FEATURE_phases list | FEATURE_enrollmentCount int64 | FEATURE_allocation string | FEATURE_interventionModel string | FEATURE_primaryPurpose class label | FEATURE_masking class label | FEATURE_healthyVolunteers bool | FEATURE_sex class label | FEATURE_oversightHasDmc bool | FEATURE_briefSummary string | FEATURE_detailedDescription string | FEATURE_conditions string | FEATURE_conditionsKeywords string | FEATURE_protocolPdfText string | FEATURE_numArms int64 | FEATURE_armDescriptions string | FEATURE_armGroupTypes list | FEATURE_numInterventions int64 | FEATURE_interventionTypes list | FEATURE_interventionDescriptions string | FEATURE_interventionNames string | FEATURE_numLocations int64 | FEATURE_locationDetails string | LABEL_ct_level_ade_population int64 | LABEL_sum_dosing_errors int64 | LABEL_dosing_error_rate float32 | LABEL_wilson_label int64 | METADATA_nctId string | METADATA_overallStatus class label | METADATA_completionDate date32 | METADATA_startDate date32 | METADATA_leadSponsorName string | METADATA_leadSponsorClass class label | METADATA_hasProtocol bool | METADATA_hasSap bool | METADATA_hasIcf bool | METADATA_protocolPdfLinks string | METADATA_count_Accidental drug intake by child int64 | METADATA_count_Accidental overdose int64 | METADATA_count_Accidental overdose (therapeutic agent) int64 | METADATA_count_Accidental underdose int64 | METADATA_count_Deliberate overdose int64 | METADATA_count_Dose calculation error int64 | METADATA_count_Drug administration error int64 | METADATA_count_Drug overdose int64 | METADATA_count_Drug overdose accidental int64 | METADATA_count_Extra dose administered int64 | METADATA_count_Incorrect dosage administered int64 | METADATA_count_Incorrect dose administered int64 | METADATA_count_Incorrect drug administration duration int64 | METADATA_count_Incorrect drug administration rate int64 | METADATA_count_Incorrect product administration duration int64 | METADATA_count_Intentional overdose int64 | METADATA_count_Medication error int64 | METADATA_count_Medication monitoring error int64 | METADATA_count_Multiple drug overdose int64 | METADATA_count_Multiple drug overdose accidental int64 | METADATA_count_Multiple drug overdose intentional int64 | METADATA_count_Multiple use of single-use product int64 | METADATA_count_Non-accidental overdose int64 | METADATA_count_Overdose int64 | METADATA_count_Overdose NOS int64 | METADATA_count_Overmedication int64 | METADATA_count_Prescribed overdose int64 | METADATA_count_Treatment noncompliance int64 | METADATA_count_Underdose int64 | METADATA_count_Unintentional medical device removal int64 | METADATA_count_Unintentional medical device removal by patient int64 | METADATA_wilson_lower_bound float32 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 134 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma.
PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer... | Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are limited and minimally effective. Dacarbazine is currently one of the standard chemotherapy drugs used for the treatment of metastatic melanoma. However, it is associated with low response rates (10-20%) and median survival of l... | Melanoma | phase II metastatic melanoma dacarbazine combination PI-88 | null | 2 | arm 1: PI-88 (muparfostat) 190 mg daily by subcutaneous injection and dacarbazine 1000 mg/m2 on day 1 of each 21 day cycle arm 2: dacarbazine 1000 mg/m2 on day 1 of every 21 day cycle by intravenous infusion | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion intervention 2: intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle | intervention 1: PI-88 and dacarbazine intervention 2: dacarbazine or DTIC | 12 | Tucson | Arizona | United States | -110.92648 | 32.22174
Denver | Colorado | United States | -104.9847 | 39.73915
Nashville | Tennessee | United States | -86.78444 | 36.16589
Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Sydney | New South Wales | Australia | 151.20732 | -33.86785
Auchenflower | Quee... | 131 | 1 | 0.007634 | 1 | NCT00130442 | 1COMPLETED | 2010-10-01 | 2005-06-01 | Cellxpert Biotechnology Corp. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.001349 |
[
4
] | 2,867 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully t... | null | Thromboembolism | null | 2 | arm 1: Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements arm 2: Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Dabigatran 150 mg BID (twice daily) intervention 2: Warfarin dosed individually to maintain INR 2.0-3.0 | intervention 1: Dabigatran intervention 2: Warfarin | 275 | Mobile | Alabama | United States | -88.04305 | 30.69436
Hartford | Connecticut | United States | -72.68509 | 41.76371
Clearwater | Florida | United States | -82.8001 | 27.96585
Augusta | Georgia | United States | -81.97484 | 33.47097
Decatur | Georgia | United States | -84.29631 | 33.77483
Baltimore | Maryland | United... | 5,635 | 2 | 0.000355 | 0 | NCT00329238 | 1COMPLETED | 2010-10-01 | 2006-05-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 1 | 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 | 0.000097 | |
[
3,
4
] | 276 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing. | null | Diabetic Foot Ulcer | Diabetic Foot Ulcers Neuroischaemic | null | 2 | arm 1: Active study treatment arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium. intervention 2: Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium. | intervention 1: Fragmin/ Dalteparin Sodium intervention 2: Placebo for Fragmin/ Dalteparin Sodium | 63 | Klagenfurt | N/A | Austria | 14.30528 | 46.62472
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Ransart | N/A | Belgium | 4.47616 | 50.46166
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Montreal | Quebec | Canada | -73.58781 | 45.50884
Prague | N/A | Czechia | 14.42076 |... | 276 | 1 | 0.003623 | 1 | NCT00662831 | 1COMPLETED | 2010-10-01 | 2008-04-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00064 |
[
3
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab. | null | Rheumatoid Arthritis | null | 2 | arm 1: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32. arm 2: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacic... | [
0,
2
] | 3 | [
2,
0,
0
] | intervention 1: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3. intervention 2: Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32. intervention 3: Placebo matched to atacicept will be administered subcutaneously once a week f... | intervention 1: Rituximab intervention 2: Atacicept intervention 3: Placebo matched to atacicept | 8 | Nice | N/A | France | 7.26608 | 43.70313
Paris | N/A | France | 2.3488 | 48.85341
Strasbourg | N/A | France | 7.74553 | 48.58392
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Malmo | N/A | Sweden | 13.00073 | 55.60587
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Newcastle | N/A | United Kingdom | -5.88979 | 54.2... | 27 | 1 | 0.037037 | 1 | NCT00664521 | 1COMPLETED | 2010-10-01 | 2008-03-01 | Merck KGaA, Darmstadt, Germany | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.006568 | |
[
5
] | 387 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that ... | This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER. The total st... | Schizophrenia | Schizophrenia Paliperidone Paliperidone extended-release Antipsychotics Agents | null | 1 | arm 1: Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day. | [
0
] | 1 | [
0
] | intervention 1: Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day. | intervention 1: Paliperidone | 8 | Chunchun | N/A | South Korea | N/A | N/A
Incheon | N/A | South Korea | 126.70515 | 37.45646
Inchun | N/A | South Korea | N/A | N/A
Kangwondo | N/A | South Korea | N/A | N/A
Kyunggido | N/A | South Korea | N/A | N/A
Kyungki | N/A | South Korea | N/A | N/A
Kyunki | N/A | South Korea | N/A | N/A
Seoul | N/A | South Korea ... | 387 | 1 | 0.002584 | 1 | NCT00761605 | 1COMPLETED | 2010-10-01 | 2008-04-01 | Janssen Korea, Ltd., Korea | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000456 |
[
3
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers | null | Carotid Atherosclerosis | null | 2 | arm 1: Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin. arm 2: Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin. | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks. intervention 2: 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin o... | intervention 1: Atorvastatin/niacin extended-release intervention 2: Atorvastatin intervention 3: Simvastatin intervention 4: Simvastatin | 0 | null | 100 | 1 | 0.01 | 1 | NCT00804843 | 1COMPLETED | 2010-10-01 | 2009-04-01 | 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.001767 | |
[
4
] | 291 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 we... | null | Chronic Obstructive Pulmonary Disease | COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease | null | 2 | arm 1: Aclidinium bromide dose, inhaled, for 52 weeks of treatment arm 2: Aclidinium bromide dose, inhaled, for 52 weeks of treatment | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment intervention 2: Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment | intervention 1: Aclidinium bromide intervention 2: Aclidinium bromide | 83 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Glendale | Arizona | United States | -112.18599 | 33.53865
Phoenix | Arizona | United States | -112.07404 | 33.44838
Fullerton | California | United States | -117.92534 | 33.87029
Lakewood | California | ... | 289 | 1 | 0.00346 | 1 | NCT00970268 | 1COMPLETED | 2010-10-01 | 2009-08-01 | 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000611 |
[
5
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this s... | null | Influenza | null | 4 | arm 1: Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the se... | [
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Oseltamivir capsules for participants ≥ 13 years. intervention 2: Pediatric suspension for participants aged ≤ 12 years. intervention 3: Matching placebo provided as capsules and as a suspension. | intervention 1: Oseltamivir intervention 2: Oseltamivir intervention 3: Placebo | 100 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Carmichael | California ... | 101 | 4 | 0.039604 | 1 | NCT01032837 | 6TERMINATED | 2010-10-01 | 2009-11-01 | Hoffmann-La Roche | 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 | 0.015507 | |
[
4
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression. | null | Uveitis | Active uveitis intermediate uveitis panuveitis posterior uveitis uveitis | null | 4 | arm 1: AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks. arm 2: AIN457 300 mg s.c. at baseline and Week 2, then every 4 weeks. arm 3: AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks arm 4: Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: AIN457 intervention 2: AIN457 intervention 3: AIN457 intervention 4: Placebo | 36 | Beverly Hills | California | United States | -118.40036 | 34.07362
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
Slingerlands | New York | United States | -73.86457 | 42.62925
Arlington | Texas | United States | -97.10807 | 32.73569
Houston | Texas | United States | -95.36327 | 29.76328
London | Ontar... | 30 | 1 | 0.033333 | 1 | NCT01095250 | 6TERMINATED | 2010-10-01 | 2010-04-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.005909 |
[
3,
4
] | 29 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD). | PD is commonly associated with depression, but conventional antidepressants have limited efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the United States as a food supplement and is promoted as a mood enhancer. SAM-e improves dopamine transmission, may have a beneficial effect on ... | Parkinson's Disease Depression | Parkinsons Disease Depression SAM-e | null | 3 | arm 1: 40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram. arm 2: 40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e. arm 3: 20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses... | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram. intervention 2: 20mg or 30mg daily in two divided doses, along with placebo SAM-e. intervention 3: oral placebo escitalopram and oral placebo SAM-e daily in two divided doses. | intervention 1: SAM-e intervention 2: oral escitalopram intervention 3: placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 29 | 0 | 0 | 0 | NCT00070941 | 1COMPLETED | 2010-10-01 | 2003-07-01 | NYU Langone 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 |
[
3
] | 39 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Dru... | PRIMARY OBJECTIVES:
I. Examine the response rate of HER2-positive metastatic breast cancer to combination therapy with trastuzumab and BMS-247550 in two cohorts of women: a. women who have received no prior chemotherapy or trastuzumab for their metastatic breast cancer; b. women who have received prior trastuzumab the... | HER2-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer | null | 1 | arm 1: Patients receive trastuzumab IV over 30-90 minutes and ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 3 | [
2,
0,
10
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies | intervention 1: trastuzumab intervention 2: ixabepilone intervention 3: laboratory biomarker analysis | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 39 | 0 | 0 | 0 | NCT00079326 | 6TERMINATED | 2010-10-01 | 2004-01-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 50 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutami... | PRIMARY OBJECTIVES:
I. To evaluate the effect of PROSTVAC-V/TRICOM (Vaccinia) on cycle 1 followed by PROSTVAC-F/TRICOM (Fowlpox) and GM-CSF on biochemical PSA progression at 6 months.
