Split (3)

train · 29.5k rows

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	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_wilson_lower_bound float32
[ 3 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.	This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week)...	Hepatitis C	Hepatitis C Telaprevir Pegylated-interferon-alfa-2a Pegasys Ribavirin Copegus	null	3	arm 1: Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administe...	[ 0, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks. intervention 2: Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50. intervention 3: Matching placebo tablet to telaprevi...	intervention 1: Telaprevir intervention 2: Pegylated-interferon-alfa-2a intervention 3: Placebo intervention 4: Ribavirin	0	null	24	NCT00580801	1COMPLETED	2010-01-01	2008-01-01	Tibotec BVBA	4INDUSTRY	false	false	false	null	0
[ 3 ]	43	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant	null	Recurrent Hepatitis C	Fibrosis progression recurrent hepatitis C viral infection liver transplant recipients everolimus Hepatitis C recurrence after orthotopic liver transplantation (OLT)	null	2	arm 1: Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor \[CNI\] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)\[MPA\], with or without steroids) / no everolimus introduction. arm 2: Initiation of everolimus with discontinuation o...	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction. intervention 2: Hepatitis C recurrence after orthotopic liver transplantation (OLT)	intervention 1: CsA-TAC (standard Treatment) intervention 2: Everolimus	1	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315	43	NCT00582738	6TERMINATED	2010-01-01	2007-12-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	342	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the funct...	This was a prospective, randomized, double blinded study in which patients undergoing cardiopulmonary bypass with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. Specifically, we will test the hypothesis that amiodarone adminis...	Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery	cardiopulmonary bypass reperfusion ventricular fibrillation ventricular fibrillation amiodarone lidocaine cardiac surgery	null	3	arm 1: Lidocaine is a class I (sodium channel block) antiarrhythmic drug. arm 2: Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm) when other medications did not help or could not be tolerated. Amiodarone is in a class of...	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Lidocaine is a class I (sodium channel block) antiarrhythmic drug intervention 2: 300 mg intervention 3: Saline	intervention 1: Lidocaine intervention 2: Amiodarone intervention 3: Placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	342	NCT00587483	1COMPLETED	2010-01-01	2007-11-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as t...	null	Mesothelioma	Mesothelioma inoperable relapsed	null	2	arm 1: Vinorelbine arm 2: Vandetanib	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: once daily oral dose	intervention 1: Vinorelbine intervention 2: Vandetanib	6	Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Halle-Dolau \| N/A \| Germany \| N/A \| N/A Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Chur \| N/A \| Switzerland \| 9.53287 \| 46.84986 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667	23	NCT00597116	6TERMINATED	2010-01-01	2007-12-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	823	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.	Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th...	Chronic Renal Failure Chronic Kidney Disease Anemia	anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin ...	intervention 1: peginesatide intervention 2: Epoetin alfa or Epoetin beta	84	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 McGehee \| Arkansas \| United States \| -91.39956 \| 33.629 Pine Bluff \| Arkansas \| United States \| -92.0032 \| 34.22843 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Glendale \| Californi...	815	NCT00597584	1COMPLETED	2010-01-01	2007-10-01	Affymax	4INDUSTRY	false	false	false	null	0
[ 4 ]	803	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.	Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th...	Chronic Renal Failure Chronic Kidney Disease Anemia	anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted t...	intervention 1: peginesatide intervention 2: Epoetin Alfa	89	Paragould \| Arkansas \| United States \| -90.49733 \| 36.0584 Fairfield \| California \| United States \| -122.03997 \| 38.24936 Granada Hills \| California \| United States \| -118.52314 \| 34.26472 Los Alamitos \| California \| United States \| -118.07256 \| 33.80307 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 ...	793	NCT00597753	1COMPLETED	2010-01-01	2007-09-01	Affymax	4INDUSTRY	false	false	false	null	0
