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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
5
] | 83 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation. | * Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppre... | Bronchiolitis Obliterans Syndrome Graft Rejection Lymphocytic Bronchiolitis Respiratory Infection | Bronchiolitis Obliterans Syndrome Acute allograft Rejection Lymphocytic bronchiolitis Respiratory infection Survival Mortality Pulmonary function FEV1 Broncho-alveolar lavage Neutrophils Interleukin Culture Azithromycin | null | 2 | arm 1: 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study arm 2: PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period. intervention 2: Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period. | intervention 1: Azithromycin intervention 2: Placebo | 1 | Leuven | N/A | Belgium | 4.70093 | 50.87959 | 83 | 0 | 0 | 0 | NCT01009619 | 1COMPLETED | 2009-12-01 | 2005-09-01 | KU Leuven | 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
] | 223 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from r... | This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or medical school team work on a medical research study), non-randomized, single-arm study of paliperidone ER in participa... | Schizophrenia | Schizophrenia Paliperidone | null | 1 | arm 1: Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion. | [
0
] | 1 | [
0
] | intervention 1: Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion. | intervention 1: Paliperidone Extended Release (ER) | 10 | Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083
Criciúma | N/A | Brazil | -49.36972 | -28.6775
Curitiba | N/A | Brazil | -49.27306 | -25.42778
Goiânia | N/A | Brazil | -49.25389 | -16.67861
Itapira | N/A | Brazil | -46.82167 | -22.43611
Marília | N/A | Brazil | -49.94583 | -22.21389
Rio de Janeiro | N/A | Brazil ... | 374 | 0 | 0 | 0 | NCT01010776 | 1COMPLETED | 2009-12-01 | 2008-02-01 | Janssen-Cilag Farmaceutica Ltda. | 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
] | 160 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | 200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus... | In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of tr... | Neovascular Age-related Macular Degeneration | bevacizumab, choroidal neovascularization | null | 1 | arm 1: bevacizumab intravitreal injection | [
0
] | 1 | [
0
] | intervention 1: intraocular bevacizumab injection | intervention 1: Bevacizumab | 0 | null | 160 | 0 | 0 | 0 | NCT01027468 | 1COMPLETED | 2009-12-01 | 2009-08-01 | Medical University of Vienna | 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
] | 611 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 1FEMALE | false | This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species. | null | Vulvovaginal Candidiasis | bioequivalence butoconazole vulvovaginal candidiasis | null | 3 | arm 1: vehicle of the test product; applied intravaginally once within 48 hours of randomization arm 2: Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization arm 3: Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization | [
2,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: vaginal cream intervention 2: vaginal cream intervention 3: vaginal cream | intervention 1: Butoconazole Nitrate Vaginal Cream intervention 2: Placebo intervention 3: Gynazole 1 vaginal cream | 1 | Charlotte | North Carolina | United States | -80.84313 | 35.22709 | 611 | 0 | 0 | 0 | NCT01039584 | 1COMPLETED | 2009-12-01 | 2008-02-01 | Padagis 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
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The aim of this study is to compare the efficacy and safety of Low molecular weight heparin (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with recurrent pregnancy loss associated with antiphospholipid syndrome (APS). | Women with antiphospholipid syndrome (APS) have live birth rates as low as 10% in pregnancies without pharmacological treatment. Low dose aspirin (LDA) ,unfractionated heparin(UFH) , Low molecular weight heparin (LMWH) , prednisone, and intravenous immunoglobulin (IVIG) have been used either alone or in combination in ... | Recurrent Abortion | Recurrent abortion Antiphospholipid syndrome unfractionated heparin Low Molecular Weight Heparin | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Enoxaparin 40mg/day by subcutaneous injection ( Clexane 40 mg, Aventis international, Sanofi-aventis France ) is started when the serum pregnancy test become positive. Enoxaparin is stopped 2 days before planned induction of labor or cesarean section and twice-daily unfractionated heparin (UFH) is initi... | intervention 1: enoxaparin 40mg plus low dose aspirin intervention 2: Heparin calcium5,000 U twice daily plus low dose aspirin | 2 | Cairo | N/A | Egypt | 31.24967 | 30.06263
Cairo | N/A | Egypt | 31.24967 | 30.06263 | 60 | 0 | 0 | 0 | NCT01051778 | 1COMPLETED | 2009-12-01 | 2006-06-01 | Cairo 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
] | 231 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery. | Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems ... | Off Pump Coronary Artery Bypass Surgery | Tranexamic Acid off-pump coronary Artery Bypass | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 1 | [
0
] | intervention 1: In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo. | intervention 1: Tranexamic Acid | 1 | Beijing | N/A | China | 116.39723 | 39.9075 | 231 | 0 | 0 | 0 | NCT01064167 | 1COMPLETED | 2009-12-01 | 2009-02-01 | Chinese Academy of Medical Sciences, Fuwai Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 60 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines. | There will be a screening exam to find out if potential subjects are eligible to be in the main part of the study. Screening will include obtaining demographics, migraine history, migraine characteristics, verification that subjects's migraine satisfies the International Headache Society criteria, migraine medication h... | Migraine Disorders | null | 3 | arm 1: Participants will receive placebo to match caffeine/propranolol (single dose) arm 2: Participants will receive caffeine/propranolol 400/40 mg combination tablet (single dose) arm 3: Participants will receive caffeine/propranolol 1000/40 mg combination tablet (single dose) | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: caffeine/propranolol combination tablet administered orally once daily intervention 2: placebo to match caffeine/propranolol combination tablet administered orally once daily | intervention 1: caffeine/propranolol combination tablet intervention 2: placebo | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 60 | 0 | 0 | 0 | NCT01080677 | 1COMPLETED | 2009-12-01 | 2007-01-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 64 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 3TRIPLE | false | 0ALL | false | The following are the study hypothesis:
* Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates.
* Secretin administration compared to placebo will result... | null | Pancreatic Disease | Genetic End Marker | null | 2 | arm 1: Human Secretin for Injection arm 2: Saline for Injection | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Human Secretin for Injection intervention 2: Saline for Injection | intervention 1: ChiRhoStim intervention 2: Placebo | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 64 | 0 | 0 | 0 | NCT01087801 | 1COMPLETED | 2009-12-01 | 2007-10-01 | ChiRhoClin, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops. | The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to:
The assessment of the ocular tolerance:
* Ocular symptoms
* Objective ocular signs.
The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of ... | Glaucoma | Bilateral Glaucoma Bilateral ocular hypertension Bilateral primary open angle glaucoma Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day) With local intolerance signs in at least one eye | null | 2 | arm 1: Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days). arm 2: Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: one drop in the conjunctival sac of each eye in the morning (84 days). intervention 2: one drop in the conjunctival sac of each eye in the morning (84 days). | intervention 1: Geltim LP 1 mg/g intervention 2: Xalatan | 1 | Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 | 150 | 0 | 0 | 0 | NCT01155219 | 1COMPLETED | 2009-12-01 | 2008-07-01 | Laboratoires Thea | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 30 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana \[IN\]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy s... | This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/500 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, Indiana) | Diabetes Mellitus | null | 3 | arm 1: None arm 2: under fed state arm 3: under fasted state | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Tablets, Oral, 5 mg, once daily, Single dose intervention 2: Tablets, Oral, 500 mg. once daily, Single dose intervention 3: Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose | intervention 1: saxagliptin intervention 2: metformin XR intervention 3: saxagliptin + metformin XR (FDC tablet) | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 90 | 0 | 0 | 0 | NCT01192139 | 1COMPLETED | 2009-12-01 | 2009-11-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 30 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucoph... | This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville, Indiana) | Diabetes Mellitus | null | 3 | arm 1: None arm 2: under fed state, single dose arm 3: under fed state, 4 days | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Tablets, Oral, 5 mg, once daily, Single dose intervention 2: Tablets, Oral, 500 mg, once daily, Single dose intervention 3: Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days | intervention 1: saxagliptin intervention 2: Glucophage XR intervention 3: saxagliptin + metformin XR (FDC tablet) | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 73 | 0 | 0 | 0 | NCT01192152 | 1COMPLETED | 2009-12-01 | 2009-11-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing usually occurs three times a week, but extended dosing schedules have been successful in adults. The investigators assessed weekly Epo dosing... | Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults with anemia due to end stage renal disease. Epo is used in preterm infants to treat the anemia of prematurity, but has not been studied using once weekly dosing. We compared reticulocyte responses of once weekly Epo dosing with t... | Preterm Infants | anemia transfusions erythropoiesis neonate preterm | null | 2 | arm 1: Epo 400 units/kg three times weekly given subcutaneously for 4 weeks arm 2: 1,200 units/kg given once a week subcutaneously for 4 weeks | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks intervention 2: Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks | intervention 1: three times weekly Epo intervention 2: weekly Epo | 1 | Albuquerque | New Mexico | United States | -106.65114 | 35.08449 | 20 | 0 | 0 | 0 | NCT01235923 | 1COMPLETED | 2009-12-01 | 2006-04-01 | University of New Mexico | 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
] | 84 | null | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs m... | null | Metastatic Breast Cancer | Metastatic Breast Cancer Advanced Postmenopausal Exemestane vs Megestrol | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Megestrol Acetate 160 mg oral tablets Qd intervention 2: exemestane (Aromasin) 25 mg oral tablets Qd | intervention 1: Megestrol acetate intervention 2: exemestane (Aromasin) | 7 | Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Nanjing | N/A | China | 118.77778 | 32.06167
Nanjing | N/A | China | 118.77778 | 32.06167
Shanghai | N/A | China | 121.45806 | 31.22222
Tianjin | N/A | China | 117.17667 | 39.14222
Xi'an | N/A | China | 108.92861 | 34.25833 | 81 | 0 | 0 | 0 | NCT01237327 | 1COMPLETED | 2009-12-01 | 2001-11-01 | 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
] | 36 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 1FEMALE | false | Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated. | This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).
