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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
2
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to determine the most tolerable and safe dose of ZD6474 (Zactima, Vandetanib) when given with standard chemotherapy, radiation therapy and surgery in patients with cancer of the esophagus | Epidermal Growth Factor Receptor (EGFR) is known to be an important prognostic factor for patients with esophageal cancer-overexpression is associated with a worse prognosis. Review of the literature demonstrates presence of EGFR expression in up 90% of cases of esophageal cancer. Additionally, Vascular Endothelial Gro... | Cancer of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Cancer of the Stomach | null | 1 | arm 1: Vandetanib 100 mg (6 patients) or 200 mg (3 patients) orally daily during the conventional 3D-guided conformal radiation therapy plus chemotherapy with carboplatin (AUC 5) on days 1 and 29, paclitaxel 50 mg/m2 i.v. weekly on days 1, 8, 15, 22, 29; and continuous infusion of 5-fluorouracil at 225 mg/m2 for 96 hou... | [
5
] | 5 | [
0,
0,
0,
0,
4
] | intervention 1: Vandetanib 100mg orally escalating to doses of 200 mg daily 7 days a week until completion of radiation therapy intervention 2: 5-FU 225 mg/m2/day continuous infusion over96 hours during radiation therapy intervention 3: Carboplatin AUC=5 days 1 and 29 during radiation therapy intervention 4: Paclitaxel... | intervention 1: Vandetanib intervention 2: 5 Fluorouracil (FU) intervention 3: Carboplatin intervention 4: Paclitaxel intervention 5: External Beam Radiation Therapy (RT) | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 9 | 0 | 0 | 0 | NCT01183559 | 1COMPLETED | 2011-08-01 | 2008-08-07 | Fox Chase 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
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in certain genes that may make them more likely to respond to this new medication. As tumors develop, the cells within the... | null | Colon Cancer Rectal Cancer | MK-2206 colon rectal 10-068 | null | 1 | arm 1: This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens. | [
0
] | 1 | [
0
] | intervention 1: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects. | intervention 1: MK-2206 | 1 | New York | New York | United States | -74.00597 | 40.71427 | 1 | 0 | 0 | 0 | NCT01186705 | 6TERMINATED | 2011-08-01 | 2010-08-01 | 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 |
[
2
] | 38 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 0ALL | null | This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of alegli... | null | Healthy Volunteer | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 1 | [
0
] | intervention 1: single oral dose | intervention 1: aleglitazar | 2 | Orlando | Florida | United States | -81.37924 | 28.53834
Knoxville | Tennessee | United States | -83.92074 | 35.96064 | 38 | 0 | 0 | 0 | NCT01197911 | 1COMPLETED | 2011-08-01 | 2010-09-01 | Hoffmann-La Roche | 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
] | 111 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis. | null | Endogenous Anterior Uveitis | null | 2 | arm 1: Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period arm 2: Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment intervention 2: 1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's dete... | intervention 1: Difluprednate 0.05% ophthalmic emulsion intervention 2: Prednisolone acetate 1.0% ophthalmic suspension | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 110 | 0 | 0 | 0 | NCT01201798 | 1COMPLETED | 2011-08-01 | 2010-10-01 | Alcon Research | 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
] | 34 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also test for safety of pazopanib when administered with ketoconazole or esomeprazole. | The study is a 2-arm, open-label, repeat-dose, single sequence, crossover, study designed to evaluate the effects of ketoconazole (Arm A) and esomeprazole (Arm B) on the pharmacokinetics (PK) of oral pazopanib in subjects with solid tumor malignancies. This study will compare the PK parameters of oral pazopanib and its... | Cancer | Esomeprazole Pharmacogenetics Pharmacokinetics Ketoconazole Pazopanib Drug Interaction Safety Solid Tumors | null | 2 | arm 1: Administration of oral pazopanib 400mg (2 200-mg tablets) once-daily each morning for at least 7 consecutive doses during Period 1. Then administration of oral ketoconazole 400 mg (2 - 200 mg tablets) followed immediately by pazopanib 400 mg (2 -200 mg tablets) once-daily each morning for a total of 5 consecutiv... | [
0,
0
] | 1 | [
0
] | intervention 1: Adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, platelet derivative growth factor receptor (PDGFR) | intervention 1: pazopanib | 2 | New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Greenville | South Carolina | United States | -82.39401 | 34.85262 | 68 | 0 | 0 | 0 | NCT01205230 | 1COMPLETED | 2011-08-01 | 2010-09-01 | 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 |
[
5
] | 75 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in patients with schizophrenia stabilized on a single antipsychotic medication. | null | Schizophrenia | Stable schizophrenia cognitive functioning | null | 2 | arm 1: Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days arm 2: Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days | [
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days. interven... | intervention 1: Seroquel XR- quetiapine fumarate extended release intervention 2: Seroquel IR - quetiapine fumarate intervention 3: Placebo matching Seroquel XR intervention 4: Placebo matching Seroquel IR | 20 | Vienna | N/A | Austria | 16.37208 | 48.20849
Middelfart | N/A | Denmark | 9.73054 | 55.50591
Berlin | N/A | Germany | 13.41053 | 52.52437
Bochum | N/A | Germany | 7.21648 | 51.48165
Hamburg | N/A | Germany | 9.99302 | 53.55073
München | N/A | Germany | 13.31243 | 51.60698
Rottweil | N/A | Germany | 8.62719 | 48.16783
G... | 125 | 0 | 0 | 0 | NCT01213836 | 1COMPLETED | 2011-08-01 | 2010-11-01 | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Da... | null | Pulmonary Tuberculosis | Tuberculosis EBA TMC207 pretomanid Early Bactericidal Activity Pulmonary Tuberculosis PA-824 bedaquiline pyrazinamide moxifloxacin ethambutol rifafour | null | 6 | arm 1: TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo administered once daily arm 2: TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyraz... | [
0,
0,
0,
0,
1,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 200 mg tablet, once daily for 14 days intervention 2: Dosed by Weight intervention 3: TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 intervention 4: Rifafour e-275 intervention 5: moxifloxacin 400 mg | intervention 1: PA-824 intervention 2: Pyrazinamide intervention 3: TMC207 intervention 4: Rifafour intervention 5: Moxifloxacin | 2 | Cape Town | N/A | South Africa | 18.42322 | -33.92584
Cape Town | N/A | South Africa | 18.42322 | -33.92584 | 85 | 0 | 0 | 0 | NCT01215851 | 1COMPLETED | 2011-08-01 | 2010-10-01 | Global Alliance for TB Drug Development | 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
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The aim of this study is to establish the efficacy and duration of effect of intra-articular (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in seronegative oligoarthritis. All patients will have seronegative arthritis affecting less than 5 joints but including at least one kn... | null | Spondylarthropathies | seronegative oligoarthritis infliximab intraarticular | null | 3 | arm 1: Intra-articular injection of steroid (80mg depomedrone) arm 2: intra-articular injection of 100mg infliximab arm 3: intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight) | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: intra-articular injection of methylprednisolone (80mg given at baseline only) intervention 2: intra-articular injection of 100mg infliximab given at baseline only intervention 3: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14 | intervention 1: methylprednisolone intervention 2: Infliximab intervention 3: Infliximab | 1 | Leeds | West Yorkshire | United Kingdom | -1.54785 | 53.79648 | 1 | 0 | 0 | 0 | NCT01216631 | 6TERMINATED | 2011-08-01 | 2010-09-01 | University of Leeds | 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
] | 400 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone. | null | Type 2 Diabetes | Type 2 diabetes metformin treated inadequate control metformin treatment alone | null | 4 | arm 1: Dapagliflozin 2.5 mg twice-daily plus open-label metformin arm 2: Dapagliflozin 5.0 mg twice-daily plus open-label metformin arm 3: Dapagliflozin 10 mg once-daily plus open-label metformin arm 4: Placebo plus open-label metformin | [
0,
0,
0,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 2.5 mg tablet, taken orally, twice daily intervention 2: 5 mg tablet taken orally, twice daily intervention 3: 10 mg tablet taken orally, once daily intervention 4: \>/= 1500 mg total daily dose, tablets taken orally, twice daily intervention 5: placebo | intervention 1: dapagliflozin intervention 2: dapagliflozin intervention 3: dapagliflozin intervention 4: metformin intervention 5: placebo | 55 | Aßlar | N/A | Germany | 8.46273 | 50.59163
Berlin | N/A | Germany | 13.41053 | 52.52437
Biberach A.d. Riss | N/A | Germany | N/A | N/A
Bosenheim | N/A | Germany | 7.91382 | 49.84472
Dippoldiswalde | N/A | Germany | 13.66905 | 50.89621
Falkensee | N/A | Germany | 13.0927 | 52.56014
Meissen | N/A | Germany | 13.4737 | 51... | 400 | 0 | 0 | 0 | NCT01217892 | 1COMPLETED | 2011-08-01 | 2010-11-01 | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 3 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgki... | To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft-vs-host disease (GvHD) prevention in human leukocyte antigen (HLA)-matched related donor peripheral blood stem cell (PBSC) or marrow transplantation (BMT), collectively hematopoietic stem cell transplantation (HSCT). This study will ... | Hematologic Diseases Acute-graft-versus-host Disease Leukemia Non-Hodgkin Lymphoma (NHL) Hodgkin Lymphoma | null | 2 | arm 1: Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis. arm 2: FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis. | [
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Immunosuppressant administered orally to:
* Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day.
* Children \< 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram.
Daily dosage m... | intervention 1: Sirolimus intervention 2: Mycophenolate mofetil (MMF) intervention 3: Carmustine intervention 4: Etoposide intervention 5: Cyclophosphamide (Cyclo, CY) intervention 6: FTBI | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 3 | 0 | 0 | 0 | NCT01220297 | 6TERMINATED | 2011-08-01 | 2006-08-01 | Stanford 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
] | 404 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day. | This is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the 5% MTF formulation versus the foam vehicle formulation.
This clinical trial is designed to compare the ... | Androgenetic Alopecia | Female Pattern Baldness | null | 2 | arm 1: 5% Minoxidil Topical Foam arm 2: Vehicle Topical Foam | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks intervention 2: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Dura... | intervention 1: 5% Minoxidil Topical Foam intervention 2: Vehicle Topical Foam | 17 | Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Wichita | Kansas | United States | -97.33754 | 37.69224
Glenn Dale | Maryland | United States | -76.82053 | 38.98761
Clinton To... | 404 | 0 | 0 | 0 | NCT01226459 | 1COMPLETED | 2011-08-01 | 2010-09-01 | Johnson & Johnson Healthcare Products Division of McNEIL-PPC, 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 |
[
4
] | 311 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery. | null | Cataract | Inflammation Pain Ocular surgery | null | 2 | arm 1: Ophthalmic suspension 3% arm 2: Vehicle of mapracorat ophthalmic suspension | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Instill study medication into study eye per dosing instructions for 14 days intervention 2: Instill study medication into the study eye per dosing instructions for 14 days | intervention 1: Mapracorat intervention 2: Vehicle | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 311 | 0 | 0 | 0 | NCT01230125 | 1COMPLETED | 2011-08-01 | 2010-11-01 | Bausch & Lomb Incorporated | 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
] | 391 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12. | The study consisted of a screening period of approximately 7 to 14 days, an open label titration period of up to 6 weeks, and a double blind treatment period of 12 weeks.