[ 3 ]	20	NA	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	0ALL	true	To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).	The use of high doses of chemotherapy and autologous stem cell transplant has been shown to prolong disease control among patients with multiple myeloma and patients with lymphomas that have relapsed or recurred. Patients who receive autologous stem cell transplants have their own stem cells collected and stored prior ...	Myeloma, Plasma-Cell Lymphoma, Malignant	nausea cancer CINV	null	1	arm 1: Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell...	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Palonosetron 0.25 mg IV over 30 seconds intervention 2: Aprepitant 125 mg PO and Aprepitant 80 mg PO intervention 3: Dexamethasone 4 mg IV and Dexamethasone 4 mg IV push	intervention 1: Palonosetron intervention 2: Aprepitant intervention 3: Dexamethasone	1	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417	18	NCT00600353	1COMPLETED	2010-01-01	2007-10-01	University of Kansas Medical Center	7OTHER	false	false	false	null	0
[ 2, 3 ]	186	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population wi...	null	Superficial Basal Cell Carcinoma	Double-Blind Placebo Topical Treatment Dose-Ranging sBCC	null	4	arm 1: Active cream, 3% AM \& PM arm 2: Placebo cream AM ; 3% active cream PM arm 3: Placebo cream AM; 1.5% active cream PM arm 4: Placebo AM and PM	[ 0, 2, 2, 2 ]	3	[ 0, 0, 10 ]	intervention 1: Topical treatment 3% active cream applied to the lesion intervention 2: Topical treatment 1.5% active cream applied to the lesion intervention 3: Topical treatment placebo applied to the lesion	intervention 1: API 31510 3% Topical Cream intervention 2: API 31510 1.5% Topical Cream intervention 3: Placebo	11	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Snellville \| Georgia \| United States \| -84.01991 \| 33.85733 Buffalo Grove \| I...	186	NCT00604890	1COMPLETED	2010-01-01	2008-03-01	BPGbio	4INDUSTRY	false	false	false	null	0
[ 4 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either ...	null	Anemia		null	2	arm 1: Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. arm 2: Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 120, 200 or 360 micrograms iv/month (starting dose) intervention 2: As prescribed	intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: Epoetin alfa	19	Badajoz \| Badajoz \| Spain \| -6.97061 \| 38.87789 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Cáceres \| Caceres \| Spain \| -6.37224 \| 39.47649 Cádizv \| Cadiz \| Spain \| N/A \| N/A Castellon \| Castellon \| Spain \| -0.04935 \| 39.98567 Ciudad Real \| Ciudad Real \| Spain \| -3.92907 \| 38.98626 Huelva \| Huelva \| Spain \| -6.9...	101	NCT00605293	1COMPLETED	2010-01-01	2008-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	62	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.	A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)	Lipoma		null	4	arm 1: Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. arm 2: Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of ...	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Administered via intralipomal injection. intervention 2: Matching vehicle placebo administered via intralipomal injection.	intervention 1: Deoxycholic Acid Injection intervention 2: Placebo	7	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 San Diego \| California \| United States \| -117.16472 \| 32.71571 Warren \| Michigan \| United States \| -83.01304 \| 42.49044 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Westwood \| New Jersey \| United States \| -74.03264 \| 40.99121 New York \| New York \| U...	62	NCT00608842	1COMPLETED	2010-01-01	2007-11-01	Kythera Biopharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	25	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor. MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to t...	null	Neuroendocrine Tumors Metastatic Neuroendocrine Tumors	MK-0646	null	1	arm 1: MK-0646	[ 0 ]	1	[ 0 ]	intervention 1: MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.	