FEATURE_phases list | FEATURE_enrollmentCount int64 | FEATURE_allocation string | FEATURE_interventionModel string | FEATURE_primaryPurpose class label | FEATURE_masking class label | FEATURE_healthyVolunteers bool | FEATURE_sex class label | FEATURE_oversightHasDmc bool | FEATURE_briefSummary string | FEATURE_detailedDescription string | FEATURE_conditions string | FEATURE_conditionsKeywords string | FEATURE_protocolPdfText string | FEATURE_numArms int64 | FEATURE_armDescriptions string | FEATURE_armGroupTypes list | FEATURE_numInterventions int64 | FEATURE_interventionTypes list | FEATURE_interventionDescriptions string | FEATURE_interventionNames string | FEATURE_numLocations int64 | FEATURE_locationDetails string | LABEL_ct_level_ade_population int64 | LABEL_sum_dosing_errors int64 | LABEL_dosing_error_rate float32 | LABEL_wilson_label int64 | METADATA_nctId string | METADATA_overallStatus class label | METADATA_completionDate date32 | METADATA_startDate date32 | METADATA_leadSponsorName string | METADATA_leadSponsorClass class label | METADATA_hasProtocol bool | METADATA_hasSap bool | METADATA_hasIcf bool | METADATA_protocolPdfLinks string | METADATA_count_Accidental drug intake by child int64 | METADATA_count_Accidental overdose int64 | METADATA_count_Accidental overdose (therapeutic agent) int64 | METADATA_count_Accidental underdose int64 | METADATA_count_Deliberate overdose int64 | METADATA_count_Dose calculation error int64 | METADATA_count_Drug administration error int64 | METADATA_count_Drug overdose int64 | METADATA_count_Drug overdose accidental int64 | METADATA_count_Extra dose administered int64 | METADATA_count_Incorrect dosage administered int64 | METADATA_count_Incorrect dose administered int64 | METADATA_count_Incorrect drug administration duration int64 | METADATA_count_Incorrect drug administration rate int64 | METADATA_count_Incorrect product administration duration int64 | METADATA_count_Intentional overdose int64 | METADATA_count_Medication error int64 | METADATA_count_Medication monitoring error int64 | METADATA_count_Multiple drug overdose int64 | METADATA_count_Multiple drug overdose accidental int64 | METADATA_count_Multiple drug overdose intentional int64 | METADATA_count_Multiple use of single-use product int64 | METADATA_count_Non-accidental overdose int64 | METADATA_count_Overdose int64 | METADATA_count_Overdose NOS int64 | METADATA_count_Overmedication int64 | METADATA_count_Prescribed overdose int64 | METADATA_count_Treatment noncompliance int64 | METADATA_count_Underdose int64 | METADATA_count_Unintentional medical device removal int64 | METADATA_count_Unintentional medical device removal by patient int64 | METADATA_wilson_lower_bound float32 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 32 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of MDCO-2010 on pharmacodynamics (biomarkers of fibrinoly... | This protocol describes a study of the investigational drug MDCO-2010 as a haemostasis modulator in patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery involving a cardiopulmonary bypass (CPB).
Perioperative bleeding is a serious complication that adversely affects the morbidity and mortality of c... | Coronary Artery Bypass Graft Cardiopulmonary Bypass | cardiac surgery coronary artery bypass graft cardiopulmonary bypass haemostasis modulator blood loss direct inhibitor of plasmin and plasma kallikrein CABG CPB | null | 6 | arm 1: 3 patients: loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg arm 2: 3 pts: loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg arm 3: 6 patients: loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg arm 4: 6 patients: loading dose 0.054 mg/kg; infusion 0.12... | [
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery intervention 2: Commercially available NaCl | intervention 1: MDCO-2010 intervention 2: Placebo | 0 | null | 32 | 0 | 0 | 0 | NCT01535222 | 1COMPLETED | 2011-06-01 | 2010-11-01 | The Medicines Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 38 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | Pharmacokinetics (PK) study | To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (R... | Rheumatoid Arthritis | methotrexate injection, subcutaneous, autoinjector | null | 4 | arm 1: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 2: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 3: Treatment Arm A - SC injection with V... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Vibex MTX Device | intervention 1: Methotrexate (MTX) | 1 | Duncansville | Pennsylvania | United States | -78.4339 | 40.42341 | 36 | 0 | 0 | 0 | NCT01737944 | 1COMPLETED | 2011-06-01 | 2011-01-01 | Antares Pharma Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial ovarian cancers, enhancing treatment efficacy. | The aims of this study are to:
* Assess the efficacy of adding pegylated IFN-α2b to denileukin diftitox to treat selected advanced-stage epithelial ovarian cancers
* Test the immune-modulating effects of adding pegylated IFN-α2b to denileukin diftitox in ovarian cancer patients and relate them to clinical efficacy
* I... | Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma | Epithelial Ovarian Cancer FIGO (Int Federation of Gyn and Ob )Stage III or Stage IV Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma Failing | null | 1 | arm 1: Administration of Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Denileukin Diftitox/SC Pegylated IFNα-2a | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 2 | 0 | 0 | 0 | NCT01773889 | 6TERMINATED | 2011-06-01 | 2009-06-01 | The University of Texas Health Science Center at San Antonio | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | In this study, we will assess opioid self-administration in a laboratory setting in persons with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate pain will be admitted to hospital for 7 weeks and transitioned from their baseline prescription opioid to a standing daily dose of Suboxo... | All participants will be admitted to the GCRU, the SRU, or the CRR and maintained on sublingual Bup/Ntx. During the first week after admission, participants will be withdrawn from their prior opioid analgesic regimen and will be stabilized on one of three doses of buprenorphine/naloxone (2/0.5, 8/2, or 16/4 mg per day)... | Opioid Dependence | opioid dependence opioid abuse suboxone prescription pain medications | null | 1 | arm 1: Buprenorphine/naloxone (Bup/Nx; Suboxone sublingual tablets, Reckitt Benckiser) will be administered sublingually at daily doses of 2/0.5, 8/2 mg, and 16/4 mg, which are within the recommended dose range for treating both pain and opioid abuse. The total daily dose will be divided and administered on a QID dosin... | [
0
] | 1 | [
0
] | intervention 1: Buprenorphine/naloxone (Bup/Nx; Suboxone sublingual tablets, Reckitt Benckiser) will be administered sublingually at daily doses of 2/0.5, 8/2 mg, and 16/4 mg, which are within the recommended dose range for treating both pain and opioid abuse. The total daily dose will be divided and administered on a ... | intervention 1: buprenorphine/naloxone combination | 1 | New York | New York | United States | -74.00597 | 40.71427 | 51 | 0 | 0 | 0 | NCT01967641 | 1COMPLETED | 2011-06-01 | 2005-11-01 | New York State Psychiatric Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis. | null | Psoriasis | psoriasis | null | 2 | arm 1: AN2728 ointment, 2% arm 2: Ointment Vehicle | [
0,
2
] | 2 | [
0,
0
] | intervention 1: AN2728 ointment, 2%, applied twice daily for 12 weeks intervention 2: Ointment Vehicle, applied twice daily for 12 weeks | intervention 1: AN2728 ointment, 2% intervention 2: Ointment Vehicle | 10 | New Haven | Connecticut | United States | -72.92816 | 41.30815
Louisville | Kentucky | United States | -85.75941 | 38.25424
Fridley | Minnesota | United States | -93.26328 | 45.08608
Henderson | Nevada | United States | -114.98194 | 36.0397
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
High Point | N... | 68 | 0 | 0 | 0 | NCT01300052 | 1COMPLETED | 2011-06-06 | 2011-01-26 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 15 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard treatment in participants with advanced solid tumors to be conducted in conformance with Good Clinical Practices.
Six d... | null | Neoplasms | Antibodies, neoplasm | null | 6 | arm 1: Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-fluorouracil \[5-FU\] 400 mg/m\^2 bolus followed by 2400 mg/m\^2 intravenous \[IV\] infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV)... | [
0,
0,
0,
0,
0,
0
] | 13 | [
0,
0,
2,
0,
0,
2,
2,
0,
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: In Part 1, robatumumab was to be administered at 10 mg/kg, 15 mg/kg (for Regimens B and C), or 20 mg/kg together with the assigned standard treatment. For Part 2, robatumumab was to be administered a... | intervention 1: Carboplatin intervention 2: Epirubicin intervention 3: Trastuzumab intervention 4: Everolimus intervention 5: Gemcitabine intervention 6: Robatumumab intervention 7: Cetuximab intervention 8: Paclitaxel intervention 9: Cisplatin intervention 10: 5-FU intervention 11: Erlotinib intervention 12: Irinoteca... | 0 | null | 15 | 0 | 0 | 0 | NCT00954512 | 6TERMINATED | 2011-06-07 | 2009-09-25 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 60 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a comparative bioavailability study to compare the pharmacokinetics and pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered in a capsule-based inhaler versus a multi-dose dry powder inhaler in patients with moderate asthma and in patients with moderate to severe Chronic obstructive pulmon... | BACKGROUND This study will evaluate the comparative bioavailability of SERETIDE delivered via the established multi-dose powder inhaler ie DISKUS/Accuhaler and a new fluticasone propionate/salmeterol capsule-based inhaler. Both formulations will be delivered at the 250/50mcg (micrograms) twice daily (bid) dose strength... | Asthma | safety replicated cross-over design pharmacodynamics Fluticasone propionate/Salmeterol capsule-based inhaler COPD asthma multi dose dry powder inhaler bioavailability pharmacokinetics | null | 4 | arm 1: Fluticasone propionate (250 micrograms \[ug\])/Salmeterol (50 ug) combination delivered in a capsule-based inhaler arm 2: Fluticasone propionate (250 ug)/Salmeterol (50 ug) combination delivered in a multi-dose dry powder inhaler arm 3: Placebo delivered in a capsule-based inhaler arm 4: Placebo delivered in a m... | [
0,
1,
2,
2
] | 2 | [
0,
0
] | intervention 1: The study consists of four treatment periods of 10 +/- 1 days each in a cross-over fashion. Each patient will be administered SERETIDE delivered via a capsule-based inhaler (Rotacaps) twice for two treatment periods and a placebo delivered via a capsule-based inhaler (Rotacaps) twice for two treatment p... | intervention 1: SERETIDE Rotacaps intervention 2: SERETIDE Diskus | 2 | Randwick | New South Wales | Australia | 151.24895 | -33.91439
Wellington | N/A | New Zealand | 174.77557 | -41.28664 | 232 | 0 | 0 | 0 | NCT01494610 | 1COMPLETED | 2011-06-08 | 2010-10-25 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,331 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®). | null | Multiple Sclerosis | null | 3 | arm 1: Participants will receive 1 capsule of placebo matching to laquinimod orally once daily for 24 months. arm 2: Participants will receive 1 capsule of laquinimod 0.6 mg orally once daily for 24 months. arm 3: Participants will receive an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once week... | [
2,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to laquinimod will be administered per schedule specified in the arm description. intervention 3: Avonex® will be administered per dose and schedule specified in the arm description. | intervention 1: Laquinimod intervention 2: Placebo intervention 3: Avonex® | 170 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Pasadena | California | Unite... | 1,324 | 0 | 0 | 0 | NCT00605215 | 1COMPLETED | 2011-06-10 | 2008-04-24 | Teva Branded Pharmaceutical Products R&D, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 28 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formul... | This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The objective is to confirm if two formulations of Amoxicillin trihydrate, in the form powder for oral suspension, are bioequivalent. The test product is Amoxicillin trihydrate - Clamoxyl 500mg/5m... | Infections, Bacterial | null | 2 | arm 1: Test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 1; followed by 14-days washout period during which no medication was administered; followed by reference product: Amoxil® 500mg/5mL in Period 2. arm 2: Reference product: Amoxil® 500mg/5mL powder for oral suspension in Period 1;... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Test formulation intervention 2: Reference formulation | intervention 1: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL intervention 2: Amoxil® 500mg/5mL powder for oral suspension | 1 | Goiânia | Goiás | Brazil | -49.25389 | -16.67861 | 28 | 0 | 0 | 0 | NCT01431989 | 1COMPLETED | 2011-06-11 | 2011-05-27 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study of SCH 900776 (MK-8776) will evaluate its safety and tolerability when given in combination with cytarabine to participants with acute leukemias. Participants in the Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard doses of c... | null | Myelogenous Leukemia, Acute Leukemia, Lymphocytic, Acute Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Myelogenous Leukemia, Chronic, Aggressive Phase | null | 5 | arm 1: Participants received MK-8776 10 mg/m\^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approxim... | [