Participants entered the open label titration period and received hydrocodone ER tablets beginning with 15 mg every 12 hours for 3 to 7 days. The ob... | Chronic Pain | osteoarthritis low back pain Moderate to Severe Pain | null | 2 | arm 1: Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain during the titration period. During the treatment period, participants were administered placebo tablets every 12 hours that matched the dosage deeme... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment ar... | intervention 1: Hydrocodone ER intervention 2: Placebo | 73 | Mobile | Alabama | United States | -88.04305 | 30.69436
Chandler | Arizona | United States | -111.84125 | 33.30616
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Buena Park | California | U... | 682 | 0 | 0 | 0 | NCT01240863 | 1COMPLETED | 2011-08-01 | 2010-11-01 | 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 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To determine the response to the combination of Revlimid (Lenalidomide)+ Vidaza (Azacitidine) in patients with relapsed/refractory CLL and SLL
Hypothesis- lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response. | Treatment response of lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response. | Chronic Lymphocytic Leukemia(CLL) Small Lymphocytic Lymphoma | chronic lymphocytic leukemia (CLL) Small Lymphocytic Lymphoma | null | 1 | arm 1: response to combination of azacitidine + lenalidomide A Phase II, Single Arm Study Examining the Combination of Revlimid (Lenalidomide) and Vidaza (Azacitidine) (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) | [
0
] | 2 | [
0,
0
] | intervention 1: Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and \< 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily o... | intervention 1: Revlimid intervention 2: Azacitidine | 1 | Hackensack | New Jersey | United States | -74.04347 | 40.88593 | 5 | 0 | 0 | 0 | NCT01241786 | 6TERMINATED | 2011-08-01 | 2010-07-01 | Hackensack Meridian Health | 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
] | 5 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | In this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in neonatal intensive care unit (NICU) infants. | A. Randomization of subjects: Infants will be randomized to receive Proparacaine versus no intervention based on computerized randomization performed by our statistician. Due to the lack of a placebo group, practitioners present at the time of examination will not able to be blinded to group assignment. Each infant wil... | Pain Retinopathy of Prematurity | Pain Retinopathy of Prematurity Neonates | null | 2 | arm 1: Infants in this group will receive 1 drop of Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops arm 2: Infants in this arm will not receive Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) prior to mydriatic eye drops. | [
0,
4
] | 1 | [
0
] | intervention 1: 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops | intervention 1: Proparacaine Hydrochloride Ophthalmic Solution | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 5 | 0 | 0 | 0 | NCT01266824 | 6TERMINATED | 2011-08-01 | 2010-12-01 | Children's Hospital of Philadelphia | 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
] | 205 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief. | null | Acute Ankle Sprain | Ankle Sprain, soft tissue injury | null | 2 | arm 1: None arm 2: Diclofenac sodium topical gel 1% | [
2,
0
] | 2 | [
0,
10
] | intervention 1: Topical gel 1%-4 times daily intervention 2: Topical gel-4 times daily | intervention 1: Diclofenac Sodium intervention 2: Placebo | 6 | Bad Nauheim | N/A | Germany | 8.73859 | 50.36463
Brühl | N/A | Germany | 6.90499 | 50.82928
Cologne | N/A | Germany | 6.95 | 50.93333
Essen | N/A | Germany | 7.01228 | 51.45657
Gilching | N/A | Germany | 11.2936 | 48.10755
Munich | N/A | Germany | 11.57549 | 48.13743 | 205 | 0 | 0 | 0 | NCT01272934 | 1COMPLETED | 2011-08-01 | 2011-01-01 | 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 |
[
0
] | 23 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache. | High Altitude Headache is the primary symptom of Acute Mountain Sickness. However, at present the reason why some individuals suffer from High Altitude Headache and others do not remains unknown. It is widely believed that elevated pressure within the brain leads to stretching of pain sensitive fibres and thus headache... | High Altitude Headache | High Altitude Headache; intra-cranial pressure; hypoxia | null | 2 | arm 1: Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). arm 2: Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). | [
0,
2
] | 2 | [
0,
0
] | intervention 1: During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two. intervention 2: During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thir... | intervention 1: Acetazolamide intervention 2: Lactose monohydrate | 1 | Bangor | Gwynedd | United Kingdom | -5.66802 | 54.66079 | 23 | 0 | 0 | 0 | NCT01288781 | 1COMPLETED | 2011-08-01 | 2011-07-01 | Bangor 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 |
[
2
] | 32 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | false | The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake. | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: LY2189265 (Dulaglutide) then Placebo: A single 1.5 milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 in Period 1, followed by a single SC injection of Placebo on Day 1 in Period 2.
On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose ... | [
0,
0
] | 5 | [
2,
0,
0,
0,
0
] | intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously intervention 3: Administered intravenously intervention 4: Administered intravenously intervention 5: Administered intravenously | intervention 1: LY2189265 intervention 2: Placebo intervention 3: Insulin intervention 4: Glucose intervention 5: Glucagon | 1 | Neuss | N/A | Germany | 6.68504 | 51.19807 | 62 | 0 | 0 | 0 | NCT01300260 | 1COMPLETED | 2011-08-01 | 2011-02-01 | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with heart failure. Subjects will undergo cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra (recombinant human Interleukin-1 receptor antagonist). | null | Heart Failure | Heart failure Inflammation Interleukin-1 Cardiopulmonary exercise | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Anakinra 100 mg subcutaneous injection daily | intervention 1: Anakinra | 1 | Richmond | Virginia | United States | -77.46026 | 37.55376 | 8 | 0 | 0 | 0 | NCT01300650 | 1COMPLETED | 2011-08-01 | 2011-02-01 | Virginia Commonwealth 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
] | 715 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age). | null | Seasonal Allergic Rhinitis SAR | Allergies Hayfever | null | 3 | arm 1: Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. arm 2: Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. arm 3: Partici... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm. interven... | intervention 1: BDP HFA intervention 2: Placebo nasal aerosol | 45 | Oxford | Alabama | United States | -85.83496 | 33.61427
Bell | California | United States | -118.18702 | 33.97751
Costa Mesa | California | United States | -117.91867 | 33.64113
Mission Viejo | California | United States | -117.672 | 33.60002
Orange | California | United States | -117.85311 | 33.78779
Paramount | Calif... | 714 | 0 | 0 | 0 | NCT01307319 | 1COMPLETED | 2011-08-01 | 2011-03-01 | 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
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | The purpose of this study is twofold:
1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in participants with high blood pressure who are currently taking lisinopril.
2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy volunteers wh... | null | Diabetes Mellitus, Type 2 | null | 4 | arm 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.
Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study. arm 2: Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8... | [
0,
2,
0,
0
] | 4 | [
2,
0,
0,
0
] | intervention 1: Administered subcutaneously intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered subcutaneously | intervention 1: LY2189265 intervention 2: Metoprolol intervention 3: Lisinopril intervention 4: Placebo | 3 | Honolulu | Hawaii | United States | -157.85833 | 21.30694
Evansville | Indiana | United States | -87.55585 | 37.97476
Dallas | Texas | United States | -96.80667 | 32.78306 | 89 | 0 | 0 | 0 | NCT01324388 | 1COMPLETED | 2011-08-01 | 2011-03-01 | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | This Phase 1 study will evaluate multiple doses across a range that has been found to be effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the Pharmacokinetic (PK) and metabolism of N6022... | This is a double-blind, randomized, placebo-controlled, multiple ascending dose study, in at least three ascending cohorts. Twenty-four subjects will be enrolled initially in the first three cohorts, with up to 40 subjects to be enrolled overall if additional cohorts are required to reach the maximum tolerated dose (MT... | Healthy | N6022, GSNORi | null | 4 | arm 1: Injectable formulation, given at doses per cohort of 5 mg given QD each day over 7 days. arm 2: Injectable formulation normal saline arm 3: Injectable formulation, given at doses of 10 mg given QD each day over 7 days. arm 4: Injectable formulation, given at doses per cohort of 20 mg given QD each day over 7 day... | [
1,
2,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Intravenous formulation, given at doses of 5 mg once each day over 7 days. intervention 2: Same administration procedures as active intervention 3: Intravenous formulation given at doses of 10 mg once each day over 7 days. intervention 4: Intravenous formulation given at doses of 20 mg once each day ove... | intervention 1: 5 mg/N6022 intervention 2: Placebo intervention 3: 10mg/N6022 intervention 4: 20mg/N6022 | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 25 | 0 | 0 | 0 | NCT01339897 | 1COMPLETED | 2011-08-01 | 2011-04-01 | Nivalis Therapeutics, 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 |
[
0
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a clinical research trial in which a novel preparatory regimen was developed for bone marrow transplant (BMT) which eliminates the primary obstacle to transplant, the lack of a matched sibling donor. It is believed this regimen is sufficiently efficacious and sufficiently gentle to apply to patients with sickle... | Hemoglobinopathies, such as sickle cell disease and thalassemia major, constitute a group of genetic diseases associated with significant morbidity and premature death. In the 1970s, the mean survival of patients with sickle cell disease was 14.3 years. With improvements in medical practice, this has improved such that... | Sickle Cell Anemia Sickle Cell-hemoglobin C Disease Sickle Cell-β0-thalassemia | sickle cell SS disease SC disease S-thalassemia transplant bone marrow transplant stem cell transplant matched sibling haploidentical hemoglobinopathy anemia desensitization | null | 1 | arm 1: Subjects receive the preparative regimen in 2 steps. The "first step" will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the "first step" of the transplant graft - the donor lymphocytes. The "second step" of the chemotherapy will be two doses of cyclophosph... | [
0
] | 8 | [
0,
0,
1,
4,
0,
0,
0,
3
] | intervention 1: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen intervention 2: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine intervention 3: Subjects will receive the cellular product in 2 s... | intervention 1: Fludarabine intervention 2: Cytarabine intervention 3: Cellular Infusions intervention 4: Total Body Irradiation intervention 5: Cyclophosphamide intervention 6: Bortezomib intervention 7: Rituximab intervention 8: Plasmapheresis | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 2 | 0 | 0 | 0 | NCT01350232 | 6TERMINATED | 2011-08-01 | 2009-09-01 | Sidney Kimmel Cancer Center at Thomas Jefferson 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 |
[
2
] | 14 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqu... | This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in app... | Allergic Rhinitis (AR) | Ciclesonide Allergic Rhinitis | null | 2 | arm 1: A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle arm 2: A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray s... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister intervention 2: A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle | intervention 1: ciclesonide nasal aerosol intervention 2: mometasone Aqueous (AQ) nasal spray | 1 | Ruddington Fields | Ruddington | United Kingdom | N/A | N/A | 28 | 0 | 0 | 0 | NCT01371786 | 1COMPLETED | 2011-08-01 | 2011-06-01 | Sumitomo Pharma America, 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
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through \<24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in... | Phase II, randomized, open-label, single-center, study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects across two dose levels (Dose Level 1 consists of a 0.7 mcg/kg loading dose immediately followed by a 0.5 mcg/kg/hr maintenance infusion; Dose Level 2 consists of a 1.0 mcg... | Sedation Pain | null | 2 | arm 1: Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion arm 2: Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion | [
0,
0
] | 1 | [
0