intervention 1: MK-0646	5	Basking Ridge \| New Jersey \| United States \| -74.54932 \| 40.70621 Commack \| New York \| United States \| -73.29289 \| 40.84288 New York \| New York \| United States \| -74.00597 \| 40.71427 Rockville Centre \| New York \| United States \| -73.64124 \| 40.65871 Sleepy Hollow \| New York \| United States \| -73.85847 \| 41.08565	25	NCT00610129	1COMPLETED	2010-01-01	2008-01-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	42	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis	This is a single institution phase 2 clinical trial evaluating the efficacy, safety, and tolerability of tailored temozolomide therapy for patients with acute myeloid leukemia (AML) and poor risk features. Patients will be assigned to 1 of 2 parallel treatment groups based on their AGAT promoter region methylation sta...	Leukemia, Myeloid		null	2	arm 1: Induction: 200 mg/m2/day oral Temozolomide x 7 days arm 2: Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days	[ 0, 0 ]	1	[ 0 ]	intervention 1: Priming, Group 2 only, 100 mg/m2/day temozolomide. Induction (both arms) 200 mg/m2/day temozolomide	intervention 1: Temozolomide	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	36	NCT00611247	1COMPLETED	2010-01-01	2007-12-01	Bruno C. Medeiros	7OTHER	false	false	false	null	0
[ 4 ]	478	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.	null	Schizophrenia	Schizophrenia Latuda Lurasidone	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 120mg/day intervention 2: 15mg/day intervention 3: Placebor Comparator intervention 4: Lurasidone 40 mg tablets	intervention 1: Lurasidone intervention 2: Olanzapine intervention 3: Placebo comparator intervention 4: Lurasidone 40 mg tablets	52	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Cerritos \| California \| United States \| -118.06479 \| 33.85835 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Orange \| California \| United States \| -117.85311 \| 33.78779 Paramount \|...	475	NCT00615433	1COMPLETED	2010-01-01	2008-01-01	Sumitomo Pharma America, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. T...	See summary	Endometriosis Infertility	Endometriosis,infertility,in vitro fertilization	null	4	arm 1: Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention arm 2: Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension admini...	[ 1, 0, 0, 1 ]	2	[ 0, 10 ]	intervention 1: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3 intervention 2: None	intervention 1: Leuprolide acetate in depot suspension intervention 2: No intervention	1	Lone Tree \| Colorado \| United States \| -104.8863 \| 39.55171	36	NCT00621179	1COMPLETED	2010-01-01	2003-03-01	Colorado Center for Reproductive Medicine	7OTHER	false	false	false	null	0
[ 2, 3 ]	8	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Allogeneic hematopoietic transplant is curative for many patients with hematological neoplasms but conditions to provide optimal engraftment and anti-tumor efficacy with minimal toxicity are still under way. Clofarabine is a newly licensed agent with dramatic anti-leukemic activity. Its incorporation into a regimen for...	Non-myeloablative conditioning allows curative allogeneic hematopoietic transplantation for patients unable to tolerate more toxic conventional conditioning regiments. These regiments continue to be refined and evolve. No standard regimen is yet agreed upon. The incorporation of the newly licenses agent Clofarabine int...	Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia Lymphoma Hodgkin's Lymphoma Multiple Myeloma	leukemia myelodysplastic syndrome chronic myelogenous leukemia lymphoma mantle cell lymphoma	null	2	arm 1: Phase 1: 1-3 patients will be treated in order to establish Cyclophosphamide and Clofarabine dose and to confirm reasonable safety and engraftment efficacy. Drug - Clofarabine,Cyclophosphamide \& Alemtuzumab - Clofar (30mg/m2) D -8 to -4; Cyclo (500mg/m2) D -8 \& -7 \& Alem (20mg over 2hrs) arm 2: Phase II pati...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Hydrocortisone 100 mg IV 30 minutes prior to each dose of Clofarabine. Ondansetron 16 mg PO or IV or another comparable antiemetic should be given prior to each dose of Clofarabine. An additional similar dose should be given prior to Cyclophosphamide dose. Clofarabine 30 mg/M2 -8 through - 4 (5 doses) i...	intervention 1: Clofar, Cyclophos, Alemtuzumab intervention 2: Clofar, Cyclophos,Alemtuzumab(Ph II)	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	8	NCT00626626	6TERMINATED	2010-01-01	2007-05-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).	This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients...	Hormone Refractory Prostate Cancer		null	1	arm 1: RAD001 at a dose of 10 mg PO daily	[ 0 ]	1	[ 0 ]	intervention 1: RAD001 at a dose of 10 mg PO daily	intervention 1: RAD001	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	35	NCT00629525	1COMPLETED	2010-01-01	2005-08-01	Daniel George, MD	7OTHER	false	false	false	null	0