II. To determine the change in PSA velocity pre-treatment to post-treatment.
SECONDARY OBJECTIVES:
I. To evaluate the percentage of ... | Recurrent Prostate Carcinoma Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer | null | 1 | arm 1: Patients receive vaccinia-PSA-TRICOM vaccine SC on day 1 and sargramostim (GM-CSF) SC on days 1-4 during weeks 1-4. Beginning in week 5, patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses (wee... | [
0
] | 5 | [
0,
0,
2,
2,
2
] | intervention 1: Given orally intervention 2: Given SC intervention 3: Given SC intervention 4: Given SC intervention 5: Given SC | intervention 1: Bicalutamide intervention 2: Goserelin Acetate intervention 3: Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine intervention 4: Recombinant Vaccinia-TRICOM Vaccine intervention 5: Sargramostim | 7 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
New Brunswick ... | 50 | 0 | 0 | 0 | NCT00108732 | 1COMPLETED | 2010-10-01 | 2006-02-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 44 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together wi... | OBJECTIVES:
Primary
* Evaluate the time to progression in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and imatinib mesylate as first-line therapy.
Secondary
* Assess the response rate in patients treated with this regimen.
* Assess the percentage of patients... | Pancreatic Cancer | recurrent pancreatic cancer stage IV pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage II pancreatic cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: gemcitabine hydrochloride intervention 2: imatinib mesylate | 8 | Chicago | Illinois | United States | -87.65005 | 41.85003
Freehold | New Jersey | United States | -74.27376 | 40.26011
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Neptune City | New Jersey | United States | -74.02792 | 40.20011
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New Bruns... | 43 | 0 | 0 | 0 | NCT00161213 | 1COMPLETED | 2010-10-01 | 2005-09-01 | University of Medicine and Dentistry of New Jersey | 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 | 3TRIPLE | false | 0ALL | true | We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antido... | The Pediatric Acute Liver Failure (PALF) Study Group to identify, characterize, and develop management strategies for infants, children and adolescents who present with acute liver failure. The PALF study group includes 20 sites (17 in the United States, 2 in the United Kingdom, and 1 in Canada). The primary objective ... | Acute Liver Failure Hepatic Encephalopathy | acute liver failure hepatic encephalopathy acetaminophen toxicity N-acetylcysteine | null | 2 | arm 1: Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and hepatic encephalopathy (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days arm 2: Eligible children were adaptively allocated ... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge. intervention 2: Eligible children were adaptively allocated within strata defined by age (... | intervention 1: N-acetylcysteine intervention 2: Placebo | 20 | San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Baltimore | Maryland ... | 184 | 0 | 0 | 0 | NCT00248625 | 1COMPLETED | 2010-10-01 | 2000-01-01 | University of Pittsburgh | 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
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with myelodysplastic syndromes. | OBJECTIVES:
Primary
* Determine the efficacy of bortezomib, in terms of reduced cytopenia, in patients with myelodysplastic syndromes.
* Determine the safety and toxic effects of this drug in these patients.
Secondary
* Determine changes in marrow blast percentage or karyotypic profile in patients treated with this... | Myelodysplastic Syndromes | previously treated myelodysplastic syndromes refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia secondary myelodysplastic syndromes de novo myelodysplastic syndromes | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: bortezomib | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 8 | 0 | 0 | 0 | NCT00262873 | 1COMPLETED | 2010-10-01 | 2005-05-01 | University of Rochester | 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
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 2MALE | false | Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone refractory and androgen independent and have not been exposed to chemotherapy. | This is a phase II open label single center study that evaluates the activity, efficacy, and toxicity of single agent Tarceva in chemotherapy-naive AIPC patients. Patients will receive single agent Tarceva at 150 mg daily without interruption until disease progression, unacceptable toxicity, or investigator's discretio... | Prostate Cancer | null | 1 | arm 1: Tarceva 150 mg QD | [
0
] | 1 | [
0
] | intervention 1: 150mg QD | intervention 1: Tarceva | 1 | Park Ridge | Illinois | United States | -87.84062 | 42.01114 | 29 | 0 | 0 | 0 | NCT00272038 | 1COMPLETED | 2010-10-01 | 2005-12-01 | Oncology Specialists, S.C. | 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
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the speed at which food travels through the stomach, intestines and colon, and if pyridostigmine improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by the Food and Drug Administration (FDA) fo... | Chronic constipation in diabetes mellitus is associated with colonic motor dysfunction and is managed with laxatives. Cholinesterase inhibitors increase colonic motility. The study evaluated the effects of a cholinesterase inhibitor (pyridostigmine vs. placebo) on gastrointestinal and colonic transit and bowel function... | Constipation Diabetes Mellitus Colonic Transit Gastric Emptying | null | 2 | arm 1: Oral pyridostigmine, starting with 60 mg capsules three times per day (TID), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg TID (a total of 360 mg per day). This dose was maintained for 7 days. arm 2: Placebo (sham) capsules, matching the appearance of the act... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days. intervention 2: If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days. | intervention 1: Pyridostigmine intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 30 | 0 | 0 | 0 | NCT00276406 | 1COMPLETED | 2010-10-01 | 2006-05-01 | 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
] | 35 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment. | null | Peritoneal Cancer Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer | Pazopanib Fallopian tube cancer Ovarian epithelial cancer Peritoneal cancer | null | 1 | arm 1: 800 mg GW786034 administered orally on a daily basis. | [
0
] | 1 | [
0
] | intervention 1: 800 mg GW786034 administered orally on a daily basis. | intervention 1: GW786034 | 10 | Atlanta | Georgia | United States | -84.38798 | 33.749
Austin | Texas | United States | -97.74306 | 30.26715
Bedford | Texas | United States | -97.14307 | 32.84402
Dallas | Texas | United States | -96.80667 | 32.78306
Fort Worth | Texas | United States | -97.32085 | 32.72541
Randwick | New South Wales | Australia | 151... | 36 | 0 | 0 | 0 | NCT00281632 | 1COMPLETED | 2010-10-01 | 2006-03-01 | 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
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer | Eligible patients will receive a minimum of six cycles of combination therapy. If a patient is still responding to the oxaliplatin at 6 cycles, the oxaliplatin may be continued with the trastuzumab up to 10 cycles at the investigator's discretion. After discontinuing the oxaliplatin/trastuzumab combination, patients sh... | Breast Cancer | Metastatic HER2/neu+ | null | 1 | arm 1: Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. | [
0
] | 2 | [
0,
0
] | intervention 1: Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes. intervention 2: Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of ... | intervention 1: Trastuzumab intervention 2: Oxaliplatin | 7 | Bowling Green | Kentucky | United States | -86.4436 | 36.99032
Alexandria | Louisiana | United States | -92.44514 | 31.31129
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Chattan... | 25 | 0 | 0 | 0 | NCT00297596 | 1COMPLETED | 2010-10-01 | 2006-02-01 | SCRI Development Innovations, LLC | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 296 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer. | null | Neoplasms, Breast | lapatinib GW572016 ErbB2 EGFR ErbB1 MBC FISH amplification Metastatic Breast Cancer dual tyrosine kinase inhibitor Her-2/neu | null | 2 | arm 1: Lapatinib 1000mg once daily in combination with trastuzumab 4mg/kg loading dose followed by 2mg/kg weekly arm 2: Lapatinib 1500mg once daily | [
0,
0
] | 2 | [
0,
2
] | intervention 1: oral lapatinib once daily intervention 2: IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose | intervention 1: Lapatinib intervention 2: Trastuzumab | 145 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Sedona | Arizona | United States | -111.76099 | 34.86974
Highland | California | United States | -117.20865 | 34.12834
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | C... | 295 | 0 | 0 | 0 | NCT00320385 | 1COMPLETED | 2010-10-01 | 2005-11-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | This study is for patients with cancer of the prostate gland that has metastasized or spread outside the prostate to other parts of the body. Patients have already been treated with a drug called docetaxel or Taxotere® (with or without the addition of a steroid called prednisone) some time in the recent past. They eith... | This study was initiated as a multicenter, open-label, randomized study, with a planned enrollment of 40 subjects. Although two treatment arms were included in this study, no comparison between the arms was intended.
Subjects with metastatic HRPC who failed first-line docetaxel therapy and required second-line therapy... | Prostate Cancer | Metastatic hormone refractory prostate cancer (HRPC) | null | 2 | arm 1: OGX-011 / mitoxantrone/prednisone: OGX-011 administered in combination with mitoxantrone and prednisone arm 2: OGX-011/docetaxel/prednisone: OGX-011 administered in combination with docetaxel and prednisone | [
0,
0
] | 2 | [
0,
0
] | intervention 1: All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibupro... | intervention 1: custirsen (OGX-011)/mitoxantrone intervention 2: custirsen (OGX-011)/docetaxel | 10 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Hamilton | Ontario | Canada | -79.84963 | 43.25011... | 69 | 0 | 0 | 0 | NCT00327340 | 1COMPLETED | 2010-10-01 | 2006-07-01 | Achieve Life Sciences | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people diagnosed with schizophrenia. | Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations and delusions, as well as overall difficulty with everyday functioning. Although the medications available to treat the disorder are generally effective, many cause undesirable side effects. Clozapine, for ex... | Schizophrenia Insulin Resistance | Glucose Metabolism | null | 2 | arm 1: Participants will take aripiprazole 15mg/day for 8 weeks. arm 2: Participants will take placebo for 8 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 15-mg dose once a day for 8 weeks intervention 2: 1 tablet placebo dose once a day for 8 weeks | intervention 1: Aripiprazole intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 30 | 0 | 0 | 0 | NCT00345033 | 1COMPLETED | 2010-10-01 | 2005-03-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The aim of this study is to test the safety and efficacy of a new algorithm for intensive s.c. insulin injection in medical emergency patients with hyperglycaemia (plasma glucose concentration ≥ 8 mmol/l) | BACKGROUND: Prospective randomized trials have shown that near-normoglycemic blood glucose control using insulin infusions achieves a significant reduction in mortality of severely ill patients in intensive care units, of patients with acute myocardial infarction and with stroke. This implies that most severely ill pat... | Hyperglycemias | Hyperglycaemia algorithm emergency s.c. insulin therapy Emergency patient | null | 2 | arm 1: Conventional insulin group:
In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician. arm 2: Intensive insulin therapy algorithm:
The algorithm in the intensive... | [
1,
0
] | 1 | [
0
] | intervention 1: Comparison of a sliding scale with an intensive s.c. scale | intervention 1: Novorapid ®, Novo Nordisk, Denmark | 1 | Basel | Canton of Basel-City | Switzerland | 7.57327 | 47.55839 | 130 | 0 | 0 | 0 | NCT00353431 | 1COMPLETED | 2010-10-01 | 2006-12-01 | University Hospital, Basel, Switzerland | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate toget... | OBJECTIVES:
Primary
* Evaluate the activity of imatinib mesylate and hydroxyurea, as measured by 6-month progression-free survival, in patients with recurrent or progressive meningioma.