] | intervention 1: For sedation according to protocol | intervention 1: Dexmedetomidine | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 5 | 0 | 0 | 0 | NCT01378988 | 1COMPLETED | 2011-08-01 | 2011-06-01 | Hospira, now a wholly owned subsidiary of 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
] | 253 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 0ALL | false | A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours. | null | Pain | Self Selection Tria | null | 1 | arm 1: Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject we... | [
0
] | 2 | [
0,
0
] | intervention 1: Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain intervention 2: Commercially available Advil; oral caplet upon incidence of pain | intervention 1: Naproxen sodium ER (BAYH6689) intervention 2: Advil | 10 | Anaheim | California | United States | -117.9145 | 33.83529
Yorba Linda | California | United States | -117.81311 | 33.88863
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Griffin | Georgia | United States | -84.26409 | 33.24678
Andover | Minnesota | United States | -93.29134 | 45.2333
Roseville | Minn... | 237 | 0 | 0 | 0 | NCT01383486 | 1COMPLETED | 2011-08-01 | 2011-07-01 | 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 |
[
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery. | null | Cataract | bromfenac concentrations ISV-303 Bromday | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 0.075% bromfenac in DuraSite dosed QD intervention 2: 0.09% bromfenac dosed QD | intervention 1: ISV-303 intervention 2: Bromday™ | 0 | null | 59 | 0 | 0 | 0 | NCT01387464 | 1COMPLETED | 2011-08-01 | 2011-07-01 | Sun Pharmaceutical Industries Limited | 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 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study. | null | Depressive Disorder, Major | null | 2 | arm 1: Period 1: Single 18-mg (milligram) oral dose of LY2216684 administered in fasted state. Period 2: Single 18-mg oral dose of LY2216684 administered in fed state. Periods will be separated by a minimum of 7 days. arm 2: Period 1: Single 18-mg oral dose of LY2216684 administered in fed state. Period 2: Single 18-mg... | [
0,
0
] | 1 | [
0
] | intervention 1: Administered orally | intervention 1: LY2216684 | 1 | Daytona Beach | Florida | United States | -81.02283 | 29.21081 | 48 | 0 | 0 | 0 | NCT01389765 | 1COMPLETED | 2011-08-01 | 2011-07-01 | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 22 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 2MALE | null | The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers | null | Healthy | null | 2 | arm 1: Tablet, Oral administration with 240 mL of water arm 2: Tablet, Oral administration with 240 mL of water | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: single dose intervention 2: single dose intervention 3: multiple doses | intervention 1: Afatinib intervention 2: Afatinib intervention 3: Rifampicin | 1 | Biberach | N/A | Germany | 8.03333 | 48.33333 | 44 | 0 | 0 | 0 | NCT01396265 | 1COMPLETED | 2011-08-01 | 2011-07-01 | Boehringer Ingelheim | 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
] | 36 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers. | null | Healthy Volunteers | Bioequivalence Healthy Volunteers | null | 2 | arm 1: Test Myrin P Forte Contains 150mg Rifampicin, 75mg Isoniazid, 275mg Ethambutol, 400mg Pyrazinamide arm 2: Reference Single drug reference preparations contain Rifampicin, Isoniazid, Ethambutol, Pyrazinamide | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose intervention 2: containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents | intervention 1: Myrin P Forte intervention 2: Single drug references | 1 | Singapore | N/A | Singapore | 103.85007 | 1.28967 | 71 | 0 | 0 | 0 | NCT01399788 | 1COMPLETED | 2011-08-01 | 2011-07-01 | 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 |
[
0
] | 591 | RANDOMIZED | PARALLEL | null | 2DOUBLE | false | 0ALL | false | Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.
Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for prevent... | null | Coronary Disease Verapamil Toxicity | Coronary Artery Disease Coronary Angiography Percutaneous Coronary Intervention Transradial Radial Artery Spasm Verapamil Adverse Effects | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. intervention 2: Intraarterial administration of 10 mL saline. | intervention 1: Verapamil intervention 2: Placebo | 1 | Budapest | N/A | Hungary | 19.04045 | 47.49835 | 591 | 0 | 0 | 0 | NCT01402427 | 1COMPLETED | 2011-08-01 | 2011-03-01 | State Health Center, Hungary | 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
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | true | The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bon... | Although multiple factors appear to be associated with the functional deterioration of advanced age, decreases in muscle mass and strength (sarcopenia) are commonly seen in aging subjects and are major risk factors for subsequent disability. There are many potential causes of sarcopenia and functional impairment in the... | Hormone Deficiency Aging | Growth Hormone Releasing Hormone Growth Hormone Insufficiency Aging Growth Hormone Physiologic Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones | null | 1 | arm 1: Drug: GHRH | [
0
] | 1 | [
0
] | intervention 1: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks | intervention 1: Growth Hormone Releasing Hormone (GHRH ) | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 13 | 0 | 0 | 0 | NCT01410799 | 6TERMINATED | 2011-08-01 | 2011-05-01 | University of Pennsylvania | 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 | 1PREVENTION | 1SINGLE | false | 0ALL | true | The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. | The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the b... | Cerebral Ischemia | propofol desflurane cerebrovascular circulation sitting | null | 2 | arm 1: anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane arm 2: anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available t... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly. intervention 2: anaesthesia was maintained by desflurane 4-7vol% intervention 3: administration of alfentanil 10 μg kg-1 for anesthetic induction intervention 4: administration of rocuronium 0.6 mg kg-1 for anesth... | intervention 1: propofol intervention 2: Desflurane intervention 3: alfentanil intervention 4: Rocuronium | 0 | null | 40 | 0 | 0 | 0 | NCT01436799 | 1COMPLETED | 2011-08-01 | 2011-03-01 | Gachon University Gil 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 |
[
2
] | 50 | RANDOMIZED | CROSSOVER | 5SCREENING | 0NONE | true | 0ALL | false | To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile. | null | Smoking Cessation | nicotine lozenge nicotine nicotine replacement therapy | null | 4 | arm 1: 2 mg test nicotine lozenge to be chewed. arm 2: 4 mg test nicotine lozenge to be chewed. arm 3: 2 mg reference nicotine lozenge to be chewed. arm 4: 4 mg reference nicotine lozenge to be chewed. | [
0,
0,
1,
1
] | 2 | [
0,
0
] | intervention 1: 2 mg nicotine lozenge in two formulations intervention 2: 4 mg nicotine lozenge in two formulations | intervention 1: Nicotine (2 mg) intervention 2: Nicotine (4 mg) | 1 | Lincoln | Nebraska | United States | -96.66696 | 40.8 | 185 | 0 | 0 | 0 | NCT01536704 | 1COMPLETED | 2011-08-01 | 2011-07-01 | 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 |
[
5
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs). | null | Epilepsy | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules intervention 2: matching placebo | intervention 1: Zonisamide at targeted daily doses of 100-500 mg/day intervention 2: Placebo administered to match targeted daily doses of 100-500 mg/day | 36 | Bonn | N/A | Germany | 7.09549 | 50.73438
Göttingen | N/A | Germany | 9.93228 | 51.53443
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hamburg | N/A | Germany | 9.99302 | 53.55073
Marburg | N/A | Germany | 8.77069 | 50.80904
Siegen | N/A | Germany | 8.02431 | 50.87481
Budapes... | 51 | 0 | 0 | 0 | NCT01546688 | 6TERMINATED | 2011-08-01 | 2008-11-01 | Eisai Limited | 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
] | 121 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intrave... | null | Rheumatoid Arthritis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 8 mg/kg iv every 4 weeks, total of 6 infusions | intervention 1: tocilizumab [RoActemra/Actemra] | 8 | Casablanca | N/A | Morocco | -7.61138 | 33.58831
Fés | N/A | Morocco | N/A | N/A
Kenitra | N/A | Morocco | -6.5802 | 34.26101
Khouribga | N/A | Morocco | -6.9063 | 32.88108
Marrakesh | N/A | Morocco | -7.99994 | 31.63416
Meknés | N/A | Morocco | N/A | N/A
Rabat | N/A | Morocco | -6.83255 | 34.01325
Salé | N/A | Morocco... | 121 | 0 | 0 | 0 | NCT01610791 | 1COMPLETED | 2011-08-01 | 2010-03-01 | Hoffmann-La Roche | 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
] | 63 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Amphetamines have been shown to improve cognition but its use is limited due to its side effects. Lisdexamfetamine is an amphetamine pro-drug, minimizing these effects and has been safely used in children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesize that lisdexamfetamin... | null | Multiple Sclerosis | null | 2 | arm 1: 30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks arm 2: Placebo will be administered in the same fashion as the treatment arm | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks intervention 2: sugar pill | intervention 1: lisdexamfetamine sulfate intervention 2: placebo | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 63 | 0 | 0 | 0 | NCT01615887 | 1COMPLETED | 2011-08-01 | 2009-11-01 | State University of New York at Buffalo | 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 | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic ... | PRIMARY OBJECTIVES:
I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patien... | Malignant Neoplasm | ondansetron palonosetron emetogenic chemotherapy HEC | null | 2 | arm 1: Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4. arm 2: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and ... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Given by mouth intervention 2: Given IV(intervenous infusion) intervention 3: Given PO intervention 4: Given PO | intervention 1: aprepitant intervention 2: palonosetron hydrochloride intervention 3: ondansetron intervention 4: dexamethasone | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 40 | 0 | 0 | 0 | NCT01640340 | 1COMPLETED | 2011-08-01 | 2011-01-01 | Ohio State University 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 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 1PREVENTION | 0NONE | false | 0ALL | true | Overweight and obesity, which afflicts \~65% of the U.S. population and more than 1 billion people worldwide, increases the risk of developing hypertension. Activation of the renin angiotensin system (RAS) is an important mechanism by which obesity leads to hypertension. In addition to its vasoconstricting and sodium r... | null | Overweight Obese Prehypertension Hypertension | angiotensin II obesity diabetes | null | 2 | arm 1: During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the fir... | [
0,
0
] | 1 | [
0
] | intervention 1: Crossover intervention comparing antihypertensive medication to no drug intervention. | intervention 1: Olmesartan medoxomil | 0 | null | 32 | 0 | 0 | 0 | NCT01684748 | 1COMPLETED | 2011-08-01 | 2009-02-01 | Virginia Polytechnic Institute and State 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 |
[
2
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and multiple doses. | This study is for research only and is not designed to treat a medical condition. | Postmenopausal Symptoms | Menopause Hot flashes Vasomotor symptoms Climacteric symptoms perimenopause Mesafem Brisdelle Low-Dose Mesylate salt of Paroxetine (LDMP) | null | 1 | arm 1: Brisdelle (paroxetine mesylate) Capsules taken orally with 240 mL of water for 20 days. | [
0
] | 1 | [
0
] | intervention 1: All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. | intervention 1: Brisdelle (paroxetine mesylate) | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 24 | 0 | 0 | 0 | NCT01829919 | 1COMPLETED | 2011-08-01 | 2011-07-01 | Noven Therapeutics | 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
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if... | This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months. | Cystic Fibrosis | CF | null | 2 | arm 1: A matching placebo (sugar pill) to esomeprazole 40mg twice daily arm 2: Esomeprazole 40mg twice daily | [
2,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: Sugar pill | intervention 1: Esomeprazole intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 17 | 0 | 0 | 0 | NCT01983774 | 1COMPLETED | 2011-08-01 | 2008-02-01 | Columbia 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 |
[
2
] | 75 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects | null | Healthy Volunteers | null | 3 | arm 1: Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe arm 2: Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT arm 3: Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately foll... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Apixaban | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 63 | 0 | 0 | 0 | NCT02034578 | 1COMPLETED | 2011-08-01 | 2011-07-01 | Bristol-Myers Squibb | 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
] | 5 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating factors, such as G-CSF or pegfilgrastim, may ... | OBJECTIVES:
Primary
* To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin and etoposide.