[ 2, 3 ]	60	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.	Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studie...	Stroke, Acute	stroke ischemic neuroprotection minocycline tissue plasminogen activator (tPA) biomarkers pharmacokinetics antiapoptotic anti-inflammatory treatment matrix metalloproteinase-9 (MMP-9) thrombolysis Minocycline to Improve Neurologic Outcome in Stroke (MINOS) cerebrovascular stroke cerebrovascular accident cerebral stroke...	null	0	null	null	1	[ 0 ]	intervention 1: Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses. Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses. Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 1...	intervention 1: Minocycline	2	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	60	NCT00630396	1COMPLETED	2010-01-01	2008-05-01	David Hess, MD	7OTHER	false	false	false	null	0
[ 3 ]	21	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an open-label, multicenter, international study designed to determine TTR stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical outcomes in patients with non-V30M TTR amyloidosis. Strong pre-clinical and clinical evidence support a daily dose of 20 mg of Fx-1006A to be the opti...	null	Transthyretin-associated Amyloidosis With Polyneuropathy	Transthyretin, TTR, amyloidosis, TTR amyloidosis, polyneuropathy	null	1	arm 1: Fx-1006A 20mg soft gelatin capsules once daily for 12 months	[ 0 ]	1	[ 0 ]	intervention 1: During Part 1, patients will receive Fx-1006A 20mg soft gelatin capsules once daily (at the same time each day) for two weeks. During Part 2, patients will receive Fx-1006A 20mg soft gelatin capsules once daily to complete a total of 12 months of dosing	intervention 1: Fx-1006A	4	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Paris \| N/A \| France \| 2.3488 \| 48.85341 Münster \| N/A \| Germany \| 7.62571 \| 51.96236 Irccs - Policlinico San Matteo \| Pavia \| Italy \| N/A \| N/A	21	NCT00630864	1COMPLETED	2010-01-01	2008-06-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation. As a consequence, they can develop an endocrine disorder called hyperparathyroidism, which can cause bone ...	The investigators plan to study the cardiovascular and bone effects of Hectorol® in 100 kidney transplant recipients. The kidney transplant patients will be screened for kidney transplant dysfunction and hyperparathyroidism. The study medication will be given to 50 patients. The other 50 patients will continue to be tr...	Hyperparathyroidism, Secondary		null	2	arm 1: Stable kidney transplant recipients will receive Doxercalciferol arm 2: Stable kidney transplant recipients will not receive any drug	[ 0, 4 ]	1	[ 0 ]	intervention 1: The study drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH\>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH \<300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.	intervention 1: doxercalciferol	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	8	NCT00646282	6TERMINATED	2010-01-01	2008-04-01	Emory University	7OTHER	false	false	false	null	0
[ 5 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double...	Insulin signaling in the brain is associated with improved cognitive function in both animal and human studies. Intranasal administration of insulin, which is non-invasive and minimizes the risk of hypoglycemia, may represent a new intervention approach with the potential to improve cognition and real life functioning ...	Schizophrenia Schizoaffective Disorder	Schizophrenia Memory Concentration Insulin	null	2	arm 1: Subjects are given a one-time, single dose of placebo intranasal spray arm 2: Subjects are given a one-time, single dose of intranasal insulin	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Placebo intervention 2: 40 IU Intranasal Insulin will be administered once	intervention 1: Placebo intervention 2: Insulin (Humulin)	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	30	NCT00646581	1COMPLETED	2010-01-01	2006-10-01	University of Massachusetts, Worcester	7OTHER	false	false	false	null	0