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: IV infusion intervention 2: IV infusion | intervention 1: MK-8776 intervention 2: Cytarabine | 0 | null | 24 | 0 | 0 | 0 | NCT00907517 | 6TERMINATED | 2011-06-13 | 2009-07-29 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 7 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This study will be conducted in two parts. Part 1 will determine whether administration of adavosertib in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolera... | null | Cervical Cancer | null | 3 | arm 1: Part 1: Dose escalation study. adavosertib capsules will be administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 . Cisplatin will be ... | [
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Adavosertib capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. intervention 2: Topotecan is administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. intervention 3: Cisplatin is admin... | intervention 1: adavosertib intervention 2: Topotecan intervention 3: Cisplatin intervention 4: Placebo to adavosertib | 0 | null | 7 | 0 | 0 | 0 | NCT01076400 | 6TERMINATED | 2011-06-13 | 2010-05-31 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 285 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice. | This is a prospective, interventional study to evaluate efficacy and safety of flexible dose dapoxetine as Premature Ejaculation (PE) Therapy. The total study duration will be 16 weeks, composed of a 2-week pretreatment phase and a 12-week open-label treatment phase, followed by a telephone contact two weeks after Week... | Sexual Dysfunction, Physiological | Sexual Dysfunction, physiological R096769 Dapoxetine Phase 3b Premature Ejaculation | null | 1 | arm 1: Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours. | [
0
] | 1 | [
0
] | intervention 1: Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours. | intervention 1: Dapoxetine | 13 | Malvern | N/A | Australia | 145.02811 | -37.86259
St Leonards | N/A | Australia | 151.19836 | -33.82344
Sydney | N/A | Australia | 151.20732 | -33.86785
Busan | N/A | South Korea | 129.03004 | 35.10168
Daegu | N/A | South Korea | 128.59111 | 35.87028
Gwangju | N/A | South Korea | 126.91556 | 35.15472
Incheon | N/A | So... | 281 | 0 | 0 | 0 | NCT01063881 | 1COMPLETED | 2011-06-14 | 2010-05-22 | Janssen Research & Development, LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 17 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective(s):
* To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease
* To assess the effect of Replagal on heart rate variability in patients 7 to 17 years of age
Secondary Objective(s):
* To determine the pharmacokinetics of Replagal at ... | TKT029 is an open label multi-center study to assess the safety of enzyme replacement therapy with Replagal (agalsidase alfa) in children with Fabry disease, who have completed 6 months of agalsidase alfa therapy in study TKT023 (Cohort 1) or who are treatment-naïve (Cohort 2) and meet all inclusion/exclusion criteria ... | Fabry Disease | Lysosomes Storage Glycolipid Fabry disease Stroke Children Pediatrics | null | 2 | arm 1: Cohort 1: Patients who completed TKT023. arm 2: Cohort 2: Treatment-naive patients. | [
0,
0
] | 1 | [
0
] | intervention 1: 0.2 mg/kg agalsidase alfa administered by IV infusion over 40 (+/- 10) minutes every other week for 52 weeks, with periodic reassessments for study continuation beyond 52 weeks | intervention 1: Agalsidase alfa | 14 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Palm Beach Gardens | Florida | United States | -80.13865 | 26.82339
Lake Charles | Louisiana | United States | -93.2044 | 30.21309
Bethesda | Maryland | United States | -77.10026 | 38.98067
Easton | Marylan... | 28 | 0 | 0 | 0 | NCT00084084 | 1COMPLETED | 2011-06-15 | 2004-06-10 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 11 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic s... | null | Solid Tumors | Head and Neck Cancer Esophageal Cancer Gastric Cancer | null | 4 | arm 1: Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. arm 2: Participants received 20 mg of adavosertib administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m\^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle. intervention 2: 5-FU 1000 mg/m\^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle intervention 3: CDDP 60 mg/m\^2 to 100 mg/m\^2 administered as an IV infusion on Day 1. intervention 4: Adavoserti... | intervention 1: adavosertib 20 mg intervention 2: 5-FU 1000 mg/m^2/day intervention 3: CDDP intervention 4: adavosertib 65 mg | 0 | null | 11 | 0 | 0 | 0 | NCT01047007 | 6TERMINATED | 2011-06-15 | 2010-01-18 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 740 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function. | null | Attention Deficit Hyperactivity Disorder | Inattention Hyperactivity Impulsivity Distractibility Procrastination Disorganized ADHD | null | 4 | arm 1: Participants received single-blind matching-placebo tablets along with open-label stimulant determined by the investigator, once daily for 5 weeks. Once assigned to a stimulant by the investigator, participants remained on the same stimulant for the duration of the trial. Participants who met eligibility criteri... | [
0,
0,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: OPDC-34712 tablets, daily, Orally. intervention 2: Matching-placebo tablets, daily, Orally. intervention 3: Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care. | intervention 1: OPDC-34712 intervention 2: Placebo intervention 3: Stimulant Therapy | 35 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Beverly Hills | California | United States | -118.40036 | 34.07362
Irvine | California | United States | -117.82311 | 33.66946
Pasadena | California | United States | -118.14452 | 34.14778
San Francisco | California | United States | -122.41942 | 37.77493
Br... | 1,307 | 0 | 0 | 0 | NCT01074294 | 1COMPLETED | 2011-06-20 | 2010-03-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy. | Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy include open and laparoscopic placement of synthetic mesh. Studies have shown that the use of synthetic mesh greatly reduces the risk of he... | Hernia Postoperative Pain | null | 1 | arm 1: bupivacaine collagen sponges | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: 5x5cm bupivacaine collagen sponges | 1 | Bellaire | Texas | United States | -95.45883 | 29.70579 | 10 | 0 | 0 | 0 | NCT01224145 | 1COMPLETED | 2011-06-20 | 2011-03-22 | Innocoll | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 151 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant. | This Phase IIIb study was multi-center and open-label with a single dose level. Subjects with a documented diagnosis of HAE Type I or II were eligible to participate in this trial. Eligible subjects included those who had received treatment for HAE with icatibant in previous clinical trials, or subjects who had been pr... | Hereditary Angioedema | HAE Type I HAE Type II HAE | null | 2 | arm 1: Single subcutaneous injection of icatibant, 30 mg arm 2: Single subcutaneous injection of icatibant, 30 mg | [
0,
0
] | 1 | [
0
] | intervention 1: Single subcutaneous injection of icatibant, 30 mg | intervention 1: Icatibant | 26 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Graz | N/A | Austria | 15.45 | 47.06667
Odense | I Og Alergicentret | Denmark | 10.38831 | 55.39594
Angers | Angers Cedex 09 | France | -0.55202 | 47.47156
Lyon | Cedex 03 | France | 4.84671 | 45.74846
Grenoble | Grenoble Cedex 09 | France | 5.71479 | 45.17869
Lill... | 119 | 0 | 0 | 0 | NCT00997204 | 1COMPLETED | 2011-06-22 | 2009-09-25 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 855 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol an... | null | Overactive Bladder | null | 1 | arm 1: Subjects decided to purchase Oxytrol. | [
0
] | 1 | [
0
] | intervention 1: Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System) | intervention 1: Oxybutynin (Oxytrol, BAY839380) | 1 | Saint Joseph | Missouri | United States | -94.84663 | 39.76861 | 785 | 0 | 0 | 0 | NCT04534491 | 1COMPLETED | 2011-06-22 | 2010-05-25 | Bayer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 547 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 3TRIPLE | false | 1FEMALE | false | The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment. | Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo. | Detrusor Overactivity Overactive Bladder | Vesicare Solifenacin Detrusor Overactivity Urinary Nerve Growth Factor Overactive Bladder Bladder wall thickness | null | 3 | arm 1: Participants received 2 placebo tablets once daily for 12 weeks. arm 2: Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks. arm 3: Participants received two 5 mg solifenacin tablets once daily for 12 weeks. | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: Matching solifenacin placebo tablet intervention 2: Tablet for oral administration | intervention 1: Placebo intervention 2: solifenacin | 79 | New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
West Reading | Pennsylvania | United States | -75.94743 | 40.3337
Graz | N/A | Austria | 15.45 | 47.06667
Linz | N/A | Austria | 14.28611 | 48.30639
Linz | N/A | Austria | 14.28611 | 48.30639
Edegem | N... | 543 | 0 | 0 | 0 | NCT01093534 | 1COMPLETED | 2011-06-23 | 2010-01-19 | Astellas Pharma Inc | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 263 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension. | null | Glaucoma, Open-Angle Ocular Hypertension | null | 1 | arm 1: Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months. | [
0
] | 1 | [
0
] | intervention 1: Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months. | intervention 1: Bimatoprost 0.03% | 1 | Shanghai | N/A | China | 121.45806 | 31.22222 | 250 | 0 | 0 | 0 | NCT02061683 | 1COMPLETED | 2011-06-24 | 2010-04-19 | Allergan | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 287 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken alone or when co-dosed with atorvastatin to subjects with dyslipidemia. | This compound has been studied in healthy subjects and subjects with type II diabetes and is now being studied in subjects with dyslipidemia. Because many patients with dyslipidemia are on statins, it is important to study how GSK1292263 behaves when taken with a potent statin, atorvastatin. The cholesterol lowering dr... | Dyslipidaemias Dyslipidemias | Pharmacodynamics Lipids Dyslipidemia Safety GSK1292263 Ezetimibe Statin Pharmacokinetics Tolerability Atorvastatin | null | 16 | arm 1: Subjects on stable 40mg atorvastatin \> 4 weeks may raise their dose to 80mg for 2 weeks in order to qualify for Part A. arm 2: Dosing for 14 days arm 3: Washout for 4 weeks arm 4: Dosing for 4 weeks arm 5: Dosing for 4 weeks arm 6: Dosing for 14 days arm 7: Dosing for 14 days arm 8: Dosing for 14 days arm 9: Do... | [
5,
0,
5,
1,
1,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
10
] | intervention 1: 10mg intervention 2: 80mg intervention 3: Placebo intervention 4: 100mg intervention 5: 300mg intervention 6: 800mg intervention 7: 10mg intervention 8: No interventions - washout period | intervention 1: 10mg atorvastatin intervention 2: 80mg atorvastatin intervention 3: GSK1292263 Placebo intervention 4: 100mg GSK1292263 intervention 5: 300mg GSK1292263 intervention 6: 800mg GSK1292263 intervention 7: 10mg ezetimibe intervention 8: Washout | 21 | Anniston | Alabama | United States | -85.83163 | 33.65983
Chula Vista | California | United States | -117.0842 | 32.64005
Stockton | California | United States | -121.29078 | 37.9577
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Miami | Florida | Un... | 787 | 0 | 0 | 0 | NCT01218204 | 1COMPLETED | 2011-06-29 | 2010-09-14 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy. | This was an open-label, long-term safety study of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy. Patients who participate in this study must have completed the Phase 2 study 0913M0621 (NCT01054443), a double-blind, placebo controlled, parallel group s... | Immune Thrombocytopenia | Splenectomy Low Platelet Count Thrombopoiesis Thrombocytopaenia Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenia (ITP) Thrombotic Thrombocytopenic Purpura (ITP) Hematologic Disease Auto-immune Thrombocytopenic Purpura S-888711 Blood Platelet Disorders Relapsed Persistent or Chronic ITP ITP | null | 1 | arm 1: Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts. If a subject's platelet count remained \< 50,000/μL, the dose could have been increased by 0.25 mg up to a maximum dose of 2.0 mg. | [
0
] | 1 | [
0
] | intervention 1: tablet | intervention 1: Lusutrombopag | 19 | Anaheim | California | United States | -117.9145 | 33.83529
Los Angeles | California | United States | -118.24368 | 34.05223
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Boynton Beach | Florida | United States | -80.06643 | 26.52535
Jacksonville | Florida | United States | -81.65565 | 3... | 19 | 1 | 0.052632 | 1 | NCT01129024 | 6TERMINATED | 2011-06-30 | 2010-04-29 | Shionogi | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.009352 |
[
2,
3
] | 79 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in... | OBJECTIVES:
* Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ (DCIS) treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole, by evaluating the maximal change in tumor diameter on mammography and MRI following treatment.