Secondary
* To evaluate th... | Lung Cancer | limited stage small cell lung cancer | null | 1 | arm 1: Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim. | [
0
] | 5 | [
0,
0,
0,
0,
4
] | intervention 1: 5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses. intervention 2: 6 mg via subcutaneous injection days 46 and 67 intervention 3: Concurrent: 120 mg/m\^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m\^2, IV on days 43-45 and days 65-66. intervention 4: Concurrent: 60 mg... | intervention 1: Filgrastim intervention 2: Pegfilgrastim intervention 3: Etoposide intervention 4: Cisplatin intervention 5: radiation therapy | 14 | Gainesville | Florida | United States | -82.32483 | 29.65163
Miami Beach | Florida | United States | -80.13005 | 25.79065
Lexington | Kentucky | United States | -84.47772 | 37.98869
Baltimore | Maryland | United States | -76.61219 | 39.29038
Billings | Montana | United States | -108.50069 | 45.78329
Omaha | Nebraska | ... | 5 | 0 | 0 | 0 | NCT00554463 | 1COMPLETED | 2011-08-03 | 2008-01-01 | Radiation Therapy 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 |
[
2
] | 30 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolle... | null | Schizophrenia Bipolar I Disorder | asenapine pediatric schizophrenia bipolar I disorder | null | 3 | arm 1: Participants 10 or 11 years of age arm 2: Participants 10 or 11 years of age arm 3: Cohort 3a: Participants 10 or 11 years of age
Cohort 3b: Participants 12 or 13 years of age
Cohort 3c: Participants 14 or 15 years of age
Cohort 3d: Participants 16 or 17 years of age | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7. intervention 2: Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7. intervention 3: Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose ... | intervention 1: Asenapine 2.5 mg intervention 2: Asenapine 5 mg intervention 3: Asenapine 10 mg | 0 | null | 30 | 0 | 0 | 0 | NCT01206517 | 1COMPLETED | 2011-08-04 | 2010-07-18 | Organon and Co | 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
] | 25 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are in... | OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of a large field image-guided IMRT, using helical tomotherapy, when given in combination with IV busulfan and VP-16 as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-identical sibling in patients with advanced... | Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid L... | Prot_SAP_000.pdf:
IRB 05013
06/29/11
Packet: 14
CITY OF HOPE
1500 E. Duarte Road
Duarte, CA 91010
Department of Hematology and Hematopoietic Cell Transplantation
TITLE:
Phase I/II Study of Intravenous (IV) Busulfan and Etoposide (VP-16) Combined with Escalated Doses of Large
Field Image-Guided Intensity... | 2 | arm 1: 1200cGy = 150cGy x 8 doses: Patients receive busulfan IV once daily over 2 hours on days -15 and -13 and then every 6 hours on days -12 to -9. Patients also receive etoposide IV on day -3. Patients undergo image-guided intensity-modulated radiation therapy using helical tomotherapy on days -8 to -5.
TRANSPLANTA... | [
0,
0
] | 7 | [
0,
0,
4,
3,
3,
3,
4
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses intervention 4: Stem cell transplantation occurs on Day 0 after High Dose Therapy intervention 5: Stem cell transplantation occurs on Day 0 after High Dose Therapy interventio... | intervention 1: busulfan intervention 2: etoposide intervention 3: intensity-modulated radiation therapy intervention 4: allogeneic hematopoietic stem cell transplantation intervention 5: allogeneic bone marrow transplantation intervention 6: peripheral blood stem cell transplantation intervention 7: tomotherapy | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 25 | 0 | 0 | 0 | NCT00540995 | 6TERMINATED | 2011-08-09 | 2007-06-11 | City of Hope Medical Center | 7OTHER | true | true | false | https://cdn.clinicaltrials.gov/large-docs/95/NCT00540995/Prot_SAP_000.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 | |
[
3
] | 243 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800. | null | Asthma | null | 3 | arm 1: Patients receive BI 671800 capsules twice daily arm 2: Patients receive Montelukast encapsulated tablets once daily arm 3: Patients receive placebo capsules and/or encapsulated placebo tablets | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma intervention 2: Patients receive placebo capsules and/or encapsulated tablets intervention 3: Double blind randomised parallel group study to assess efficacy and tolerability... | intervention 1: BI 671800 intervention 2: Placebo intervention 3: Montelukast | 53 | Denver | Colorado | United States | -104.9847 | 39.73915
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Plymouth | Minnesota | United States | -93.45551 | 45.01052
Portland | Oregon | United States | -122.67621 | 45.52345
Charleston | South Carolina | United States | -79.93275 | 32.77632
El Paso... | 243 | 0 | 0 | 0 | NCT01103349 | 1COMPLETED | 2011-08-09 | 2010-04-20 | Boehringer Ingelheim | 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
] | 1 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload.
PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect ... | PRIMARY OBJECTIVES:
I. To determine labile plasma iron (LPI) levels in iron overloaded patients after allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
II. To determine safety and tolerability of low dose deferasirox in the post allogeneic HSCT setting.
SECONDARY OBJECTIVES:
I. To determine ability of defe... | Iron Overload Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myel... | HSCT, iron overload, deferasirox, labile plasma iron | null | 1 | arm 1: Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: deferasirox | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 1 | 0 | 0 | 0 | NCT01159067 | 6TERMINATED | 2011-08-09 | 2010-07-01 | 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 |
[
3
] | 31 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | Background:
\- Recent studies have shown that the premalignant conditions monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of progressing to multiple myeloma (MM). There are currently no known effective treatments to prevent MGUS or SMM from developing in... | Background:
* Multiple myeloma (MM) is a plasma cell neoplasm with a median survival of 3-4 years.
* Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM) are premalignant plasma cell proliferative disorders characterized by elevated monoclonal protein and bone marrow plasma cells. MGU... | Multiple Myeloma Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance | 18-FDG PET/CT Abnormal Plasma Cells Serum Free Light-Chain Abnormality Serum M-Protein DCE-MRI Multiple Myeloma Smoldering Multiple Myeloma SMM MM | null | 1 | arm 1: Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI). | [
0
] | 3 | [
0,
10,
0
] | intervention 1: The patient will receive 5mCi of F-18 NaF IV (intravenous) bolus, followed by a \~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of \~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break... | intervention 1: 18-NaF PET intervention 2: DCE-MRI intervention 3: 18-FDG PET/CT | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 31 | 0 | 0 | 0 | NCT01237054 | 1COMPLETED | 2011-08-09 | 2010-10-17 | 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
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia | This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with schizophrenia who are stabilised on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or placebo for 7 weeks. They will undergo weekly revi... | Schizophrenia | H3 Antagonist Schizophrenia double blind Histamine randomised placebo controlled Cognition | null | 2 | arm 1: Repeat dose. arm 2: Repeat dose. Placebo to match GSK239512 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Histamine H3 Antagonist intervention 2: Placebo to match GSK239512 | intervention 1: GSK239512 intervention 2: Placebo | 15 | Garden Grove | California | United States | -117.94145 | 33.77391
Los Angeles | California | United States | -118.24368 | 34.05223
National City | California | United States | -117.0992 | 32.67811
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.715... | 50 | 0 | 0 | 0 | NCT01009060 | 1COMPLETED | 2011-08-10 | 2009-12-01 | 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 |
[
2,
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung... | This is a Phase I-II study evaluating the feasibility, safety, and efficacy of swallowed MnSOD plasmid/liposome (PL) transgene given as protection against radiation-induced esophagitis during concurrent paclitaxel and carboplatin chemotherapy with thoracic radiation in subjects with locally advanced non-small cell lung... | Esophageal Toxicity | NSCLC lung cancer chemotherapy radiation therapy radiation toxicity | Prot_SAP_000.pdf:
01-054 v 05-08-14
Page 1
UPCI #01-054: Concurrent Chemotherapy (Paclitaxel and Carboplatin) and Thoracic Radiotherapy
with Swallowed Manganese Superoxide Dismutase (MnSOD) Plasmid Liposome (PL) Protection in
Patients with Locally Advanced Stage III Non-Small Cell Lung Cancer a Pha... | 1 | arm 1: MnSOD PL (0.3, 3, or 30 mg) + (Paclitaxel + Carboplatin (45mg/m\^2)) + Radiation 1.9-2.1 Gy daily 5 times per week (4-6 hr after the first MnSOD PL dose). The total dose planned at 77.0 Gy with a range of 69-84Gy in 34-38 fractions over 7-8 weeks. | [
0
] | 4 | [
6,
0,
0,
4
] | intervention 1: 15 ml of liquid that contains either 0.3 mg, 3.0 mg or 30.0 mg (depending on which cohort is open when the subject is entered) of MnSOD PL This will be given on Day 1 and 3 of each week of the experimental treatment for a total of 14 doses. intervention 2: Chemotherapy to stop the growth of tumor cells.... | intervention 1: Manganese Superoxide Dismutase Plasmid Liposome intervention 2: carboplatin intervention 3: paclitaxel intervention 4: Radiation Therapy | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 18 | 0 | 0 | 0 | NCT00618917 | 6TERMINATED | 2011-08-11 | 2005-11-11 | Joel Greenberger | 7OTHER | true | true | false | https://cdn.clinicaltrials.gov/large-docs/17/NCT00618917/Prot_SAP_000.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 |
[
2
] | 26 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is that multiple doses of MK-4305 do not produce... | null | Sleep Apnea | Insomnia obstructive sleep apnea orexin receptor antagonist | null | 2 | arm 1: In Period 1, suvorexant (40 mg tablets) administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening. arm 2: In Period 1, placebo administered orall... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 40 mg tablets, orally once daily for 4 consecutive days in the evening intervention 2: Placebo tablets, orally once daily for 4 consecutive days in the evening | intervention 1: Suvorexant intervention 2: Matching Placebo | 0 | null | 52 | 0 | 0 | 0 | NCT01300455 | 1COMPLETED | 2011-08-11 | 2011-03-19 | 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
] | 198 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease. | null | Alzheimer's Disease | Alzheimer's disease antibody amyloid | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
2,
0,
0
] | 6 | [
2,
2,
2,
0,
2,
2
] | intervention 1: 0.1 mg/kg every 60 days (10 doses total) intervention 2: 0.5 mg/kg every 60 days (10 doses total) intervention 3: 1 mg/kg every 60 days (10 doses total) intervention 4: Placebo every 60 days (10 doses total) intervention 5: 3 mg/kg every 60 days (10 doses total) intervention 6: 8.5 mg/kg every 60 days (... | intervention 1: PF-04360365 0.1 mg/kg intervention 2: PF-04360365 0.5 mg/kg intervention 3: PF-04360365 1 mg/kg intervention 4: Placebo intervention 5: PF-04360365 3 mg/kg intervention 6: PF-04360365 8.5 mg/kg | 42 | Peoria | Arizona | United States | -112.23738 | 33.5806
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Miami | Florida | United States | -80.19366 | 25.77427
South Miami | Florida | United States | -80.29338 | 25.7076
South Miami | Florida | United Stat... | 194 | 1 | 0.005155 | 1 | NCT00722046 | 1COMPLETED | 2011-08-16 | 2008-12-05 | Pfizer | 4INDUSTRY | false | false | false | null | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000911 |
[
2,
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sc... | The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remain... | Multiple Sclerosis | cannabis marijuana Multiple Sclerosis spasticity | null | 3 | arm 1: Inhaled cannabis is compared to oral placebo. arm 2: Inhaled placebo is compared to oral THC. arm 3: Inhaled placebo is compared to oral placebo. | [
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks. intervention 2: Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks. intervention 3: Participants will be instructed to take two placebo tablet... | intervention 1: Inhaled Cannabis intervention 2: Oral THC intervention 3: Oral Placebo intervention 4: Inhaled placebo | 1 | Sacramento | California | United States | -121.4944 | 38.58157 | 41 | 0 | 0 | 0 | NCT00682929 | 6TERMINATED | 2011-08-17 | 2004-04-14 | University of California, Davis | 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
] | 18 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 1SINGLE | true | 0ALL | false | This will be the first study in which LY2881835 is given to humans in order to evaluate the safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the body and its effect on blood sugar levels.