Secondary
* Evaluate the progression-free survival (PFS)
* Overall survival (OS),
* Objective response rate among patients treated... | Glioblastoma Gliosarcoma | adult grade I meningioma adult grade II meningioma adult grade III meningioma adult papillary meningioma adult anaplastic meningioma recurrent adult brain tumor glioblastoma multiforme (GBM) Imatinib Imatinib mesylate Hydroxyurea Droxia Hydrea Hydroxycarbamide Gleevec Meningioma | null | 1 | arm 1: All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs. | [
0
] | 2 | [
0,
0
] | intervention 1: Hydroxyurea is administered orally twice a day. The dose will be set at 500 mg twice a day for all patients. If vomiting occurs not additional trial medication should be taken that day in an effort to replace the material that has been vomited. It is recommended that patients take their prescribed hydro... | intervention 1: hydroxyurea intervention 2: imatinib mesylate | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 21 | 0 | 0 | 0 | NCT00354913 | 1COMPLETED | 2010-10-01 | 2005-05-01 | 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
] | 10 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | true | Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.
At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Re... | Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11) in patients with recurrent anaplastic astrocytomas (AA), mixed malignant glioma, and oligodendrogliomas (OA). Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days (treatment cycle).
Baseline data (collected \<14 ... | Astrocytoma Glioma Oligodendroglioma | Recurrent Anaplastic Astrocytoma Mixed Malignant Glioma Oligodendroglioma Irinotecan Brain tumor Nitrosoureas Brain and nervous system | null | 1 | arm 1: Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depen... | [
0
] | 2 | [
0,
0
] | intervention 1: Irinotecan injections. Irinotecan hydrochloride \[CPT-11; CAMPTOSAR\] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 ... | intervention 1: Irinotecan Hydrochloride (HCI) Treatment intervention 2: Continued Irinotecan Hydrochloride (HCI) Treatment | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 10 | 0 | 0 | 0 | NCT00360828 | 6TERMINATED | 2010-10-01 | 2006-02-01 | H. Lee Moffitt Cancer Center and Research 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 |
[
4
] | 50 | RANDOMIZED | CROSSOVER | 1PREVENTION | 0NONE | false | 2MALE | false | This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in 4 study periods. The first period is a 16-week on-demand treatment, during which subjects will utilize BeneFIX to treat bleeding events ... | null | Hemophilia B | Hemophilia B BeneFIX | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 100 IU/kg once weekly then crossover to 50 IU/kg twice weekly intervention 2: 50 IU/kg twice weekly then crossover to 100 IU/kg once weekly | intervention 1: Recombinant Coagulation Factor IX (BeneFIX) intervention 2: Recombinant Coagulation Factor IX (BeneFIX) | 19 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Houston | Texas | United States | -95.36327 | 29.76328
Edmonton | Alberta | Cana... | 181 | 0 | 0 | 0 | NCT00364182 | 1COMPLETED | 2010-10-01 | 2007-05-01 | 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
] | 110 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the en... | PRIMARY OBJECTIVES:
I. To evaluate the frequency and severity of hemorrhage toxicities in patients with advanced non-small cell lung cancer treated with the combination of carboplatin, paclitaxel, cetuximab and bevacizumab followed by therapy with cetuximab and bevacizumab.
SECONDARY OBJECTIVES:
I. To evaluate progr... | Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Squamous Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | null | 1 | arm 1: INDUCTION THERAPY: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
... | [
0
] | 3 | [
2,
0,
2
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV | intervention 1: cetuximab intervention 2: paclitaxel intervention 3: bevacizumab | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 102 | 0 | 0 | 0 | NCT00368992 | 1COMPLETED | 2010-10-01 | 2006-08-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 152 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain. | Pfizer decided to discontinue additional enrollment into the study effective Sept 5 2010 after assessing the feasibility of completing this study in a realistic timeframe.The study was not stopped for any safety concerns. | Bone Neoplasms Pain, Intractable Cancer | null | 2 | arm 1: flexible dosing arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days). intervention 2: Placebo | intervention 1: Pregabalin intervention 2: Placebo | 55 | Celebration | Florida | United States | -81.53313 | 28.32529
Kissimmee | Florida | United States | -81.41667 | 28.30468
Pensacola | Florida | United States | -87.21691 | 30.42131
Pensacola | Florida | United States | -87.21691 | 30.42131
Louisville | Kentucky | United States | -85.75941 | 38.25424
Edina | Minnesota | U... | 152 | 0 | 0 | 0 | NCT00381095 | 6TERMINATED | 2010-10-01 | 2006-12-01 | Pfizer's Upjohn has merged with Mylan to form Viatris 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
] | 94 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be ... | null | Prostate Cancer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression intervention 2: Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression | intervention 1: dasatinib intervention 2: dasatinib | 11 | Los Angeles | California | United States | -118.24368 | 34.05223
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Seattle | W... | 95 | 0 | 0 | 0 | NCT00385580 | 1COMPLETED | 2010-10-01 | 2007-01-01 | 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 | |
[
4
] | 669 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied. | null | Hepatitis B, Chronic | null | 2 | arm 1: TDF=tenofovir arm 2: ETV=entecavir; TDF=tenofovir | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks intervention 2: Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks | intervention 1: Entecavir intervention 2: Entecavir + Tenofovir | 68 | Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
San Jose | California | United States | -121.89496 | 37.33939
New Haven | Connecticut | United States | -72.92816 | 41.30815
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Ge... | 379 | 0 | 0 | 0 | NCT00410072 | 1COMPLETED | 2010-10-01 | 2007-04-01 | 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
] | 116 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing... | null | Colon Cancer Colorectal Cancer Rectal Cancer Cancer Metastatic Cancer Metastatic Colorectal Cancer Oncology | k-ras biomarker colorectal colon rectal FOLFOX FOLFIRI | null | 1 | arm 1: Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal. | [
0
] | 2 | [
2,
0
] | intervention 1: Administered by intravenous infusion intervention 2: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines. | intervention 1: Panitumumab intervention 2: FOLFIRI | 0 | null | 115 | 0 | 0 | 0 | NCT00411450 | 1COMPLETED | 2010-10-01 | 2006-11-01 | Amgen | 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
] | 110 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair.
The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort.
The primary outcome variable is length of hospitalizatio... | This will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. This is intended to be a definitive study.
Power calculations based on the known length of hospitalization listed above with α = 0.0... | Postoperative Pain | Pectus Excavatum Bar Repair Pain Control Pectus Excavatum Repair | null | 2 | arm 1: Epidural analgesia arm 2: IV narcotic analgesia | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Upon arrival to the operating room, patients will have a thoracic epidural (T 6-9) placed while in the sitting position. All epidural catheters will be inserted 3-5 cm within the epidural space and will be placed by attending anesthesiologists. Patients will receive midazolam 0.025 - 0.05 mg/kg IV (max ... | intervention 1: Epidural Analgesia intervention 2: Patient-Controlled IV Analgesia | 1 | Kansas City | Missouri | United States | -94.57857 | 39.09973 | 0 | 0 | 0 | 0 | NCT00413582 | 1COMPLETED | 2010-10-01 | 2006-10-01 | Children's Mercy Hospital Kansas City | 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 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | null | This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenal... | null | Myelodysplastic Syndromes Thrombocytopenia | Revlimid Lenalidomide Low Platelet Count Low Risk Myelodysplastic Syndrome Intermediate 1 Myelodysplastic Syndrome MDS Myelodysplastic Syndrome | null | 5 | arm 1: 750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 2: Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) arm 3: Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 we... | [
1,
2,
2,
1,
1
] | 2 | [
2,
0
] | intervention 1: AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg. intervention 2: Subjects in the control group will receive placebo via subcutaneous injection. | intervention 1: AMG 531 intervention 2: Placebo | 0 | null | 37 | 0 | 0 | 0 | NCT00418665 | 1COMPLETED | 2010-10-01 | 2006-12-01 | Amgen | 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
] | 50 | RANDOMIZED | PARALLEL | 6HEALTH_SERVICES_RESEARCH | 0NONE | true | 1FEMALE | null | This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contrace... | null | Post Partum | Teen Plan B Post Partum Emergency Contraception | null | 2 | arm 1: No advance supply of emergency contraception arm 2: Advance supply of emergency contraception is given | [
4,
1
] | 1 | [
0
] | intervention 1: PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS. | intervention 1: Plan B (Levonorgestrel) | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 50 | 0 | 0 | 0 | NCT00433004 | 1COMPLETED | 2010-10-01 | 2007-02-01 | 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 |
[
4
] | 1,199 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | null | This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis. | null | Male Osteoporosis | Osteoporosis males vertebral fractures clinical fractures bone mineral density bone biomarkers zoledronic acid | null | 2 | arm 1: 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a tota... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Zoledronic acid 5 mg iv given once a year. intervention 2: Placebo intravenous (i.v.) once a year | intervention 1: Zoledronic acid 5 mg iv intervention 2: Placebo | 128 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Córdoba | N/A | Argentina | -64.18853 | -31.40648
Mar del Plata | N/A | Argentina | -57.5562 | -38.00042
San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601
Geelong-VIC | N/A | Australia | N/A | N/A
Maroochydore-QLD | N/A | Australia | N/A | N/A
Randwic... | 1,199 | 0 | 0 | 0 | NCT00439647 | 1COMPLETED | 2010-10-01 | 2006-12-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA. | JIA is a type of arthritis with no definite cause and an onset prior to 16 years of age. JIA causes joint destruction, pain, and permanent disability. There are multiple types of JIA; collectively, they represent one of the most common chronic diseases in children and the most prevalent pediatric rheumatic illness. Pol... | Juvenile Chronic Polyarthritis Juvenile Idiopathic Arthritis Juvenile Rheumatoid Arthritis | Childhood Arthritis Juvenile Arthritis Juvenile Arthritis Treatment Childhood Arthritis Drug Treatment Juvenile Arthritis Remission Inactive Disease in Juvenile Arthritis Childhood Polyarthritis Extended Oligoarthritis | null | 2 | arm 1: Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone arm 2: Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decrea... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone intervention 2: methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, ... | intervention 1: methotrexate intervention 2: methotrexate - etanercept - prednisolone arm | 15 | Palo Alto | California | United States | -122.14302 | 37.44188
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Boston | Massachusetts | United States | -71.05977 | 42.35843
Hackensack | New Jersey | United States | -74.04347 | 40.88593
Ne... | 85 | 0 | 0 | 0 | NCT00443430 | 1COMPLETED | 2010-10-01 | 2007-05-01 | Seattle Children's Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 81 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest tolerable dose until toxicity, progression, or withd... | This multicenter, open-label study of fostamatinib will take place in two phases.