* Identify those cellular an... | Breast Cancer | breast cancer in situ ductal breast carcinoma in situ | null | 1 | arm 1: tamoxifen or letrozole work in treating women with ductal carcinoma in situ | [
0
] | 4 | [
0,
0,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: letrozole intervention 2: tamoxifen citrate intervention 3: conventional surgery intervention 4: neoadjuvant therapy | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | 0 | 0 | 0 | NCT00290745 | 1COMPLETED | 2011-06-30 | 2002-02-19 | University of California, San Francisco | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 60 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC). | The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients wit... | Advanced Carcinoma Non-small Cell Lung Cancer | advanced cancer lung cancer NSCLC Non-small Cell Lung Cancer aflibercept chemotherapy | null | 4 | arm 1: Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has b... | [
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Administered in combination with the other two interventions via intravenous infusion. intervention 2: Administered in combination with the other two interventions via intravenous infusion. intervention 3: Administered in combination with the other two interventions via intravenous infusion. | intervention 1: Aflibercept intervention 2: Pemetrexed intervention 3: Cisplatin | 15 | Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Stanford | California | United States | -122.16608 | 37.42411
Boynton Beach | Florida | United States | -80.06643 | 26.52535
Hines | Illinois | United States | -87.8395 | 41.85364
Hazard | Kentucky | U... | 60 | 0 | 0 | 0 | NCT00794417 | 6TERMINATED | 2011-06-30 | 2008-11-30 | Regeneron Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 114 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight w... | This study will enroll 180 hospitalized patients with Type 2 diabetes and moderate to end stage renal insufficiency (estimated glomerular filtration rate is \< 30 ml/min/1.73m2 or dialysis) in the Chicagoland area. Participants will be randomized into 1 of 2 protocols after hospital admission. Blood glucose levels will... | Type 2 Diabetes Renal Insufficiency | glargine glulisine type 2 diabetes renal insufficiency | null | 2 | arm 1: Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. arm 2: Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine. intervention 2: Participants randomized to receive this intervention will receive an experimental do... | intervention 1: 0.5 units/kg daily insulin intervention 2: 0.25 units/kg daily insulin | 3 | Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Maywood | Illinois | United States | -87.84312 | 41.8792 | 114 | 0 | 0 | 0 | NCT00911625 | 1COMPLETED | 2011-06-30 | 2009-01-21 | Loyola University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 939 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemot... | null | Non Small Cell Lung Cancer | Recurrent or Progressive Non-Small Cell Lung Cancer Second-line therapy Docetaxel Pemetrexed Cetuximab Failed platinum-based therapy NSCLC | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
1,
0,
1
] | 3 | [
0,
2,
0
] | intervention 1: Pemetrexed 500 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles. intervention 2: Cetuximab 400/250 mg/m\^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progressi... | intervention 1: Pemetrexed intervention 2: Cetuximab intervention 3: Docetaxel | 67 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tuscon | Arizona | United States | N/A | N/A
Greenbrae | California | United States |... | 889 | 2 | 0.00225 | 1 | NCT00095199 | 1COMPLETED | 2011-07-01 | 2005-01-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000617 |
[
4
] | 594 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer. | null | Breast Neoplasms | advanced breast cancer sunitinib docetaxel Phase 3 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel) intervention 2: Docetaxel 100 mg/m2 every 3 weeks in the comparator arm | intervention 1: Sunitinib malate intervention 2: Taxotere | 144 | Berkely | California | United States | N/A | N/A
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Beaumont | Texas | United States | -94.10185 | 30.08605
Burleson | Texas | United States | -97.32085 | 32.54208
Cleburne | Texas | United States | -97.38668 | 32.34764
Fort Worth | Texas | United States | -97.... | 588 | 1 | 0.001701 | 1 | NCT00393939 | 1COMPLETED | 2011-07-01 | 2007-02-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0003 |
[
4
] | 820 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack). | null | Myocardial Infarction | myocardial infarction, aliskiren, heart failure Post acute myocardial infarction with systolic dysfunction | null | 2 | arm 1: Core Study: Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for next 34 weeks orally once daily in the morning.
Extension Study: Patients from both the core arms who completed core study and signed informed consent form were included in this arm of extension study.
Patients re... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Aliskiren was available in 75 mg tablet, 150 mg tablet intervention 2: Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only. | intervention 1: Aliskiren intervention 2: placebo | 23 | Novartis US | New Jersey | United States | N/A | N/A
Novartis Argentina | N/A | Argentina | N/A | N/A
Novartis Belgium | N/A | Belgium | N/A | N/A
Novartis Canada | N/A | Canada | N/A | N/A
Bogotá | N/A | Colombia | -74.08175 | 4.60971
Prague | Praha 3 | Czechia | 14.42076 | 50.08804
Novartis Denmark | N/A | Denmark | ... | 1,241 | 1 | 0.000806 | 1 | NCT00414609 | 1COMPLETED | 2011-07-01 | 2006-12-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000142 |
[
4
] | 12,944 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.
The study... | null | Atherosclerosis Myocardial Ischemia Myocardial Infarction | null | 2 | arm 1: Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. arm 2: Loading oral dose of one 40 mg ... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year intervention 2: oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year | intervention 1: Vorapaxar intervention 2: Placebo | 0 | null | 12,887 | 7 | 0.000543 | 1 | NCT00527943 | 6TERMINATED | 2011-07-01 | 2007-12-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000263 | |
[
5
] | 180 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticos... | null | Liver Transplantation | null | 2 | arm 1: Participants received mycophenolate mofetil (MMF) 3 grams per day (g/d), orally (PO), twice per day (BID) with meals from Day 0 to Day 4; the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12. Participants also re... | [
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12. intervention 2: Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ... | intervention 1: Mycophenolate mofetil, adjusted dose intervention 2: Tacrolimus intervention 3: Corticosteroids, IV intervention 4: Mycophenolate mofetil, Standard dose intervention 5: Corticosteroids, PO | 16 | Besançon | N/A | France | 6.01815 | 47.24878
Bordeaux | N/A | France | -0.5805 | 44.84044
Caen | N/A | France | -0.35912 | 49.18585
Clichy | N/A | France | 2.30952 | 48.90018
Créteil | N/A | France | 2.46569 | 48.79266
Grenoble | N/A | France | 5.71479 | 45.17869
Lille | N/A | France | 3.05858 | 50.63297
Lyon | N/A | F... | 183 | 10 | 0.054645 | 1 | NCT00545402 | 1COMPLETED | 2011-07-01 | 2007-11-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.029949 | |
[
4
] | 1,494 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 2MALE | true | Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further im... | null | Prostate Cancer | Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist | null | 2 | arm 1: placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks arm 2: ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: intravenous infusion given every three weeks intervention 2: 10 mg oral once daily dose intervention 3: placebo oral tablet once daily | intervention 1: Docetaxel intervention 2: ZD4054 intervention 3: Placebo | 147 | Greenbrae | California | United States | -122.5247 | 37.94854
San Diego | California | United States | -117.16472 | 32.71571
Norwich | Connecticut | United States | -72.07591 | 41.52426
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Fort Myers | Florida | United States | -81.84059 | 26.62... | 1,047 | 1 | 0.000955 | 1 | NCT00617669 | 1COMPLETED | 2011-07-01 | 2008-01-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000169 |
[
3
] | 221 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively. | null | Acute Coronary Syndrome (ACS) | null | 2 | arm 1: Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days. arm 2: A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind. | [
0,
2
] | 2 | [
0,
10
] | intervention 1: None intervention 2: Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study. | intervention 1: cangrelor intervention 2: Placebo | 1 | La Jolla | California | United States | -117.2742 | 32.84727 | 218 | 7 | 0.03211 | 1 | NCT00767507 | 1COMPLETED | 2011-07-01 | 2008-10-01 | The Medicines Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.01564 | |
[
4
] | 1,192 | NON_RANDOMIZED | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed. | Open-label extension | Pulmonary Arterial Hypertension | Open-label study | null | 1 | arm 1: Sitaxsentan | [
0
] | 1 | [
0
] | intervention 1: Sitaxsentan 100 mg tablets once daily | intervention 1: Sitaxsentan | 91 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Torrence |... | 1,192 | 3 | 0.002517 | 1 | NCT00811018 | 6TERMINATED | 2011-07-01 | 2003-03-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000856 |
[
5
] | 2,337 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting. | null | Hypertension | Hypertension valsartan | null | 3 | arm 1: Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target arm 2: Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsart... | [
1,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally intervention 2: From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally intervention 3: As directed by investigator intervention 4: Vals... | intervention 1: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy intervention 2: Valsartan and amlodipine intervention 3: Usual care intervention 4: Valsartan intervention 5: Valsartan and hydrochlorothiazide (HCTZ) - combination arm | 3 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Melbourne | N/A | Australia | 144.96332 | -37.814
Melbourne | N/A | Australia | 144.96332 | -37.814 | 3,747 | 1 | 0.000267 | 0 | NCT00902304 | 1COMPLETED | 2011-07-01 | 2009-07-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000047 |
[
3
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma. | OBJECTIVES:
* Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
* Assess the quantitative and qualitative toxic effects of this drug in this patient population.
OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence o... | Adult Meningioma | recurrent adult brain tumor adult grade I meningioma | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 20 mg/kg/day PO | intervention 1: hydroxyurea | 133 | Fairbanks | Alaska | United States | -147.71639 | 64.83778
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Duarte | California | United States | -117.97729 | 34.13945
Oakland | California | ... | 28 | 0 | 0 | 0 | NCT00003590 | 1COMPLETED | 2011-07-01 | 1998-11-01 | SWOG Cancer Research Network | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 3,069 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | true | This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality. | Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease a... | Dementia Alzheimer's Disease | null | 2 | arm 1: Placebo 1 pill twice a day arm 2: Ginkgo biloba EGb761 120 mg twice daily | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 120mg twice a day intervention 2: One pill twice daily | intervention 1: Ginkgo biloba intervention 2: Placebo | 5 | Sacramento | California | United States | -121.4944 | 38.58157
Baltimore | Maryland | United States | -76.61219 | 39.29038
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Charlottesville | Virginia | United States | -78.47668 | 38.02... | 3,069 | 0 | 0 | 0 | NCT00010803 | 1COMPLETED | 2011-07-01 | 2000-10-01 | National Center for Complementary and Integrative Health (NCCIH) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytara... | OBJECTIVES:
* Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine.