Part II employs crossover design with subjects randomly assigned to one of the two treatment s... | Healthy | PK and safety Pharmacokinetic profile (PK) and safety | null | 2 | arm 1: Ortho-Cyclen® is a comparator drug intervention arm 2: AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen. intervention 2: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE | intervention 1: Ortho-Cyclen intervention 2: AG200-15 | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 70 | 0 | 0 | 0 | NCT01243580 | 1COMPLETED | 2009-12-01 | 2009-08-01 | Agile Therapeutics | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid he... | see above | Atrial Fibrillation | atrial fibrillation amiodarone | null | 2 | arm 1: standard dose amiodarone arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: standard dose amiodarone intervention 2: placebo delivered blinded | intervention 1: amiodarone intervention 2: Placebo | 0 | null | 16 | 0 | 0 | 0 | NCT01461733 | 1COMPLETED | 2009-12-01 | 2007-07-01 | Ottawa Hospital 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 |
[
0
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | 6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function. | null | Pulmonary Arterial Hypertension | null | 1 | arm 1: 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months | [
0
] | 1 | [
0
] | intervention 1: 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months | intervention 1: Bosentan | 0 | null | 8 | 0 | 0 | 0 | NCT01721564 | 1COMPLETED | 2009-12-01 | 2006-04-01 | Prof David S Celermajer | 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
] | 47 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 2DOUBLE | false | 0ALL | false | The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, th... | null | Diabetes Mellitus, Type 2 | null | 4 | arm 1: Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. arm 2: Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days. arm 3: Participants received 10 mg LY2405319 injected SC once daily for 28 days. arm 4: Participants received 20 mg LY... | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Administered SC intervention 2: Administered SC | intervention 1: LY2405319 intervention 2: Placebo | 7 | Cypress | California | United States | -118.03729 | 33.81696
Tustin | California | United States | -117.82617 | 33.74585
DeLand | Florida | United States | -81.30312 | 29.02832
Miramar | Florida | United States | -80.23227 | 25.98731
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Portland | Oregon | United St... | 46 | 0 | 0 | 0 | NCT01869959 | 1COMPLETED | 2009-12-01 | 2009-04-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 40 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773 | null | Diabetes Mellitus, Type 2 | null | 5 | arm 1: Single Dose Administration (type 2 diabetes and mild renal impairment) arm 2: Single Dose Administration (type 2 diabetes and moderate renal impairment) arm 3: Single Dose Administration (severe renal impairment 8) arm 4: Single Dose Administration (kidney failure) arm 5: Single Dose Administration (type 2 diabe... | [
0,
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: oral administration intervention 2: oral administration intervention 3: oral administration intervention 4: oral administration intervention 5: oral administration | intervention 1: BI 10773 intervention 2: BI 10773 intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: BI 10773 | 2 | Kiel | N/A | Germany | 10.13489 | 54.32133
Neuss | N/A | Germany | 6.68504 | 51.19807 | 40 | 0 | 0 | 0 | NCT01907113 | 1COMPLETED | 2009-12-01 | 2009-07-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study m... | null | Hepatitis C, Chronic | null | 3 | arm 1: multiple rising doses arm 2: multiple rising doses arm 3: None | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: BI 207127 NA intervention 2: Placebo | 0 | null | 73 | 0 | 0 | 0 | NCT02176525 | 1COMPLETED | 2009-12-01 | 2007-12-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens recei... | null | HIV Infections | null | 1 | arm 1: Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID). | [
0
] | 1 | [
0
] | intervention 1: All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand. | intervention 1: Enfuvirtide | 5 | Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Chiang Mai | N/A | Thailand | 98.98468 | 18.79038
Nonthaburi | N/A | Thailand | 100.51477 | 13.86075 | 23 | 0 | 0 | 0 | NCT02582983 | 1COMPLETED | 2009-12-01 | 2004-02-01 | 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
] | 22 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST... | This non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Meas... | Metastatic Transitional Cell Cancer of the Urothelial Tract | null | 1 | arm 1: Docetaxel administered at a dose of 60mg/m\^2 IV infusion, followed by oxaliplatin at a dose of 110mg/m\^2 as a 2 hour IV infusion. | [
0
] | 2 | [
0,
0
] | intervention 1: Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.... | intervention 1: Docetaxel intervention 2: Oxaliplatin | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 22 | 0 | 0 | 0 | NCT03159143 | 1COMPLETED | 2009-12-02 | 2004-12-17 | Leonard Appleman | 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
] | 175 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies | null | Lymphoma Leukemia Multiple Myeloma | HDAC inhibitor Oral LBH589 Lymphoma Leukemia Multiple myeloma | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: LBH589 | 7 | Augusta | Georgia | United States | -81.97484 | 33.47097
Boston | Massachusetts | United States | -71.05977 | 42.35843
Houston | Texas | United States | -95.36327 | 29.76328
Parkville | Victoria | Australia | 144.95 | -37.78333
Prahran | Victoria | Australia | 144.99318 | -37.85114
Frankfurt/M | N/A | Germany | N/A | N... | 176 | 0 | 0 | 0 | NCT00621244 | 1COMPLETED | 2009-12-03 | 2003-03-01 | 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 |
[
3
] | 99 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is being conducted to assess the potential anti-inflammatory effects of a 3-month treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques, as assessed by FDG-PET/CT. | null | Atherosclerosis | FDG-PET/CT, atherosclerosis | null | 3 | arm 1: Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks arm 2: Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks. arm 3: Participants received 1 tablet of 7.5 mg Los... | [
0,
2,
0
] | 2 | [
0,
0
] | intervention 1: GW856553 tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised GW856553X active substance. Tablets are available containing 7.5 mg of GW856553X and are packed into high-density polyethylene (HDPE) bottles. intervention 2: Placebo t... | intervention 1: LOSMAPIMOD 7.5 MG intervention 2: Placebo | 4 | Oxford | Oxfordshire | United Kingdom | -1.25596 | 51.75222
Cambridge | N/A | United Kingdom | 0.11667 | 52.2
London | N/A | United Kingdom | -0.12574 | 51.50853
London | N/A | United Kingdom | -0.12574 | 51.50853 | 99 | 0 | 0 | 0 | NCT00633022 | 1COMPLETED | 2009-12-03 | 2008-06-02 | 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
] | 26 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals. | This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals. Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Bra... | Diabetes Mellitus, Type 2 | Metformin Rosiglitazone Healthy volunteers Avandamet Fed conditions Bioequivalence | null | 2 | arm 1: Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2 arm 2: Reference product: Avan... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Avandamet reference product intervention 2: Avandamet test product | intervention 1: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg intervention 2: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg | 1 | Goiânia | Goiás | Brazil | -49.25389 | -16.67861 | 26 | 0 | 0 | 0 | NCT01332071 | 1COMPLETED | 2009-12-06 | 2009-11-24 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive... | null | Anemia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study dependi... | intervention 1: methoxy polyethylene glycol-epoetin beta [C.E.R.A.] | 23 | Almelo | N/A | Netherlands | 6.6625 | 52.35667
Amersfoort | N/A | Netherlands | 5.3875 | 52.155
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Assen | N/A | Netherlands | 6.5625 | 52.99667
Beverwijk | N/A | Netherlands | 4.65694 | 52.48333
Breda | N/A | Netherlands | 4.77596 | 51.58656
Delft | N/A | Netherlands | 4... | 20 | 0 | 0 | 0 | NCT00642304 | 1COMPLETED | 2009-12-09 | 2008-03-27 | 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 | |
[
2
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MK-3614 in male participants with mild to moderate hypertension. The primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well tolerated to permit continued clinical investigation... | null | Hypertension | null | 6 | arm 1: Participants received 0.25 mg of MK-3614 twice daily (BID) every 12 hours orally for 10 days. arm 2: Participants received 0.50 mg of MK-3614 in the morning (AM) and 0.25 mg of MK-3614 in the evening (PM) 12 hours apart orally for 10 days. arm 3: Participants were to receive 0.75 mg of MK-3614 BID every 12 hours... | [
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Participants were administered 0.25 mg tablet, orally for a total daily dose according to randomization. intervention 2: Participants were administered dose matched placebo tablets according to randomization. | intervention 1: MK-3614 intervention 2: Placebo for MK-3614 | 0 | null | 30 | 0 | 0 | 0 | NCT01033643 | 1COMPLETED | 2009-12-09 | 2009-05-27 | 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
] | 100 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP).
The study was conducted with two parallel study arms with crossover between treatments ev... | Afamelanotide is a man-made drug being studied for use as a preventative medication for Erythropoietic Protoporphyria (EPP) sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH).
