florida | United States | -80.2706 | 26.27119
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Atlan... | 0 | NCT00406848 | |
[
3
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying the side effects and how well giving alvocidib together with cytarabine and mitoxantrone works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cance... | PRIMARY OBJECTIVES:
I. To determine the efficacy and toxicities of flavopiridol (alvocidib) followed by ara-C and mitoxantrone in adults with newly diagnosed acute myelogenous leukemia (AML) with poor-risk features.
II. To determine the disease free and overall survival of patients exhibiting a response to treatment ... | Adult Acute Basophilic Leukemia Adult Acute Eosinophilic Leukemia Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblas... | null | 1 | arm 1: Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Beginning 35-63 days after completion of course 1, patients achieving complete or partial remission may receive a second course of treatment as a... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV | intervention 1: alvocidib intervention 2: cytarabine intervention 3: mitoxantrone hydrochloride | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00407966 | |
[
4
] | 591 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied | The Induction Period First Cohort (IP1C) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. The Induction Period Second Cohort arms (IP2C 30/10 mg/kg and 10 mg/kg) were not placebo-controlled, their sole purpose being to provide sufficient numbers of p... | Ulcerative Colitis | null | 3 | arm 1: Induction Period; 3 arms for Cohort 1: ABA 30/\~10 mg/kg (ABA administered at 30 mg/kg followed by ABA at \~10 mg/kg), ABA \~10 mg/kg, ABA 3 mg/kg
Induction Period; 2 arms for Cohort 2: ABA 30/\~10 mg/kg and Second Cohort ABA \~10 mg/kg
1 arm for maintenance period (ABA \~10 mg/kg) arm 2: 1 arm for induction p... | [
0,
2,
5
] | 3 | [
0,
0,
0
] | intervention 1: Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57 (ABA 30/\~10 mg/kg Group).
Induction Period 3 months
Maintenance Period 12 months ... | intervention 1: abatacept (ABA) intervention 2: placebo intervention 3: abatacept | 143 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Torringto... | 0 | NCT00410410 | |
[
2,
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent ris... | Secondary Hyperparathyroidism in the renal transplant recipient can cause abnormal bone and mineral metabolism, resulting in hypercalcemia that is detrimental to renal function, causing renal dysfunction and calcinosis. These patients often require parathyroidectomy to correct the hypercalcemia. Surgery is not without ... | Secondary Hyperparathyroidism Hypercalcemia | hypercalcemia transplant | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Cinacalcet HCl | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 0 | NCT00415584 |
[
4
] | 336 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks. | null | Chronic Kidney Disease Hyperphosphatemia | Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind intervention 2: 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind intervention 3: Current approved dosing recommendations for 12 weeks | intervention 1: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) intervention 2: Placebo intervention 3: Another phosphate binder (Sevelamer) | 68 | Adelaide | N/A | Australia | 138.59863 | -34.92866
Nedlands | N/A | Australia | 115.8073 | -31.98184
Parkville | N/A | Australia | 144.95 | -37.78333
St Leonards | N/A | Australia | 151.19836 | -33.82344
Sydney | N/A | Australia | 151.20732 | -33.86785
Woolloongabba | N/A | Australia | 153.03655 | -27.48855
Graz | N/A ... | 0 | NCT00416520 |
[
4
] | 34 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
* To assess the efficacy of immediate release methylphenidate, sustained release methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of cognitive functioning in patients with brain tumors. | All three drugs used in this clinical research study are widely used stimulants to help cancer patients who have fatigue and problems with concentration.