Phase I Two cohorts, of 6 patients each, will be sequentially assigned to receive 200 mg (Cohort 1) and 250 mg (Cohort 2) PO bid of R788. Patients will be enrolled at 250 mg bid in Cohort 2 only if \< 1/6 patients in Cohort 1 experience ... | Lymphoma | DLCL Nodular lymphoma Mantle cell lymphoma Syk kinase | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 200 mg PO BID | intervention 1: fostamatinib | 11 | 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
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Boston | Massachus... | 81 | 0 | 0 | 0 | NCT00446095 | 1COMPLETED | 2010-10-01 | 2007-04-01 | Rigel 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
] | 33 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach... | null | Head and Neck Cancer Cancer of the Pharynx Cancer of the Larynx Nose Neoplasms Paranasal Sinus Neoplasms Cancer of the Oral Cavity | Cancer of the Nasal Cavity | null | 1 | arm 1: Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients intervention 2: 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation intervention 3: continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours intervention 4: Radiotherapy ... | intervention 1: Cetuximab intervention 2: Hydroxyurea intervention 3: Fluorouracil intervention 4: radiotherapy | 1 | New York | New York | United States | -74.00597 | 40.71427 | 33 | 0 | 0 | 0 | NCT00462735 | 1COMPLETED | 2010-10-01 | 2007-02-01 | Johnny Kao | 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
] | 501 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain. | null | Pain, Postoperative | pain after hysterectomy amount of opioids used | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 150 mg/day double blind (divided doses) intervention 2: 300 mg/day double blind (divided doses) intervention 3: matched placebo | intervention 1: pregabalin (Lyrica) intervention 2: pregabalin (Lyrica) intervention 3: matched placebo | 42 | Mobile | Alabama | United States | -88.04305 | 30.69436
Glendale | Arizona | United States | -112.18599 | 33.53865
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Glendale | California | United ... | 494 | 0 | 0 | 0 | NCT00468845 | 1COMPLETED | 2010-10-01 | 2007-06-01 | Pfizer's Upjohn has merged with Mylan to form Viatris 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
] | 92 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis. | This study is a multinational, European, multicenter, randomized, open-label, active comparator controlled study with 2 study periods: a screening phase of up to 6 weeks, and an open-label treatment phase of 18 months. Approximately 100 adult men with osteoporosis associated with sustained glucocorticoid therapy will b... | Osteoporosis | Glucocorticoid Induced | null | 2 | arm 1: Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD). arm 2: Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 20 µg/day sc for 18 months intervention 2: 35 mg/week po for 18 months | intervention 1: Teriparatide intervention 2: Risedronate | 13 | Bad Nauheim | N/A | Germany | 8.73859 | 50.36463
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Hamburg | N/A | Germany | 9.99302 | 53.55073
Heinsberg | N/A | Germany | 6.0998 | 51.06358
Leverkusen | N/A | Germany | 6.98432 | 51.0303
Magdeburg | N/A | Germany | 11.62916 | 52.12773
Potsdam | N/A | Germany | 13.06566 | ... | 92 | 0 | 0 | 0 | NCT00503399 | 1COMPLETED | 2010-10-01 | 2007-07-01 | 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 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to learn if the combination of rabbit anti-thymocyte globulin (Thymoglobulin®), sirolimus (Rapamune®), and mycophenolate mofetil (Cellcept®) can help to prevent graft versus host disease (GVHD). The safety of this drug combination will also be studied.
Primary Objective: To ... | Rabbit anti-thymocyte globulin (rATG), sirolimus, and mycophenolate mofetil (MMF) are all designed to prevent GVHD.
If you are found to be eligible to take part in this study, you will receive rATG through a needle in your vein over 3-4 hours on each of the 4 days before the stem cell transplant.
Beginning 2 days bef... | Hematological Malignancies Myelodysplastic Syndrome Leukemia Lymphoma | Hematological Malignancies Myelodysplastic Syndrome Graft Versus Host Disease GVHD Allogeneic Hematopoietic Stem Cell Transplantation AHSCT Leukemia Lymphoma T-Cells Thymoglobulin ATG rATG Rabbit Antithymocyte Globulin Rapamune Sirolimus Mycophenolate Mofetil Cellcept MMF | null | 1 | arm 1: Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27. | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: 15 mg/kg by vein or by mouth every 12 hours. intervention 2: 1.5 mg/kg by vein daily for 4 days intervention 3: 6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day. intervention 4: Stem cell infusion on Day 0. | intervention 1: Mycophenolate Mofetil (MMF) intervention 2: Thymoglobulin intervention 3: Sirolimus intervention 4: Stem Cell Transplant | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 10 | 0 | 0 | 0 | NCT00506948 | 6TERMINATED | 2010-10-01 | 2006-09-01 | 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,
4
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | In up to 1 out of 3 patients with epilepsy, seizures continue to occur despite the use of one or more antiepileptic medications. Patients also have significant problems with side-effects of these medications as doses are increased.
Our body naturally generates miniature pumps located on the surfaces of many organs to ... | The Center for Disease Control reports that epilepsy afflicts 2.7 million Americans with annual costs of $15.5 billion. They estimate that 3% of Americans will have a diagnosis of epilepsy by age 80, and decided in 1997 to focus on treatment, with a motto of "no seizures, no side effects".
Antiepileptic drugs (AED) ca... | Epilepsy | Epilepsy Seizure p-glycoprotein | null | 1 | arm 1: Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain. | [
0
] | 1 | [
0
] | intervention 1: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication. | intervention 1: Carvedilol-CR | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | 0 | 0 | 0 | NCT00524134 | 6TERMINATED | 2010-10-01 | 2008-12-01 | 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 |
[
0
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using porfimer sodium may be effective against mouth or throat dysplasia and cancer of the mouth and throat.
PURPOSE: This phase I trial i... | OBJECTIVES:
* To determine the response of patients with recurrent dysplasia, squamous cell carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity or the larynx treated with photodynamic therapy using porfimer sodium.
* To identify the local toxicity of this treatment in these patients.
OUTLINE: Pat... | Head and Neck Cancer | recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage 0 laryngeal cancer stage 0 lip and oral cavity cancer | null | 1 | arm 1: Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. | [
0
] | 2 | [
0,
0
] | intervention 1: IV intervention 2: None | intervention 1: porfimer sodium intervention 2: Photdynamic Therapy (PDT) | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 30 | 0 | 0 | 0 | NCT00530088 | 6TERMINATED | 2010-10-01 | 2001-10-01 | Roswell Park Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 308 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major Depressive Disorder (MDD). | • Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD) without psychotic features, single or recurrent | Major Depressive Disorder | Mental Health Adolescents Major Depressive Disorder Depression Adolescent Depression Pediatric Depression | null | 2 | arm 1: Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg arm 2: Placebo Selegiline Transdermal System 6, 9 or 12 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study intervention 2: Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study | intervention 1: Selegiline Transdermal System intervention 2: Placebo | 20 | Dothan | Alabama | United States | -85.39049 | 31.22323
National City | California | United States | -117.0992 | 32.67811
San Diego | California | United States | -117.16472 | 32.71571
Gainesville | Florida | United States | -82.32483 | 29.65163
North Miami | Florida | United States | -80.18671 | 25.89009
Tampa | Flori... | 308 | 0 | 0 | 0 | NCT00531947 | 1COMPLETED | 2010-10-01 | 2007-07-01 | Somerset Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
2
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bi... | null | Glioma | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 500mg/m2 po bid (starting dose) | intervention 1: capecitabine [Xeloda] | 9 | San Francisco | California | United States | -122.41942 | 37.77493
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Chicago | Illinois | United States | -87.65005 | 41.85003
Boston | Massachusetts | United States | -71.05977 | 42.35843
Durham | North Carolina | United States | -78.89862 | 3... | 22 | 0 | 0 | 0 | NCT00532948 | 1COMPLETED | 2010-10-01 | 2007-05-01 | 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
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this research study is to determine the safety and learn more about the dose of Activated Protein C (APC) in reducing the damage from stroke. | An ischemic stroke occurs when there is damage to the brain caused by blockage in the blood vessels supplying the brain. Approximately 500,000 people in the United States experience this type of stroke each year. The only approved treatment for acute stroke is to attempt to dissolve the blood clot using t-PA (tissue pl... | Stroke | Acute Ischemic Stroke | null | 1 | arm 1: Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one ho. | [
0
] | 1 | [
0
] | intervention 1: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset | intervention 1: Activated Protein C | 9 | Orange | California | United States | -117.85311 | 33.78779
Maywood | Illinois | United States | -87.84312 | 41.8792
St Louis | Missouri | United States | -90.19789 | 38.62727
Brooklyn | New York | United States | -73.94958 | 40.6501
Brooklyn | New York | United States | -73.94958 | 40.6501
New York | New York | United... | 12 | 0 | 0 | 0 | NCT00533546 | 6TERMINATED | 2010-10-01 | 2007-09-01 | University of Rochester | 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
] | 319 | NON_RANDOMIZED | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | false | The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain. | This was an open-label multi-center study of the safety of fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication was administered under the tongue as a simple spray and could be self-administered by patients or assisted by their caregivers. In addition to safety, there was a questi... | Cancer Pain | null | 2 | arm 1: Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administere... | [
0,
0
] | 1 | [
0
] | intervention 1: Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg | intervention 1: Fentanyl sublingual spray | 52 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Winfield | Alabama | United States | -87.81725 | 33.92899
Glendale | Arizona | United States | -112.18599 | 33.53865
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Laguna Hills | California | United States | -117.71283 | 33.61252
Loma Linda | Cali... | 498 | 0 | 0 | 0 | NCT00538863 | 1COMPLETED | 2010-10-01 | 2007-12-01 | INSYS 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 | |
[
4
] | 489 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo. | null | Schizophrenia | Schizophrenia SM-13496 Latuda Lurasidone | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 1 | [
0
] | intervention 1: Once daily | intervention 1: Lurasidone HCl | 48 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Costa Mesa | California | United States | -117.91867 | 33.64113
Garden Grove | California | United States | -117.94145 | 33.77391
Paramount | California | United States | -118.15979 | 33.88946
Pas... | 496 | 0 | 0 | 0 | NCT00549718 | 1COMPLETED | 2010-10-01 | 2007-10-01 | 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 |
[
2,
3
] | 1 | null | null | 0TREATMENT | null | false | 0ALL | false | RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. When t... | OBJECTIVES:
Primary
* Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.