[ 4 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.	Same as above.	Photoaging		null	2	arm 1: adapalene arm 2: Tretinoin	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: applied topically once daily in the evening intervention 2: applied topically once daily in the evening	intervention 1: adapalene gel, 0.3% intervention 2: tretinoin 0.05% emollient cream	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	30	NCT00647556	1COMPLETED	2010-01-01	2008-04-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream.	null	Squamous Cell Carcinoma		null	1	arm 1: Active Cream 3%; AM \& PM	[ 0 ]	1	[ 0 ]	intervention 1: Topical Cream; 3% active; AM \& PM application	intervention 1: API 31510	5	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 San Diego \| California \| United States \| -117.16472 \| 32.71571 Buffalo Grove \| Illinois \| United States \| -87.95979 \| 42.15141 Smithtown \| New York \| United States \| -73.20067 \| 40.85593 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375	35	NCT00652080	1COMPLETED	2010-01-01	2008-06-01	BPGbio	4INDUSTRY	false	false	false	null	0
[ 4 ]	561	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, l...	null	Diabetes Mellitus, Type 2		null	4	arm 1: patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356 arm 2: patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose arm 3: patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose...	[ 1, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 5 mg/daily intervention 2: 10 mg/daily intervention 3: three times daily intervention 4: once daily intervention 5: 0.6 mg/daily	intervention 1: BI 1356 intervention 2: BI 1356 intervention 3: voglibose placebo intervention 4: BI 1356 placebo intervention 5: voglibose	47	Asahi, Chiba \| N/A \| Japan \| N/A \| N/A Funabashi, Chiba \| N/A \| Japan \| N/A \| N/A Hitachinaka, Ibaraki \| N/A \| Japan \| N/A \| N/A Hitachiota, Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Imizu, Toyama \| N/A \| Japan \| N/A \| N/A Inashiki-gun, Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Izumisano, Osaka \| N/A \| Japan \| N/...	782	NCT00654381	1COMPLETED	2010-01-01	2008-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatm...	To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).	Psoriasis		null	1	arm 1: Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recomme...	[ 0 ]	1	[ 0 ]	intervention 1: Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. Th...	intervention 1: Alefacept	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	15	NCT00655564	1COMPLETED	2010-01-01	2008-05-01	Wake Forest University	7OTHER	false	false	false	null	0
[ 3 ]	68	RANDOMIZED	PARALLEL	9OTHER	3TRIPLE	false	0ALL	false	The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.	This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.	Alcoholism		null	3	arm 1: Acamprosate arm 2: Naltrexone arm 3: None	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration intervention 2: 50mg capsule, Once daily, 1 week duration intervention 3: Matched placebo capsule, 1 week duration	intervention 1: Acamprosate intervention 2: Naltrexone intervention 3: Placebo	1	La Jolla \| California \| United States \| -117.2742 \| 32.84727	62	NCT00656630	1COMPLETED	2010-01-01	2007-12-01	The Scripps Research Institute	7OTHER	false	false	false	null	0
[ 4 ]	1,061	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).	This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.	Gastroesophageal Reflux Disease (GERD)	GERD erosive GERD erosive esophagitis	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.	intervention 1: Rabeprazole sodium intervention 2: Esomeprazole	88	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Isidro Casanova, La Matanza \| BUE \| Argentina \| N/A \| N/A Ramos Mejía \| BUE \| Argentina \| -58.55318 \| -34.6551 San Isidro \| BUE \| Argentina \| -58.52111 \| -34.46971 Capital Federal \| CBA \| Argentina \| N/A \| N/A Mendoza \| MEN \| Argentina \| -68.84582 \| -32.88946 ...	1,046	NCT00658528	1COMPLETED	2010-01-01	2008-02-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,069	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).	This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastro...	Gastroesophageal Reflux Disease (GERD)	GERD erosive GERD erosive esophagitis	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, once daily for 4-8 weeks.	intervention 1: Rabeprazole sodium intervention 2: Esomeprazole	83	Moline \| Illinois \| United States \| -90.51513 \| 41.5067 La Plata \| Argentina \| Argentina \| -57.95442 \| -34.92126 Buenos Aires \| BUE \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| BUE \| Argentina \| -58.37723 \| -34.61315 Ciudad Autonoma de Bs. As. \| CBA \| Argentina \| N/A \| N/A Ciudad Autonoma de Bs. As. \| CBA \| Argen...	