Before treatment starts, you will have a physical exam, including measurement of blood pressure, and neuropsychological and symptom evaluations. The neuropsychologic... | Brain Tumor | Brain Tumor Methylphenidate Ritalin Modafinil Provigil Fatigue Concentration | null | 3 | arm 1: 10 mg by mouth (PO) twice daily for 4 Weeks arm 2: 200 mg PO once daily for 4 Weeks arm 3: 18 mg PO once daily for 4 Weeks | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg by mouth (PO) twice daily x 4 Weeks intervention 2: 200 mg PO Once Daily x 4 Weeks intervention 3: 18 mg PO Once Daily x 4 Weeks | intervention 1: IR Methylphenidate intervention 2: Modafinil intervention 3: SR Methylphenidate | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00418691 |
[
4
] | 742 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population. | null | Asthma | Moderate Asthma Severe Asthma | null | 2 | arm 1: Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) arm 2: Budesonide HFA pMDI 160 ug x 2 actuations BID | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) intervention 2: Budesonide HFA pMDI 160 ug x 2 actuations BID | intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Budesonide HFA pMDI | 122 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Muscle Shoals | Alabama | United States | -87.66753 | 34.74481
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas ... | 0 | NCT00419952 |
[
3
] | 81 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group I... | null | Lupus Nephritis | Lupus Nephritis enteric-coated mycophenolate sodium EC-MPS Myfortic | null | 2 | arm 1: Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily fo... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks. intervention 2: Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight. intervention 3: All patients re... | intervention 1: Mycophenolate sodium intervention 2: Prednisone intervention 3: Methylprednisolone | 17 | Bogotá | N/A | Colombia | -74.08175 | 4.60971
Créteil | N/A | France | 2.46569 | 48.79266
Nantes | N/A | France | -1.55336 | 47.21725
Paris | N/A | France | 2.3488 | 48.85341
Berlin | N/A | Germany | 13.41053 | 52.52437
Tübingen | N/A | Germany | 9.05222 | 48.52266
Athens | N/A | Greece | 23.72784 | 37.98376
Budapest |... | 0 | NCT00423098 |
[
3,
4
] | 88 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The hematopoetic cytokine erythropoietin (EPO) has been shown to reduce programmed cell death and tissue destruction in experimental models of acute kidney ischemia-reperfusion injury. Thus, treatment with high dose recombinant human EPO (rHuEPO) may prevent kidney tissue damage and loss of renal function after success... | Erythropoietin (EPO) has pleiotropic effects well beyond the maintenance of red blood cell mass. In the embryo, EPO is a major regulator of vascular formation and organ growth, and EPO receptors are found in almost every embryonic tissue. EPO receptors also exist in many adult tissues including renal tissue, and even t... | Kidney Transplantation | null | 2 | arm 1: Erythropoietin alpha 3 x 40.000 IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation arm 2: Placebo 3x IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Erythropoietin alpha 3 x 40.000 IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation intervention 2: Placebo 3x IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation | intervention 1: Recombinant erythropoietin alpha (rHuEPO alpha) intervention 2: Placebo | 1 | Hanover | N/A | Germany | 9.73322 | 52.37052 | 0 | NCT00425698 | |
[
0
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 2MALE | false | This study is a pilot study to determine whether patients with TNFα excess have decreased calcium absorption in response to calcitriol (1,25-dihydroxyvitamin D, the active form of vitamin D) compared to normal controls. This initial pilot study is being done to determine if it is feasible to conduct a study where TNFα ... | Vitamin D is important for the maintenance of normal calcium homeostasis by improving the efficacy of calcium absorption from the small intestine. The efficacy of calcium absorption is decreased with aging, menopause, and other inflammatory states. Subjects who have low intestinal absorption of calcium are at risk for ... | Rheumatoid Arthritis Crohn's Disease | Calcium absorption Vitamin D | null | 1 | arm 1: Calcitriol 0.25 mcg orally twice a day for 7 days or calcitriol 0.50 mcg orally twice a day for 7 days. | [
0
] | 1 | [
0
] | intervention 1: 0.25 mcg PO BID for 1 week for low dose then 0.25 mcg PO BID for high dose | intervention 1: calcitriol | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00427804 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Primary Objectives:
1. To determine the patient's tumor response rate that this protocol will produce.
2. To determine the 1 year progression-free survival that this protocol will produce.
Secondary Objective:
1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcomin... | GM-CSF stimulates the immune system and may increase the effectiveness of Herceptin.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physic... | Breast Cancer | Breast Cancer Carcinoma of the Breast HER-2/neu Overexpression Herceptin Trastuzumab GM-CSF Sargramostim Leukine | null | 1 | arm 1: Herceptin 4 mg/kg IV Over 90 Minutes + GM-CSF 250 mcg/m\^2 subcutaneously | [
0
] | 2 | [
0,
0
] | intervention 1: 4 mg/kg IV Over 90 Minutes intervention 2: 250 mcg/m\^2 Subcutaneously | intervention 1: Herceptin intervention 2: GM-CSF | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00429104 |
[
3
] | 7 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 3TRIPLE | false | 0ALL | true | RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in treating nausea and vomiting caused by chemotherapy.