The study will involve the use of an implant, which comes in the form of a small rod ... | Erythropoietic Protoporphyria | Erythropoietic Protoporphyria EPP Afamelanotide | null | 2 | arm 1: Group A was administered active implants on Days 0, 120, 240 and placebo implants on Days 60, 180, 300 arm 2: Group B was administered placebo implants on Days 0, 120, 240 and active implants on Days 60, 180, 300 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 16mg subcutaneous implant intervention 2: Placebo subcutaneous implant | intervention 1: Afamelanotide intervention 2: Placebo | 0 | null | 200 | 0 | 0 | 0 | NCT04053270 | 1COMPLETED | 2009-12-09 | 2007-05-01 | Clinuvel Pharmaceuticals Limited | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 188 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Su... | Rationale: Once Suboxone becomes available for widespread clinical use, it is anticipated that opioid-dependent patients seeking treatment with buprenorphine will be placed directly onto Suboxone. Two strategies that have had good success for inducting patients onto Suboxone have been developed: 1) a "bridging" procedu... | Opiate Dependence Drug Dependence Substance Dependence | null | 2 | arm 1: Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. arm 2: Participants received 8 mg Subutex and plac... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride and Naloxone. Daily dosage of 8 mg - 24 mg. Duration: 28 Days intervention 2: 2 mg and 8 mg sublingual tablets, Contains Buprenorphine Hydrochloride. Daily dosage of 8 mg - 24 mg. Duration: 28 Days | intervention 1: Suboxone (SCH 000484) intervention 2: Subutex (SCH 028444) | 0 | null | 187 | 0 | 0 | 0 | NCT00604188 | 1COMPLETED | 2009-12-10 | 2008-02-22 | 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
] | 461 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants. | null | ADHD | null | 3 | arm 1: SPD503 (Guanfacine Extended Release) arm 2: SPD503 (Guanfacine Extended Release) arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg intervention 2: SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg intervention 3: Placebo matched to Guanfacine Hydrochloride Extended Release | intervention 1: SPD503-AM intervention 2: SPD503-PM intervention 3: Placebo | 61 | Dothan | Alabama | United States | -85.39049 | 31.22323
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
El Centro | California | United States | -115.56305 | 32.792
Rolling Hills Estates | California | United States | -118.35813 | 33.78779
San D... | 455 | 0 | 0 | 0 | NCT00734578 | 1COMPLETED | 2009-12-10 | 2008-09-02 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 535 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). | The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared. | Clostridium Infections Diarrhea | CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea | null | 2 | arm 1: Vancomycin arm 2: PAR-101/OPT-80 | [
1,
0
] | 2 | [
0,
0
] | intervention 1: capsules intervention 2: Capsules | intervention 1: PAR-101/OPT-80 intervention 2: Vancomycin | 116 | Gadsden | Alabama | United States | -86.00639 | 34.01434
Phoenix | Arizona | United States | -112.07404 | 33.44838
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
La Mesa | California | United States | -117.02308 | 32.76783
Modesto | California | United States | -120.99688 | 37.6391
Palm Springs | Californ... | 524 | 0 | 0 | 0 | NCT00468728 | 1COMPLETED | 2009-12-11 | 2006-10-04 | Optimer 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
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will involve the use of a new compound, SB-656933. Accumulation of inflammatory white blood cells (mostly polymorphonuclear neutrophils)in the gut (colon) may be contributing to the pathology of ulcerative colitis. It has been shown that SB-656933 reduces polymorphonuclear neutrophils (PMN) accumulation in p... | null | Colitis, Ulcerative | CD11b Ulcerative colitis 99mTc-HMPAO-labelled leukocyte scintigraphy | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 7 days repeat dose | intervention 1: SB-656933 | 1 | Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 | 3 | 0 | 0 | 0 | NCT00748410 | 6TERMINATED | 2009-12-12 | 2009-01-22 | 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
] | 3 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The main purpose of this study was to determine the safety and tolerability of 3 different doses of duvoglustat (AT2220) in participants affected by Pompe disease. The study also evaluated the effects of duvoglustat on functional parameters in Pompe disease. | This was a Phase 2, open-label study in participants with Pompe disease, a lysosomal storage disorder. Duvoglustat is designed to act as a pharmacological chaperone of alpha-glucosidase, in order to restore enzyme activity. This study consisted of a 28-day screening period, an 11-week treatment period, and a 1-week fol... | Pompe Disease | Amicus Therapeutics Duvoglustat AT2220 | null | 3 | arm 1: Regimen 1: Low-dose duvoglustat (2.5 grams \[g\]) once a day (QD) for 3 days, followed by no drug for 4 days, for 11 weeks. arm 2: Regimen 1: High-dose duvoglustat (5.0 g) QD for 3 days, followed by no drug for 4 days, for 11 weeks. arm 3: Regimen 2: High-dose duvoglustat (5.0 g) QD for 7 days, followed by no dr... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Powder in a bottle for dissolution in water for oral administration | intervention 1: Duvoglustat | 1 | Decatur | Georgia | United States | -84.29631 | 33.77483 | 3 | 0 | 0 | 0 | NCT00688597 | 6TERMINATED | 2009-12-14 | 2008-12-08 | Amicus Therapeutics | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 239 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate palonosetron versus ondansetron as rescue medication in subjects that develop postoperative nausea and vomiting (PONV) in the Postanaesthesia Care Unit (PACU). | Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can lead to subject discomfort and dissatisfaction as well as considerable subsequent medical and economic consequences. In this multi-center, open-label, parallel, randomized, pilot study, outpatient surgical patients who experience ... | Postoperative Nausea and Vomiting | PONV rescue | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Subjects will receive ondansetron 4 mg intravenously (IV) and will be followed for 72 hours.
Ondansetron is a selective 5-HT3 receptor antagonist. It is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose ... | intervention 1: Ondansetron intervention 2: Palonosetron | 8 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Laguna Hills | California | United States | -117.71283 | 33.61252
San Francisco | California | United States | -122.41942 | 37.77493
Miami | Florida | United States | -80.19366 | 25.77427
Kansas City | Kansas | United States | -94.62746 | 39.11417
Durham | North... | 98 | 0 | 0 | 0 | NCT00967499 | 1COMPLETED | 2009-12-18 | 2009-07-13 | 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 |
[
4
] | 538 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)
compared to placebo in elderly participants with chronic primary
insomnia. Primary efficacy variable is Wake time After Sleep
Onset (WASO), averaged over all in-treatment time points
and measured by polysomnography (PSG... | Insomnia is a common complaint or disorder throughout the
world. About one third of the population in the industrial
countries reports difficulty initiating or maintaining sleep,
resulting in a non-refreshing or non-restorative sleep. The
majority of the insomniacs suffer chronically from their
complaints.
The ma... | Insomnia Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders | elderly randomized placebo controlled | null | 4 | arm 1: one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 2: one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 3: one pla... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: one tablet daily intervention 2: one tablet daily | intervention 1: Esmirtazapine intervention 2: Placebo | 0 | null | 537 | 0 | 0 | 0 | NCT00561821 | 1COMPLETED | 2009-12-21 | 2007-11-20 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 2MALE | false | This study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by viral load reduction, will also be assessed in Part II.... | null | Hepatitis C | null | 8 | arm 1: Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10. arm 2: Healthy male participants in this Part I serial panel receive 200 mg... | [
0,
0,
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males) intervention 2: Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 conse... | intervention 1: MK-3281 intervention 2: Placebo to MK-3281 | 0 | null | 60 | 0 | 0 | 0 | NCT00635804 | 1COMPLETED | 2009-12-22 | 2008-02-19 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether TAC-101 combined with Transcatheter Arterial Chemoembolization (TACE) is more effective than TACE alone in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 in combination with TACE. | Advanced metastatic hepatocellular carcinoma (HCC) is not treatable by surgical approaches or locoregional therapies such as hepatic artery hemoembolization or radiofrequency ablation (RFA) which are effective in controlling localized tumors. Transcatheter arterial chemoembolization (TACE) is the most commonly performe... | Advanced Hepatocellular Carcinoma | null | 2 | arm 1: Participants were administered with placebo tablets matching to TAC-101 orally, every day on the first 14 days (Days 1 to 14) followed by a 7-day (Days 15 to 21) treatment recovery period. Repeated every 21 days cycle up to new lesions were observed or the participant met a treatment discontinuation criterion. a... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Participants received TAC-101 20 mg (2 x 10-mg formulated tablets) administered orally every day with approximately 8 oz. water within 1 hour following a morning meal for 14 days followed by a 7-day recovery period, repeated every 21 days. intervention 2: Participants received placebo (two matching tabl... | intervention 1: TAC-101 intervention 2: Placebo | 29 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Jonan-ku | Fukuoka | Japan | N/A | N/A
Kurume | Fukuoka | Japan | 130.51667 | 33.31667
Oogaki | Gifu | Japan | N/A | N/A
Fukuyama | Hiroshima | Japan | 133.36667 | 34.48333
Asahikawa | Hokkaido | Japan | 142.36489 | 43.77... | 52 | 0 | 0 | 0 | NCT00667628 | 6TERMINATED | 2009-12-22 | 2008-04-24 | Taiho Oncology, 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
] | 37 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 2MALE | false | It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions. | It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.