1,058	NCT00658775	1COMPLETED	2010-01-01	2008-02-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	273	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.	null	Plaque Psoriasis Psoriasis	Enbrel Psoriasis Topical Psoriasis Wyeth Psoriasis Active Psoriasis	null	2	arm 1: A arm 2: B	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks. intervention 2: ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.	intervention 1: Etanercept intervention 2: Etanercept	38	Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A San Miguel \| Buenos Aires \| Argentina \| -58.71229 \| -34.54335 Feldkirch \| N/A \| Austria \| 9.6 \| 47.23306 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| Belgium \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/...	273	NCT00663052	1COMPLETED	2010-01-01	2008-06-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	420	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	true	Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism...	null	Benign Prostatic Hypertrophy		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg) intervention 2: Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28 intervention 3: Placebo on Week 0, Week 2, Week 26 and Week 28	intervention 1: Cetrorelix 78+78 intervention 2: Cetrorelix 78 + Placebo intervention 3: Placebo	55	Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Minsk \| N/A \| Belarus \| 27.56653 \| 53.90019 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A ...	420	NCT00663858	1COMPLETED	2010-01-01	2008-03-01	AEterna Zentaris	4INDUSTRY	false	false	false	null	0
[ 5 ]	24	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	false	0ALL	false	This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on blood pressure in people already taking a blood pressure medication called an ACE inhibitor.	The prevalence of metabolic syndrome and Type 2 diabetes mellitus (T2DM) has reached epidemic proportions in developed countries and is closely associated with hypertension. As new oral hypoglycemic agents become available for clinical use, practitioners wishing to treat both hyperglycemia and hypertension will use var...	Metabolic Syndrome Hypertension	Metabolic syndrome Hypertension Sitagliptin Enalapril	null	3	arm 1: Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior . arm 2: Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on st...	[ 2, 2, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Enalapril 0mg after 5 days of placebo versus after 5 days sitagliptin 100mg/d intervention 2: Enalapril 5 mg after 5 days placebo versus after 5 days sitagliptin 100mg/d intervention 3: Enalapril 10mg after 5 days placebo versus after 5 days sitagliptin 100 mg/d intervention 4: Sitagliptin 100mg/day for...	intervention 1: Placebo intervention 2: Enalapril 5mg intervention 3: Enalapril 10mg intervention 4: Sitagliptin	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	24	NCT00666848	1COMPLETED	2010-01-01	2008-03-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 4 ]	5	NA	SINGLE_GROUP	6HEALTH_SERVICES_RESEARCH	0NONE	false	0ALL	true	The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.	null	Cough	Hyper-responsiveness, reflux cough	null	1	arm 1: 20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte	[ 5 ]	2	[ 0, 0 ]	intervention 1: 20 mg BD tablet 8 weeks duration intervention 2: 300 mg od nocte tablet 8weeks duration	intervention 1: Omeprazole intervention 2: Ranitidine	1	Cottingham \| East Yorkshire \| United Kingdom \| -0.7554 \| 52.50243	3	NCT00668317	6TERMINATED	2010-01-01	2006-09-01	Hull University Teaching Hospitals NHS Trust	2OTHER_GOV	false	false	false	null	0
[ 0 ]	180	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	true	Lacerations (deep cuts) are a frequent cause of visits to emergency departments and laceration repair is one of the most common procedures performed in that setting. Children are often anxious when they visit the emergency department, and visits where they anticipate needing painful procedures can be particularly stres...	The goal of this study is to improve sedation of children undergoing laceration repair in the emergency department. Currently, children who require sedation for laceration repair most often receive short acting benzodiazepines (i.e.,midazolam) orally (by mouth). Studies on the effectiveness of oral midazolam for minor ...	Anxiety	Sedation Anxiety Minor procedures Emergency Department	null	3	arm 1: Oral midazolam 0.5mg/kg arm 2: Intranasal midazolam 0.3mg/kg arm 3: Buccal midazolam 0.3mg/kg	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg. intervention 2: 0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth. intervention 3: ora...	intervention 1: Aerosolized Intranasal midazolam intervention 2: Aerosolized Buccal Midazolam intervention 3: Oral midazolam	0	null	180	NCT00675909	1COMPLETED	2010-01-01	2006-11-01	Seattle Children's Hospital	7OTHER	false	false	false	null	0