PURPO... | OBJECTIVES:
Primary
* Compare the degree of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients with newly diagnosed cancer treated with diphenhydramine hydrochloride, lorazepam, and dexamethasone vs standard antiemetic therapy during the first course of emetogenic chemotherapy.
Secondary
* Compar... | Nausea Vomiting Unspecified Childhood Solid Tumor, Protocol Specific | nausea vomiting emetic chemotherapy unspecified childhood solid tumor, protocol specific | null | 2 | arm 1: Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump. arm 2: Patients receive ondansetron hydrochloride IV twice... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV | intervention 1: Decadron® intervention 2: Benadryl® intervention 3: Ativan® intervention 4: ondansetron hydrochloride | 7 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Orlando | Florida | United States | -81.37924 | 28.53834
Tampa | Florida | United States | -82.45843 | 27.94752
Jackson | Mississippi | United States | -90.18481 | 32.29876
Nashville | Tennessee | United States | -86.78444 | 36.16589
San Antonio | Texas | Unit... | 0 | NCT00429702 |
[
5
] | 263 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa. | Azithromycin is an antibiotic that has been shown to improve lung function in patients with cystic fibrosis (CF) whose lungs are infected with a bacterium called Pseudomonas aeruginosa. Scientists are not sure how azithromycin works in cystic fibrosis. It does not appear to work by killing the bacteria Pseudomonas aeru... | Cystic Fibrosis | azithromycin, Zithromax | null | 2 | arm 1: azithromycin 250 mg tablets arm 2: placebo tablets (matched to active drug in appearance) | [
1,
2
] | 2 | [
0,
0
] | intervention 1: * One (1) tablet three times weekly for patients who weigh 40-79 lbs
* Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs intervention 2: * One (1) tablet three times weekly for patients who weigh 40-79 lbs
* Two (2) tablets three times weekly for patients who weig... | intervention 1: azithromycin 250 mg tablets intervention 2: placebo tablets | 40 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Hartford | Connecticut | United States | -72.68509 | 41.76371
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lexington | Kentucky | Un... | 0 | NCT00431964 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will determine the safety and effectiveness of an experimental vaccine in controlling the abnormal growth of cells in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML). It will test ... | Leukemias and the related disorders myelodysplastic syndrome and myeloproliferative diseases represent a wide group of bone marrow stem cell malignancies. Some patients can be cured with chemotherapy or by allogeneic stem cell transplantation. However, standard treatment approaches are not effective for patients who be... | Myelodysplastic Syndrome Acute Myeloid Leukemia (AML) Chronic Myeloid Leukemia (CML) | Myelodysplastic Syndrome (MDS) Acute Myelogenous Leukemia (AML) Chronic Myelogenous Leukemia (CML) Acute Lymphoblastic Leukemia (ALL) Wilm's Tumor-1 Peptide Leukemia Myelodysplastic Syndrome MDS Acute Myelogenous Leukemia AML Chronic Myelogenous Leukemia CML Acute Lymphoblastic Leukemia ALL | null | 1 | arm 1: WT1 vaccination (9 doses of WT-1:126-134 peptide (in Montanide adjuvant) administered concomitantly with GM-CSF (Sargramostim) | [
0
] | 1 | [
0
] | intervention 1: WT1 vaccination (9 doses of WT-1:126-134 peptide (in Montanide adjuvant) administered concomitantly with GM-CSF (Sargramostim) | intervention 1: WT1 Peptide Vaccine | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00433745 |
[
2
] | 16 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse tra... | null | HIV Infections | Treatment Naive | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 100mg po bid intervention 2: 1000mg po bid | intervention 1: Ritonavir intervention 2: saquinavir [Invirase] | 8 | Chicago | Illinois | United States | -87.65005 | 41.85003
Somers Point | New Jersey | United States | -74.5946 | 39.31762
Voorhees Township | New Jersey | United States | -74.49062 | 40.4795
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Dallas | Texas | United States | -96.80667 | 32.78306
Ottawa |... | 0 | NCT00435929 |
[
2,
3
] | 92 | RANDOMIZED | FACTORIAL | 1PREVENTION | 4QUADRUPLE | true | 0ALL | true | The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes. | There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effe... | Glucose Intolerance Type 2 Diabetes Mellitus Metabolic Syndrome | Glucose intolerance Type 2 diabetes mellitus Metabolic syndrome | null | 4 | arm 1: Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily arm 2: Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily arm 3: Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily arm 4: Vitamin D3-Placebo plus Calcium-Placebo | [
5,
5,
5,
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: Vitamin D3 2,000 IU orally once daily intervention 2: Calcium Carbonate 400 mg orally twice daily intervention 3: Vitamin D3-Placebo intervention 4: Calcium-Placebo | intervention 1: Vitamin D3 2,000 IU orally once daily intervention 2: Calcium Carbonate 400 mg orally twice daily intervention 3: Vitamin D3-Placebo intervention 4: Calcium-Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00436475 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2\* in beta-thalassemia patients with deferasirox treatment. | null | Beta-thalassemia Iron Overload | Iron Chelation Deferasirox Chelator Desferal beta-thalassemia Iron overload | null | 1 | arm 1: Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For ... | [