* Determine the rate and duration of complete hematologic responses after 6 an... | Leukemia | chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle intervention 2: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose... | intervention 1: cytarabine intervention 2: imatinib mesylate | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Portland | Oregon | United States | -122.67621 | 45.52345 | 24 | 0 | 0 | 0 | NCT00022490 | 6TERMINATED | 2011-07-01 | 2001-06-01 | OHSU Knight Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 65 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent can... | OBJECTIVES:
* Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study.
* Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients.
* Ass... | Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer | recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder squamous cell carcinoma of the bladder adenocarcinoma of the bladder recurrent urethral cancer anterior urethral cancer posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional ce... | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: gemcitabine hydrochloride intervention 2: paclitaxel | 92 | Mobile | Alabama | United States | -88.04305 | 30.69436
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Valdosta | Georgia | United States | -83.28032 | 30.83334
Springfield | Illinois | United States | -89.64371 | 39.80172
Chanute | Kansas ... | 51 | 0 | 0 | 0 | NCT00022633 | 6TERMINATED | 2011-07-01 | 2001-07-01 | SWOG Cancer Research Network | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 41 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherap... | OBJECTIVES:
* Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide, and paclitaxel with combined androgen-blockade therapy.
* Determine the type, frequency, and severity of toxicity of this regimen in this pa... | Prostate Cancer | adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer | null | 1 | arm 1: Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel | [
0
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None | intervention 1: bicalutamide intervention 2: estramustine intervention 3: etoposide intervention 4: flutamide intervention 5: goserelin intervention 6: leuprolide intervention 7: nilutamide intervention 8: paclitaxel | 91 | Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United St... | 35 | 0 | 0 | 0 | NCT00028769 | 1COMPLETED | 2011-07-01 | 2001-12-01 | SWOG Cancer Research Network | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 57 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treatin... | OBJECTIVES:
* Determine the response rates (confirmed complete and partial responses) in patients with unresectable, locally advanced or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine.
* Determine the overall survival of patients treated with this regimen.
* Determine the... | Extrahepatic Bile Duct Cancer Gallbladder Cancer | unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer adenocarcinoma of the gallbladder adenocarcinoma with squamous metaplasia of the gallbladder squamous cell carcinoma of the gallbladder adenocarcinoma of the extrahepatic bile ... | null | 1 | arm 1: Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days | [
0
] | 2 | [
0,
0
] | intervention 1: 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days intervention 2: 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days | intervention 1: capecitabine intervention 2: gemcitabine hydrochloride | 112 | Mobile | Alabama | United States | -88.04305 | 30.69436
Anchorage | Alaska | United States | -149.90028 | 61.21806
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Berkeley | California | United States | -122.27275 | 37.87159
Fairfield | California | United States | -122.03997 | 38.24936
Greenbrae | Califo... | 51 | 0 | 0 | 0 | NCT00033540 | 1COMPLETED | 2011-07-01 | 2003-09-01 | SWOG Cancer Research Network | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine alteplase, also known as tPA , is the standard drug used to treat patients with acute ischemic stroke. tPA attacks the fibrin portion of t... | Study Population: All acute ischemic stroke patients treated with standard iv tPA therapy within 3 hours from stroke onset will be considered for study participation. Patient will be selected by criteria to minimize likelihood of toxicity and maximize likelihood of response. These criteria include age 18-85 years old a... | Ischemic Stroke | Alteplase Recombinant tissue plasminogen activator Reperfusion therapy Magnetic Resonance Imaging Clinical Trial Tinzaparin Eptifibatide Ischemic Stroke | null | 2 | arm 1: Patients are eligible for the MRI arm if all clinical and all MRI inclusion and exclusion criteria are met.
A single dose of aspirin 81 mg orally (or rectal dose equivalent), a single weight-based dose of subcutaneous tinzaparin sodium. Possible dose escalated iv eptifibatide. arm 2: Patients are eligible for t... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: A single 81 mg aspirin tablet orally (or rectal suppository equivalent dose) given as soon as possible after start of standard iv tPA and consent. intervention 2: A single weight-based dose of 80 anti-Xa International Units/kilogram (IU/kg)administered by subcutaneous (SQ) injection. intervention 3: Ept... | intervention 1: Aspirin intervention 2: tinzaparin sodium intervention 3: eptifibatide | 3 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Bethesda | Maryland | United States | -77.10026 | 38.98067
Bethesda | Maryland | United States | -77.10026 | 38.98067 | 18 | 0 | 0 | 0 | NCT00061373 | 1COMPLETED | 2011-07-01 | 2003-05-01 | National Institute of Neurological Disorders and Stroke (NINDS) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 66 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Drugs used in chemotherapy 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 bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tu... | PRIMARY OBJECTIVES:
I. To determine the safety, feasibility of administration, response rates and progression free survival among chemotherapy naïve patients with advanced colorectal cancer treated with FOLFOX6 plus bevacizumab and cetuximab (FBC).
II. To determine the survival of patients with advanced colorectal ca... | Adenocarcinoma of the Rectum Mucinous Adenocarcinoma of the Colon Recurrent Colon Cancer Recurrent Rectal Cancer Signet Ring Adenocarcinoma of the Colon Stage IV Colon Cancer Stage IV Rectal Cancer | null | 1 | arm 1: Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat ev... | [
0
] | 5 | [
2,
2,
0,
0,
0
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV | intervention 1: cetuximab intervention 2: bevacizumab intervention 3: oxaliplatin intervention 4: leucovorin calcium intervention 5: fluorouracil | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 66 | 0 | 0 | 0 | NCT00100841 | 1COMPLETED | 2011-07-01 | 2004-11-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 76 | null | null | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin work better by making tumor cells more sensitiv... | OBJECTIVES:
Primary
* Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix.
* Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
* De... | Cervical Cancer | recurrent cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical small cell carcinoma cervical squamous cell carcinoma stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer | null | 0 | null | null | 2 | [
2,
0
] | intervention 1: None intervention 2: None | intervention 1: cetuximab intervention 2: cisplatin | 18 | Burbank | California | United States | -118.30897 | 34.18084
Los Angeles | California | United States | -118.24368 | 34.05223
Savannah | Georgia | United States | -81.09983 | 32.08354
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Kansas City | Kansas | United States | -94.62746 | 39.11417
New Orleans | ... | 69 | 0 | 0 | 0 | NCT00101192 | 1COMPLETED | 2011-07-01 | 2004-09-01 | Gynecologic Oncology Group | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 213 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo.
Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home... | About 10% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, and have well-documented reduced quality of life. There are no therapies that have withstood the test of adequately conducted and credible randomized clinical trials.
There is ample evidence o... | Syncope, Vasovagal, Neurally-Mediated | vasovagal syncope randomized clinical trial quality of life | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 1 | [
0
] | intervention 1: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily | intervention 1: fludrocortisone acetate | 14 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Nashville | Tennessee | United States | -86.78444 | 36.16589
Richmond | Virginia | United States | -77.46026 | 37.55376
Calgary | Alberta | Canada | -114.08529 | 51.05011
Calgary | Alberta | Canada | -114.08529 | 51.05011
Winnipeg | Manitoba | Canada | -97.1... | 210 | 0 | 0 | 0 | NCT00118482 | 1COMPLETED | 2011-07-01 | 2005-05-01 | University of Calgary | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 309 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic... | null | Diabetic Macular Edema | null | 2 | arm 1: 32 mg taken orally daily for up to 48 months arm 2: Taken orally daily for up to 48 months | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Administered orally intervention 2: Administered orally | intervention 1: Ruboxistaurin intervention 2: Placebo | 41 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Artesia | California | United States | -118.08312 | 33.86585
Newark | Delaware | United States | -75.74966 | 39.68372
Jacksonville | Florida | United States | -81.65565 | 30.33218
Augusta | Georgia | United States | -81.97484 | 33.47097
Indianapolis | Indiana | ... | 302 | 0 | 0 | 0 | NCT00133952 | 1COMPLETED | 2011-07-01 | 2005-08-01 | Chromaderm, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 26 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to investigate the acute effects of the thiazolidinedione agent pioglitazone (which has combined PPAR alpha and gamma stimulation) on insulin's ability to suppress glucose production, stimulated glucose uptake, and impact a number of other metabolically important endpoints, including produc... | Participants in this study were given a supply of either pioglitazone (a medication used to treat diabetes) or matched placebo for a duration of 10 days or 21 days. Changes to the body's response to insulin in the liver and in peripheral tissues (eg, muscle and fat) will be measured using a procedure called a pancreati... | Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus | null | 2 | arm 1: Participants received Pioglitazone 45 mg via oral capsule daily for 10 or 21 days in randomized, placebo-controlled crossover fashion, separated by a wash-out period.
The investigators used a research procedure called a "pancreatic clamp" study to study the effects of the pioglitazone. During the clamp procedur... | [
1,
2
] | 3 | [
0,
0,
3
] | intervention 1: This was a randomized placebo-controlled crossover study in which subjects received both agents in random order, separated by a wash-out period. Following 10 or 21 days' intervention, subjects underwent a pancreatic clamp study. intervention 2: This was a randomized placebo-controlled crossover study in... | intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Pancreatic Clamp Study | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 58 | 0 | 0 | 0 | NCT00179400 | 1COMPLETED | 2011-07-01 | 2000-12-01 | Albert Einstein College of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 28 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast canc... | PRIMARY OBJECTIVES:
I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of complete hormonal blockade (CHB) for 2 weeks followed by four three-week cycles of Xeloda, Methotrexate and Navelbine with continuation of complete hormonal b... | Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Progesterone Receptor-positive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer | null | 1 | arm 1: See detailed description | [
0
] | 9 | [
0,
0,
0,
0,
0,
0,
3,
4,
10
] | intervention 1: Given PO intervention 2: Given IM intervention 3: Given PO intervention 4: Given IV intervention 5: Given IV intervention 6: Given IV intervention 7: Undergo lumpectomy or mastectomy intervention 8: Undergo radiation therapy intervention 9: Correlative studies | intervention 1: exemestane intervention 2: triptorelin pamoate intervention 3: capecitabine intervention 4: methotrexate intervention 5: vinorelbine tartrate intervention 6: paclitaxel intervention 7: therapeutic conventional surgery intervention 8: radiation therapy intervention 9: laboratory biomarker analysis | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 27 | 0 | 0 | 0 | NCT00194792 | 6TERMINATED | 2011-07-01 | 2005-08-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 144 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | The project aims to describe and compare the outcome of 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle, liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for symptoms of aggression and non-metabolic adver... | This randomized clinical trial assesses both the safety and efficacy of atypical antipsychotic agents in antipsychotic-naive aggressive children with various childhood psychiatric disorders during 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole.