The study consists of two parts. In part A, healthy subjects will participate and in part ... | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Administered orally intervention 2: Administered orally | intervention 1: LY2881835 intervention 2: Placebo | 1 | Singapore | N/A | Singapore | 103.85007 | 1.28967 | 51 | 0 | 0 | 0 | NCT01358981 | 1COMPLETED | 2011-08-17 | 2011-05-24 | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer. | This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patien... | Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV | Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV CS-1008 Paclitaxel Carboplatin | null | 1 | arm 1: CS-1008 will be administered with paclitaxel and carboplatin. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6 intervention 2: Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles intervention 3: Carboplatin (target area under the concentration versus time curve of 6.0 mg/... | intervention 1: CS-1008 intervention 2: Paclitaxel intervention 3: Carboplatin | 3 | Birmingham | Alabama | United States | -86.80249 | 33.52066
St Louis | Missouri | United States | -90.19789 | 38.62727
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 24 | 0 | 0 | 0 | NCT00945191 | 1COMPLETED | 2011-08-23 | 2009-10-06 | Daiichi Sankyo | 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
] | 177 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides. | null | Dyslipidemia | null | 8 | arm 1: Subjects with hypercholesterolemia and normal triglycerides arm 2: Subjects with hypercholesterolemia and normal triglycerides arm 3: Subjects with hypercholesterolemia and normal triglycerides arm 4: Subjects with hypercholesterolemia and normal triglycerides arm 5: Subjects with hypercholesterolemia and elevat... | [
0,
0,
0,
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: ETC-1002 daily for 12 weeks intervention 2: Placebo daily for 12 weeks | intervention 1: ETC-1002 intervention 2: Placebo | 11 | Chandler | Arizona | United States | -111.84125 | 33.30616
Greenbrae | California | United States | -122.5247 | 37.94854
Santa Rosa | California | United States | -122.71443 | 38.44047
Jacksonville | Florida | United States | -81.65565 | 30.33218
Chicago | Illinois | United States | -87.65005 | 41.85003
Iowa City | Iow... | 177 | 0 | 0 | 0 | NCT01262638 | 1COMPLETED | 2011-08-23 | 2010-12-01 | Esperion Therapeutics, 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
] | 87 | RANDOMIZED | SEQUENTIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT). | null | Secondary Hyperparathyroidism | Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Parathyroid hormone | null | 2 | arm 1: Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort. arm 2: Participants received placebo administered... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Administered intravenously (IV) at the end of hemodialysis intervention 2: Administered intravenously at the end of hemodialysis | intervention 1: Etelcalcetide intervention 2: Placebo | 13 | Azusa | California | United States | -117.90756 | 34.13362
Costa Mesa | California | United States | -117.91867 | 33.64113
Lynwood | California | United States | -118.21146 | 33.93029
Riverside | California | United States | -117.39616 | 33.95335
San Diego | California | United States | -117.16472 | 32.71571
Denver | C... | 78 | 1 | 0.012821 | 1 | NCT01254565 | 1COMPLETED | 2011-08-24 | 2011-02-20 | KAI Pharmaceuticals | 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 | 0.002267 |
[
4
] | 348 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period. | null | Asthma | asthma | null | 3 | arm 1: Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks arm 2: Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks arm 3: Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice da... | [
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Vilanterol inhalation powder inhaled orally once daily for 12 weeks intervention 2: Salmeterol inhalation powder inhaled orally twice daily for 12 weeks intervention 3: Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler intervention 4: Placebo inhalation powder inhaled orally twice da... | intervention 1: Vilanterol intervention 2: Salmeterol Inhalation Powder intervention 3: Placebo Inhalation Powder NDPI intervention 4: Placebo Inhalation Powder Diskus | 34 | Huntington Beach | California | United States | -117.99923 | 33.6603
Orlando | Florida | United States | -81.37924 | 28.53834
Tallahassee | Florida | United States | -84.28073 | 30.43826
Lawrenceville | Georgia | United States | -83.98796 | 33.95621
Skillman | New Jersey | United States | -74.7146 | 40.42011
Raleigh | ... | 347 | 0 | 0 | 0 | NCT01181895 | 1COMPLETED | 2011-08-26 | 2010-09-01 | 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 |
[
3
] | 32 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This phase II trial studies the side effects and how well giving rituximab and dexamethasone together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Othe... | PRIMARY OBJECTIVES:
I. To estimate clinical response rate (RR) at 3 and 6 months. II. To estimate Grade 2-4 -infusion-related toxicity.
SECONDARY OBJECTIVES:
I. To evaluate laboratory parameters and correlate with clinical response including: antibody dependent cell mediated cytotoxicity and effector cell phenotype ... | Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Marginal Zone Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Grade ... | null | 2 | arm 1: Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients received previous treatment. Patients enrolled in the trial received dexa... | [
5,
5
] | 4 | [
10,
2,
0,
10
] | intervention 1: Correlative studies intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies | intervention 1: pharmacological study intervention 2: rituximab intervention 3: dexamethasone intervention 4: laboratory biomarker analysis | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 32 | 0 | 0 | 0 | NCT00244855 | 1COMPLETED | 2011-08-29 | 2004-05-01 | Fred Hutchinson 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
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study assessed the safety and efficacy of Panobinostat as a single agent in the treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential Thrombocythemia. There were two cohorts - participants with JAK2 mutation and participants without JAK2 mutation. | null | Primary Myelofibrosis Post-Polycythemia Vera Post-Essential Thrombocytopenia | Bone marrow Myelofibrosis JAK2mutation Post-Polycythemia Vera Post-Essential Thrombocytopenia | null | 1 | arm 1: Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible. | [
0
] | 1 | [
0
] | intervention 1: Panobinostat oral capsules | intervention 1: Panobinostat | 9 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Duarte | California | United States | -117.97729 | 34.13945
Stanford | California | United States | -122.16608 | 37.42411
Augusta | Georgia | United States | -81.97484 | 33.47097
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts... | 35 | 0 | 0 | 0 | NCT00931762 | 6TERMINATED | 2011-08-29 | 2009-08-31 | 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 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause damage of the bone, muscles, joints, and tis... | In this study, participants with hemophilia A or hemophilia B due to a nonsense mutation were treated with an investigational drug called ataluren (PTC124). Evaluation procedures to determine if a participant qualifies for the study was performed within 14 days prior to the start of treatment. Eligible participants who... | Hemophilia A Hemophilia B | Hemophilia A Hemophilia B Factor VIII Factor IX FVIII FIX Nonsense mutation Premature stop codon HA HB PTC124 Ataluren | null | 1 | arm 1: Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 mg/kg in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening or 10 mg/kg in the morning, 10 mg/kg at... | [
0
] | 1 | [
0
] | intervention 1: Oral powder | intervention 1: Ataluren | 13 | Peoria | Illinois | United States | -89.58899 | 40.69365
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Worcester | Massachusetts | United States | -71.80229 | 42.26259
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Nashville | ... | 13 | 0 | 0 | 0 | NCT00947193 | 6TERMINATED | 2011-08-30 | 2009-10-14 | PTC Therapeutics | 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
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone \& in combination with MMX Mesalazine/mesalamine. | null | Healthy | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 intervention 2: MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofl... | intervention 1: Ciprofloxacin XR + MMX Placebo intervention 2: MMX Mesalazine/mesalamine + Ciprofloxacin XR | 1 | Lenexa | Kansas | United States | -94.73357 | 38.95362 | 59 | 0 | 0 | 0 | NCT01402947 | 1COMPLETED | 2011-08-30 | 2011-07-25 | 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 | |
[
3
] | 41 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients. | null | Metastatic Breast Cancer | Hormone Receptor Positive Metastatic Breast Cancer | null | 1 | arm 1: Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 ... | [
0
] | 2 | [
0,
0
] | intervention 1: Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight \< 80 Kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 Kg. intervention 2: Ful... | intervention 1: capecitabine intervention 2: fulvestrant | 10 | Miami | Florida | United States | -80.19366 | 25.77427
Athens | Georgia | United States | -83.37794 | 33.96095
Augusta | Georgia | United States | -81.97484 | 33.47097
Galesburg | Illinois | United States | -90.37124 | 40.94782
Park Ridge | Illinois | United States | -87.84062 | 42.01114
Billings | Montana | United Sta... | 41 | 1 | 0.02439 | 1 | NCT00534417 | 1COMPLETED | 2011-09-01 | 2007-10-01 | Accelerated Community Oncology Research Network | 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.004319 |
[
3
] | 138 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | true | The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC). | Prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer-related death in men in the United States. Chemotherapy, either as a single agent or in combination, may lead to clinical response, pain control, and/or improved quality of life. Docetaxel is now the first-line standar... | Prostate Cancer | Prostate Cancer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 4 | [
2,
0,
0,
2
] | intervention 1: IMC-A12 is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-A12 treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met. intervention 2: Mitoxantrone is t... | intervention 1: IMC-A12 intervention 2: Mitoxantrone intervention 3: Prednisone intervention 4: IMC-1121B (ramucirumab) | 36 | La Jolla | California | United States | -117.2742 | 32.84727
New Haven | Connecticut | United States | -72.92816 | 41.30815
Boca Raton | Florida | United States | -80.0831 | 26.35869
Port Saint Lucie | Florida | United States | -80.35033 | 27.29393
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illino... | 132 | 5 | 0.037879 | 1 | NCT00683475 | 1COMPLETED | 2011-09-01 | 2008-08-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.016286 |
[
4
] | 150 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctoco... | null | Congenital Bleeding Disorder Haemophilia A | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion. | intervention 1: turoctocog alfa | 63 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Long Beach | California | United States | -118.18923 | 33.76696
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Augusta | Georgia | United States | -81.97484 | 33.47097
Indianapolis | Indiana | Un... | 150 | 15 | 0.1 | 1 | NCT00840086 | 1COMPLETED | 2011-09-01 | 2009-04-01 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.061541 | |
[
4
] | 463 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD) | null | Major Depressive Disorder | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase) intervention 2: 20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase) interventio... | intervention 1: Placebo intervention 2: fluoxetine intervention 3: duloxetine intervention 4: duloxetine | 56 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Dothan | Alabama | United States | -85.39049 | 31.22323
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Carson | California | United States | -118.28202 | 33.83141
Escondido | California | United States | -117.08642 | 33.11921
Imperial | Californ... | 783 | 22 | 0.028097 | 1 | NCT00849693 | 1COMPLETED | 2011-09-01 | 2009-03-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.018627 | |
[
4
] | 3,597 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | true | 1FEMALE | false | This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary. | null | Pregnancy Prevention | Contraception Oral contraceptives | null | 1 | arm 1: Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE. | [
0
] | 1 | [
0
] | intervention 1: One tablet daily.
Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days... | intervention 1: DR-103 | 94 | Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | Un... | 3,597 | 3 | 0.000834 | 1 | NCT00996580 | 1COMPLETED | 2011-09-01 | 2009-10-01 | Teva Women's Health | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000284 |
[
3
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Primary Objective:
\- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.
Secondary Ob... | The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.
Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (... | Rheumatoid Arthritis | null | 3 | arm 1: Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks. arm 2: Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks. arm 3: Sarilumab 150 mg qw and placebo (matched to golimumab) q4w... | [
2,
1,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Pharmaceutical form: solution for injection
Route of administration: subcutaneous intervention 2: Pharmaceutical form: solution for injection
Route of administration: subcutaneous intervention 3: Pharmaceutical form: solution for injection
Route of administration: subcutaneous intervention 4: Pharmac... | intervention 1: Sarilumab intervention 2: Placebo intervention 3: Golimumab intervention 4: methotrexate (MTX) intervention 5: Folic/folinic acid | 14 | Freehold | New Jersey | United States | -74.27376 | 40.26011
New York | New York | United States | -74.00597 | 40.71427
Jackson | Tennessee | United States | -88.81395 | 35.61452
Austin | Texas | United States | -97.74306 | 30.26715
Barranquilla | N/A | Colombia | -74.78132 | 10.96854
Barranquilla | N/A | Colombia | -7... | 16 | 2 | 0.125 | 1 | NCT01217814 | 6TERMINATED | 2011-09-01 | 2010-11-01 | Sanofi | 4INDUSTRY | false | false | false | null | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.034977 | |
[
3
] | 92 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Primary Objective:
To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg.
Secondary Obje... | The duration of study participation depended on the status of the patient at screening:
* For participants receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening, the study participation was to be approximately 17 weeks including a screening period of 1 week, a double-blind treatment perio... | Hypercholesterolemia | 10020603 | null | 3 | arm 1: Placebo (for alirocumab) subcutaneous (SC) administration every 2 weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks. arm 2: Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks. arm 3: Alirocumab 150 mg SC administration Q2W i... | [
2,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: One subcutaneous (SC) injection in the abdomen only. intervention 2: One SC injection in the abdomen only. intervention 3: Over-encapsulated tablet orally once daily in the evening with dinner. intervention 4: One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with... | intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Atorvastatin intervention 4: Placebo (for atorvastatin) | 20 | Mesa | Arizona | United States | -111.82264 | 33.42227
Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Newport Beach | California | United States | -117.92895 | 33.61891
Doral | Florida | United States | -80.35533 | 25.81954
Jacksonville | Florid... | 92 | 4 | 0.043478 | 1 | NCT01288469 | 1COMPLETED | 2011-09-01 | 2011-01-01 | Sanofi | 4INDUSTRY | false | false | false | null | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.017036 |
[
4
] | 170 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chr... | OBJECTIVES:
* Compare the incidence of complete remission (CR) following induction with the ALL-2 regimen (cytarabine and high-dose mitoxantrone) vs the L-20 regimen (vincristine and prednisone) in previously untreated adult patients with acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, and lymphoid blast c... | Leukemia Lymphoma | blastic phase chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia chronic myelogenous leukemia, BCR-ABL1 positive T-cell adult acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia stage I adult lymphoblastic lymphoma stage II adult lymphoblastic lymphoma stage III adult lymphobla... | null | 2 | arm 1: See detail description arm 2: See detail description | [
0,
1
] | 15 | [
2,
2,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
4
] | 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 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None intervention 15: None | intervention 1: dactinomycin intervention 2: sargramostim intervention 3: carmustine intervention 4: cyclophosphamide intervention 5: cytarabine intervention 6: daunorubicin hydrochloride intervention 7: doxorubicin hydrochloride intervention 8: etoposide intervention 9: mercaptopurine intervention 10: methotrexate int... | 7 | Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Atlanta | Georgia | United States | -84.38798 | 33.749
New York | New York | United States | -74.00597 | 40.71427
Valhalla | New York | United States | -73.77513 | 41.07482
Durham | North Carol... | 170 | 0 | 0 | 0 | NCT00002766 | 1COMPLETED | 2011-09-01 | 1996-03-01 | 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 |
[
2,
3
] | 21 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation thera... | OBJECTIVES:
* Determine the maximum tolerated dose and the recommended phase II dose of concurrent celecoxib and limited-field radiotherapy in intermediate-prognosis patients with locally advanced non-small cell lung cancer.
* Determine the efficacy and toxicity of this regimen in these patients.
* Determine how the p... | Lung Cancer | stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer | null | 3 | arm 1: COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a... | [
0,
0,
0
] | 2 | [
0,
4
] | intervention 1: None intervention 2: None | intervention 1: celecoxib intervention 2: radiation therapy | 44 | Colorado Springs | Colorado | United States | -104.82136 | 38.83388
Gainesville | Florida | United States | -82.32483 | 29.65163
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Rome | Georgia | United States | -85.16467 | 34.25704
Harvey | Illinois | ... | 18 | 0 | 0 | 0 | NCT00046839 | 1COMPLETED | 2011-09-01 | 2002-07-01 | Radiation Therapy 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
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. | OBJECTIVES:
I. Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib.
II. Determine the survival of patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the pharmacokinetic predictor... | Anaplastic Thyroid Cancer Recurrent Thyroid Cancer | null | 1 | arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: sorafenib tosylate | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 20 | 0 | 0 | 0 | NCT00126568 | 6TERMINATED | 2011-09-01 | 2005-06-01 | 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
] | 66 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | true | In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to ... | null | Obesity | null | 2 | arm 1: Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). arm 2: Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). | [
0,
1
] | 3 | [
0,
5,
5
] | intervention 1: Metformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated. intervention 2: The life style intervention changes will include a hypocaloric diet represen... | intervention 1: Metformin intervention 2: Dietary modification with caloric restriction intervention 3: Establishment of exercise protocol | 1 | Jacksonville | Florida | United States | -81.65565 | 30.33218 | 66 | 0 | 0 | 0 | NCT00139477 | 1COMPLETED | 2011-09-01 | 2003-11-01 | Nemours Children's 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 | |
[
4
] | 30 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | * To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
* To assess the effect of a long term treatment with Genotonorm on bone mineralisation
* To assess the effect of a long term treatment with Genotonorm on body composition | This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns. | Endocrine System Diseases | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day | intervention 1: Somatropin | 2 | Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341 | 51 | 0 | 0 | 0 | NCT00174187 | 6TERMINATED | 2011-09-01 | 2000-09-01 | 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
] | 429 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Research studies have shown that children who are long-term survivors of childhood leukemia may be at greater risk for early bone loss called osteoporosis. This bone loss may lead to a greater risk of broken bones and other spine and bone problems. However, researchers still do not know much about how frequently this l... | The main objectives of the study are:
* To estimate, using quantitative computed tomography (QCT), the prevalence of diminished bone mineral density (BMD) in patients treated with contemporary, protocol-based multiagent chemotherapy (+cranial irradiation) for childhood acute lymphoblastic leukemia (ALL).
* To investig... | Leukemia, Lymphoblastic, Acute Osteoporosis | Bone Density | null | 2 | arm 1: Nutritional counseling + placebo arm 2: Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period | [
2,
0
] | 2 | [
0,
10
] | intervention 1: Calcium carbonate 100mg/day (Tums), vitamin D 800 units/day intervention 2: Placebo | intervention 1: Calcium carbonate (Tums), vitamin D intervention 2: Placebo | 3 | Memphis | Tennessee | United States | -90.04898 | 35.14953
Memphis | Tennessee | United States | -90.04898 | 35.14953
Memphis | Tennessee | United States | -90.04898 | 35.14953 | 424 | 0 | 0 | 0 | NCT00186901 | 1COMPLETED | 2011-09-01 | 2000-07-01 | St. Jude Children's Research 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 |
[
4
] | 81 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children. | Autism is a developmental disorder that affects every child differently. A wide range of symptoms accompany autism, including self-injurious behavior, aggression, and severe tantrums. Despite an improved ability to reduce these symptoms, existing drug treatments continue to be associated with adverse side effects. Also... | Autistic Disorder | Children Adolescents Aripiprazole Cycloserine Aggression Irritability Self-Injurious Behavior Social Interaction Antipsychotics Pharmacology Glutamatergic Agents | null | 3 | arm 1: Participants will take placebo arm 2: Participants will take aripiprazole arm 3: Participants first will take aripiprazole then will also take D-cycloserine | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 kg maximum do... | intervention 1: Aripiprazole intervention 2: Placebo intervention 3: D-cycloserine | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 90 | 0 | 0 | 0 | NCT00198107 | 1COMPLETED | 2011-09-01 | 2005-09-01 | Indiana 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 |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in which the usual survival is between 7-10 years are being asked to take part in this study. Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of patients (called complete response or comp... | Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in which the usual survival is between 7-10 years are being asked to take part in this study. Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of patients (called complete response or comp... | Lymphoma | Lymphoma | null | 1 | arm 1: Initial patients (n=9) received fludarabine (25 mg/m2 IV) and mitoxantrone (10 mg/m2 IV)with sequential administration of GM-CSF (500 mcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m2) on day 8.
After a change in the protocol, all additional patients (n=6) received fludarabine (25 mg/m2 IV) and cyclo... | [
1
] | 1 | [
0
] | intervention 1: Initial patients (n=9) received fludarabine (25 mg/m\^2 intravenously) and mitoxantrone (10 mg/m\^2 intravenously)with sequential administration of GM-CSF(Granulocyte-macrophage colony stimulating factor) (500 µcg subcutaneously) on days 6 and 7 and rituximab (375 mg/m\^2) on day 8.
After a change in t... | intervention 1: Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 15 | 0 | 0 | 0 | NCT00208975 | 6TERMINATED | 2011-09-01 | 2002-07-01 | 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 |
[
4
] | 34 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 1FEMALE | true | RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.
PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works compared to a placebo in ... | OBJECTIVES:
Primary
* Compare the efficacy of pyridoxine vs placebo in preventing palmar-plantar erythrodysesthesia (PPE) in patients receiving doxorubicin HCl liposome for recurrent ovarian, fallopian tube, or peritoneal cavity cancer, metastatic breast cancer, or advanced endometrial cancer.
* Compare quality of li... | Breast Cancer Drug/Agent Toxicity by Tissue/Organ Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | drug/agent toxicity by tissue/organ fallopian tube cancer peritoneal cavity cancer recurrent ovarian epithelial cancer recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma stage IV breast cancer male breast cancer recurrent breast cancer | null | 2 | arm 1: Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28. arm 2: Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo twice 100 mg daily on days 1-28. | [
0,
2
] | 3 | [
7,
0,
0
] | intervention 1: Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28. intervention 2: Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28. intervention 3: IV, ... | intervention 1: pyridoxine hydrochloride intervention 2: Placebo intervention 3: doxorubicin HCL liposome | 8 | Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 ... | 29 | 0 | 0 | 0 | NCT00245050 | 1COMPLETED | 2011-09-01 | 2004-04-01 | Case 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 |
[
4
] | 184 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experi... | null | B-Cell Chronic Lymphocytic Leukemia | null | 2 | arm 1: Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle) arm 2: Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle) | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Rituximab intervention 4: Pentostatin | 11 | Ocoee | Florida | United States | -81.54396 | 28.56917
Terre Haute | Indiana | United States | -87.41391 | 39.4667
Westminster | Maryland | United States | -76.99581 | 39.57538
Saint Joseph | Missouri | United States | -94.84663 | 39.76861
Albany | New York | United States | -73.75623 | 42.65258
Hickory | North Carolin... | 177 | 0 | 0 | 0 | NCT00254163 | 1COMPLETED | 2011-09-01 | 2003-12-01 | US Oncology Research | 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
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP). | Superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. In the absence of treatment, STP may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism.
Current standard therapy for STP consis... | Superficial Thrombophlebitis Upper Extremity Superficial Thrombophlebitis Lower Extremity Superficial Thrombophlebitis | Superficial Thrombophlebitis STP Fragmin Ibuprofen Superficial Thrombus Superficial Phlebitis phlebitis | null | 1 | arm 1: Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol | [
1
] | 1 | [
0
] | intervention 1: Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneo... | intervention 1: Dalteparin sodium injection | 2 | Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 72 | 0 | 0 | 0 | NCT00264381 | 1COMPLETED | 2011-09-01 | 2002-10-01 | University of Oklahoma | 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
] | 225 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention. | This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, g... | Obesity | obesity treatment weight loss antiobesity drugs zonisamide | null | 3 | arm 1: Zonisamide 400 mg arm 2: Zonisamide 200 mg arm 3: matching placebo | [
0,
0,
2
] | 1 | [
0
] | intervention 1: zonisamide 400 mg, 200 mg, or placebo | intervention 1: Zonisamide | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 225 | 0 | 0 | 0 | NCT00275834 | 1COMPLETED | 2011-09-01 | 2006-01-01 | 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 |
[
3
] | 15 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The aim of this study is to assess the efficacy and safety of betaine in reducing urine oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients.
Hypothesis:
Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I patients. | Our prior genotyping results have shown an association between the G170R allele and the clinical response to VB6. Patients homozygous for this change show a complete response and heterozygous patients a partial response. Since VB6 is a safe and completely effective treatment for patients homozygous for G170R, we will n... | Hyperoxaluria | Primary Hyperoxaluria | null | 2 | arm 1: Subjects were randomly assigned oral betaine 12 grams/day in subjects younger than 10 years of age, and 20 grams/day in subjects 10 years of age and older, in two divided doses. This was followed by a 2 month washout period. Subjects then received the alternative study medication, oral lactose placebo, in two do... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects were randomly assigned oral betaine 12 grams/day in subjects younger than 10 years of age, and 20 grams/day in subjects 10 years of age and older, in two divided doses, for 2 months. intervention 2: Subjects received oral lactose placebo, in two doses daily, for 2 months. | intervention 1: Betaine intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 26 | 0 | 0 | 0 | NCT00283387 | 1COMPLETED | 2011-09-01 | 2007-02-01 | 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
] | 48 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, w... | OBJECTIVES:
Primary
* Determine the increase in clinical/radiographic complete response rate in patients with previously untreated metastatic squamous cell carcinoma of the head and neck treated with induction therapy comprising cetuximab, carboplatin, and paclitaxel.
* Determine the toxic effects of this regimen in ... | Head and Neck Cancer | stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the lip and oral cavity | null | 1 | arm 1: Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin area under the curve (AUC) 2 and Paclitaxel 135 mg/m\^2 for 6 courses. | [
0
] | 5 | [
2,
0,
0,
3,
4
] | intervention 1: Beginning weekly dose 400 mg/m\^2 IV over 1-2 hours, and 250 mg/m\^2 weeks 2-6. intervention 2: AUC 2 weekly for 6 courses. intervention 3: 135 mg/m\^2 weekly for 6 courses. intervention 4: Following induction in second part of study. intervention 5: Following induction in second part of study. | intervention 1: Cetuximab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Conventional Surgery intervention 5: Radiation Therapy | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 47 | 0 | 0 | 0 | NCT00301028 | 1COMPLETED | 2011-09-01 | 2006-04-01 | 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
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Monoclonal antibodies, such as alemtuzumab, 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 fludarabine and busulfan, work in diffe... | OBJECTIVES:
Primary
* Determine the engraftment rate with reduced toxicity ablative conditioning regimen comprising alemtuzumab, fludarabine, and busulfan followed by allogeneic stem cell transplantation in pediatric patients with stem cell defects, marrow failure syndromes, hemoglobinopathy, severe immunodeficiency ... | Congenital Amegakaryocytic Thrombocytopenia Diamond-blackfan Anemia Leukemia Myelodysplastic Syndromes Severe Congenital Neutropenia | de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia congenital amegakaryocytic thrombocytopenia Diamond-Blackfan anemia severe congenital neutropenia secondary acute myeloi... | null | 1 | arm 1: Alemtuzumab 0.5 mg/kg (maximum 15 mg) daily for 3 days; Busulfan i.v. every 6 hours from day -9 to day -6 for 16 total doses; Fludarabine phosphate from day -5 for 4 days at 1.3 mg/kg (if patient was less than 12 kg) or 40 mg/m\*2 per dose; Cyclosporine continuous infusion 3 mg/kg/Day beginning day -1 for GVHD p... | [
0
] | 10 | [
2,
0,
0,
0,
0,
0,
3,
3,
3,
3
] | 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 9: None intervention 10: None | intervention 1: alemtuzumab intervention 2: busulfan intervention 3: cyclosporine intervention 4: fludarabine phosphate intervention 5: methotrexate intervention 6: methylprednisolone intervention 7: allogeneic bone marrow transplantation intervention 8: allogeneic hematopoietic stem cell transplantation intervention 9... | 2 | San Francisco | California | United States | -122.41942 | 37.77493
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 35 | 0 | 0 | 0 | NCT00301834 | 1COMPLETED | 2011-09-01 | 2005-01-01 | 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 |
[
3
] | 39 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. | PRIMARY OBJECTIVES:
I. Determine the response rate, defined as survival and complete discontinuation of supplemental oxygen at day 28, in pediatric patients with acute noninfectious pulmonary dysfunction (idiopathic pneumonia syndrome \[IPS\]) after undergoing allogeneic stem cell transplantation treated with etanerce... | Accelerated Phase Chronic Myelogenous Leukemia Blastic Phase Chronic Myelogenous Leukemia Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Childhood Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Chronic Phase Chronic Myelogenous Leukemia de Novo Myelod... | null | 1 | arm 1: Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednis... | [
0
] | 2 | [
2,
0
] | intervention 1: Given IV and subcutaneously intervention 2: Given IV and orally | intervention 1: etanercept intervention 2: methylprednisolone | 26 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Arcadia | California | United States | -118.03534 | 34.13973
Loma Linda | California | United States | -117.26115 | 34.04835
Aurora | Colorado | United States | -104.83192 | 39.72943
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511... | 28 | 0 | 0 | 0 | NCT00309907 | 1COMPLETED | 2011-09-01 | 2006-04-01 | Children's 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
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%. | Overall Study Design:
Structure:
This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.
Duration:
Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. ... | Glaucoma Cataract | Glaucoma Cataract | null | 3 | arm 1: Pred Forte 1% dosed four times daily decreasing to once daily over four weeks. arm 2: EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks. arm 3: Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks. | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Four drops daily decreasing to once daily over four weeks. intervention 2: Prednisolone Acetate four times daily decreasing to once daily over four weeks. intervention 3: Dosed four times daily decreasing to once daily over four weeks. | intervention 1: Pred Forte intervention 2: EconoPred Plus intervention 3: Prednisolone Acetate | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 51 | 0 | 0 | 0 | NCT00345046 | 1COMPLETED | 2011-09-01 | 2002-09-01 | Indiana 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 |
[
0
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This is a 6-week, randomized, double blind, parallel groups designed, olanzapine-controlled trial of oral dipyridamole in symptomatic patients with a (DSM IV) diagnosis of schizophrenia, schizoaffective or schizophreniform disorder. This pilot study aims to provide preliminary estimates of whether the effect sizes of d... | Since the demonstrated success of chlorpromazine in treating psychosis in the1950's, the pharmacotherapy of schizophrenia has focused mainly on drugs with antidopaminergic actions. These drugs have robust effects on reality distortion and disorganization symptom complexes, but minimal effect on cognitive impairment, ne... | Schizophrenia Schizoaffective Disorder Schizophreniform Disorder | Schizophrenia Positive symptoms Negative symptoms Cognitive deficits | null | 2 | arm 1: Dipyridamole arm 2: Olanzapine | [
0,
1
] | 2 | [
0,
10
] | intervention 1: Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm intervention 2: Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm | intervention 1: Dipyridamole intervention 2: Olanzapine | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 20 | 0 | 0 | 0 | NCT00349973 | 1COMPLETED | 2011-09-01 | 2001-05-01 | University of Maryland, Baltimore | 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
] | 37 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by ... | OBJECTIVES:
Primary
* Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and azacitidine in patients with advanced myelodysplastic syndromes (MDS).
Secondary
* Review clinical outcomes, as defined by the International Working Group criteria, in patients treated with this regimen.
* Dete... | Leukemia Myelodysplastic Syndromes | refractory anemia with excess blasts previously treated myelodysplastic syndromes chronic myelomonocytic leukemia de novo myelodysplastic syndromes secondary myelodysplastic syndromes | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity. intervention 2: Oral lenalidomide once daily on days 1-14 ... | intervention 1: azacitidine intervention 2: lenalidomide | 3 | Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 37 | 0 | 0 | 0 | NCT00352001 | 1COMPLETED | 2011-09-01 | 2006-05-01 | Mikkael Sekeres MD | 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
] | 135 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objective:
* Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck.