0
] | 1 | [
0
] | intervention 1: Oral deferasirox 30mg/kg/day once per day for 77 weeks. | intervention 1: Deferasirox | 3 | Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00447694 |
[
3
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders. | Autism is increasingly being recognized as a common disorder with enormous public health significance. The core symptoms of autism include severe deficits in social relatedness and communication, and interfering repetitive behavior. No medications have been shown to consistently improve any of these symptoms.
The cent... | Autistic Disorder Asperger Syndrome Child Development Disorders, Pervasive | Autistic Disorder Asperger's PDD NOS Pervasive Developmental Disorder Autism N-acetylcysteine acetylcysteine NAC antioxidant treatment core symptoms Autism Spectrum Disorders Asperger's Disorder Pervasive Developmental Disorder Not Otherwise Specified Pervasive Developmental Disorders | null | 2 | arm 1: Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths. arm 2: Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be ... | intervention 1: N-acetylcysteine intervention 2: Placebo | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00453180 |
[
3
] | 106 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen. | null | Colorectal Cancer | Colon Cancer Rectal Cancer | null | 3 | arm 1: FOLFIRI + placebo vandetanib arm 2: FOLFIRI + low dose vandetanib arm 3: FOLFIRI + high dose vandetanib | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: once daily oral tablet two doses intervention 2: Intravenous infusion | intervention 1: Vandetanib intervention 2: FOLFIRI | 21 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756
New York | New York | United States | -74.00597 | 40.71427
Nashville | Tennessee | United States | -86.78444 | 36.16589
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Ramos Mejía | N/A | Arg... | 0 | NCT00454116 |
[
0
] | 13 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale.
(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.
T... | Aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. Multiple clinical trials in both children and adults have shown the effectiveness in the treatment of autism with medications like Aripiprazole. This study aims at assessing the effect of aripi... | Autism | Aggression Irritability Global autism severity | null | 2 | arm 1: Subjects in the experimental group will receive Aripiprazole arm 2: Subjects in the control group will receive sugar pill | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects under 40 kg will be started on 2.5mg per day of aripiprazole for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medicat... | intervention 1: Aripiprazole intervention 2: Placebos | 1 | Piscataway | New Jersey | United States | -74.39904 | 40.49927 | 0 | NCT00468130 |
[
3
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma. | null | Multiple Myeloma | Avastin AMBER Myeloma Velcade | null | 2 | arm 1: Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase.... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 15 mg/kg administered by intravenous infusion intervention 2: 1.3 mg/m\^2 administered by intravenous bolus injection intervention 3: Intravenous repeating dose | intervention 1: Bevacizumab intervention 2: Bortezomib intervention 3: placebo | 0 | null | 0 | NCT00473590 |
[
5
] | 93 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 1FEMALE | false | This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation \& evacuation (D\&E) compared to delayed insertion 3-6 weeks post-D\&E. Eighty-eight women undergoing D\&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at M... | The D\&E will be performed in the usual fashion. The uterus will be sounded to the fundus. Once the D\&E is complete, the investigator or co-investigator will check the post-enrollment exclusion criteria to ensure that no events during the D\&E made the subject ineligible. If the subject remains eligible, the randomiza... | Contraceptive Usage | levonorgestrel IUD IUD dilation and evacuation contraception | null | 2 | arm 1: Levonorgestrel IUD will be inserted immediately after completion of D\&E arm 2: Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D\&E procedure) | [
0,
1
] | 1 | [
0
] | intervention 1: intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem | intervention 1: Levonorgestrel IUD | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00475228 |
[
4
] | 397 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational ... | null | Macular Edema Retinal Vein Occlusion | Lucentis RVO BRVO Edema | null | 3 | arm 1: None arm 2: None arm 3: None | [
3,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 2: Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention... | intervention 1: Ranibizumab injection 0.3 mg intervention 2: Ranibizumab injection 0.5 mg intervention 3: Sham injection | 0 | null | 0 | NCT00486018 |
[
3
] | 14 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC. | Primary objective
To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.