Aim 1: To evaluate effects of ... | Aggression Attention Deficit-Hyperactivity Oppositional Defiant Disorder Pervasive Development Disorders Bipolar Disorder | Antipsychotic treatment Insulin action/secretion Abdominal fat mass, total body fat Aggression Resting metabolic rates | ICF_000.pdf:
ICF_001.pdf:
Prot_002.pdf:
Principal Investigator/Pr... | 3 | arm 1: Participants in this group will be randomized to flexibly-dosed treatment with aripiprazole. arm 2: Participants in this group will be randomized to flexibly-dosed treatment with olanzapine. arm 3: Participants in this group will be randomized to flexibly-dosed treatment with risperidone. | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: randomized to begin 12 week trial of risperidone intervention 2: randomized to begin 12 week trial of olanzapine intervention 3: randomized to 12 week trial of aripiprazole | intervention 1: risperidone intervention 2: olanzapine intervention 3: aripiprazole | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 144 | 0 | 0 | 0 | NCT00205699 | 1COMPLETED | 2011-07-01 | 2006-04-01 | Washington University School of Medicine | 7OTHER | true | true | true | https://cdn.clinicaltrials.gov/large-docs/99/NCT00205699/ICF_000.pdf https://cdn.clinicaltrials.gov/large-docs/99/NCT00205699/ICF_001.pdf https://cdn.clinicaltrials.gov/large-docs/99/NCT00205699/Prot_002.pdf https://cdn.clinicaltrials.gov/large-docs/99/NCT00205699/SAP_003.pdf | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 656 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 3TRIPLE | false | 0ALL | null | It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, espe... | GEHC has decided not to provide this detail | Renal Insufficiency Diabetes Mellitus | Iodixanol Iopamidol computed tomography Patients with pre-existing renal impairment and diabetes | null | 2 | arm 1: Iodixanol 320 mg I/mL arm 2: Iopamidol 300 mg I/mL | [
1,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Iodixanol 320-Arm 1 intervention 2: Iopamidol 300-Arm 2 | 2 | Princeton | New Jersey | United States | -74.65905 | 40.34872
Amersham | N/A | United Kingdom | -0.61667 | 51.66667 | 648 | 0 | 0 | 0 | NCT00209417 | 6TERMINATED | 2011-07-01 | 2005-06-01 | GE Healthcare | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The optimal sequence and /or modality for adjuvant therapy in the management of Mixed Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis.
The proposed study will sandwich radiation between the two ... | Uterine sarcomas account for only 2-4% of uterine malignancies, yet they are responsible for 26% of uterine cancer deaths. Mixed mesodermal tumors (MMT), previously known as carcinosarcoma, are the most common of the uterine sarcomas in the United States. Prognosis for these patients is generally grim due to the propen... | Uterine Cancer | Mixed Mesodermal Tumor MMT Uterine Cancer Radiation Therapy Chemotherapy | null | 1 | arm 1: Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifos... | [
0
] | 3 | [
0,
1,
0
] | intervention 1: Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L / day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divid... | intervention 1: Ifosfamide intervention 2: Radiation Therapy intervention 3: Cisplatin | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 27 | 0 | 0 | 0 | NCT00231842 | 1COMPLETED | 2011-07-01 | 2003-02-01 | Montefiore Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 81 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential us... | Uterine papillary serous carcinoma (UPSC) is an uncommon, but aggressive variant of endometrial carcinoma that has a high recurrence rate and poor response to therapy. It has a propensity to metastasize throughout the abdomen, similar to serous carcinoma of the ovary. In fact, many patients with disease apparently conf... | Uterine Cancer | Uterine Papillary Serous Carcinoma UPSC Radiation Therapy Chemotherapy | null | 1 | arm 1: Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy | [
0
] | 3 | [
0,
3,
0
] | intervention 1: Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles intervention 2: Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT foll... | intervention 1: Carboplatin and Paclitaxel and Pelvic Radiation Therapy intervention 2: Carboplatin and Paclitaxel and Pelvic Radiation Therapy intervention 3: Carboplatin and Paclitaxel and Radiation Therapy | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 72 | 0 | 0 | 0 | NCT00231868 | 1COMPLETED | 2011-07-01 | 2001-12-01 | Montefiore Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery. | To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal... | Burns | Burns | null | 2 | arm 1: intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery) arm 2: intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: intravenous infusion of Factor VIIa intervention 2: intravenous infusion of placebo (sterile water) | intervention 1: Recombinant Factor VIIa intervention 2: Placebo | 1 | Fort Sam Houston | Texas | United States | -98.4417 | 29.45303 | 20 | 0 | 0 | 0 | NCT00243243 | 1COMPLETED | 2011-07-01 | 2006-01-01 | United States Army Institute of Surgical Research | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This ... | OBJECTIVES:
Primary
* Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium.
Secondary
* Evaluate the progression-free survival of patients treated with this drug.
* Evaluate the response rate (confirmed and unconfirmed, partial and complete) i... | Lung Cancer | bronchoalveolar cell 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: pemetrexed | [
0
] | 1 | [
0
] | intervention 1: Pemetrexed 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any... | intervention 1: pemetrexed | 112 | Anchorage | Alaska | United States | -149.90028 | 61.21806
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Aurora | Colorado | United States | -104.83192 | 39.72943
Denver | Colorad... | 24 | 0 | 0 | 0 | NCT00265785 | 6TERMINATED | 2011-07-01 | 2006-07-01 | SWOG Cancer Research Network | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studyin... | OBJECTIVES:
Primary
* Determine the complete response (CR) rate (CR and incomplete blood count recovery (CRi)) of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride.
Secondary
* Evaluate disease free and overall survival of patients with acute... | Leukemia | adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) adult ac... | null | 1 | arm 1: Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m\^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m\^2/day I.V. on days 1, 2, and 3. | [
0
] | 2 | [
0,
0
] | intervention 1: 10 mg/m2/ min IV for 12 hours intervention 2: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3 | intervention 1: Gemcitabine Hydrochloride intervention 2: Mitoxantrone Hydrochloride | 2 | Durham | North Carolina | United States | -78.89862 | 35.99403
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 24 | 0 | 0 | 0 | NCT00268242 | 6TERMINATED | 2011-07-01 | 2006-01-01 | The Cleveland Clinic | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether supplementation with an oil-based cholesterol suspension will correct the biochemical abnormalities in cholesterol and its precursors in individuals with the Smith-Lemli-Opitz syndrome. | This study involves treating individuals with the Smith-Lemli-Opitz syndrome, a rare inborn error of cholesterol metabolism, with supplemental cholesterol to determine it effects on biochemical sterol metabolites, growth, neuropsychological development, ophthalmologic and auditory function, ERG (electroretinogram) para... | Smith-Lemli-Opitz Syndrome | cholesterol Smith-Lemli-Opitz syndrome mental retardation sterols congenital anomalies | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 200 mg/mL suspension of crystalline cholesterol in oil. Dosage (generally 75-300 mg/kg/day in divided doses) is based on initial cholesterol levels and regulated to increase, yet maintain, cholesterol levels no higher than normal ranges. | intervention 1: crystalline cholesterol oil-based suspension | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 23 | 0 | 0 | 0 | NCT00272844 | 1COMPLETED | 2011-07-01 | 1998-01-01 | Boston Children's Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 302 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere). | This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity:
* the maximum tolerated dose (MTD) of ABI-007 300 mg/m\^2 every 3 weeks;
* ABI-007 100 mg/m\^2 administered weekly for 3 weeks with a 1 week rest;
* ABI-007 150 mg/m\^2 administered weekly for 3 ... | Metastatic Breast Cancer | Metastatic breast cancer, nab paclitaxel, docetaxel, | null | 4 | arm 1: ABI-007 300 mg/m\^2 administered once every third week (q3w). arm 2: ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest arm 3: ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest arm 4: Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w). | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m\^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment. intervention 2: Docetaxel dosed q3w at 100 mg/m\^2 | intervention 1: ABI-007 intervention 2: Docetaxel | 1 | Kiev | N/A | Ukraine | 30.5238 | 50.45466 | 300 | 0 | 0 | 0 | NCT00274456 | 1COMPLETED | 2011-07-01 | 2005-11-01 | Celgene | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 94 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways ... | OBJECTIVES:
* Determine the safety of high-dose cyclophosphamide, rituximab, and pegfilgrastim in patients with B-cell leukemia or low-grade or mantle cell lymphoma.
* Determine the molecular response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive rituximab IV over... | Leukemia Lymphoma | stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia small lymphocytic lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymph... | null | 1 | arm 1: Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support. | [
0
] | 3 | [
2,
2,
0
] | intervention 1: 6 mg SQ 24-48 hours after last dose of cyclophosphamide. intervention 2: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52. intervention 3: 50 mg/kg/day on Days 15, 16, 17, and 18. | intervention 1: Pegfilgrastim intervention 2: Rituximab intervention 3: Cyclophosphamide | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 81 | 0 | 0 | 0 | NCT00278161 | 1COMPLETED | 2011-07-01 | 2005-01-01 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 75 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This p... | OBJECTIVES:
Primary
* Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.
Secondary
* Determine the toxicity of this regimen in these patients.
* Determine the survival patterns of patients treated with this regimen.
* Assess the ... | Lung Cancer | stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer | null | 1 | arm 1: adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles | [
5
] | 2 | [
0,
0
] | intervention 1: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25) intervention 2: 75 mg/m² intravenously, once, every 3 weeks | intervention 1: carboplatin intervention 2: docetaxel | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 72 | 0 | 0 | 0 | NCT00280735 | 1COMPLETED | 2011-07-01 | 2004-05-01 | UNC Lineberger Comprehensive Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary objective of this study was to evaluate the tolerability and safety of rituximab in combination with methotrexate (MTX) and etanercept or adalimumab in participants with active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of rituximab in combination with MTX and etanercept ... | The study consists of 4 parts: screening, treatment, post-treatment, and safety follow-up. Prior to Day 1, participants were discontinued from all disease-modifying anti-rheumatic drugs (DMARDs) except MTX and etanercept or adalimumab. All participants who met eligibility criteria and were enrolled in the trial were ra... | Rheumatoid Arthritis | null | 2 | arm 1: The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Wee... | [
0,
5
] | 7 | [
2,
0,
0,
0,
0,
0,
7
] | intervention 1: Participants will receive 500 mg rituximab on Day 1 and Day 15 intervention 2: Participants will receive placebo on Day 1 and Day 15 intervention 3: Participants must have been treated with MTX ≥15 mg per week and ≤25 mg per week (dose may have been as low as 10 mg if unable to tolerate higher dose) for... | intervention 1: IDEC-C2B8 (rituximab) intervention 2: Placebo intervention 3: Methotrexate intervention 4: Etanercept intervention 5: Adalimumab intervention 6: Methylprednisolone intervention 7: Folate | 18 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Paradise Valley | Arizona | United States | -111.94265 | 33.53115
Palm Desert | California | United States | -116.37697 | 33.72255
Jupiter | Florida | United States | -80.09421 | 26.93422
Sarasota | Florida | United States | -82.53065 | 27.33643
Boise | Idaho |... | 100 | 0 | 0 | 0 | NCT00298272 | 6TERMINATED | 2011-07-01 | 2006-05-01 | Biogen | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 721 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients. | null | Graft Rejection | Everolimus heart transplant heart disease transplantation heart IVUS assessment at 12 months rate of graft loss acute rejection episodes survival | null | 3 | arm 1: Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough le... | [
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments. intervention 2: Mycophenolate mofetil supplied as 500 mg tablets. intervention 3: Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standa... | intervention 1: everolimus intervention 2: mycophenolate mofetil intervention 3: cyclosporine intervention 4: corticosteroids | 64 | 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
Gainesville | Florida | United States | -82.32483 | 29.65163
Atlanta | Georgia | United States | -84.38798 | 33.749
Maywood | ... | 714 | 0 | 0 | 0 | NCT00300274 | 1COMPLETED | 2011-07-01 | 2006-01-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 32 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is determine the safety of 5-fluorouracil, bevacizumab and erlotinib when administered in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating(Phase II portion) patients wi... | * All participants will receive the following drugs: 5-fluorouracil (5-FU) given as a continuous 24-hour infusion; Bevacizumab given intravenously; erlotinib given orally at home. In the Phase I portion, we are looking for the highest dose of erlotinib that can be given safely in combination with the 5-FU, bevacizumab ... | Rectal Cancer Adenocarcinoma of the Rectum | Fluorouracil bevacizumab erlotinib external beam radiation therapy EBRT | null | 1 | arm 1: Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation. | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles. intervention 2: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles. intervention 3: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles. intervention 4: Given on days 1-5 and ... | intervention 1: 5-fluorouracil intervention 2: bevacizumab intervention 3: erlotinib intervention 4: External beam radiation therapy (EBRT) | 3 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 32 | 0 | 0 | 0 | NCT00307736 | 1COMPLETED | 2011-07-01 | 2006-05-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 42 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer. | OBJECTIVES:
* Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389.