Secondary
* Determine the incidence of life-threatening infection in patients receiving this treatment.
* Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in p... | Graft Versus Host Disease Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases | graft versus host disease adult acute megakaryoblastic leukemia (M7) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia with 11q23 (MLL) abnormalities ad... | null | 1 | arm 1: Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. | [
0
] | 7 | [
2,
0,
0,
0,
0,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None | intervention 1: alemtuzumab intervention 2: busulfan intervention 3: cyclophosphamide intervention 4: methotrexate intervention 5: tacrolimus intervention 6: allogeneic hematopoietic stem cell transplantation intervention 7: peripheral blood stem cell transplantation | 2 | Seattle | Washington | United States | -122.33207 | 47.60621
Seattle | Washington | United States | -122.33207 | 47.60621 | 1 | 0 | 0 | 0 | NCT00555048 | 6TERMINATED | 2010-10-01 | 2007-09-01 | 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 |
[
2
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization. | Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and syste... | Corneal Neovascularization | null | 1 | arm 1: Each patient will receive topical Avastin in one eye. | [
0
] | 1 | [
0
] | intervention 1: Avastin (bevacizumab) 1% | intervention 1: Topical Avastin 1% | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 24 | 0 | 0 | 0 | NCT00559936 | 1COMPLETED | 2010-10-01 | 2007-02-01 | Massachusetts Eye and Ear Infirmary | 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
] | 37 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing... | null | Precocious Puberty | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: One intra muscular injection at day 1 and month 3. | intervention 1: Triptorelin pamoate 11.25mg (Decapeptyl® SR) | 18 | Angers | N/A | France | -0.55202 | 47.47156
Besançon | N/A | France | 6.01815 | 47.24878
Bordeaux | N/A | France | -0.5805 | 44.84044
Dijon | N/A | France | 5.01667 | 47.31667
Le Havre | N/A | France | 0.10785 | 49.49346
Lille | N/A | France | 3.05858 | 50.63297
Lyon | N/A | France | 4.84671 | 45.74846
Marseille | N/A ... | 37 | 0 | 0 | 0 | NCT00564850 | 1COMPLETED | 2010-10-01 | 2007-10-01 | Ipsen | 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
] | 92 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who receive the addition of any additional treatment t... | null | Bipolar Disorder | Open-label extension Tolerability Lamotrigine Safety Bipolar I disorder | null | 1 | arm 1: study drug | [
0
] | 1 | [
0
] | intervention 1: lamotrigine 50mg/day-400mg/day | intervention 1: BW430C (lamotrigine) | 52 | Aichi | N/A | Japan | 130.62158 | 32.51879
Chiba | N/A | Japan | 140.11667 | 35.6
Chiba | N/A | Japan | 140.11667 | 35.6
Chiba | N/A | Japan | 140.11667 | 35.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 3... | 92 | 0 | 0 | 0 | NCT00566020 | 1COMPLETED | 2010-10-01 | 2008-05-01 | 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
] | 4 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. They grow into different types of blood cells that the body needs, including red blood cells, white blood... | Allogeneic stem cell transplantation with high-dose chemotherapy affords a better chance of cure of malignant and non-malignant hematological diseases compared to autologous transplantation, because of the lack of stem cell contamination and the immune mediated graft vs. leukemia effect. Unfortunately, high-dose chemot... | Myelodysplastic and Myeloproliferative Disorders Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Multiple Myeloma Plasma Cell Dyscrasia Lymphoproliferative Disorders Hematologic Diseases | Myelodysplastic and Myeloproliferative Disorders Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Multiple Myeloma Plasma Cell dyscrasia Lymphoproliferative disorders Hematologic Diseases Fludarabine Busulfan Campath Alemtuzumab allogeneic stem cell transplant | null | 2 | arm 1: Recipients of HLA identical sibling stem cell transplants arm 2: Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants | [
0,
0
] | 5 | [
0,
0,
0,
3,
0
] | intervention 1: 10 mg/day IV daily for 3 days on days -6 to D-4. Campath may be omitted from the conditioning regimen for patients with malignant diseases and matched related donor transplants intervention 2: 3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4 intervention 3: 30mg/m2/day IV da... | intervention 1: Campath intervention 2: Busulfan intervention 3: Fludarabine intervention 4: Hematopoietic stem cell infusion intervention 5: FK-506 | 2 | Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328 | 4 | 0 | 0 | 0 | NCT00579111 | 6TERMINATED | 2010-10-01 | 2007-06-01 | Baylor College of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy). | In this study one cycle of chemotherapy will be administered and then those subjects who respond well to that cycle will be started on radiation therapy along with chemotherapy and those that don't respond well to the initial cycle of chemotherapy, will undergo a total laryngectomy (surgery to remove the voice box) fol... | Cancer of Larynx | Cancer of Larynx | null | 1 | arm 1: Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followe... | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1\. Day 1: 100 mg/m2, administered as an i.v. infusion will run over one hour. 2. Day #23: Subjects with a \< 50% response (NR) to induction chemotherapy will undergo salvage laryngectomy followed by RT. Cisplatin will be added to radiation for patients whose surgical pathology reveals high-risk feature... | intervention 1: Cisplatin intervention 2: Cetuximab intervention 3: 5-Fluorouracil intervention 4: Docetaxel | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 4 | 0 | 0 | 0 | NCT00599131 | 6TERMINATED | 2010-10-01 | 2007-08-01 | University of Michigan Rogel 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
] | 604 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents. | null | Obesity | obesity weight loss lorcaserin APD356 BLOOM-DM hypertension dyslipidemia sleep apnea glucose tolerance cardiovascular disease Arena | null | 3 | arm 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening arm 2: Lorcaserin 10 mg tablet each morning and evening arm 3: Matching placebo tablet each morning and evening | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. intervention 2: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. intervention 3: Matching placebo tablet each morning and evening for a duration of 52 weeks. | intervention 1: Lorcaserin 10 mg once daily (QD) intervention 2: Lorcaserin 10 mg twice a day (BID) intervention 3: Matching Placebo | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 603 | 0 | 0 | 0 | NCT00603291 | 1COMPLETED | 2010-10-01 | 2007-12-01 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual treatment is a type of laser, called panretinal photocoagulation. One drawback is that the amount of space within the eye for use of this... | The purpose is to compare the efficacy of ranibizumab versus additional panretinal photocoagulation on diabetic neovascularization that is persistent despite previous treatment with panretinal photocoagulation. We hypothesize that ranibizumab intravitreal injections would induce neovascular regression in similar or bet... | Proliferative Diabetic Retinopathy | ICF_001.pdf:
U.S. ICF: Ranibizumab (Lucentis)
Page 1 of 20
Subject’s initials _______
Protocol Number FVF3817s
Version Date July 23, 2008
RUSH UNIVERSITY MEDICAL CENTERSubject
Information Sheet and Consent Form
Principal Investigator: Mathew W. MacCumber, M.D.,
Ph.D.
Sub-Investigators:
Jack A. Cohen, M.D., Michae... | 2 | arm 1: Intravitreal injection of 0.5-mg dose of ranibizumab arm 2: Additional panretinal photocoagulation (up to 500 300-500 um laser spots) | [
0,
1
] | 2 | [
0,
3
] | intervention 1: One 0.5 mg intravitreal injection intervention 2: panretinal photocoagulation (up to 500 300-500 um laser spots) | intervention 1: ranibizumab intervention 2: Laser photocoagulation | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 8 | 0 | 0 | 0 | NCT00606138 | 1COMPLETED | 2010-10-01 | 2008-01-01 | Rush University Medical Center | 7OTHER | true | false | true | https://cdn.clinicaltrials.gov/large-docs/38/NCT00606138/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/38/NCT00606138/ICF_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
] | 104 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Purpose: The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery. After release from the hospital, the patient will control blood sugar with subcutaneous insulin injections or pills. With this approach, ... | Research Design: A randomized control trial comparing intensive intravenous insulin (IVI) for use in the hospital followed by intensive subcutaneous (sc) insulin use for in-patient and out-patient glycemic control will be conducted. | Kidney Transplantation Diabetes Hyperglycemia | Kidney Transplantation Diabetes Hyperglycemia | null | 2 | arm 1: The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL. arm 2: The cont... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: The intravenous regular insulin infusion will be delivered continuously during the transplant surgery and after surgery for a total of three days. While receiving the insulin infusion, the dose will be calculated to keep the blood sugar levels between 70-110 mg/dL.