The treatment's sequence attributed to each volunteer on the study period i... | Prostatic Hyperplasia | Bioequivalence Healthy volunteers tamsulosin hydrochloride Fed administration | null | 2 | arm 1: Reference drug administration followed by Test drug administration arm 2: Test drug administration followed by Reference drug administration | [
1,
1
] | 2 | [
0,
0
] | intervention 1: SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim) intervention 2: tamsulosin hydrochloride 0,4 mg (Synthon BV) | intervention 1: Reference formulation intervention 2: Test formulation | 1 | Campinas | São Paulo | Brazil | -47.06083 | -22.90556 | 40 | 0 | 0 | 0 | NCT01330303 | 1COMPLETED | 2009-12-22 | 2009-12-08 | 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
] | 49 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnos... | null | Lymphoma, T-Cell, Peripheral | null | 1 | arm 1: Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulo... | [
0
] | 6 | [
0,
0,
0,
0,
0,
10
] | intervention 1: Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles. intervention 2: Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (... | intervention 1: Denileukin diftitox intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisone intervention 6: Pegfilgrastim | 49 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Stanford | California | United States | -122.16608 | 37.42411
Denver | Colorado | United States | -104.9847 | 39.73915
New Haven | Connecticut | United States | -72.92816 | 41.30815
Ocala | Florida | Un... | 49 | 0 | 0 | 0 | NCT00211185 | 1COMPLETED | 2009-12-23 | 2004-03-14 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 38 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple myeloma who have received at least two prior therapies and are refractory to their last therapy. Patients must have received in prior therapy either bortezomib or lenalidomide | null | Multiple Myeloma | Multiple myeloma adults LBH589 refractory | null | 1 | arm 1: Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: LBH589 | 29 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Berkeley | California | United States | -122.27275 | 37.87159
Duarte | California | United States | -117.97729 | 34.13945
San Francisco | California | United States | -122.41942 | 37.77493
Stanford | California | United States | -122.16608 | 37.42411
Denver |... | 38 | 0 | 0 | 0 | NCT00445068 | 6TERMINATED | 2009-12-25 | 2007-04-16 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 83 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I). To evaluate the preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee in comparison with placebo (Part I... | null | Osteoarthritis, Knee | monoclonal antibody | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
0,
0,
2
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: single dose of 10 mcg/kg IV intervention 2: single dose of 100 mcg/kg IV intervention 3: single dose of 200 mcg/kg IV intervention 4: single dose of 25 mcg/kg IV intervention 5: single dose of 50 mcg/kg IV intervention 6: single dose of Placebo IV | intervention 1: PF-04383119 (tanezumab) intervention 2: PF-04383119 (tanezumab) intervention 3: PF-04383119 (tanezumab) intervention 4: PF-04383119 (tanezumab) intervention 5: PF-04383119 (tanezumab) intervention 6: PF-04383119 (tanezumab) | 12 | Takasaki | Gunma | Japan | 139.01667 | 36.33333
Fujisawa-shi | Kanagawa | Japan | N/A | N/A
Kawasaki | Kanagawa | Japan | 139.71722 | 35.52056
Yokohama | Kanagawa | Japan | 139.65 | 35.43333
Beppu-shi | Oita Prefecture | Japan | N/A | N/A
Fuchū | Tokyo | Japan | 139.48216 | 35.67452
Minato-ku | Tokyo | Japan | N/A | N/... | 83 | 0 | 0 | 0 | NCT00669409 | 1COMPLETED | 2009-12-25 | 2008-06-06 | 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
] | 254 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia. | null | Primary Insomnia | null | 8 | arm 1: After an \~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period ... | [
0,
0,
0,
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: oral tablet taken before bedtime intervention 2: Dose-matched placebo to suvorexant taken before bedtime (oral tablet) | intervention 1: Suvorexant intervention 2: Dose-matched Placebo to Suvorexant | 0 | null | 492 | 0 | 0 | 0 | NCT00792298 | 1COMPLETED | 2009-12-26 | 2008-11-05 | 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
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extensi... | null | Foetal Growth Problem Small for Gestational Age | null | 5 | arm 1: In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime arm 2: In the 156-week main period, subjects r... | [
0,
0,
4,
0,
0
] | 2 | [
0,
0
] | intervention 1: 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge intervention 2: 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge | intervention 1: somatropin intervention 2: somatropin | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 80 | 0 | 0 | 0 | NCT00184717 | 1COMPLETED | 2009-12-28 | 2004-08-18 | Novo Nordisk 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 | |
[
4
] | 801 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, ... | This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 participants who were to complete former studies in this program (370 participants from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 participants from studies MRZ 602... | Glabellar Lines | null | 1 | arm 1: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitutio... | [
0
] | 1 | [
0
] | intervention 1: Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area. | intervention 1: IncobotulinumtoxinA (Xeomin) (20 units) | 25 | Los Angeles | California | United States | -118.24368 | 34.05223
Englewood | Colorado | United States | -104.98776 | 39.64777
Aventura | Florida | United States | -80.13921 | 25.95648
Coral Gables | Florida | United States | -80.26838 | 25.72149
Lincolnshire | Illinois | United States | -87.9084 | 42.19002
Carmel | Ind... | 796 | 0 | 0 | 0 | NCT00512135 | 1COMPLETED | 2009-12-28 | 2007-06-18 | Merz Pharmaceuticals GmbH | 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
] | 497 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied | null | Type 2 Diabetes Mellitus | Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases | null | 4 | arm 1: Dapagliflozin: 1 mg arm 2: Dapagliflozin: 2.5 mg arm 3: Dapagliflozin: 5 mg arm 4: Placebo: 0 mg | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, Once Daily, Up to 24 weeks intervention 2: Tablets, Oral, Once Daily, Up to 24 weeks | intervention 1: Dapagliflozin intervention 2: Placebo | 62 | Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Fresno | California | United States | -119.77237 | 36.74773
Lomita | California | United States | -118.31507 | 33.79224
Los Gatos | Californ... | 282 | 0 | 0 | 0 | NCT00736879 | 1COMPLETED | 2009-12-29 | 2008-09-22 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 174 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | true | DMD/BMD is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. ... | This study is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study, designed to document the clinical benefit of ataluren when administered as therapy of patients with DMD/BMD due to a nonsense mutation (premature stop codon) in the dystrophin gene. | Duchenne Muscular Dystrophy Becker Muscular Dystrophy | Duchenne muscular dystrophy Becker muscular dystrophy Nonsense mutation Premature stop codon DMD/BMD PTC124 | null | 3 | arm 1: Participants will receive ataluren suspension orally 3 times a day (TID), 20 milligrams/kilogram (mg/kg) at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks. arm 2: Participants will receive ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and ... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Ataluren will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to ataluren will be administered as the schedule specified in the respective arm. | intervention 1: Ataluren intervention 2: Placebo | 37 | Sacramento | California | United States | -121.4944 | 38.58157
Aurora | Colorado | United States | -104.83192 | 39.72943
Pensacola | Florida | United States | -87.21691 | 30.42131
Iowa City | Iowa | United States | -91.53017 | 41.66113
Kansas City | Kansas | United States | -94.62746 | 39.11417
Boston | Massachusetts |... | 174 | 1 | 0.005747 | 1 | NCT00592553 | 1COMPLETED | 2009-12-31 | 2008-02-29 | PTC Therapeutics | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.001015 |
[
5
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated ... | null | Anemia | null | 1 | arm 1: Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. | [
0
] | 1 | [
0
] | intervention 1: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose) | intervention 1: methoxy polyethylene glycol-epoetin beta | 32 | Aalst | N/A | Belgium | 4.0355 | 50.93604
Antwerp | N/A | Belgium | 4.40026 | 51.22047
Antwerp | N/A | Belgium | 4.40026 | 51.22047
Assebroek | N/A | Belgium | 3.2623 | 51.19367
Ath | N/A | Belgium | 3.77801 | 50.62937
Baudour | N/A | Belgium | 3.8332 | 50.48296
Bonheiden | N/A | Belgium | 4.54714 | 51.02261
Brussels |... | 34 | 0 | 0 | 0 | NCT00642668 | 1COMPLETED | 2009-12-31 | 2008-06-30 | 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
] | 204 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group. | null | Complicated Intra-abdominal Infections | null | 2 | arm 1: NXL104/ceftazidime + metronidazole arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: IV TID intervention 2: IV TID | intervention 1: ceftazidime/NXL104 + metronidazole intervention 2: meropenem | 45 | Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Palm Springs | California | United States | -116.54529 | 33.8303
Detroit | Michigan | United States | -83.04575 | 42.33143
Butte | Montana | United States | -112.53474 | 46.00382
Somers Poin... | 203 | 0 | 0 | 0 | NCT00752219 | 1COMPLETED | 2009-12-31 | 2009-03-31 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 240 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD). | This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg (once daily) or Ranitidine 150 mg (twice daily). | Gastroesophageal Reflux Disease (GERD) | Gastroesophageal Reflux Disease GERD | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 50 mg capsule, taken orally, once daily for 26 weeks. intervention 2: 150 mg capsule, taken orally, twice daily for 26 weeks. | intervention 1: Rabeprazole ER intervention 2: Ranitidine | 4 | Moline | Illinois | United States | -90.51513 | 41.5067
Moline | Illinois | United States | -90.51513 | 41.5067
Moline | Illinois | United States | -90.51513 | 41.5067
Moline | Illinois | United States | -90.51513 | 41.5067 | 232 | 0 | 0 | 0 | NCT00838526 | 1COMPLETED | 2009-12-31 | 2008-08-31 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 197 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpo... | Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of ritu... | Vasculitis Wegener's Granulomatosis Microscopic Polyangiitis | ANCA Vasculitis Wegener's Granulomatosis microscopic polyangiitis ANCA-positive ANCA-associated ANCA-associated vasculitis MPA | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 375 mg/m\^2 infusions once weekly for 4 week intervention 2: 2 mg/kg/day orally for months 1-3 intervention 3: 2 mg/kg/day orally for months 4-6 intervention 4: 1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab intervention 5: During the remission induction phase, all pa... | intervention 1: Rituximab plus cyclophosphamide placebo (rituximab group) intervention 2: Cyclophosphamide plus rituximab placebo (control group) intervention 3: Azathioprine intervention 4: Methylprednisolone (or other glucocorticoid) intervention 5: Prednisone | 8 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Rochester | Minnesota | United States | -92.4699 | 44.02163
New York | New York | United States | -74.00597 | 40.71427
Durham | North Caro... | 197 | 1 | 0.005076 | 1 | NCT00104299 | 1COMPLETED | 2010-01-01 | 2005-01-01 | National Institute of Allergy and Infectious Diseases (NIAID) | 0NIH | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000897 |
[
4
] | 663 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation. | null | Fibrillation, Atrial | Lovaza Omega-3 fatty acids Omacor Paroxysmal atrial fibrillation | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: omega-3-acid ethyl esters intervention 2: Placebo | 178 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Anchorage | Alaska | United States | -149.90028 | 61.21806
Cottonwood | Arizona | United States | -112.00988 | 34.73919
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United... | 663 | 1 | 0.001508 | 1 | NCT00402363 | 1COMPLETED | 2010-01-01 | 2006-11-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000266 |
[
4
] | 560 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use. | The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation. | Fibromyalgia | FMS Fibro Pain Body Pain Tenderness Joint pain Stiffness Muscular Pain | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: flexible dosing | intervention 1: Xyrem® | 91 | Anniston | Alabama | United States | -85.83163 | 33.65983
Auburn | Alabama | United States | -85.48078 | 32.60986
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Anaheim | California | United States | -117.9145 | 33.83529
Carmichael | California | Un... | 560 | 1 | 0.001786 | 1 | NCT00423605 | 1COMPLETED | 2010-01-01 | 2006-12-01 | Jazz Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000315 |
[
3
] | 55 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of carboxyamidotriazole plus ra... | PRIMARY OBJECTIVES:
I. To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme.
II. To determine the toxicity of CAI when combined with cranial irradiation. III. To estimate correlations between pharmacokinetic ... | Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma | null | 1 | arm 1: Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progres... | [
0
] | 3 | [
4,
0,
10
] | intervention 1: Undergo radiotherapy intervention 2: Given orally intervention 3: Correlative studies | intervention 1: radiation therapy intervention 2: carboxyamidotriazole intervention 3: pharmacological study | 8 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Baltimore | Maryland | United States | -76.61219 | 39.29038
Detroit | Michigan | United States | -83.04575 | 42.33143
Winston-Salem | North Carolina |... | 55 | 0 | 0 | 0 | NCT00004146 | 1COMPLETED | 2010-01-01 | 2000-03-01 | 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
] | 58 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. | PRIMARY OBJECTIVES:
I. Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.
II. Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients rece... | Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer | null | 1 | arm 1: Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. | [
0
] | 3 | [
0,
10,
10
] | intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies | intervention 1: bortezomib intervention 2: laboratory biomarker analysis intervention 3: pharmacological study | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 55 | 0 | 0 | 0 | NCT00023712 | 1COMPLETED | 2010-01-01 | 2001-11-05 | 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
] | 98 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal ... | OUTLINE: Patients are stratified according to risk (low-intermediate vs high-intermediate or high).
Patients receive induction chemotherapy comprising cyclophosphamide IV, doxorubicin IV over 15 minutes, and vincristine IV over 1-2 minutes on day 1; oral prednisone once daily on days 1-5; and filgrastim (G-CSF) subcut... | Lymphoma | stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma | null | 1 | arm 1: Patients received 4 cycles if accelerated R-CHOP (cyclophosphamide. doxorubicin, vincristine and prednisone + rituximab) followed by 3 cycles ICE (ifosfamide, carboplatin and etoposide) consolidation therapy. | [
0
] | 11 | [
2,
2,
0,
0,
0,
0,
0,
0,
0,
3,
4
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None | intervention 1: filgrastim intervention 2: rituximab intervention 3: carboplatin intervention 4: cyclophosphamide intervention 5: doxorubicin hydrochloride intervention 6: etoposide intervention 7: ifosfamide intervention 8: prednisone intervention 9: vincristine sulfate intervention 10: peripheral blood stem cell tran... | 1 | New York | New York | United States | -74.00597 | 40.71427 | 98 | 0 | 0 | 0 | NCT00039195 | 1COMPLETED | 2010-01-01 | 2006-11-01 | Memorial Sloan Kettering Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer. | OBJECTIVES:
* Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols.
* Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive topotecan ... | Cervical Cancer | recurrent cervical cancer cervical squamous cell carcinoma | null | 1 | arm 1: Topotecan weekly | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: topotecan hydrochloride | 27 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Sylmar | California | United States | -118.44925 | 34.30778
Hartford | Connecticut | United States | -72.68509 | 41.76371
New Brit... | 25 | 0 | 0 | 0 | NCT00087126 | 1COMPLETED | 2010-01-01 | 2005-02-01 | Gynecologic Oncology Group | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults.
The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food all... | This is a dual-center double-blind, placebo controlled trial of omalizumab for the treatment of EE. Omalizumab will be dosed depending on the patient's body weight and baseline IgE level. Omalizumab or placebo will be administered subcutaneously every 4 weeks for 16 weeks. At study entry subjects will have EGD with bio... | Esophagitis | eosinophilic esophagitis omalizumab | null | 2 | arm 1: placebo group arm 2: Xolair group | [
2,
0
] | 2 | [
0,
0
] | intervention 1: omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks intervention 2: Placebo given IV once every 2-4 weeks based on weight | intervention 1: omalizumab intervention 2: Placebo | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 30 | 0 | 0 | 0 | NCT00123630 | 1COMPLETED | 2010-01-01 | 2005-11-01 | University of Utah | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 77 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that lead to a decrease in the blood level of functional "C1... | A prospectively planned interim analysis will be performed on the double-blind data. | Hereditary Angioedema Angioneurotic Edema | null | 3 | arm 1: 100 IU/kg Recombinant human C1 inhibitor arm 2: 50 IU/kg Recombinant human C1 inhibitor arm 3: None | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: IV intervention 2: saline solution | intervention 1: Recombinant Human C1 Inhibitor intervention 2: placebo | 1 | Leiden | N/A | Netherlands | 4.49306 | 52.15833 | 100 | 0 | 0 | 0 | NCT00225147 | 1COMPLETED | 2010-01-01 | 2005-07-01 | Pharming Technologies B.V. | 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
] | 56 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with first or second-generation antipsychotics, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion crit... | The aim of this study is to investigate the effects of pioglitazone added to weight-lifestyle intervention vs. placebo plus lifestyle intervention on reversing or reducing impaired or abnormal triglycerides, HDL and glucose metabolism in schizophrenics treated with first or second-generation antipsychotics.. Another ai... | Diabetes Schizophrenia Insulin Resistance Cognitive Impairment | atypical antipsychotics hyperglycemia triglycerides HDL cholesterol insulin resistance schizophrenia verbal memory | null | 2 | arm 1: Pioglitazone (30-45 mg/daily) plus life-style diet group arm 2: Placebo capsules daily plus life-style diet group | [
1,
2
] | 3 | [
0,
5,
10
] | intervention 1: pioglitazone 30-45 mg/day intervention 2: life style diet education group 1x/week intervention 3: placebo comparator capsules | intervention 1: Pioglitazone intervention 2: Life style diet group intervention 3: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 56 | 0 | 0 | 0 | NCT00231894 | 1COMPLETED | 2010-01-01 | 2005-05-01 | Nathan Kline Institute for Psychiatric 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 |
[
5
] | 112 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if lamotrigine add-on therapy is associated with decreased cocaine craving and improvement in depressive symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study is examining whether lamotrigine add-on therap... | One hundred and twenty (120) adult outpatients with bipolar I, II, not otherwise specified, or cyclothymic disorder and current cocaine dependence will be enrolled. After obtaining informed consent baseline assessment measures will be administered including the Structured Clinical Interview for Diagnostic Statistical M... | Bipolar Disorder Cocaine Dependence | Bipolar Disorder Cocaine Dependence Dual Diagnosis | null | 2 | arm 1: Placebo arm 2: LAmotrigine | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Lamotrigine intervention 2: Placebo | intervention 1: Lamotrigine intervention 2: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 112 | 0 | 0 | 0 | NCT00280293 | 1COMPLETED | 2010-01-01 | 2006-03-01 | University of Texas Southwestern Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 2 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine how well subjects respond to treatment with Rituximab plus Beta-Glucan. | Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL is a cancer of the B-lymphocytes, which make antibodies that help protect the body against harmful foreign substances, such as bacteria and viruses. Similar to CLL, small lymphocytic lymphoma (SLL) is a less-common cancer of the B-lym... | Leukemia, Lymphocytic, Chronic Lymphoma, Small Lymphocytic | chronic lymphocytic leukemia small lymphocytic lymphoma rituximab beta-glucan | null | 0 | null | null | 2 | [
0,
7
] | intervention 1: 375 mg/m2, IV (in the vein), once a week for 4 weeks intervention 2: 250 mg, orally (tablet), three times a day for 9 weeks | intervention 1: Rituximab intervention 2: Beta-Glucan | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 2 | 0 | 0 | 0 | NCT00290407 | 6TERMINATED | 2010-01-01 | 2006-03-01 | University of Louisville | 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 | 1PREVENTION | 4QUADRUPLE | true | 1FEMALE | null | The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing reg... | The prevalence of hypovitaminosis D in reproductive aged African-American women occurs at a rate of \> 40%. Two factors have contributed to this public health problem: an inadequate DRI for vitamin D and avoidance of sun exposure/use of sunscreen. This startling rate of hypovitaminosis D requires that the DRI for vitam... | Vitamin D Deficiency | vitamin D cholecalciferol pregnancy bone mineral density | null | 3 | arm 1: Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day arm 2: Experimental group receiving 2000 IU total vitamin D3/day. arm 3: Experimental group receiving 4000 IU/day cholecalciferol | [
1,
0,
0
] | 2 | [
0,
0
] | intervention 1: randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day intervention 2: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy | intervention 1: cholecalciferol (vitamin D3) intervention 2: cholecalciferol | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 501 | 0 | 0 | 0 | NCT00292591 | 1COMPLETED | 2010-01-01 | 2004-01-01 | 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 |
[
3
] | 326 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human case... | Two main types of influenza virus--Types A and B--are responsible for the seasonal flu epidemics that occur each year. The influenza A viruses can be broken down into subtypes based on two proteins on the surface of the virus: hemagglutinin (H) and neuraminidase (N). The A subtypes usually found in humans are H1N1, H1N... | Influenza Avian Influenza Severe Influenza | Antibody Response Antiviral Efficacy Bird Flu Severe Respiratory Distress Viral Replication and Shedding | null | 4 | arm 1: All participants \>= 15 years will receive standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days. arm 2: All participants \>= 15 years will receive high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age... | [
1,
1,
1,
1
] | 1 | [
0
] | intervention 1: Oseltamivir is a sialic acid analogue that potently and specifically inhibits the viral neuraminidases by competitively and reversibly interacting with the active enzyme site of influenza A and B viruses. Oseltamivir will be administered orally in standard formulations (capsules for adults and children ... | intervention 1: Oseltamivir | 12 | Singapore | N/A | Singapore | 103.85007 | 1.28967
Singapore | N/A | Singapore | 103.85007 | 1.28967
Singapore | N/A | Singapore | 103.85007 | 1.28967
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Nonthaburi | N/A | Thailand | 100.51477 | 13.86075
Nonthaburi | N/A | Thai... | 326 | 0 | 0 | 0 | NCT00298233 | 1COMPLETED | 2010-01-01 | 2006-02-01 | 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 |
[
3
] | 69 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma | This is a Phase II clinical trial to determine whether administration of ONTAK will result in a significant response rate in patients with metastatic melanoma.
Although the development of effective immunotherapy and the characterization of multiagent chemotherapy regimens have substantially improved in the treatment o... | Malignant Melanoma | Melanoma Metastatic Stage IV Ontak | null | 1 | arm 1: Single-arm: Ontak | [
0
] | 1 | [
0
] | intervention 1: 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles. | intervention 1: Denileukin diftitox | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 69 | 0 | 0 | 0 | NCT00299689 | 1COMPLETED | 2010-01-01 | 2006-03-01 | James Graham Brown 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
] | 13 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study examined whether the anti-inflammatory medicines infliximab, sirolimus or daclizumab, when given with a participant's current therapies, would prevent the growth of new blood vessels in the eye in participants with age-related macular degeneration (AMD).