* Estimate progression-free and overall survival probability in these patients.
* Evaluate the qualitative and quantitat... | Head and Neck Cancer | metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous c... | null | 1 | arm 1: eribulin mesylate | [
0
] | 1 | [
0
] | intervention 1: 1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle. | intervention 1: eribulin mesylate | 139 | Anchorage | Alaska | United States | -149.90028 | 61.21806
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Burbank | California | United States | -118.30897 | 34.18084
Duarte | California | United States | -117.97729 | 34.13945
Orange | California | United States | -117.85311 | 33.78779
Fort Lauderdale | ... | 40 | 0 | 0 | 0 | NCT00337129 | 1COMPLETED | 2011-07-01 | 2006-05-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,292 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis. | null | Multiple Sclerosis | FTY720 Interferon RRMS Multiple Sclerosis Efficacy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules ... | intervention 1: Fingolimod 1.25 mg intervention 2: Fingolimod 0.5 mg intervention 3: Interferon β-1a 30 µg | 170 | Cullman | Alabama | United States | -86.84361 | 34.17482
Phoenix | Arizona | United States | -112.07404 | 33.44838
Oceanside | California | United States | -117.37948 | 33.19587
Danbury | Connecticut | United States | -73.45401 | 41.39482
Fairfield | Connecticut | United States | -73.26373 | 41.14121
New Haven | Connec... | 2,307 | 0 | 0 | 0 | NCT00340834 | 1COMPLETED | 2011-07-01 | 2006-05-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 41 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. | PRIMARY OBJECTIVES:
I. Test whether the complete response rate among older patients with previously untreated acute myeloid leukemia (AML) with the del (5q) cytogenetic abnormality treated with lenalidomide is sufficiently high to warrant a phase III investigation.
II. Estimate the frequency and severity of toxicitie... | 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: INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to mainte... | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: lenalidomide | 54 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Redding | California | United States | -122.39168 | 40.58654
Roseville | California | United States | -121.28801 | 38.75212
Sacramento | California | United States | -121.4944 | 38.58157
Tampa | Florida | United States | -82.45843 | 27.94752
Decatur | Illino... | 45 | 0 | 0 | 0 | NCT00352365 | 1COMPLETED | 2011-07-01 | 2006-06-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The primary purpose of this study is to evaluate two glycemic control regimens on clinical outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the inflammatory and immune responses to the glycemic control regimens. | This is a multi-center explanatory trial of strict glycemic control for surgical patients with necrotizing soft tissue infection (NSTI). The primary objective of this study is to verify feasibility of the intervention, provide unbiased and evidence-based estimates of treatment effects, and obtain data needed to design ... | Necrotizing Fasciitis | Strict glycemic control | null | 2 | arm 1: Strict glycemic control with a blood glucose target range of 80-110 mg/dL arm 2: Conventional glycemic control with blood glucose target range of 110-140 mg/dL | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Blood glucose target range is 80-110 mg/dL. intervention 2: Blood glucose target range is 110-140 mg/dL. | intervention 1: Strict Glycemic control intervention 2: Conventional Glycemic Control | 2 | Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412 | 5 | 0 | 0 | 0 | NCT00353275 | 6TERMINATED | 2011-07-01 | 2009-08-01 | The University of Texas Health Science Center, Houston | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 32 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing ... | * Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days.
* Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle.
* Bevacizumab will be give... | Pancreatic Cancer Adenocarcinoma of the Pancreas | null | 1 | arm 1: single-arm, no masking | [
5
] | 3 | [
0,
0,
0
] | intervention 1: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects. intervention 2: Taken orally every day. Participants may continue to receive study treatment as long as... | intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Gemcitabine | 3 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 30 | 0 | 0 | 0 | NCT00366457 | 1COMPLETED | 2011-07-01 | 2006-08-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II trial is studying how well E7389 works as second-line therapy in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppi... | PRIMARY OBJECTIVE:
I. To determine the objective response (complete and partial) to E7389 in patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed after prior gemcitabine hydrochloride-based therapy.
SECONDARY OBJECTIVE:
I. To determine the antitumor activity of E7389,... | Adenocarcinoma of the Pancreas Pancreatic Cancer Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer | null | 1 | arm 1: Patients receive E7389 IV on days 1 and 8. | [
0
] | 1 | [
0
] | intervention 1: Given IV | intervention 1: eribulin mesylate | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 15 | 0 | 0 | 0 | NCT00383760 | 1COMPLETED | 2011-07-01 | 2006-08-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 38 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | Dr. Wang's merit review is aimed at providing a better understanding of the relationship between SLC6A3/SLC6A4 and the mental health of veterans exposed to high levels of combat stress, specifically focusing on PTSD symptoms, related co-morbidities, treatment outcomes and seeks new approaches to therapy for our Veteran... | Background: Post-traumatic Stress Disorder (PTSD), a debilitating condition that develops following exposure to trauma, is highly prevalent in military personnel and veterans due to high risk of trauma exposure in combat. Trauma exposure, as an environmental insult, is necessary, but itself is not sufficient to cause P... | PTSD | Clinical Genetics Monoamine transporter Pharmacogenetics Post Traumatic Stress Disorder | null | 1 | arm 1: This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond ... | [
5
] | 1 | [
0
] | intervention 1: SSRI | intervention 1: Paroxetine | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 38 | 0 | 0 | 0 | NCT00403455 | 1COMPLETED | 2011-07-01 | 2006-10-01 | VA Office of Research and Development | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 517 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.
The primary objective of the study is to evaluate the effect of fetal bovine serum \[FBS\]-free/human serum albumin \[HSA\]-free formulation of Interferon \[IFN\] beta-1a ... | null | Multiple Sclerosis | Rebif New Formulation Clinical Isolated Syndrome Multiple Sclerosis | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Single dose of RNF administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months, or 36 months for patients enrolled in the OL extension. intervention 2: Single dos... | intervention 1: RNF intervention 2: RNF intervention 3: Placebo | 67 | Mendoza | N/A | Argentina | -68.84582 | -32.88946
Sydney | N/A | Australia | 151.20732 | -33.86785
Graz | N/A | Austria | 15.45 | 47.06667
Innsbruck | N/A | Austria | 11.39454 | 47.26266
B-Leuven | N/A | Belgium | N/A | N/A
Bruges | N/A | Belgium | 3.22424 | 51.20892
Pleven | N/A | Bulgaria | 24.61667 | 43.41667
Rousse... | 655 | 0 | 0 | 0 | NCT00404352 | 1COMPLETED | 2011-07-01 | 2006-11-01 | Merck KGaA, Darmstadt, Germany | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blockin... | OBJECTIVES:
Primary
* To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
* To determine the time to progression.
Secondary
* To correlate c-kit mutational status with response to therapy.
* To evaluate the use of... | Mucosal Melanoma Acral/Lentiginous Melanoma Chronically Sun Damaged Melanomas | Imatinib Gleevec | null | 1 | arm 1: Imatinib | [
0
] | 1 | [
0
] | intervention 1: Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. | intervention 1: Imatinib | 5 | Denver | Colorado | United States | -104.9847 | 39.73915
Tampa | Florida | United States | -82.45843 | 27.94752
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Houston | Texas | United States | -95.36327 | 29.76328 | 24 | 0 | 0 | 0 | NCT00424515 | 1COMPLETED | 2011-07-01 | 2006-07-01 | Dana-Farber Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 212 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children. | Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school. They also have difficulty relating with peers. If left untreated, the disorder may cause adverse effects that can last into ... | Attention Deficit Disorder With Hyperactivity | ADHD Guanfacine Methylphenidate Focalin XR Pediatric Cognitive function Combination therapy | null | 3 | arm 1: weeks 1-4: Guanfacine weeks 5-8: Guanfacine + Placebo arm 2: weeks 1-4: Placebo weeks 5-8: Placebo+DMPH arm 3: weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH | [
1,
1,
0
] | 2 | [
0,
0
] | intervention 1: Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures intervention 2: Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects ... | intervention 1: Guanfacine intervention 2: Methylphenidate (MPH) | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 207 | 0 | 0 | 0 | NCT00429273 | 1COMPLETED | 2011-07-01 | 2007-01-01 | University of California, Los Angeles | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 228 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer | A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with International Federation of Gynecology (FIGO) Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Ch... | Neoplasms, Uterine Cervix Metastatic Cervical Cancer | pazopanib ErB1/ErB2 lapatinib persistent VEGF recurrent metastatic cervical cancer advanced FIGO Stage IVB | null | 3 | arm 1: Pazopanib plus lapatinib arm 2: Lapatinib arm 3: Pazopanib | [
0,
1,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: pazopanib (GW786034) intervention 2: lapatinib (GW572016) | 63 | Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
Stanford | California | United States | -122.16608 | 37.42411
Augusta | Georgia | United States | -81.97484 | 33.47097
Boston | Massachusetts | United States | -71.05977 | 42.35843
Albuquerque | ... | 226 | 0 | 0 | 0 | NCT00430781 | 1COMPLETED | 2011-07-01 | 2006-11-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
4
] | 101 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 0NONE | true | 0ALL | false | The diagnosis of growth hormone deficiency (GHD) in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests that are considered to be gold standard tests for the diagnosis of GHD are the insulin tolerance test (ITT) and growth hormone rel... | Thirty control subjects (i.e., without AGHD) were matched to the 30 AGHD patients who were not previously matched. Matching was based upon gender, age, BMI, and estrogen status for females. They received one oral dose of AEZS-130 followed by serial blood draws for growth hormone (GH), insulin-like growth factor 1 (IGF-... | Diagnosis of Adult Growth Hormone Deficiency (AGDH) | Ghrelin mimetic, growth hormone secretagogue | null | 2 | arm 1: A single oral administration of AEZS-130 (0.5 mg/kg po) as Growth Hormone Stimulation Test arm 2: This trial was set up as a multi-center, randomized, cross-over study investigating AEZS-130 as a Growth Hormone Stimulation Tests in terms of safety and efficacy compared to L-ARG+GHRH. When GHRH became unavailable... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: A single oral administration of AEZS-130 as Growth Hormone Stimulation Test intervention 2: A single administration of L-ARG+GHRH (iv bolus) followed by a 30min infusion of L-ARG as Growth Hormone Stimulation Test | intervention 1: AEZS-130 (formerly ARD-07) intervention 2: L-ARG+GHRH | 13 | Tempe | Arizona | United States | -111.90931 | 33.41477
Los Angeles | California | United States | -118.24368 | 34.05223
Torrance | California | United States | -118.34063 | 33.83585
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland ... | 153 | 0 | 0 | 0 | NCT00448747 | 1COMPLETED | 2011-07-01 | 2007-06-01 | AEterna Zentaris | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving. | The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatie... | Bipolar Disorder Alcohol Dependence | bipolar disorder alcohol dependence mania manic disorder depression | null | 2 | arm 1: This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. arm 2: This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine p... | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Inactive ingredient matching the active medication in appearance. intervention 2: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder. | intervention 1: Placebo intervention 2: Quetiapine | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 90 | 0 | 0 | 0 | NCT00457197 | 1COMPLETED | 2011-07-01 | 2007-03-01 | University of Texas Southwestern Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 5 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 2MALE | false | This phase II trial is studying sorafenib tosylate and gene expression in patients undergoing surgery for high-risk localized prostate cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Studying samples of blood a... | PRIMARY OBJECTIVES:
I. To compare the gene expression changes (transcript profiles) between pre- and post-treatment tumor specimens in order to determine the molecular impact of multi-kinase inhibition on prostate cancer. While this analysis will initially be targeted to tumor cells, gene expression changes in the sur... | Adenocarcinoma of the Prostate Stage II Prostate Cancer Stage III Prostate Cancer | null | 2 | arm 1: Patients receive sorafenib tosylate PO BID on days 1-14. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 days after completion of sorafenib tosylate, patients undergo radical prostatectomy on approximately day 43. arm 2: tients receive sor... | [
0,
0
] | 9 | [
0,
6,
10,
6,
3,
3,
10,
6,
6
] | intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Undergo prostatectomy intervention 7: Correlative studies intervention 8: Correlative studies intervention 9: Correlative studies | intervention 1: sorafenib tosylate intervention 2: microarray analysis intervention 3: immunohistochemistry staining method intervention 4: gene expression analysis intervention 5: needle biopsy intervention 6: therapeutic conventional surgery intervention 7: laboratory biomarker analysis intervention 8: western blotti... | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 5 | 0 | 0 | 0 | NCT00466752 | 1COMPLETED | 2011-07-01 | 2006-12-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Dr... | PRIMARY OBJECTIVES:
I. To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen.
SECONDARY OBJECTIVES:
I. To determine the extent... | Brenner Tumor Fallopian Tube Cancer Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mixed Epithelial Carcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Ovarian Undifferentiated Adenocarcinoma Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stag... | null | 1 | arm 1: INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANC... | [
0
] | 4 | [
2,
0,
10,
10
] | intervention 1: Given SC intervention 2: Given IV intervention 3: Correlative studies intervention 4: Correlative studies | intervention 1: sargramostim intervention 2: paclitaxel albumin-stabilized nanoparticle formulation intervention 3: laboratory biomarker analysis intervention 4: immunologic technique | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 21 | 0 | 0 | 0 | NCT00466960 | 1COMPLETED | 2011-07-01 | 2006-05-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug trials. | Familial Hypercholesterolemia (FH) is an autosomal dominant metabolic disorder characterized by markedly elevated low density lipoprotein (LDL), premature onset of atherosclerosis, and development of xanthomata. There are two distinct subpopulations that have a high unmet medical need due to the lack of alternative the... | Lipid Metabolism, Inborn Errors Hypercholesterolemia, Autosomal Dominant Hyperlipidemias Metabolic Diseases Hyperlipoproteinemia Type II Metabolism, Inborn Errors Genetic Diseases, Inborn Infant, Newborn, Diseases Metabolic Disorder Congenital Abnormalities Hypercholesterolemia Hyperlipoproteinemias Dyslipidemias Lipid... | Familial Hypercholesterolemia Heterozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia ISIS 301012 mipomersen Open Label Extension | null | 2 | arm 1: Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years. arm 2: Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first... | [
0,
0
] | 1 | [
0
] | intervention 1: 200 mg/ml, in 1 ml solution for subcutaneous injection. | intervention 1: mipomersen sodium | 5 | Chicago | Illinois | United States | -87.65005 | 41.85003
Auburn | Maine | United States | -70.23117 | 44.09785
Biddeford | Maine | United States | -70.45338 | 43.49258
Scarborough | Maine | United States | -70.32172 | 43.57814
Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 21 | 0 | 0 | 0 | NCT00477594 | 1COMPLETED | 2011-07-01 | 2007-05-01 | Kastle Therapeutics, LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 95 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer. | null | Breast Cancer | recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer | null | 1 | arm 1: The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at... | [
0
] | 6 | [
2,
0,
0,
0,
0,
10
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None | intervention 1: trastuzumab intervention 2: cyclophosphamide intervention 3: doxorubicin hydrochloride intervention 4: lapatinib ditosylate intervention 5: paclitaxel intervention 6: laboratory biomarker analysis | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427 | 95 | 0 | 0 | 0 | NCT00482391 | 1COMPLETED | 2011-07-01 | 2007-03-01 | Memorial Sloan Kettering Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 318 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease. | Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of COPD, what clinical variables are associated ... | Chronic Obstructive Pulmonary Disease | COPD Antibiotics | null | 2 | arm 1: Placebo pills t.i.d. for 8 days arm 2: Amoxycillin and clavulanate t.i.d. for 8 days | [
2,
1
] | 2 | [
0,
0
] | intervention 1: One pill to be taken every eight hours for 8 days intervention 2: 500-125 mg to be taken every eight hours for 8 days | intervention 1: Placebo intervention 2: Amoxicillin and clavulanic acid | 13 | Barcelona | Catalonia | Spain | 2.15899 | 41.38879
Barcelona | Catalonia | Spain | 2.15899 | 41.38879
Figueres | Catalonia | Spain | 2.96163 | 42.26645
Girona | Catalonia | Spain | 2.82493 | 41.98311
Girona | Catalonia | Spain | 2.82493 | 41.98311
Hostalric | Catalonia | Spain | 2.63333 | 41.75
Lleida | Catalonia | Spa... | 310 | 0 | 0 | 0 | NCT00495586 | 1COMPLETED | 2011-07-01 | 2007-10-01 | Catalan Society of Family Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized n... | PRIMARY OBJECTIVES:
I. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.
II. Det... | Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma | null | 1 | arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Paclitaxel Albumin-Stabilized Nanoparticle Formulation | 20 | Aurora | Colorado | United States | -104.83192 | 39.72943
New Britain | Connecticut | United States | -72.77954 | 41.66121
Lewes | Delaware | United States | -75.13935 | 38.77456
Chicago | Illinois | United States | -87.65005 | 41.85003
Elkton | Maryland | United States | -75.83327 | 39.60678
Worcester | Massachusetts ... | 47 | 0 | 0 | 0 | NCT00499252 | 1COMPLETED | 2011-07-01 | 2007-06-01 | Gynecologic Oncology Group | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 27 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery. | This is a phase II one arm study. Patients with HER2(Human Epidermal Growth Factor Receptor 2) positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.
Approximately 50 patients will take part at multi-sites with potentially 20 patients parti... | Breast Cancer | Breast Cancer | null | 1 | arm 1: Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ... | [
1
] | 3 | [
0,
0,
0
] | intervention 1: Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion.
As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52. int... | intervention 1: Pre operativeTrastuzumab intervention 2: ABI-007 (Abraxane) intervention 3: Vinorelbine | 2 | Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United States | -84.38798 | 33.749 | 27 | 0 | 0 | 0 | NCT00503750 | 1COMPLETED | 2011-07-01 | 2008-04-01 | Emory University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | false | The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption. | null | Insomnia Spinal Cord Injury Tetraplegia Sleep Disorders | sleep melatonin spinal cord injury insomnia tetraplegia | null | 2 | arm 1: 8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over) arm 2: placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over) | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 8 mg nightly intervention 2: Nightly 8mg of placebo (same appearance as ramelteon) | intervention 1: Ramelteon intervention 2: Placebo | 1 | Palo Alto | California | United States | -122.14302 | 37.44188 | 8 | 0 | 0 | 0 | NCT00507546 | 1COMPLETED | 2011-07-01 | 2007-07-01 | US Department of Veterans Affairs | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 514 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease. | To maintain treatment blind, two different active patch sizes were used (10 cm\^2 \& 20 cm\^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose. | Parkinson's Disease | Parkinson's disease rotigotine patch transdermal dopamine agonist off time Neupro | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
2
] | 5 | [
0,
0,
10,
0,
0
] | intervention 1: 2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks intervention 2: 4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks intervention 3: Placebo transdermal patch applied daily intervention 4: 6 mg... | intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo intervention 4: Rotigotine intervention 5: Rotigotine | 77 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Gilbert | Arizona | United States | -111.78903 | 33.35283
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | Unite... | 514 | 0 | 0 | 0 | NCT00522379 | 1COMPLETED | 2011-07-01 | 2007-07-01 | UCB Pharma | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
1\. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with \<5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a his... | Fludarabine is a chemotherapy drug that is approved for the treatment of patients with Chronic Lymphocytic Leukemia (CLL). Cyclophosphamide is also a chemotherapy drug that is commonly used to treat patients with CLL. Rituximab and alemtuzumab are special proteins (antibodies) that specifically target and attach to pro... | Leukemia Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia CML Leukemia Cyclophosphamide Fludarabine Alemtuzumab Rituximab CFAR | null | 1 | arm 1: CFAR = Cyclophosphamide 200 mg/m\^2/day 3-5 intravenous (IV) 5-30 minutes, Fludarabine 20 mg/m\^2/day 3-5 IV 5-30 minutes, Alemtuzumab 30 mg 1, 3,5 IV 2-4 hours, and Rituximab 375 mg/m\^2/day 2 IV 4-6 hours | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 200 mg/m\^2/day 3-5 IV 5-30 minutes intervention 2: 20 mg/m\^2/day 3-5 IV 5-30 minutes intervention 3: 30 mg Days 1, 3, 5 IV 2-4 hours intervention 4: 375 mg/m\^2/day 2 IV 4-6 hours | intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Alemtuzumab intervention 4: Rituximab | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 60 | 0 | 0 | 0 | NCT00525603 | 1COMPLETED | 2011-07-01 | 2005-06-01 | M.D. Anderson Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 9 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX based therapy on postoperative problems after liver surgery for patients with metastatic colorectal cancer. | Although early stage, localized colon and rectal cancers are associated with 5 year survival rates of nearly 90%, only a minority of patients present with localized disease. Unfortunately, at the time of their initial presentation, approximately 35% of patients with colon or rectal cancer have metastatic disease. Nearl... | Colorectal Cancer Metastases | Colorectal Cancer Metastasis Neoadjuvant Therapy | null | 2 | arm 1: Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 m... | [
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None | intervention 1: Cetuximab intervention 2: Bevacizumab intervention 3: Leucovorin intervention 4: Oxaliplatin intervention 5: Fluorouracil | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 9 | 0 | 0 | 0 | NCT00537823 | 6TERMINATED | 2011-07-01 | 2007-06-01 | Washington University School of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin. | null | Impaired Glucose Tolerance | null | 2 | arm 1: Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily. arm 2: Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: exenatide 10 mcg twice daily intervention 2: metformin 500 twice daily | intervention 1: Exenatide intervention 2: Metformin | 2 | Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483
Saint Paul | Minnesota | United States | -93.09327 | 44.94441 | 50 | 0 | 0 | 0 | NCT00546728 | 1COMPLETED | 2011-07-01 | 2007-10-01 | St. Paul Heart Clinic | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 60 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed b... | OBJECTIVES:
* To evaluate the outcome of patients with poor-risk, age-adjusted International Prognostic Index high- and high-intermediate-risk, intermediate- and high-grade non-Hodgkin lymphoma undergoing high-dose therapy comprising etoposide and cyclophosphamide, either carmustine or total-body irradiation, and auto... | Lymphoma | stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV mantle cell lymphoma stage III mantle cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large ... | null | 2 | arm 1: total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematologic stem cell transplantation, peripheral blood stem cell transplantation arm 2: Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood st... | [
1,
1
] | 7 | [
0,
0,
0,
3,
3,
4,
0