After the regular insulin infusion is... | intervention 1: insulin intervention 2: NPH Insulin or glargine insulin and aspartame insulin | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 93 | 0 | 0 | 0 | NCT00609986 | 1COMPLETED | 2010-10-01 | 2007-07-01 | Medical University of South Carolina | 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
] | 258 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474). | null | Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident | null | 2 | arm 1: Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year arm 2: Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Vorapaxar 2.5 mg oral tablet intervention 2: matching placebo oral tablet | intervention 1: Vorapaxar 2.5 mg intervention 2: Placebo | 0 | null | 0 | 0 | 0 | 0 | NCT00617123 | 1COMPLETED | 2010-10-01 | 2008-07-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 301 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | true | 1FEMALE | false | The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment o... | null | Contraception | null | 1 | arm 1: Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA)
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and
2 mm in diameter which is placed at the inner side of the non-dominant upper-arm
about 8-10 cm above the medial epicondyle. The Radiopaque I... | [
0
] | 1 | [
0
] | intervention 1: One implant inserted for a 3-year treatment period | intervention 1: Radiopaque Etonogestrel Implant | 0 | null | 301 | 0 | 0 | 0 | NCT00620035 | 1COMPLETED | 2010-10-01 | 2007-03-01 | 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 | |
[
3
] | 18 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Numerous neuroprotectants have been effective when given prior to ischemic stroke in animals, yet they have all have failed when given after ischemic stroke in humans. A novel approach to ischemic neuroprotection is needed. Many patients who undergo cardiac, vascular, and neurosurgical procedures develop ischemic centr... | Numerous neuroprotectants have been effective when given prior to ischemic stroke in animals, yet they have all have failed when given after ischemic stroke in humans. A novel approach to ischemic neuroprotection is needed. Many patients who undergo cardiac, vascular, and neurosurgical procedures develop ischemic centr... | Spinal Ischemia Stroke Neuroprotection | Surgical complications Spinal ischemia Stroke Neuroprotection | null | 2 | arm 1: Patients received 1mg/kg IV Darbepoetin immediately prior to surgery arm 2: No Darbepoetin | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery intervention 2: None | intervention 1: Darbepoetin alfa intervention 2: Standard care | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 18 | 0 | 0 | 0 | NCT00647998 | 1COMPLETED | 2010-10-01 | 2008-01-01 | 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 |
[
3
] | 79 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week. | null | Alzheimer Disease | antibody immunotherapy | null | 3 | arm 1: 5 mg/week arm 2: 10 mg/week arm 3: Placebo | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 5 mg bapineuzumab subcutaneous injection once per week for 6 months intervention 2: 10 mg bapineuzumab subcutaneous injection once per week for 6 months intervention 3: Placebo subcutaneous injection once per week for 6 months | intervention 1: bapineuzumab intervention 2: bapineuzumab intervention 3: placebo | 17 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Sun City | Arizona | United States | -112.27182 | 33.59754
Encino | California | United States | -118.50119 | 34.15917
Los Alamitos | California | United States | -118.07256 | 33.80307
Newport Beach | California | United States | -117.92895 | 33.61891
Delray Bea... | 79 | 0 | 0 | 0 | NCT00663026 | 1COMPLETED | 2010-10-01 | 2008-11-01 | 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 |
[
2,
3
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis. | null | Posterior Blepharitis | null | 3 | arm 1: 2.5% IL-1Ra arm 2: Artificial Tear arm 3: 5% IL-1Ra | [
1,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: 2.5% custom made topical IL-1Ra three times a day in both eyes for three months intervention 2: custom eye drop to be applied three times a day in both eyes for three months intervention 3: 5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months | intervention 1: 2.5% IL-1Ra intervention 2: Placebo intervention 3: 5% IL-1Ra | 0 | null | 75 | 0 | 0 | 0 | NCT00681109 | 1COMPLETED | 2010-10-01 | 2008-01-01 | Reza Dana, 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 | |
[
2,
3
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unresectable or metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab and MEDI-522, can block tumor growth i... | PRIMARY OBJECTIVES:
I. To assess the appropriate dose of bevacizumab when administered with humanized monoclonal antibody MEDI-522 in patients with unresectable or metastatic renal cell carcinoma previously treated with sunitinib malate or sorafenib tosylate. (Phase I) II. To compare the progression-free survival of t... | Recurrent Renal Cell Cancer Renal Cell Carcinoma Stage III Renal Cell Cancer Stage IV Renal Cell Cancer | null | 2 | arm 1: Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15. arm 2: Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22. | [
1,
1
] | 2 | [
0,
2
] | intervention 1: Given IV intervention 2: Given IV | intervention 1: etaracizumab intervention 2: bevacizumab | 5 | Marysville | California | United States | -121.59135 | 39.14573
Sacramento | California | United States | -121.4944 | 38.58157
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Portland | Oregon | United States | -122.67621 | 45.52345 | 3 | 0 | 0 | 0 | NCT00684996 | 6TERMINATED | 2010-10-01 | 2008-06-01 | 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 | |
[
3
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | false | The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy. | null | Prostate Cancer | prostate cancer hormone treatment | null | 2 | arm 1: 300 mg orally, once daily for up to 18 months arm 2: orally, once daily for up to 18 months | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 300 mg orally, once daily for up to 18 months intervention 2: None | intervention 1: vandetanib intervention 2: Placebo | 11 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Kingston | Ontario | Canada | -76.48098 | 44.22976
London | Ontario | Canada | -81.23304 | 42.98339
Toront... | 17 | 0 | 0 | 0 | NCT00686036 | 6TERMINATED | 2010-10-01 | 2008-05-01 | Genzyme, a Sanofi 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
] | 51 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 0ALL | false | This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators b... | The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas... | Bariatric Surgery | Bariatric Surgery Glucose Regulation Cardiac Function Body Composition | null | 1 | arm 1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. | [
0
] | 1 | [
0
] | intervention 1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. | intervention 1: GLP-1 | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | 0 | 0 | 0 | NCT00686972 | 6TERMINATED | 2010-10-01 | 2007-05-01 | Johns Hopkins 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
] | 102 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA)... | null | Hepatitis C, Chronic Liver Cirrhosis | hepatitis C | null | 1 | arm 1: None | [
0
] | 2 | [
2,
0
] | intervention 1: Administered at 1.0 µg/kg/week SC for 48 weeks intervention 2: Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL; treatm... | intervention 1: Peginterferon alfa-2b intervention 2: Ribavirin | 0 | null | 102 | 0 | 0 | 0 | NCT00687219 | 1COMPLETED | 2010-10-01 | 2007-06-01 | 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 |
[
5
] | 151 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.
1. Etanercept alone treatment group (25mg, twice/week, s.c.)
2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week) | null | Rheumatoid Arthritis | null | 2 | arm 1: etanercept (25mg, twice/week, s.c.) arm 2: etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: etanercept (25 mg, twice/week, s.c.) intervention 2: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week) | intervention 1: ETN Alone intervention 2: ETN+MTX | 1 | Tokyo | Tokyo | Japan | 139.69171 | 35.6895 | 147 | 0 | 0 | 0 | NCT00688103 | 1COMPLETED | 2010-10-01 | 2005-06-01 | Japan Biological Agent Study Integrated Consortium | 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
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA), including right-sided infective endocarditis (RIE). | Patients who meet all inclusion criteria and exhibit none of the exclusion criterial will be randomized to one of two treatment arms:
1. daptomycin Intravenously (IV) 10 mg/kg every 24 hours
2. vancomycin IV dosed to maintain trough levels of 15 to 20 μg/mL.
The suggested duration of therapy with daptomycin or vancom... | Endocarditis, Bacterial Infective Endocarditis | Gram-positive bacterial infections Staph Aureus Bacteremia MRSA Infective Endocarditis Right-sided Infective endocarditis SABIE SAIE RIE | null | 2 | arm 1: Daptomycin 10 mg/kg IV every 24 hours arm 2: Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL | [
0,
0
] | 2 | [
0,
0
] | intervention 1: daptomycin 10 mg/kg IV every 24 hours intervention 2: Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL | intervention 1: daptomycin intervention 2: vancomycin | 2 | Greenville | North Carolina | United States | -77.36635 | 35.61266
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 36 | 0 | 0 | 0 | NCT00695903 | 6TERMINATED | 2010-10-01 | 2008-09-17 | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 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
] | 54 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carbopl... | DOXIL pegylated liposomal doxorubicin (PLD) is approved for use in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Data suggest that combination therapy of carboplatin plus DOXIL provides superior benefit to single agent therapy. Bevacizumab, a vascular endotheli... | Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms | Ovarian cancer fallopian tube cancer primary peritoneal cancer DOXIL carboplatin bevacizumab | null | 1 | arm 1: doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle | [
0
] | 1 | [
0
] | intervention 1: 30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle | intervention 1: doxorubicin HCL liposome; bevacizumab; carboplatin | 1 | Horsham | Pennsylvania | United States | -75.12851 | 40.17844 | 54 | 0 | 0 | 0 | NCT00698451 | 1COMPLETED | 2010-10-01 | 2008-08-01 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 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
] | 30 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement. | Cardiothoracic surgery is a commonly performed procedure in the United States. Many sites previously used cefazolin, an antibiotic, as standard prophylaxis to prevent surgical site infections. However, given most bacteria causing surgical site infections are now resistant to cefazolin, most center are using vancomycin,... | Late Effects of Surgery Staphylococcus Aureus Surgical Site Infection | Daptomycin Antibiotic Prophylaxis Pharmacokinetics Surgical Wound Infection Staphylococcus aureus Cardiopulmonary Bypass Surgery | null | 2 | arm 1: The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis. arm 2: 15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control... | [
0,
4
] | 1 | [
0
] | intervention 1: Subjects enrolled in the intervention group will receive a single intravenous administration of daptomycin 8 mg/kg 30-60 minutes prior to surgery (incision). The 500 mg vial will be reconstituted with 10 mL of 0.9% normal saline (NS) and further diluted in 50 mL of 0.9% NS to be given over a 30 minute i... | intervention 1: daptomycin | 1 | Torrance | California | United States | -118.34063 | 33.83585 | 30 | 0 | 0 | 0 | NCT00701636 | 1COMPLETED | 2010-10-01 | 2008-07-01 | Lundquist Institute for Biomedical Innovation at Harbor-UCLA 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,
3
] | 8 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy. | This is an open label, multi-center, phase I/II dose-escalation clinical trial investigating the safety of zalutumumab in combination with radiotherapy. The safety of zalutumumab doses in combination with radiotherapy (RT) will be investigated using 3 patient cohorts in a dose-escalation / de-escalation design based on... | Head and Neck Cancer Squamous Cell Carcinoma | null | 2 | arm 1: Zalutumumab in combination with radiotherapy for 8 weeks. The treatment period of 8 weeks is followed by a 3 week follow-up period where all adverse events are collected and then additionally a 2 year follow-up period where only serious adverse events are collected. arm 2: Zalutumumab in combination with radioth... | [
0,
0
] | 1 | [
0
] | intervention 1: Eight weekly infusions | intervention 1: Zalutumumab | 8 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Dijon | N/A | France | 5.01667 | 47.31667
Nantes | N/A | France | -1.55336 | 47.21725
Toulouse | N/A | France | 1.44367 | 43.60426
Leeds | N/A | United Kingdom | -1.54785 | 53.79648
London | N/A | United Kingdom | -0.12574 | 51.50853
Manchester | N/A | United Kingdom | -2.2... | 8 | 0 | 0 | 0 | NCT00707655 | 6TERMINATED | 2010-10-01 | 2008-09-01 | Genmab | 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
] | 206 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase ... | null | Human Immunodeficiency Virus Infection | Human Immunodeficiency Virus infection | null | 2 | arm 1: lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily arm 2: lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: LPV/r 400/100 mg BID intervention 2: FTC/TDF 200/300 mg QD intervention 3: RAL 400 mg BID | intervention 1: lopinavir/ritonavir (LPV/r) intervention 2: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) intervention 3: raltegravir (RAL) | 37 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Beverly Hills | California | United States | -118.40036 | 34.07362
Atlantis | Florida | United States | -80.10088 | 26.5909
Ft. Pierce | Florida | United States | -80.32561 | 27.44671
Orlando | Florida | United States | -81.37924 | 28.53834
Tampa | Florida | Uni... | 206 | 0 | 0 | 0 | NCT00711009 | 1COMPLETED | 2010-10-01 | 2008-07-01 | Abbott | 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
] | 32 | RANDOMIZED | PARALLEL | 6HEALTH_SERVICES_RESEARCH | 0NONE | false | 0ALL | true | The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus | Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While... | Deep Sedation Anesthesia, General | depth of sedation nitrous oxide general anesthesia anesthesia indices | null | 2 | arm 1: Sevoflurane based general anesthesia arm 2: Propofol based general anesthesia | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture. intervention 2: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture. | intervention 1: Sevoflurane group intervention 2: Propofol group | 1 | Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 28 | 0 | 0 | 0 | NCT00717574 | 1COMPLETED | 2010-10-01 | 2008-03-01 | 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 |
[
2,
3
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis. | null | Breast Cancer | Breast cancer Women w/Her2 positive ERnegative not metastasized | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherap... | intervention 1: trastuzumab (Herceptin®) | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 1 | 0 | 0 | 0 | NCT00726180 | 6TERMINATED | 2010-10-01 | 2008-07-01 | University of Michigan Rogel 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 |
[
0
] | 1 | RANDOMIZED | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer.
PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine... | OBJECTIVES:
Primary
* To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.
Secondary
* To compare the tolerability of an opioid rota... | Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Pain Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | pain unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leuk... | null | 2 | arm 1: Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks. arm 2: Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are sw... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally | intervention 1: methadone hydrochloride intervention 2: morphine sulfate intervention 3: oxycodone hydrochloride | 2 | Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Houston | Texas | United States | -95.36327 | 29.76328 | 1 | 0 | 0 | 0 | NCT00726830 | 6TERMINATED | 2010-10-01 | 2009-03-01 | 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 |
[
0
] | 126 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy. | Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade... | Proliferative Diabetic Retinopathy Vitreous Hemorrhage | Proliferative diabetic retinopathy vitrectomy bevacizumab vitreous hemorrhage | null | 3 | arm 1: Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy arm 2: Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy arm 3: Patients will not receive bevacizumab before nor during vitrectomy | [
0,
0,
4
] | 1 | [
0
] | intervention 1: Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) | intervention 1: Bevacizumab | 1 | Seongnam | Gyunggi-do | South Korea | 127.39683 | 35.54127 | 126 | 0 | 0 | 0 | NCT00745498 | 1COMPLETED | 2010-10-01 | 2008-06-01 | Seoul National University Bundang 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 |
[
0
] | 5 | RANDOMIZED | PARALLEL | 9OTHER | 0NONE | false | 0ALL | true | The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders. | This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provider as needing antipsychotic treatment of a bipolar disorder.
This study proposes to monitor changes in metabolic param... | Bipolar Disorder | bipolar children antipsychotic side effect | null | 2 | arm 1: risperidone arm 2: aripiprazole | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing. intervention 2: children will have a flexible dosing titration based on their unique respons... | intervention 1: risperidone intervention 2: aripiprazole | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 3 | 0 | 0 | 0 | NCT00746252 | 6TERMINATED | 2010-10-01 | 2008-06-01 | 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 |
[
5
] | 32 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia. | This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or ... | Primary Hypercholesterolemia | cholesterol hypercholesterolemia omega 3 | null | 2 | arm 1: P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment. arm 2: Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment. | [
5,
5
] | 2 | [
0,
0
] | intervention 1: 4 grams/day - 4 one gram capsules intervention 2: 4 grams/day - 4 one gram capsules | intervention 1: P-OM3 intervention 2: Placebo | 1 | Addison | Illinois | United States | -87.98896 | 41.9317 | 32 | 0 | 0 | 0 | NCT00746811 | 1COMPLETED | 2010-10-01 | 2010-01-01 | Provident Clinical Research | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 62 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy. | null | Diabetic Foot Ulcer | Diabetic Foot Ulcers Neuroischaemic | null | 1 | arm 1: Active study treatment | [
0
] | 1 | [
0
] | intervention 1: Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium | intervention 1: Fragmin | 27 | Vienna | N/A | Austria | 16.37208 | 48.20849
Ransart | N/A | Belgium | 4.47616 | 50.46166
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Prague | N/A | Czechia | 14.42076 | 50.08804
Zlín | N/A | Czechia | 17.67065 | 49.22645
Aarhus C | N/A | Denmark | 10.21231 | 56.16558
Karlsbad | N/A | Germany | N/A | N/A
Melissi... | 62 | 0 | 0 | 0 | NCT00765063 | 1COMPLETED | 2010-10-01 | 2008-10-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 12 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 1FEMALE | true | Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?
Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption followi... | null | Breast Cancer Osteoporosis Osteopenia Fracture | null | 1 | arm 1: aromatase inhibitor therapy for six weeks | [
0
] | 1 | [
0
] | intervention 1: Any aromatase inhibitor started as initial adjuvant therapy | intervention 1: Aromatase Inhibitor | 0 | null | 10 | 0 | 0 | 0 | NCT00766532 | 1COMPLETED | 2010-10-01 | 2009-01-01 | University of Wisconsin, Madison | 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
] | 158 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD). | Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for CHD.
Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (LDL-C) ... | Hypercholesterolemia Coronary Heart Disease | null | 2 | arm 1: Participants received placebo subcutaneous injection once a week for 26 weeks. arm 2: Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 200 mg/mL intervention 2: 1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water). | intervention 1: Mipomersen sodium intervention 2: Placebo | 62 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Muscle Shoals | Alabama | United States | -87.66753 | 34.74481
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Beverly Hill... | 157 | 0 | 0 | 0 | NCT00770146 | 1COMPLETED | 2010-10-01 | 2008-11-01 | Kastle Therapeutics, LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 | |
[
4
] | 109 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after previous treatment. | null | Chronic Hepatitis C | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 750 mg every 8 hours for 12 weeks intervention 2: 600 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5 mcg/kg/week for 24 weeks | intervention 1: MP-424 intervention 2: Ribavirin intervention 3: Peginterferon Alfa-2b | 1 | Kawasaki | Takatsu-ku | Japan | 139.71722 | 35.52056 | 109 | 0 | 0 | 0 | NCT00780910 | 1COMPLETED | 2010-10-01 | 2008-11-01 | Mitsubishi Tanabe Pharma Corporation | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3,
4
] | 86 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is designed to determine the long-term safety and tolerability of Fx-1006A as well as the effects of Fx-1006A on clinical outcomes in patients with ATTR-PN.
All patients who enroll in this extension study will receive once-daily oral 20 mg Fx-1006A for 12 months; therefore, patients randomized to placebo in... | null | Familial Amyloid Polyneuropathy ATTR-PN | FAP Familial Amyloid Polyneuropathy ATTR-PN transthyretin TTR amyloid polyneuropathy familial hereditary amyloidosis FoldRx | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Fx-1006A 20mg soft gelatin capsule administered orally once daily (at the same time each day) for 12 months. | intervention 1: Fx-1006A | 11 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Ciudad de Buenos Aires | N/A | Argentina | N/A | N/A
Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642
Paris | N/A | France | 2.3488 | 48.85341
Münster | N/A | Germany | 7.62571 | 51.96236
Lisbon | N/A | Portugal | -9.1498 | 38.72509
Lisbon | N/A | Portugal | -... | 85 | 0 | 0 | 0 | NCT00791492 | 1COMPLETED | 2010-10-01 | 2008-07-01 | 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 |
[
2,
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria. | This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus infection.
Subjects received blinded study medication for a total of 5 doses in 1 of the following regimens:
* 10 mg BCV administe... | Viruria | CMX001 Kidney transplant HSCT transplant BK Virus Post kidney transplant patients with BK virus viruria > 10^4 Post HSCT transplant patients with BK virus viruria > 10^4 | null | 2 | arm 1: Under Amendments 1 and 2, subjects received 1 of 2 dose regimens of brincidofovir, as follows:
* 20 mg BCV once weekly (QW) on Days 0, 7, and 14; or
* 10 mg BCV twice weekly (BIW) BIW on Days 0, 3, 7, 10, and 14.
Under Amendment 3, subjects received 40 mg BCV QW for a total of 5 doses on Days 0, 7, 14, 21, and... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Placebo intervention 2: Brincidofovir | 15 | San Francisco | California | United States | -122.41942 | 37.77493
San Francisco | California | United States | -122.41942 | 37.77493
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Baltimo... | 28 | 0 | 0 | 0 | NCT00793598 | 1COMPLETED | 2010-10-01 | 2009-11-01 | Chimerix | 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
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis. | Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for coronary heart disease (CHD).
Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (Apo-B). Apo-B plays a role in producing low density lipopro... | Hypercholesterolemia Coronary Heart Disease | null | 2 | arm 1: Weekly subcutaneous injections for 26 weeks arm 2: 200 mg weekly subcutaneous injections for 26 weeks | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 200 mg (1 mL), weekly subcutaneous injections for 26 weeks intervention 2: 1 mL weekly subcutaneous injections for 26 weeks | intervention 1: Mipomersen intervention 2: Placebo | 27 | Jupiter | Florida | United States | -80.09421 | 26.93422
Winter Park | Florida | United States | -81.33924 | 28.6
Atlanta | Georgia | United States | -84.38798 | 33.749
Kansas City | Kansas | United States | -94.62746 | 39.11417
Boston | Massachusetts | United States | -71.05977 | 42.35843
St Louis | Missouri | United ... | 58 | 0 | 0 | 0 | NCT00794664 | 1COMPLETED | 2010-10-01 | 2009-01-01 | Kastle Therapeutics, LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 41 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction. | This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, wit... | Cardiovascular Disease HIV Infection | HIV cardiovascular risk atherogenic lipid profile brachial artery reactivity omega three fatty acids | null | 2 | arm 1: Lovaza, dietary counseling arm 2: Placebo, dietary counseling | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks. intervention 2: 2 capsules given twice daily | intervention 1: Lovaza intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 82 | 0 | 0 | 0 | NCT00795717 | 1COMPLETED | 2010-10-01 | 2008-07-01 | Tufts 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
] | 39 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS). | This is an open-label (both physician and patient know the name and dosage of drug), multi-center study. This study consists of two parts, Phase I and Phase II. In Phase I, approximately 9 participants will be enrolled ie, 3 participants for dose level 1 (15 mg/m2 of JNJ-30979754) and 6 participants for dose level 2 (2... | Myelodysplastic Syndrome | Myelodysplastic syndrome MDS Decitabine JNJ-30979754 | null | 3 | arm 1: JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 arm 2: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 arm 3: JNJ-30979754 (dec... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. intervention 2: Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycl... | intervention 1: JNJ-30979754 15 mg/m2 intervention 2: JNJ-30979754 20 mg/m2 | 7 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Hamamatsu | N/A | Japan | 137.73333 | 34.7
Hidaka | N/A | Japan | 139.36233 | 35.91664
Nagasaki | N/A | Japan | 129.88333 | 32.75
Nagoya | N/A | Japan | 136.90641 | 35.18147
Shinjuku | N/A | Japan | 139.70854 | 35.69115
Tokyo | N/A | Japan | 139.69171 | 35.6895 | 43 | 0 | 0 | 0 | NCT00796003 | 1COMPLETED | 2010-10-01 | 2008-07-01 | Janssen Pharmaceutical K.K. | 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
] | 13 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibit... | Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the ... | Rheumatoid Arthritis | null | 2 | arm 1: 1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks arm 2: Participants will receive 1 SQ injection of etanercept each week for 12 weeks | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 40 mg injection of adalimumab administered subcutaneously intervention 2: 1.0 ml .9% saline placebo administered subcutaneously intervention 3: 50 mg dimeric fusion protein administered subcutaneously | intervention 1: Adalimumab intervention 2: Adalimumab placebo intervention 3: Etanercept | 16 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Palo Alto | California | United States | -122.14302 | 37.44188
New Haven | Connecticut | United States | -72.92816 | 41.30815
Sarasota | Florida | United States | -82.53065 | 27.33643
Tampa | Florida | United States | -82.45843 | 27.94752
Chicago | Illinois | ... | 13 | 0 | 0 | 0 | NCT00796705 | 6TERMINATED | 2010-10-01 | 2008-11-01 | National Institute of Allergy and Infectious Diseases (NIAID) | 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 | |
[
5
] | 147 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 1FEMALE | true | Background of the study:
Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the ... | null | in Vitro Fertilization Ovulation Induction | embryonic structures sperm injections, intracytoplasmic IVF GnRH antagonist ovarian stimulation cycle day 2 versus cycle day 5 | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 1 | [
0
] | intervention 1: Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm | intervention 1: Mild stimulation | 2 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Utrecht | N/A | Netherlands | 5.12222 | 52.09083 | 147 | 0 | 0 | 0 | NCT00823472 | 6TERMINATED | 2010-10-01 | 2009-01-01 | UMC Utrecht | 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
] | 95 | NA | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | The primary objective of the study was to evaluate the safe and effective use of the single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon beta-1a) in participants with multiple sclerosis (MS). | The Main Study was a 4-week treatment period which consisted of 1 Avonex manual injection using a prefilled syringe, followed by 3 Avonex injections using the single-use autoinjector. The Extension Study was designed to provide continuation of treatment with the Avonex single-use autoinjector to eligible participants w... | Multiple Sclerosis | null | 1 | arm 1: Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.