Participants 55 years of age and older with AMD and d... | There has been much interest in the possible role of the immune system in AMD. Experimental models and patient material have, to date, suggested a role for macrophages and complement. This study hypothesized that the underlying mechanism that leads to choroidal neovascularization (CNV) is similar to those at play in at... | Age-Related Macular Degeneration Choroidal Neovascularization | Age-Related Macular Degeneration Rapamycin Remicade Daclizumab Immunosuppression Infliximab Choroidal Neovascularization Sirolimus AMD Ocular Inflammation | null | 4 | arm 1: Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study. arm 2: Participants randomized to IV infliximab received 3 mg/kg of IV infliximab month... | [
1,
1,
1,
5
] | 4 | [
0,
0,
10,
0
] | intervention 1: Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study. intervention 2: Participants randomized to IV infliximab received 3 mg/kg of I... | intervention 1: Intravenous Daclizumab intervention 2: Intravenous Infliximab intervention 3: Observation intervention 4: Oral Rapamycin | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 13 | 0 | 0 | 0 | NCT00304954 | 1COMPLETED | 2010-01-01 | 2006-02-01 | National Eye Institute (NEI) | 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
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemi... | PRIMARY OBJECTIVES:
I. Determine the toxicity and the proportion of complete remissions associated with two different treatment schedules of vorinostat (SAHA) in patients with acute myeloid leukemia.
SECONDARY OBJECTIVES:
I. Determine the toxic effects of SAHA in this study population. II. Examine for preliminary ev... | Adult Acute Erythroid Leukemia (M6) Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturatio... | null | 2 | arm 1: Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment repeats every 21 days for u... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Given orally once daily intervention 2: Given orally three times daily | intervention 1: vorinostat intervention 2: vorinostat | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 37 | 0 | 0 | 0 | NCT00305773 | 1COMPLETED | 2010-01-01 | 2006-01-01 | 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
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluate... | Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. Randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib; a cytogenic response (CgR) less than a partia... | Leukemia, Myeloid, Chronic | Chronic phase CML, with a suboptimal response after treatment with imatinib | null | 2 | arm 1: Participants with chronic phase chronic myeloid leukemia (CML) who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg. arm 2: Participants with chronic phase CML who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water. intervention 2: Dasatinib tablets administered orally at a dose of 100 mg once daily. | intervention 1: Imatinib intervention 2: Dasatinib | 27 | Antwerp | N/A | Belgium | 4.40026 | 51.22047
Charleroi | N/A | Belgium | 4.44448 | 50.41136
Helsinki | N/A | Finland | 24.93545 | 60.16952
Tampere | N/A | Finland | 23.78712 | 61.49911
Lyon | N/A | France | 4.84671 | 45.74846
Marseille | N/A | France | 5.38107 | 43.29695
Montpellier | N/A | France | 3.87635 | 43.61093
... | 32 | 0 | 0 | 0 | NCT00320190 | 6TERMINATED | 2010-01-01 | 2006-08-01 | 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
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving... | OBJECTIVES:
Primary
* Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) at 3 months after treatment with everolimus and imatinib mesylate.
Sec... | Kidney Cancer | stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer | null | 1 | arm 1: Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth | [
0
] | 2 | [
0,
0
] | intervention 1: 2.5 mg by mouth daily intervention 2: 600 mg by mouth daily | intervention 1: Everolimus intervention 2: imatinib mesylate | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 19 | 0 | 0 | 0 | NCT00331409 | 1COMPLETED | 2010-01-01 | 2006-01-01 | OHSU Knight Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 45 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in combination with naltrexone in methamphetamine dependence. | Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine dependence compared to placebo. The proposed s... | Methamphetamine Dependence | Methamphetamine Dependence | null | 2 | arm 1: Naltrexone tablets
N-Acetyl Cysteine: 600mg tablets, daily arm 2: Inactive placebo ("sugar pill") | [
0,
2
] | 2 | [
0,
0
] | intervention 1: daily intervention 2: daily | intervention 1: Naltrexone plus N-Acetyl Cysteine intervention 2: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 45 | 0 | 0 | 0 | NCT00332605 | 1COMPLETED | 2010-01-01 | 2006-06-01 | University of Chicago | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU. | Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occurs with opioid administration. In addition, patients may be more alert with less opioid medication. Currently, dexmedet... | Post-operative Pain Respiratory Depression | Dexmedetomidine Sedation Opioid Respiratory depression | null | 2 | arm 1: One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug. arm 2: The second group (the study group) will receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 24 hours after they are admitted to an ope... | [
2,
1
] | 2 | [
0,
10
] | intervention 1: Dexmedetomidine titrated over 24 hours intervention 2: None | intervention 1: Dexmedetomidine intervention 2: Placebo (Normal Saline) | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 38 | 0 | 0 | 0 | NCT00345384 | 1COMPLETED | 2010-01-01 | 2008-05-01 | Baylor 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 |
[
2,
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase I/II trial is studying the side effects and best dose of SGN-30 when given together with ifosfamide, carboplatin, and etoposide and to see how well they work in treating young patients with recurrent anaplastic large cell lymphoma. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, w... | PRIMARY OBJECTIVES:
I. Define and describe the toxicities of monoclonal antibody SGN-30 alone (window) and in combination with ifosfamide, carboplatin, and etoposide (ICE) in pediatric patients with CD30-positive recurrent anaplastic large cell lymphoma.
II. Define, preliminarily, the antitumor activity of monoclonal... | Anaplastic Large Cell Lymphoma Recurrent Childhood Anaplastic Large Cell Lymphoma | null | 1 | arm 1: Patients receive monoclonal antibody SGN-30 IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV over 2 hours on days 1-3, carboplatin IV over 1 hour on day 1, and etoposide IV over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 cours... | [
0
] | 9 | [
2,
0,
0,
0,
0,
0,
0,
10,
10
] | intervention 1: Given IV intervention 2: Given IT intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Given IT intervention 7: Given IT intervention 8: Correlative studies intervention 9: Correlative studies | intervention 1: monoclonal antibody SGN-30 intervention 2: therapeutic hydrocortisone intervention 3: ifosfamide intervention 4: carboplatin intervention 5: etoposide intervention 6: methotrexate intervention 7: cytarabine intervention 8: pharmacological study intervention 9: laboratory biomarker analysis | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 5 | 0 | 0 | 0 | NCT00354107 | 6TERMINATED | 2010-01-01 | 2007-01-01 | 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 | |
[
4
] | 727 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benef... | The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the recommended drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to sh... | Cardiac Arrest | Vasopressin Adrenaline Survival Return of spontaneous of circulation | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1 mg intervention 2: 40 IU | intervention 1: Adrenaline intervention 2: Vasopressin | 4 | Singapore | N/A | Singapore | 103.85007 | 1.28967
Singapore | N/A | Singapore | 103.85007 | 1.28967
Singapore | N/A | Singapore | 103.85007 | 1.28967
Singapore | N/A | Singapore | 103.85007 | 1.28967 | 0 | 0 | 0 | 0 | NCT00358579 | 1COMPLETED | 2010-01-01 | 2006-03-01 | Singapore General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 107 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in lessening the decreased mental function sometimes caused by anti-HIV drugs. | Cognitive impairment, including disabling cognitive, behavioral, and social dysfunction, continues to be a major problem faced by HIV-infected people taking antiretroviral therapy (ART). Research is needed to develop treatment that can be given alongside ART to prevent or lessen cognitive impairment caused by ART. Mino... | HIV Infections | Treatment Experienced | null | 2 | arm 1: 100 mg orally every 12 hours arm 2: orally every 12 hours | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tetracycline antibiotic, 100 mg taken orally every 12 hours intervention 2: Tetracycline antibiotic placebo, orally every 12 hours | intervention 1: Minocycline intervention 2: Placebo (Tetracycline) | 16 | Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland |... | 107 | 0 | 0 | 0 | NCT00361257 | 6TERMINATED | 2010-01-01 | 2007-03-01 | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 83 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) is more effective in the reduction of alcohol craving and drinking compared to placebo in individuals with particular genetic predisposition. | About 300 non-treatment seeking alcoholics will be recruited through advertisement and paid for their participation. They will be assessed, subtyped for mu-opiate receptor and catechol-O-methyltransferase (COMT) allelic variants and 88 individuals (44 with the more common AA gene and 44 with either an AG or GG gene) wi... | Alcohol Dependence | Alcohol dependence Alcoholism Craving Genetic | null | 2 | arm 1: Naltrexone one capsule a day arm 2: One capsule a day match to naltrexone | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7) intervention 2: Placebo for 7 days matched to Naltrexone | intervention 1: Naltrexone intervention 2: Placebo | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 83 | 0 | 0 | 0 | NCT00366626 | 1COMPLETED | 2010-01-01 | 2006-04-01 | 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 |
[
3
] | 13 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse. | Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. The objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this informat... | Marijuana Dependence | Baclofen Marijuana Dependence Marijuana Withdrawal | null | 6 | arm 1: Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at eac... | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). intervention 2: Marijuana: Participants each received a single marijuana cigarette (provided by the National Institu... | intervention 1: Baclofen intervention 2: Marijuana intervention 3: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 39 | 0 | 0 | 0 | NCT00373295 | 1COMPLETED | 2010-01-01 | 2006-05-01 | New York State Psychiatric Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and wee... | null | Schizophrenia Schizoaffective Disorder | schizophrenia cognition | null | 2 | arm 1: First group will be randomized to take Armodafinil (Nuvigil) 150 mg, along with their current anti psychotic medication and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked. arm 2: Second group will be... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: armodafinil (Nuvigil)150 mg qd intervention 2: identical in appearance to active comparator | intervention 1: armodafinil (Nuvigil) intervention 2: placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 58 | 0 | 0 | 0 | NCT00373672 | 1COMPLETED | 2010-01-01 | 2006-08-01 | Northwestern 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
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's cells. Giving NK cells from a related donor may kill the tumor cells.