] | intervention 1: Unique to the Carmustine in Conditioning arm intervention 2: Used in Both Arms intervention 3: Used in Both Arms intervention 4: Both arms are given autologous stem cell transplantation intervention 5: Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the ma... | intervention 1: carmustine intervention 2: cyclophosphamide intervention 3: etoposide intervention 4: autologous hematopoietic stem cell transplantation intervention 5: peripheral blood stem cell transplantation intervention 6: total-body irradiation intervention 7: G-CSF | 2 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Duarte | California | United States | -117.97729 | 34.13945 | 60 | 0 | 0 | 0 | NCT00559104 | 1COMPLETED | 2011-07-01 | 1998-10-01 | City of Hope Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value... | null | ESRD Diabetes | ESRD Diabetes CAPD APD | null | 2 | arm 1: Dianeal only arm 2: Physioneal, Extraneal, Nutrineal | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose) intervention 2: Physioneal 40 or Physioneal 35 intervention 3: Extraneal - 7.5% Icodextrin intervention 4: Nutrineal - 1.1% Amino Acids | intervention 1: Dianeal intervention 2: Physioneal intervention 3: Extraneal intervention 4: Nutrineal | 16 | Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Sydney | New South Wales | Australia | 151.20732 | -33.86785
Sydney | New South Wales | Australia | 151.20732 | -33.86785
Wollongong | New South Wales | Australia | 150.89345 | -34.424
Brisbane | Queensland | Australia | 153.02809 | -27.46794
Adelaide | S... | 251 | 0 | 0 | 0 | NCT00567398 | 1COMPLETED | 2011-07-01 | 2008-04-01 | Vantive Health LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline ... | The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the un... | ESRD Diabetes CAPD APD | ESRD Diabetes CAPD APD | null | 2 | arm 1: Dianeal only arm 2: PEN solutions: Nutrineal, Extraneal, and Physioneal | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Physioneal 40 or Physioneal 35 intervention 2: Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose) intervention 3: 7.5% Icodextrin intervention 4: Amino Acids 1.1% | intervention 1: Physioneal intervention 2: Dianeal intervention 3: Extraneal intervention 4: Nutrineal | 19 | Shatin | N.T. | Hong Kong | 114.18333 | 22.38333
Tai Po | N.T. | Hong Kong | 114.16877 | 22.45007
Kowloon | N/A | Hong Kong | 114.18333 | 22.31667
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.752... | 251 | 0 | 0 | 0 | NCT00567489 | 1COMPLETED | 2011-07-01 | 2008-01-01 | Vantive Health LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 21 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | Literature regarding the effect of food on the pharmacokinetic (PK) profile of enteric-coated mycophenolate sodium combined with tacrolimus and corticosteroid withdrawal is lacking. The objective of this study is to identify pharmacokinetic variables of mycophenolate sodium (Myfortic®) in the fed and fasting state in s... | Mycophenolate sodium (Myfortic®) is an antiproliferative immunosuppressant used in renal transplantation. Mycophenolate sodium is formulated as an enteric coated tablet that releases mycophenolic acid (MPA) which in turn inhibits inosine monophosphate dehydrogenase (IMPDH). Through inhibition of IMPDH, the de novo path... | Kidney Transplantation | null | 2 | arm 1: Mycophenolate sodium taken with a meal. arm 2: Mycophenolate sodium taken separately from food by 2 hours. | [
0,
0
] | 1 | [
0
] | intervention 1: Myfortic 720 mg orally twice daily | intervention 1: Myfortic | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | 0 | 0 | 0 | NCT00585468 | 1COMPLETED | 2011-07-01 | 2007-12-01 | University of Utah | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF). | Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated thi... | Atrial Fibrillation Heart Failure | Atrial Fibrillation Heart Failure AV Node ablation Cardiac pacemaker Antiarrhythmic drug | null | 2 | arm 1: FDA approved rate and rhythm control drugs arm 2: AV Node ablation and device implant | [
1,
1
] | 2 | [
0,
1
] | intervention 1: Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.
Rate Control:
Beta-Blocker:
* metoprolol
* atenolol
* carvedilol
Calcium Channel Blocker:
* verapamil
* diltiazem
Rhythm Control:
* procainamide
* quinidine
*... | intervention 1: FDA approved rate and rhythm control drugs intervention 2: AV Node ablation and device implant | 6 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Evansville | Indiana | United States | -87.55585 | 37.97476
Rochester | Minnesota | United States | -92.4699 | 44.02163
Portland | Oregon | United States | -122.67621 | 45.52345
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
Calgary | Alberta ... | 27 | 0 | 0 | 0 | NCT00589303 | 6TERMINATED | 2011-07-01 | 2007-12-01 | Mayo Clinic | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 262 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN). | null | Neuralgia | Neuralgia neuropathy | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally). | intervention 1: E2007 | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 524 | 0 | 0 | 0 | NCT00592904 | 1COMPLETED | 2011-07-01 | 2008-01-01 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 317 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated. | null | Macular Edema Associated With Diabetes Mellitus | randomized sham-controlled multicenter macular edema | null | 2 | arm 1: None arm 2: None | [
3,
0
] | 2 | [
0,
0
] | intervention 1: Clinicians decision to use optional laser therapy. intervention 2: Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years. | intervention 1: Standard of Care intervention 2: Macugen | 73 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Santa Ana | California | United States | -117.86783 | 33.74557
Denver | Colorado... | 446 | 0 | 0 | 0 | NCT00605280 | 1COMPLETED | 2011-07-01 | 2005-09-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 375 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo ... | This is an efficacy study to test the ability of WR 279,396 topical cream to treat uncomplicated cutaneous leishmaniasis caused primarily by Leishmania major in adults and children in Tunisia where the disease in endemic. A total of 375 volunteers will be randomized to the three arms described above to determine produc... | Cutaneous Leishmaniasis | cutaneous leishmaniasis, topical treatment, Tunisia | null | 3 | arm 1: WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) arm 2: Paromomycin Alone topical cream (15% paromomycin topical cream) arm 3: The cream base without the addition of paromomycin or gentamicin | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. intervention 2: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions dai... | intervention 1: WR 279,396 topical cream intervention 2: Paromomycin Alone topical cream intervention 3: Vehicle placebo cream | 1 | Tunis | N/A | Tunisia | 10.16579 | 36.81897 | 375 | 0 | 0 | 0 | NCT00606580 | 1COMPLETED | 2011-07-01 | 2008-01-01 | U.S. Army Medical Research and Development Command | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 191 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before. | The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety con... | Colorectal Neoplasms | metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study | null | 2 | arm 1: Treatment arm A - sunitinib plus mFOLFOX6 arm 2: Treatment arm B - bevacizumab plus mFOLFOX6 | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2). intervention 2: FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo... | intervention 1: sunitinib intervention 2: mFOLFOX6 intervention 3: bevacizumab intervention 4: mFOLFOX6 | 97 | Fairhope | Alabama | United States | -87.90333 | 30.52297
Mobile | Alabama | United States | -88.04305 | 30.69436
Chandler | Arizona | United States | -111.84125 | 33.30616
Mesa | Arizona | United States | -111.82264 | 33.42227
Bentonville | Arkansas | United States | -94.20882 | 36.37285
Fayetteville | Arkansas | Unit... | 189 | 0 | 0 | 0 | NCT00609622 | 6TERMINATED | 2011-07-01 | 2008-04-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PD... | The primary objective of this study is to evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have de... | Pulmonary Arterial Hypertension | ambrisentan PAH combination therapy phosphodiesterase type-5 inhibitor (PDE-5i) cardiovascular endothelin receptor antagonist ERA | null | 2 | arm 1: Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i; sildenafil or tadalafil). arm 2: Patients were assigned placebo at randomization and received at least one dose of place... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Ambrisentan was administered orally once daily; dose level was 5 mg for the first 4 weeks, followed by 10 mg for the remainder of the study; ambrisentan was supplied as 5-mg and 10-mg tablets. intervention 2: Placebo to match ambrisentan was administered orally once daily. intervention 3: Sildenafil was... | intervention 1: Ambrisentan intervention 2: Placebo intervention 3: Sildenafil intervention 4: Tadalafil | 30 | Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Torrance | California | United States | -118.34063 | 33.83585
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Gainesville | ... | 75 | 0 | 0 | 0 | NCT00617305 | 1COMPLETED | 2011-07-01 | 2008-04-01 | Gilead Sciences | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Objectives:
Primary:
To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free survival.
Secondary:
1. To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent sm... | The Study Drugs:
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the effects of Vascular endothelial growth factor (VEGF), a blood-vessel stimulating agent that plays an... | Cervical Cancer Uterine Cancer | Cervical Cancer Uterine Cancer Bevacizumab Avastin Anti-VEGF monoclonal antibody rhuMAb-VEGF Paclitaxel Taxol | null | 1 | arm 1: Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m\^2 IV weekly. | [
0
] | 2 | [
0,
0
] | intervention 1: 10 mg/kg IV twice weekly on days 1 and 15. intervention 2: 60 mg/m\^2 IV weekly on days 1, 8, 15, and 22. | intervention 1: Bevacizumab intervention 2: Paclitaxel | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 3 | 0 | 0 | 0 | NCT00626561 | 6TERMINATED | 2011-07-01 | 2008-02-01 | M.D. Anderson Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 13 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 2MALE | null | To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed. | null | Hypertension | null | 2 | arm 1: Active Drug arm 2: Tablet which has the same appearance and taste but doesn't contain active ingredient | [
0,
2
] | 1 | [
0
] | intervention 1: None | intervention 1: SK3530 100mg, Placebo, Amlodipine | 2 | Pusan | N/A | South Korea | 128.3681 | 36.3809
Seoul | N/A | South Korea | 126.9784 | 37.566 | 24 | 0 | 0 | 0 | NCT00626743 | 1COMPLETED | 2011-07-01 | 2008-05-01 | SK Chemicals Co., Ltd. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 20 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This single center Phase I dose escalation trial will evaluate the safety, tolerability and efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts 2 and 3 will be limited to locally recurre... | LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 ... | Breast Cancer | Refractory Malignancy Breast Cancer LBH589 Capecitabine Lapatinib | null | 3 | arm 1: MTD, LBH589 with Capecitabine arm 2: LBH589 and Lapatinib arm 3: LBH589, Capecitabine and Lapatinib (Breast Cancer Patients) | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once dete... | intervention 1: LBH589 intervention 2: Capecitabine intervention 3: Lapatinib | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 20 | 0 | 0 | 0 | NCT00632489 | 1COMPLETED | 2011-07-01 | 2008-05-01 | SCRI Development Innovations, LLC | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES. | null | Night Eating Syndrome | Eating disorder | null | 2 | arm 1: Escitalopram arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 10-20 mg intervention 2: Placebo | intervention 1: Escitalopram intervention 2: Placebo | 2 | St Louis | Missouri | United States | -90.19789 | 38.62727
Durham | North Carolina | United States | -78.89862 | 35.99403 | 40 | 0 | 0 | 0 | NCT00636649 | 1COMPLETED | 2011-07-01 | 2008-10-01 | Duke University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.