[ 5 ]	28	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	1FEMALE	true	The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS	Inclusion criteria: PCOS women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with ...	Polycystic Ovary Syndrome PCOS Insulin Sensitivity		null	2	arm 1: Placebo tablet and birth control pill daily arm 2: metformin 2000 mg and birth control pill daily	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: placebo birth control pill daily intervention 2: 2000 mg per day for 3 months daily birth control pill	intervention 1: placebo intervention 2: metformin	1	Richmond \| Virginia \| United States \| -77.46026 \| 37.55376	23	NCT00682890	6TERMINATED	2010-01-01	2005-11-01	Virginia Commonwealth University	7OTHER	false	false	false	null	0
[ 4 ]	1,491	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.	In addition to the 5-year analysis conducted in September 2003, two other analyses were planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final analysis at 10 years was considered more appropriate than...	Breast Cancer	adjuvant treatment	null	2	arm 1: docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment arm 2: 5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatm...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: intravenous intervention 2: intravenous intervention 3: intravenous intervention 4: intravenous	intervention 1: Docetaxel intervention 2: 5-fluorouracil intervention 3: Doxorubicin intervention 4: Cyclophosphamide	20	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Cairo \| N/A \| Egypt \|...	1,480	NCT00688740	1COMPLETED	2010-01-01	1997-06-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,245	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an oint...	null	Psoriasis Vulgaris		null	4	arm 1: Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) arm 2: Ointment Vehicle arm 3: Calcipotriol 25 mcg/g in the ointment vehicle arm 4: Hydrocortisone 10 mg/g in the ointment vehicle	[ 0, 2, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Once daily application intervention 2: None intervention 3: None intervention 4: None	intervention 1: Calcipotriol plus hydrocortisone (LEO 80190) intervention 2: LEO 80190 Vehicle intervention 3: Hydrocortisone intervention 4: Calcipotriol	11	Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/...	1,688	NCT00691002	1COMPLETED	2010-01-01	2008-05-01	LEO Pharma	4INDUSTRY	false	false	false	null	-0
[ 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Open-label, multicenter, international, single-treatment study designed to determine TTR stabilization as well as Fx-1006A safety and tolerability, and its effects on clinical outcomes in patients with V122I or wild-type TTR amyloid cardiomyopathy. The study will be conducted in two parts. Part 1 will include a six-we...	null	Cardiomyopathy	Transthyretin TTR ATTR TTR amyloidosis cardiomyopathy V122I wild-type TTR SSA Patients with V122I or wild-type TTR amyloid cardiomyopathy	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Fx-1006A 20mg soft gelatin capsules once daily (at the same time each day) for 12 months	intervention 1: Fx-1006A	6	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 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 \| Uni...	35	NCT00694161	1COMPLETED	2010-01-01	2008-08-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic syndromes are a group of disorders characterized by progressive bone marrow failure and an increased risk of development of leukemia.	This is a randomized (patients are assigned by chance to a treatment group), double-blind (neither the patient or the physician know which treatment is being received by the patient), placebo-controlled, multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) accordin...	