Secondary Objectives:
* Evaluate the effect of zoledronate on change in BMD at the total hip
* Evaluate risk factors for developing osteoporosis on chemotherapy
* Determine corr... | Medicines called "bisphosphonates" have been shown to help people with cancer that has spread to their bones. Zoledronic acid is a "bisphosphonate". Some bisphosphonates are pills that can be swallowed. Other bisphosphonates such as zoledronic acid need to be given by vein (or intravenously). Some studies have shown th... | Non-Hodgkin's Lymphoma Lymphoma | Non-Hodgkin's Lymphoma Lymphoma Zoledronic Acid Zoledronate Zometa Vitamin D Calcium Carbonate Bone Loss | null | 2 | arm 1: Oral Vitamin D 400 mg daily + Calcium 1200 mg daily arm 2: Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m\^2 intravenous at baseline and 6 months. | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 4 mg/m\^2 by vein over 30 Minutes at baseline and 6 months. intervention 2: 400 mg by mouth daily intervention 3: 1200 mg by mouth daily | intervention 1: Zoledronic Acid intervention 2: Vitamin D intervention 3: Calcium Carbonate | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 74 | 0 | 0 | 0 | NCT00352846 | 1COMPLETED | 2011-09-01 | 2006-01-01 | 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 |
[
5
] | 31 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes.
The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first ou... | Screening Assessment
Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF):
* Demographic Data: Date of birth, sex, marital status, educati... | Genital Herpes | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 800 mg orally three times daily for 7 weeks intervention 2: 500 mg orally once daily for 7 weeks | intervention 1: acyclovir intervention 2: valacyclovir | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 58 | 0 | 0 | 0 | NCT00362297 | 1COMPLETED | 2011-09-01 | 2006-09-01 | 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
] | 46 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as topotecan, 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 Avastin (bevacizumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow... | OBJECTIVES:
Primary
* Determine the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with topotecan hydrochloride and bevacizumab who have failed prior systemic chemotherapy.
Secondary
* Determine the objective response rates in patients treated with this regimen.
* Mea... | Lung Cancer | recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer | null | 1 | arm 1: Weekly topotecan hydrochloride and bi-weekly Avastin (bevacizumab) in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy. | [
0
] | 2 | [
2,
0
] | intervention 1: Will be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason. intervention 2: Topotecan 4 mg/m\^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on... | intervention 1: bevacizumab intervention 2: topotecan hydrochloride | 2 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483 | 43 | 0 | 0 | 0 | NCT00365547 | 1COMPLETED | 2011-09-01 | 2006-09-01 | Masonic Cancer Center, University of Minnesota | 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
] | 45 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the o... | * In this study we are looking for the highest dose of Velcade that can be given to people safely when given with tacrolimus and methotrexate. Not everyone who participates in the study will receive the same amount of the study drug. The dose the participant will receive depends upon the number of subjects enrolled on ... | Hematologic Malignancies | Velcade Bortezomib Allogeneic Stem Cell Transplant GVHD | null | 1 | arm 1: None | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: Infusion for a total of 3 doses intervention 2: Taken until Doctor determines it is not necessary any more intervention 3: Infusion for a total of 4 doses intervention 4: Allogeneic Non-myeloablative peripheral blood stem cell transplantation | intervention 1: Bortezomib (Velcade) intervention 2: Tacrolimus intervention 3: Methotrexate intervention 4: blood stem cell transplantation | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 45 | 0 | 0 | 0 | NCT00369226 | 1COMPLETED | 2011-09-01 | 2006-08-01 | 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 |
[
2
] | 26 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting. | null | Breast Cancer | Breast cancer over-expressing HER2. First-line treatment with sunitinib/docetaxel/trastuzumab. | null | 1 | arm 1: Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose) | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute ... | intervention 1: Herceptin intervention 2: Sunitinib intervention 3: Taxotere | 7 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Brussels | N/A | Belgium | 4.34878 | 50.85045
Charleroi | N/A | Belgium | 4.44448 | 50.41136
Sint-Niklaas | N/A | Belgium | 4.1437 | 51.16509
Wilrijk | N/A | Belgium | 4.39513 | 51.16734
Meldola | FC | Italy | 12.0626 | 44.12775
Milan | N/A | Italy | 12.59836 | 42.78235 | 25 | 0 | 0 | 0 | NCT00372424 | 1COMPLETED | 2011-09-01 | 2006-12-01 | 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 |
[
3
] | 43 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substance... | OBJECTIVES:
Primary
* Determine the complete response rate (complete response and complete response unconfirmed) in patients with newly diagnosed, AIDS-related B-cell non-Hodgkin's lymphoma treated with doxorubicin hydrochloride liposome, rituximab, cyclophosphamide, vincristine, and prednisone (DR-COP).
* Determine ... | Lymphoma | contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage I grade 3 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma AIDS-related diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous s... | Prot_SAP_001.pdf:
AIDS MALIGNANCY
CLINICAL TRIALS CONSORTIUM
AMC PROTOCOL #047:
A Phase II Trial of Doxil, Rituximab, Cyclophosphamide,
Vincristine, and Prednisone (DR-COP) in Patients with Newly
Diagnosed AIDS-associated B-Cell Non-Hodgkin’s Lymphoma
A Multi-Center Trial of the AIDS Malignancy
C... | 1 | arm 1: Single arm interventional study: all subjects receive DR-COP regimen. | [
0
] | 10 | [
2,
2,
2,
2,
0,
0,
0,
0,
10,
10
] | intervention 1: Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle. intervention 2: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Da... | intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: rituximab intervention 4: sargramostim intervention 5: cyclophosphamide intervention 6: pegylated liposomal doxorubicin hydrochloride intervention 7: prednisone intervention 8: vincristine sulfate intervention 9: immunohistochemistry staining meth... | 14 | La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Miami | Florida | United States | -80.19366 | 25.77427
Chicago | Illinois | United States | -87.65005 | 41.85003
New Orleans | Lo... | 40 | 0 | 0 | 0 | NCT00389818 | 1COMPLETED | 2011-09-01 | 2007-01-01 | AIDS Malignancy Consortium | 5NETWORK | true | true | false | https://cdn.clinicaltrials.gov/large-docs/18/NCT00389818/Prot_SAP_001.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 |
[
0
] | 127 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between ... | This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emerge... | Kidney Stones Ureteral Stones | Kidney Stones Ureteral Stones Flomax Emergency Medicine Urology | null | 2 | arm 1: Placebo arm 2: Intervention - Tamsulosin | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Study Drug intervention 2: Placebo | intervention 1: Tamsulosin intervention 2: Placebo | 1 | Royal Oak | Michigan | United States | -83.14465 | 42.48948 | 100 | 0 | 0 | 0 | NCT00448123 | 1COMPLETED | 2011-09-01 | 2007-02-01 | Robert Swor | 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
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
* To determine the clinical activity of Pemetrexed + Gemcitabine in non-clear cell renal cell cancer (RCC). Clinical activity will take into account response rate and progression free survival (PFS).
Secondary Objectives:
* To determine the toxicity of Pemetrexed + Gemcitabine in non-clear cell RC... | Pemetrexed is a chemotherapy drug that is used to treat cancer. It is given intravenously (by IV--through a vein in your arm). It interferes with cell reproduction.
Gemcitabine is a cancer-fighting (chemotherapy) drug that is given by IV. It interferes with the growth of cells and is used to treat cancer.
Dexamethaso... | Renal Cell Carcinoma | Renal Cell Carcinoma Non-Clear Cell Pemetrexed Gemcitabine LY231514 Alimta MTA Multitargeted Antifolate NSC-698037 Gemcitabine Hydrochloride Gemzar RCC | null | 1 | arm 1: Pemetrexed 500 mg/m\^2 intravenous (IV) and Gemcitabine 1500 mg/m\^2 IV on Day 1. | [
0
] | 2 | [
0,
0
] | intervention 1: 500 mg/m\^2 IV Over 10 Minutes on Day 1. intervention 2: 1500 mg/m\^2 IV Over 30 Minutes on Day 1, Immediately After Infusion of Pemetrexed. | intervention 1: Pemetrexed intervention 2: Gemcitabine | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 15 | 0 | 0 | 0 | NCT00491075 | 6TERMINATED | 2011-09-01 | 2005-12-01 | 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
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are required for their ben... | null | Sepsis | Sepsis Statin Infection Immunomodulatory | null | 2 | arm 1: Simvastatin 80 mg once daily PO (or via NG or G-tube) arm 2: Identical-appearing placebo PO (or via NG or G-tube) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 80 mg once daily PO/NG x 4 days intervention 2: once daily x 4 days | intervention 1: Simvastatin intervention 2: Identical-appearing placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 68 | 0 | 0 | 0 | NCT00528580 | 6TERMINATED | 2011-09-01 | 2008-02-01 | University of Chicago | 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
] | 22 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib. | OBJECTIVES:
Primary
* To determine the overall response rate (complete response and partial response) in patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced adenocarcinoma of the lung treated with dasatinib.
Secondary
* To determine the progression-free survival and overall survival of p... | Lung Cancer | adenocarcinoma of the lung stage IIIA non-small 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: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: dasatinib | 1 | New York | New York | United States | -74.00597 | 40.71427 | 21 | 0 | 0 | 0 | NCT00570401 | 1COMPLETED | 2011-09-01 | 2006-06-01 | 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 |
[
3
] | 14 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no alternatives to colchi... | Familial Mediterranean fever (FMF) is an autosomal recessive autoinflammatory genetic disorder resulting in recurrent attacks of fever, serositis, arthritis and rash. Late complications of untreated FMF include the development of renal amyloidosis. FMF is a rare orphan disease in the United States. Treatment with colch... | Familial Mediterranean Fever | FMF IL1 Trap (Rilonacept) Periodic fever syndromes Autoinflammatory syndromes Familial Mediterranean Fever colchicine | null | 2 | arm 1: Treatment Arm A: Rilonacept (IL-1 Trap) at a dose of 2.2 mg/kg/wk (max 160 mg)given by subcutaneous injection for 3 months plus colchicine at a stable dose for those subjects already taking colchicine, or without colchicine for those intolerant or non-compliant with colchicine. Since the colchicine dose is stabl... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2.2 mg/kg/wk by subcutaneous injection, for 3 months intervention 2: placebo by subcutaneous injection weekly for 3 months | intervention 1: Rilonacept intervention 2: Placebo | 5 | Los Angeles | California | United States | -118.24368 | 34.05223
Madera | California | United States | -120.06072 | 36.96134
Bethesda | Maryland | United States | -77.10026 | 38.98067
New York | New York | United States | -74.00597 | 40.71427
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 27 | 0 | 0 | 0 | NCT00582907 | 1COMPLETED | 2011-09-01 | 2008-08-01 | 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 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The main purpose of this study us to determine the best treatment for patients with endometrial cancer who are at an elevated risk for recurrence. | Endometrial cancer is the most common gynecologic malignancy in the United States with 40,880 new cases diagnosed and 7,310 deaths attributable to this malignancy expected in 2005. The majority of patients diagnosed with endometrial cancer have early stage disease that is amenable to treatment with hysterectomy and bil... | Uterine Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Paclitaxel will be administered at an appropriate dose (175 mg/m2) as a 3-hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing the Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate (GFR... | intervention 1: Paclitaxel and carboplatin combination | 1 | Birmingham | Alabama | United States | -86.80249 | 33.52066 | 9 | 0 | 0 | 0 | NCT00584909 | 6TERMINATED | 2011-09-01 | 2006-03-01 | University of Alabama at Birmingham | 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 |
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