Secondary Objectives
To evaluate the safety and adverse event profile of the combination of paclitaxel po... | Advanced Non-small Cell Lung Cancer | paclitaxel poliglumex xyotax alimta advanced non-small cell lung cancer | null | 1 | arm 1: The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur prov... | [
0
] | 1 | [
0
] | intervention 1: The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can o... | intervention 1: paclitaxel poliglumex, pemetrexed | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 0 | NCT00487669 |
[
3
] | 42 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) no... | Patients will have blood and bone marrow tests performed as well as chest and sinus X-rays and tests of their heart and lung function. Approximately 5 tablespoons of blood will be drawn.
All patients in this study will receive imatinib mesylate by mouth for 9 days, unless the patient is known to be allergic or have sy... | Leukemia | Chronic Myelogenous Leukemia Allogeneic Stem Cell Transplantation Leukemia Imatinib Mesylate Gleevec Busulfan Busulfex Myleran Fludarabine ATG STI571 Antithymocyte Globulin Thymoglobulin | null | 1 | arm 1: Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 an... | [
0
] | 8 | [
0,
0,
0,
0,
0,
0,
3,
3
] | intervention 1: 400 mg by mouth twice daily for 9 Days intervention 2: 40 mg/m\^2 by vein daily for 4 Days intervention 3: 130 mg/m\^2 by vein daily for 2 Days intervention 4: 2.5 mg/kg by vein daily for 3 Days intervention 5: Tacrolimus levels maintained between 5-15 ng/dl, first as continuous IV infusion, and convert... | intervention 1: Imatinib Mesylate intervention 2: Fludarabine (Fludara) intervention 3: Busulfan intervention 4: Antithymocyte Globulin (ATG) intervention 5: Tacrolimus intervention 6: Methotrexate intervention 7: Donor lymphocyte infusion (DLI) intervention 8: Stem Cell Transplant | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00499889 |
[
3
] | 32 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of... | This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avas... | Glioblastoma Multiforme | Glioblastoma Multiforme Brain and Central Nervous System Tumors Recurrent Malignant Glioma Recurrent Glioblastoma Multiforme Avastin Bevacizumab Temodar Temozolomide | null | 1 | arm 1: Patients will receive up to 12 cycles of bevacizumab (Avastin) and metronomic temozolomide (Temodar), and each cycle is 28 days. Bevacizumab will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily i... | [
0
] | 2 | [
0,
0
] | intervention 1: Bevacizumab administered intravenously 10mg/kg every other week. intervention 2: Temozolomide 50mg/m2 given orally on a daily basis. | intervention 1: Bevacizumab intervention 2: Metronomic Temozolomide | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00501891 |
[
3
] | 27 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | Primary Objectives:
1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
3. To evaluate the impact of so... | Campath is a drug that can specifically attack some types of T-cell lymphoma cells.
Before the study begins, you will have a physical exam, including blood (about 2 tablespoons) and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. To collect... | Lymphoma | T-Cell Lymphoma Lymphoma Campath-1H Allogenic Transplantation Stem Cell Transplant Alemtuzumab | null | 1 | arm 1: 3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide... | [
0
] | 13 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
4
] | intervention 1: 3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment. intervention 2: 10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization. intervention 3: 250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization. interventio... | intervention 1: Campath-1H intervention 2: G-CSF intervention 3: GM-CSF intervention 4: BCNU intervention 5: Stem Cell Transplant intervention 6: Preparative Regimen for Allogenic Stem Cell Transplantation intervention 7: Cytarabine intervention 8: Etoposide intervention 9: Melphalan intervention 10: Campath interventi... | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00505921 |
[
4
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin al... | null | Anemia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels. | intervention 1: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) | 14 | Danderyd | N/A | Sweden | 18.02376 | 59.40398
Eksjö | N/A | Sweden | 14.97205 | 57.66643
Eskilstuna | N/A | Sweden | 16.5077 | 59.36661
Gävle | N/A | Sweden | 17.14174 | 60.67452
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Huddinge | N/A | Sweden | 17.98192 | 59.23705... | 0 | NCT00517881 | |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-... | OBJECTIVES:
Primary
* Estimate the objective response rate in patients receiving vinflunine and cetuximab as second-line therapy for stage IIIB or IV non-small cell lung cancer.
Secondary
* Determine the progression-free survival of patients treated with this regimen.
* Determine the safety of this regimen in these... | Lung Cancer | stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer | null | 1 | arm 1: Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the princip... | [
0
] | 2 | [
2,
0
] | intervention 1: 400 mg/m² week 1,then 250 mg/m² weekly intervention 2: Vinflunine 320 mg/m² every 21 days | intervention 1: cetuximab intervention 2: vinflunine | 2 | Burlington | North Carolina | United States | -79.4378 | 36.09569
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00519831 |
[
4
] | 567 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, durin... | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose... | Chronic Pain Osteoarthritis of the Knee | Chronic pain, OA of the knee, opioid, transdermal | null | 2 | arm 1: Buprenorphine transdermal system 10 and 20 applied for 7-day wear arm 2: Placebo transdermal system to match BTDS patches, applied for 7-day wear | [
0,
2
] | 2 | [
0,
0
] | intervention 1: transdermal system 10 and 20 applied for 7-day wear intervention 2: transdermal system (placebo) applied for 7-day wear | intervention 1: Buprenorphine intervention 2: Placebo | 87 | Mobile | Alabama | United States | -88.04305 | 30.69436
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United S... | 0 | NCT00531427 |
[
4
] | 671 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg... | null | Hepatitis B, Chronic | null | 3 | arm 1: PegIntron 1.0 mcg/kg weekly (QW) \* 24 weeks + 24 weeks follow-up arm 2: PegIntron 1.5 mcg/kg QW \* 24 wks + 24 wks follow-up arm 3: PegIntron 1.5 mcg/kg QW \* 48 wks + 24 wks follow-up | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks intervention 2: 1.5 mcg/kg S.C. QW for 24 weeks intervention 3: 1.5 mcg/kg S.C. QW for 48 weeks | intervention 1: pegylated interferon alpha-2b intervention 2: pegylated interferon alpha-2b intervention 3: pegylated interferon alpha-2b | 0 | null | 0 | NCT00536263 | |
[
3
] | 131 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | true | The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to 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 grows and spreads... | This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives) study of intetumumab in combination with docetaxel and predni... | Prostatic Neoplasms | Prostatic neoplasms CNTO 95 Intetumumab Docetaxel Prednisone | null | 2 | arm 1: Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m\^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered... | [
1,
0
] | 4 | [
0,
0,
2,
0
] | intervention 1: Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks. intervention 2: Prednisone 5 mg orally twice daily. intervention 3: Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks. intervention 4: Placebo matching to intetumumab, as intravenous infusion every ... | intervention 1: Docetaxel intervention 2: Prednisone intervention 3: Intetumumab intervention 4: Placebo | 59 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Bernardino | California | United States | -117.28977 | 34.10834
Wichita | Kansas | United States | -97.33754 | 37.69224
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Charlesto... | 0 | NCT00537381 |
[
0
] | 25 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | false | We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra ... | Patients will be randomized to one of two study groups. They will then be asked to rate their pain and nausea on a line graph. If the patient is a female of child bearing age, a urine pregnancy test will be done per standard of care. After this, an IV catheter will be placed in a vein in the patients arm. Pain medicine... | Nausea | Narcotics Nausea | null | 2 | arm 1: Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic arm 2: Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline. | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 10 c of saline intervention 2: Physician ordered dose | intervention 1: Saline intervention 2: Phenergan | 1 | Newark | Delaware | United States | -75.74966 | 39.68372 | 0 | NCT00541671 |
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