PURPOSE: This study furthers the research of previous stu... | We believe that administration of related allogeneic (donor) natural killer cells along with IL-2, rather than autologous natural killer cells will provide the most effective anticancer therapy in this setting, and wish to test this approach. To do this, we will select a related donor who is partially HLA-matched with ... | Breast Cancer | stage IV breast cancer male breast cancer recurrent breast cancer | null | 1 | arm 1: All patients with advanced metastatic breast cancer treated with natural killer cells after receiving fludarabine, cyclosphosphamide and total body irradiation. | [
0
] | 5 | [
0,
0,
4,
10,
2
] | intervention 1: administered intravenously 25 mg/m\^2 times 5 doses intervention 2: administered intravenously 60 mg/kg days times 2 doses. intervention 3: 200 cGy (gray) on day -1 intervention 4: Infused cell dose is within the range of 1.5-8.0 x 10\^7/kg. Cell counts are based on total cells infused after the activat... | intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Total body irradiation intervention 4: Natural killer cell infusion intervention 5: Interleukin-2 | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 6 | 0 | 0 | 0 | NCT00376805 | 6TERMINATED | 2010-01-01 | 2006-04-01 | Masonic Cancer Center, University of Minnesota | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well giving bevacizumab together with sorafenib works in treating patients with unresectable stage III or stage IV malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other... | PRIMARY OBJECTIVES:
I. Determine the clinical biologic activity of sorafenib tosylate and bevacizumab, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, in patients with unresectable stage III or stage IV malignant melanoma previously treated with at least 2 regime... | Recurrent Melanoma Stage III Skin Melanoma Stage IV Skin Melanoma | null | 1 | arm 1: Patients receive oral sorafenib tosylate on days 1-5, 8-12, 15-19, and 22-26 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. | [
0
] | 4 | [
2,
10,
10,
0
] | intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Given orally | intervention 1: Bevacizumab intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study intervention 4: Sorafenib Tosylate | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 14 | 0 | 0 | 0 | NCT00387751 | 1COMPLETED | 2010-01-01 | 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 | |
[
0
] | 14 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 2MALE | null | Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) t... | null | Low Back Pain | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 30-60mg of duloxetine daily intervention 2: Placebo pill once daily | intervention 1: duloxetine intervention 2: Placebo | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 14 | 0 | 0 | 0 | NCT00388414 | 1COMPLETED | 2010-01-01 | 2006-09-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 118 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect® in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible patients attended two screening visits and were booke... | see above | Articular Cartilage Lesion of the Femoral Condyle | Cartilage Articular Femoral Knee | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
3
] | intervention 1: 10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.
The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm². interven... | intervention 1: ChondroCelect implantation intervention 2: Microfracture | 12 | Bruges | N/A | Belgium | 3.22424 | 51.20892
Bruges | N/A | Belgium | 3.22424 | 51.20892
Brussels | N/A | Belgium | 4.34878 | 50.85045
Deurne | N/A | Belgium | 4.46595 | 51.22134
Ghent | N/A | Belgium | 3.71667 | 51.05
Herentals | N/A | Belgium | 4.83248 | 51.17655
Kortrijk | N/A | Belgium | 3.26487 | 50.82803
Leuven | ... | 112 | 0 | 0 | 0 | NCT00414700 | 1COMPLETED | 2010-01-01 | 2002-02-01 | TiGenix n.v. | 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
] | 16 | RANDOMIZED | FACTORIAL | 1PREVENTION | 1SINGLE | false | 0ALL | true | The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney dis... | Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients w... | Chronic Kidney Disease | phosphate, phosphorus, FGF-23, PTH, 1,25D | null | 4 | arm 1: 25% of subjects will receive binders plus a phosphate restricted diet. arm 2: 25% binders + unrestricted phosphate diet. arm 3: 25% placebo + phosphate restricted diet. arm 4: 25% placebo + unrestricted phosphate diet. | [
1,
1,
1,
1
] | 4 | [
0,
7,
7,
0
] | intervention 1: Lanthanum carbonate 1000mg 3x/day intervention 2: Low phosphorus diet will consist of 800 mg of phosphorus per day. intervention 3: Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. intervention 4: Lan... | intervention 1: Lanthanum Carbonate intervention 2: Low Phosphorus Diet intervention 3: Unrestricted Phosphorus Diet intervention 4: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 16 | 0 | 0 | 0 | NCT00438932 | 1COMPLETED | 2010-01-01 | 2007-01-01 | 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 |
[
5
] | 260 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 0ALL | true | The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 po... | Atrial fibrillation is the most common complication after bypass surgery. It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortali... | Atrial Fibrillation | atrial fibrillation coronary artery disease bypass graft surgery | null | 2 | arm 1: Highly purified pharmaceutical grade omega three polyunsaturated fatty acids arm 2: olive oil | [
0,
2
] | 1 | [
0
] | intervention 1: 2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days. | intervention 1: Omega Three Polyunsaturated fatty acids | 1 | Iowa City | Iowa | United States | -91.53017 | 41.66113 | 260 | 0 | 0 | 0 | NCT00446966 | 1COMPLETED | 2010-01-01 | 2007-02-01 | Chirag Sandesara | 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 | 0TREATMENT | 0NONE | false | 2MALE | true | The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer. | This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and theref... | Prostatic Neoplasms | null | 1 | arm 1: GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days. | [
0
] | 2 | [
0,
0
] | intervention 1: Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic. intervention 2: GM-CSF is a biologic response modifier, classified as a colony stimulating factor. | intervention 1: Mitoxantrone intervention 2: GM-CSF | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 10 | 0 | 0 | 0 | NCT00477087 | 6TERMINATED | 2010-01-01 | 2006-07-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 26 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. ... | OBJECTIVES:
Primary
* Determine the activity of gefitinib and etoposide, in terms of overall response rate, in patients with hormone-refractory advanced prostate cancer previously treated with docetaxel-based therapy.
Secondary
* Determine the toxicity of this regimen in these patients.
* Determine whether related ... | Prostate Cancer | adenocarcinoma of the prostate recurrent prostate cancer stage III prostate cancer stage IV prostate cancer | null | 1 | arm 1: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial.
Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). | [
0
] | 1 | [
0
] | intervention 1: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple). | intervention 1: Gefitinib plus etoposide | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 26 | 0 | 0 | 0 | NCT00483561 | 6TERMINATED | 2010-01-01 | 2004-01-01 | University of Nebraska | 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
] | 1,280 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese). | Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor. | Atrial Fibrillation | BAY59-7939 Rivaroxaban Non-Valvular Atrial Fibrillation Japanese Patients Phase III 12620 | null | 2 | arm 1: Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period arm 2: Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Participants orally administered rivaroxaban 15 mg OD (CrCL \[creatinine clearance\] \>= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min) intervention 2: Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 ... | intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Warfarin intervention 3: Rivaroxaban placebo intervention 4: Warfarin placebo | 165 | Kasugai | Aichi-ken | Japan | 136.97229 | 35.24762
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Okazaki | Aichi-ken... | 2,536 | 0 | 0 | 0 | NCT00494871 | 1COMPLETED | 2010-01-01 | 2007-06-01 | Bayer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device. | null | Open-angle Glaucoma Ocular Hypertension | Intraocular pressure Open-angle glaucoma Ocular hypertension Adherence Compliance | null | 2 | arm 1: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. arm 2: One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication. | [
0,
0
] | 4 | [
0,
0,
0,
1
] | intervention 1: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. intervention 2: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. intervention 3: One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travaler... | intervention 1: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav) intervention 2: Travoprost 0.004% eye drops intervention 3: Timolol 0.05% eye drops intervention 4: Travalert Dosing Aid | 1 | Zaragoza | N/A | Spain | -0.87734 | 41.65606 | 102 | 0 | 0 | 0 | NCT00508469 | 1COMPLETED | 2010-01-01 | 2007-10-01 | Alcon Research | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 7 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II trial study has a 6-patient feasibility portion studying the tolerability of chemotherapy with vincristine sulfate together with topotecan hydrochloride, cyclophosphamide, and bevacizumab in treating young patients with refractory or first recurrent extracranial Ewing's sarcoma. If the therapy is consider... | PRIMARY OBJECTIVES:
I. To determine the feasibility of administering bevacizumab in combination with vincristine (vincristine sulfate), topotecan hydrochloride, and cyclophosphamide (VTC) to younger patients with refractory or first recurrent Ewing sarcoma.
II. To compare the progression-free survival of patients tre... | Ewing Sarcoma of Bone Extraosseous Ewing Sarcoma Peripheral Primitive Neuroectodermal Tumor Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | null | 3 | arm 1: Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 \[course 5\], 17, 18 \[course 6\], 26, 27 \[cou... | [
0,
0,
1
] | 4 | [
0,
0,
0,
2
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV | intervention 1: topotecan hydrochloride intervention 2: vincristine sulfate intervention 3: cyclophosphamide intervention 4: bevacizumab | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 6 | 0 | 0 | 0 | NCT00516295 | 1COMPLETED | 2010-01-01 | 2008-02-01 | 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 | |
[
4
] | 208 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .
PURPOSE: This randomized phase III trial is studying BAK gel to see how well it w... | OBJECTIVES Primary
* Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel versus placebo, in terms of improving sensory neuropathy, in cancer patients with chemotherapy-induced peripheral neuropathy\> Secondary\>
* Compare motor and autonomic symptoms and functioning, mood states, pain,... | Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific | null | 2 | arm 1: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel\> topically to each\> area of pain,\> numbness,\> and/or tingling\> on the\> feet and/or hands twice daily\> for\> 4 weeks. arm 2: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on t... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Applied topically intervention 2: Applied topically | intervention 1: baclofen/amitriptyline/ketamine gel intervention 2: placebo | 165 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Jacksonville | Florida | United States | -81.65565 | 30.33218
Aurora | Illinois | United States | -88.32007 | 41.76058
Bloomington | Illinois | United States | -88.99369 | 40.4842
Canton | Illinois | United States | -90.03512 | 40.55809
Carthage | Illinois | ... | 203 | 0 | 0 | 0 | NCT00516503 | 1COMPLETED | 2010-01-01 | 2008-02-01 | Alliance for Clinical Trials in Oncology | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vi... | A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other gr... | Macular Degeneration | Anti-VEGF therapy photodynamic therapy neovascularization | null | 2 | arm 1: Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. arm 2: Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will r... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 0.5 mg. given as an intraocular injection intervention 2: Standard dosage of 6 mgs. / meter2 of body surface area given intravenously. | intervention 1: ranibizumab intervention 2: verteporfin | 3 | Santa Barbara | California | United States | -119.69819 | 34.42083
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Arlington | Texas | United States | -97.10807 | 32.73569 | 60 | 0 | 0 | 0 | NCT00527475 | 1COMPLETED | 2010-01-01 | 2007-05-01 | Texas Retina Associates | 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
] | 124 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard plat... | null | Non-Small Cell Lung Cancer | null | 2 | arm 1: Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcit... | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: 150 mg, PO, daily intervention 2: 15 mg/kg, IV, Day 1 of Cycles 1 through 7 intervention 3: At the discretion of the investigator | intervention 1: Erlotinib intervention 2: Bevacizumab intervention 3: Standard platinum-based chemotherapy | 57 | East Bentleigh | Victoria | Australia | N/A | N/A
Geelong | Victoria | Australia | 144.36069 | -38.14711
Leuven | N/A | Belgium | 4.70093 | 50.87959
Bayonne | N/A | France | -1.473 | 43.49316
Dijon | N/A | France | 5.01667 | 47.31667
Le Mans | N/A | France | 0.20251 | 48.0021
Marseille | N/A | France | 5.38107 | 43.296... | 123 | 0 | 0 | 0 | NCT00531960 | 1COMPLETED | 2010-01-01 | 2008-01-01 | 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 | |
[
5
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | After Laparoscopic surgery most patients experience some form of mild to moderate pain. The current standard of care is to treat this pain with local anesthetics (numbing medication, that deadens the nerve endings) to the small surgical incisions (cuts) and narcotic systemic analgesics (medication injected into your ve... | The procedure of the current study is to randomly assign patients undergoing minimally invasive surgeries (laparoscopic cholecystectomies and laparoscopic Lap-Banding procedures) to one of two groups. Both groups will have the standard surgical procedure performed and then at the completion will have the on-Q system pl... | Postoperative Pain | null | 2 | arm 1: Bupivacaine arm 2: Saline | [
0,
2
] | 1 | [
0
] | intervention 1: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally | intervention 1: On-Q Pain Pump | 1 | Brooklyn | New York | United States | -73.94958 | 40.6501 | 30 | 0 | 0 | 0 | NCT00533845 | 1COMPLETED | 2010-01-01 | 2007-09-01 | Maimonides Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 131 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis. | The study was designed to evaluate the efficacy of SFP-containing dialysate solution in maintaining physiological iron levels during chronic hemodialysis, as measured by the primary endpoint of the percent of patients whose Hemoglobin (Hgb) decreased by at least 1.0 gram/ deciliter (g/dL) from baseline. The efficacy an... | End-Stage Renal Disease (ESRD) | Subjects with ESRD receiving chronic Hemodialysis | null | 5 | arm 1: Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 2: 5 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 3: 10 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 4: 12 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 5: 15 micrograms (µg) of iron/ deciliter (dL) of dialysate | [
2,
0,
0,
0,
0
] | 5 | [
1,
0,
0,
0,
0
] | intervention 1: Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 2: Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 3: Patients received 10 microgr... | intervention 1: Standard Bicarbonate Solution intervention 2: Soluble Ferric Pyrophosphate intervention 3: Soluble Ferric Pyrophosphate intervention 4: Soluble Ferric Pyrophosphate intervention 5: Soluble Ferric Pyrophosphate | 28 | Tempe | Arizona | United States | -111.90931 | 33.41477
Hacienda Heights | California | United States | -117.96868 | 33.99307
Los Angeles | California | United States | -118.24368 | 34.05223
Whittier | California | United States | -118.03284 | 33.97918
Augusta | Georgia | United States | -81.97484 | 33.47097
Meridian |... | 131 | 0 | 0 | 0 | NCT00548249 | 1COMPLETED | 2010-01-01 | 2007-08-01 | Rockwell Medical Technologies, 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
] | 132 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in children. | null | Adenoids Hypertrophy | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months). intervention 2: Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16... | intervention 1: Mometasone Furoate nasal spray intervention 2: Placebo | 0 | null | 132 | 0 | 0 | 0 | NCT00552032 | 1COMPLETED | 2010-01-01 | 2007-08-01 | 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 | |
[
4
] | 123 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163 | null | Diabetic Neuropathy, Painful | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks | intervention 1: pregabalin | 27 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Date-shi | Fukushima | Japan | N/A | N/A
Nihommatsu | Fukushima | Japan | 140.43333 | 37.58333
Shirakawa-shi | Fukushima | Japan | N/A | N/A
Sukagawa | Fukushima | Japan | 140.38333 | 37.28333
Kamakura | Kanagawa | Japan | 139.54698 | 35.31085
Yokohama | Kanagawa | Japa... | 123 | 0 | 0 | 0 | NCT00553280 | 1COMPLETED | 2010-01-01 | 2008-02-01 | 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
] | 216 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | false | The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising... | This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospi... | Cardiovascular Disease | null | 2 | arm 1: The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide arm 2: Standard Practice | [
0,
1
] | 2 | [
0,
10
] | intervention 1: Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg) intervention 2: Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions | intervention 1: Red Heart Pill 2b (Polypill) intervention 2: Standard Practice | 3 | Colombo | N/A | Sri Lanka | 79.84868 | 6.93548
Kandy | N/A | Sri Lanka | 80.6336 | 7.2906
Kegalle | N/A | Sri Lanka | 80.3436 | 7.2523 | 203 | 0 | 0 | 0 | NCT00567307 | 1COMPLETED | 2010-01-01 | 2009-01-01 | Wake Forest University Health Sciences | 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
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer. | null | Breast Cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles intervention 2: Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles | intervention 1: Ixabepilone intervention 2: Capecitabine | 4 | Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Maebashi | Gunma | Japan | 139.08333 | 36.4
Osaka | Osaka | Japan | 135.50107 | 34.69379
Sunto-Gun | Shizuoka | Japan | N/A | N/A | 9 | 0 | 0 | 0 | NCT00568022 | 1COMPLETED | 2010-01-01 | 2008-02-01 | R-Pharm | 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
] | 53 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | null | Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, bo... | This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory ... | Fibromyalgia Persian Gulf Syndrome | null | 2 | arm 1: LDN first, then placebo. arm 2: Placebo first, then LDN. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3-4.5mg Naltrexone once daily intervention 2: Placebo pill once daily | intervention 1: Low Dose Naltrexone intervention 2: Placebo - sugar pill | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 56 | 0 | 0 | 0 | NCT00568555 | 1COMPLETED | 2010-01-01 | 2007-06-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | The purpose of this study is to look at how people respond to the treatment of warts through use of the Candida antigen to get an immune response to rid the body of human papillomavirus (HPV). The immune system is the part of the body that fights infections like HPV which causes warts. This research study will examine ... | The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA) approved. The primary goal of this work was to assess the safety of Candin as an investigational new drug (IND) for the treatment of warts. In addition, clinical resolution of treated and untreated warts was evaluated and immuno... | Warts HPV | Warts Candida HPV Injections, Intralesional Immune System | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments. | intervention 1: Candida Antigen | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 18 | 0 | 0 | 0 | NCT00569231 | 1COMPLETED | 2010-01-01 | 2007-02-01 | University of Arkansas | 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
] | 303 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution. | The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter l... | Bacteremia | Sodium citrate Gentamicin Prophylaxis Hemodialysis Central venous catheter | null | 2 | arm 1: Catheter lock with heparin 1,000 units/mL arm 2: Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4% | [
1,
1
] | 2 | [
0,
0
] | intervention 1: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis intervention 2: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis | intervention 1: Heparin 1000U/mL intervention 2: 4% Sodium Citrate with Gentamicin 320 mcg/mL | 1 | Mountain View | California | United States | -122.08385 | 37.38605 | 303 | 0 | 0 | 0 | NCT00571259 | 1COMPLETED | 2010-01-01 | 2003-09-01 | Satellite Healthcare | 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
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine.
Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing e... | The incidence of type 2 DM is increasing worldwide at an alarming rate. Unfortunately, the number of individuals with glycemic control at or below the American Diabetes Association goal of 7% has dropped. In fact, the number of patients with their important cardiometabolic risk factors of glucose, lipids and blood pres... | Type 2 Diabetes | Type 2 diabetes Insulin Glargine Endogenous Glucose Production | null | 1 | arm 1: Placebo: administer single dose of Placebo subcutaneously (SC) with blood glucose monitoring over 24 hours.
Then Insulin Glargine SQ 8 weeks later, in increasing doses (0.5, 1.0, 1.5, 2.0 u/kg body wt.) with blood glucose monitoring monitoring over a 24 hour period. Each dose is separated by 8 weeks (5 separate... | [
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours intervention 2: 8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits) intervention 3: None interven... | intervention 1: Placebo intervention 2: Insulin Glargine 0.5 u/kg body wt SC intervention 3: Insulin Glargine 1.0 u/kg body wt SC intervention 4: Insulin Glargine 1.5 u/kg body wt SC intervention 5: Insulin Glargine 2.0 u/kg body wt SC | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 60 | 0 | 0 | 0 | NCT00574912 | 1COMPLETED | 2010-01-01 | 2007-03-01 | Vanderbilt University Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells). | This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRC... | Liposarcoma,Myxoid | Myxoid Liposarcoma Trabectedin Dexamethasone | null | 1 | arm 1: Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be... | [
0
] | 2 | [
0,
0
] | intervention 1: Trabectedin 1.5 mg/m\^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin. intervention 2: Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion | intervention 1: Trabectedin intervention 2: Dexamethasone | 8 | Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768
Park Ridge | Illinois | United States | -87.84062 | 42.01114
Iowa City | Iowa | United States | -91.53017 | 41.66113
Boston | Massachusetts | United States | -71.05977 | 42.35843
Bourdeaux | N/A | France | 5.13611 | 44.58582
Lyon | N/A | France | 4.84671 | 4... | 29 | 0 | 0 | 0 | NCT00579501 | 1COMPLETED | 2010-01-01 | 2007-04-01 | 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 |
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