In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled s... | [
0
] | 3 | [
1,
1,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: single-use autoinjector with a prefilled liquid Avonex syringe intervention 2: Avonex prefilled syringe via manual IM injection intervention 3: BG9418 (interferon beta-1a) | 16 | Gilbert | Arizona | United States | -111.78903 | 33.35283
Phoenix | Arizona | United States | -112.07404 | 33.44838
Maitland | Florida | United States | -81.36312 | 28.62778
Atlanta | Georgia | United States | -84.38798 | 33.749
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Boston | Massachusetts | United ... | 91 | 0 | 0 | 0 | NCT00828204 | 1COMPLETED | 2010-10-01 | 2009-01-01 | Biogen | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Endpoint:
To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in patients with locally advanced pancreatic cancer (LAPC).
Secondary Endpoints:
1. To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median overall survival.
2. To determine the radio... | The Study Drugs:
Vorinostat is designed to interfere with the growth of cancer cells.
Study Drug Dose Level:
If you are found to be eligible to take part in the study, you will begin receiving vorinostat. The dose you receive will be based on how many participants have been enrolled before you, and on the safety dat... | Pancreatic Cancer | Pancreas Pancreatic Cancer Locally Advanced Pancreatic Cancer LAPC Non-Metastatic Unresectable Vorinostat XRT RT Radiation Therapy SAHA Suberoylanilide Hydroxamic Acid MSK-390 | null | 1 | arm 1: Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6. | [
0
] | 2 | [
4,
0
] | intervention 1: Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6. intervention 2: Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6. | intervention 1: Chemoradiation (Radiation Therapy) intervention 2: Vorinostat | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 3 | 0 | 0 | 0 | NCT00831493 | 6TERMINATED | 2010-10-01 | 2009-05-01 | 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
] | 30 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to determine whether preoperative administration of Rivastigmine prevents the incidence of postoperative delirium in patients undergoing major surgery as well as postoperative cognitive dysfunction. | Postoperative delirium (POD) and Postoperative cognitive dysfunction (POCD) are common significant postoperative complications in elderly patients. A reduction of postoperative complications would lead to improved functional status, greater independence and reduction in health care cost. Scientific evidence shows that ... | Delirium Postoperative Cognitive Dysfunction | Postoperative Delirium Postoperative Cognitive Dysfunction Rivastigmine Exelon Memory impairment Delirium Cognitive function | null | 2 | arm 1: Group receiving Rivastigmine Patch arm 2: A 2x2 gauze and a Tegaderm dressing applied to upper back within 3 hours of surgery for a period of 24 hours. | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Rivastigmine Patch 4.6 mg/24 hours: 5 cm2 size containing 9 mg rivastigmine applied to upper back preoperatively for a period of 24 hours intervention 2: A 2x2 gauze and a Tegaderm dressing applied to upper back within 3 hours of surgery for a period of 24 hours. | intervention 1: Rivastigmine Patch intervention 2: Placebo Patch | 1 | New York | New York | United States | -74.00597 | 40.71427 | 28 | 0 | 0 | 0 | NCT00835159 | 1COMPLETED | 2010-10-01 | 2008-12-01 | NYU Langone 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 |
[
3
] | 44 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC). | The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants. | Metastatic Colorectal Cancer | Antibodies, Monoclonal Colorectal Neoplasms | null | 1 | arm 1: Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) | [
0
] | 4 | [
2,
0,
0,
0
] | intervention 1: IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 intervention 2: Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 intervention 3: FA 400 mg/m² IV infusion bolus injection intervention 4: 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² I... | intervention 1: IMC-11F8 (necitumumab) intervention 2: Oxaliplatin intervention 3: Folinic acid (FA) intervention 4: 5-FU | 5 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Haine-Saint-Paul | N/A | Belgium | 4.1885 | 50.45544
Barcelona | N/A | Spain | 2.15899 | 41.38879
Madrid | N/A | Spain | -3.70256 | 40.4165
Valencia | N/A | Spain | -0.37966 | 39.47391 | 44 | 0 | 0 | 0 | NCT00835185 | 1COMPLETED | 2010-10-01 | 2007-08-01 | 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 |
[
4
] | 202 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa-
2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the
addition of boceprevir to peg... | null | Hepatitis C, Chronic | null | 2 | arm 1: Peginterferon alfa-2a (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + peginterferon alfa-2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divide... | [
2,
0
] | 4 | [
0,
10,
2,
0
] | intervention 1: 800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks intervention 2: 800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks intervention 3: Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneou... | intervention 1: Boceprevir intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin | 0 | null | 201 | 0 | 0 | 0 | NCT00845065 | 1COMPLETED | 2010-10-01 | 2009-02-01 | 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
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH). | null | Nonalcoholic Steatohepatitis (NASH) Hepatic Steatosis | Non-alcoholic steatohepatitis Omega-3 fatty acids MRI NASH | null | 2 | arm 1: Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks arm 2: Participants receive daily placebo and dietary counseling for 24 weeks | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks. intervention 2: Daily placebo with dietary counseling for 24 weeks. | intervention 1: Omega-3-acid ethyl esters (Lovaza) intervention 2: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 9 | 0 | 0 | 0 | NCT00845845 | 6TERMINATED | 2010-10-01 | 2006-03-01 | University of Illinois at 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 |
[
4
] | 297 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease. | Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to... | Alzheimer's Disease | Alzheimer's Disease | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 20 mg oral tablets once daily | intervention 1: Memantine | 33 | Edmonton | Alberta | Canada | -113.46871 | 53.55014
Kelowna | British Columbia | Canada | -119.48568 | 49.88307
Kelowna | British Columbia | Canada | -119.48568 | 49.88307
Penticton | British Columbia | Canada | -119.58584 | 49.48062
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Saint John | New Brunswick | Canada... | 297 | 0 | 0 | 0 | NCT00857233 | 6TERMINATED | 2010-10-01 | 2004-06-01 | H. Lundbeck A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
5
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative. | In patients with chronic obstructive pulmonary disease (COPD), the treatment with inhaled corticosteroids (ICS) is controversial. Preliminary results of our recent pilot study in 30 COPD patients showed for the first time, that ICS response mey be predicted by a bronchoprovocation challenge test with mannitol. However,... | COPD | Inhaled corticosteroids COPD mannitol | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 1 | [
0
] | intervention 1: After 4 weeks of inhalative therapy with tiotropium (all patients), patient get randomized to receive either inhalative budesonide (1600ug per day or placebo | intervention 1: Budesonide | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 68 | 0 | 0 | 0 | NCT00860938 | 1COMPLETED | 2010-10-01 | 2007-04-01 | Cantonal Hosptal, Baselland | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD. | null | Crohn´s Disease | null | 2 | arm 1: Mesalazine (Mesalamine) 2 g sachet; 6 g daily arm 2: Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 6 g/day orally, 2 g in the morning and 4 g in the evening intervention 2: 6 g/day orally, 2 g in the morning and 4 g in the evening | intervention 1: Pentasa intervention 2: Placebo | 15 | San Diego | California | United States | -117.16472 | 32.71571
Clearwater | Florida | United States | -82.8001 | 27.96585
John's Creek | Georgia | United States | N/A | N/A
Mexico | Montana | United States | N/A | N/A
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Cincinnati | Ohio | United States | -84... | 19 | 0 | 0 | 0 | NCT00862121 | 6TERMINATED | 2010-10-01 | 2009-04-01 | Ferring 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
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a study for patients with advanced cancer of the biliary tree, such as cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of Gemcitabine, Taxotere, and Xeloda every 21 days for at least 9 weeks. Treatment will continue until their cancer progresses. This chemotherapy regimen has bee... | After initial presentation of our data concerning this regimen (in pancreatic cancer) at the 2003 and 2004 ASCO meetings, a number of practitioners began using the regimen for pancreatic cancer patients. More importantly, several of these investigators began using the same regimen for patients with unresectable and met... | Biliary Cancer | Biliary Cancer | null | 1 | arm 1: Gemcitabine, docetaxel, and capecitabine | [
0
] | 1 | [
0
] | intervention 1: Day 1-14: Capecitabine 600 mg/m2/day (maximum dose 2000 mg/m2/day total divided into BID PO doses) Day 4 and 11: Gemcitabine 600 mg/m2 IV over 60 mins Day 4 and 11: Docetaxel 30 mg/m2 IV over 60 mins preceded by 12 mg dexamethasone IV or PO or 4 mg if diabetic | intervention 1: Gemcitabine, docetaxel, and capecitabine | 1 | New York | New York | United States | -74.00597 | 40.71427 | 4 | 0 | 0 | 0 | NCT00868998 | 6TERMINATED | 2010-10-01 | 2005-08-01 | 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 |
[
4
] | 3,080 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery. | null | Coronary Artery Bypass Myocardial Infarction Ventricular Dysfunction, Left Stroke Cardiopulmonary Bypass | null | 2 | arm 1: Acadesine intravenous (IV) infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB) arm 2: Normal saline, IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline i... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Acadesine 42 mg/kg diluted in normal saline to a total of 500 mL, delivered as an IV infusion over approximately 7 hours commencing within approximately 30 minutes before induction of anesthesia at a rate of 0.1 mg/kg/min (translating into 1.2 mL/min for a 500 mL solution). In addition, a 5 µg/mL cardio... | intervention 1: Acadesine intervention 2: Normal Saline | 0 | null | 2,899 | 0 | 0 | 0 | NCT00872001 | 6TERMINATED | 2010-10-01 | 2009-04-01 | 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 |
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