Myelodysplastic Syndromes Anemia	MDS Myelodysplastic syndromes Anemia Epoetin alfa EPO	null	4	arm 1: Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks arm 2: Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks arm 3: Placebo Matching volume 1 mL for 48 weeks arm 4: Placebo Matching volume 2 mLfor 48 weeks	[ 0, 0, 2, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Matching volume 2 mLfor 48 weeks intervention 2: 40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks intervention 3: Matching volume 1 mL for 48 weeks intervention 4: 80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks	intervention 1: Placebo intervention 2: Epoetin alfa intervention 3: Placebo intervention 4: Epoetin alfa	0	null	25	NCT00695396	6TERMINATED	2010-01-01	2008-06-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 4 ]	712	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.	null	Refractory Partial Seizures	Partial onset seizures E2007 perampanel refractory partial seizures adjunctive therapy seizure frequency reduction in seizure frequency safety concomitant AED(s)	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a tot...	intervention 1: perampanel intervention 2: perampanel intervention 3: perampanel intervention 4: Placebo	137	Woodville \| South Australia \| Australia \| 138.54291 \| -34.877 Woodville South \| South Australia \| Australia \| 138.53477 \| -34.88186 Clayton \| Victoria \| Australia \| 145.11667 \| -37.91667 Fitzroy \| Victoria \| Australia \| 144.97833 \| -37.79839 Heidelberg \| Victoria \| Australia \| 145.06667 \| -37.75 Parkville \| Victoria \| ...	706	NCT00700310	1COMPLETED	2010-01-01	2008-08-01	Eisai Inc.	4INDUSTRY	false	false	false	null	-0
[ 4 ]	337	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia. Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.	null	Anemia Chronic Renal Insufficiency	Treatment associated with CRI	null	2	arm 1: HX575, EPO HEXAL arm 2: ERYPO	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Solution for injection (s.c.) intervention 2: Solution for injection (s.c.)	intervention 1: HX575 recombinant human erythropoietin alfa intervention 2: ERYPO	123	Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Steyr \| N/A \| Austria \| 14.42127 \| 48.04274 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Pazardzhik \| N/A \| Bulgaria \| 24.33333 \| 42.2 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sta...	607	NCT00701714	6TERMINATED	2010-01-01	2007-09-01	Sandoz	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this trial is to evaluate the safety and tolerability of lithium in people with progressive supranuclear palsy or corticobasal degeneration.	Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are progressive, adult-onset neurodegenerative disorders characterized by the accumulation of hyperphosphorylated tau. Symptomatic treatment is of minimal benefit to individuals with PSP or CBD, and there are no effective disease modifying agents....	Progressive Supranuclear Palsy Corticobasal Degeneration	progressive supranuclear palsy corticobasal degeneration PSP CBD lithium tau	null	1	arm 1: All participants will receive lithium. The dosage will be titrated over a 5-week period. Participants will then be followed prospectively for 6 months. Participants will be evaluated at the screening visit, baseline visit, and weeks 2 and 5 during the titration phase. Clinic study visits will then occur on alter...	[ 5 ]	1	[ 0 ]	intervention 1: All participants will receive lithium. The dosage will be titrated over a 5-week period and then continued for an additional 6 months.	intervention 1: Lithium	9	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 New York \| New Yo...	17	NCT00703677	1COMPLETED	2010-01-01	2008-09-01	Westat	7OTHER	false	false	false	null	0
[ 0 ]	25	RANDOMIZED	FACTORIAL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.	Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there ...	Recovery Time Bruising	Nasal Surgery Septorhinoplasty fibrin glue fibrinogen Swelling fibrin tisseel	null	3	arm 1: Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe ...	[ 3, 0, 0 ]	5	[ 0, 3, 3, 3, 10 ]	intervention 1: One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery. intervention 2: Septorhinoplasty to correct nasal deviation. intervention 3: Simple taping over the nose following nasal surgery. intervention 4: A molded cast will be placed on top of the nose following nasal surgery. interventio...	intervention 1: Fibrinogen intervention 2: Septorhinoplasty intervention 3: Taping after septorhinoplasty. intervention 4: Cast applied to the nose after nasal surgery intervention 5: Saline	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	25	NCT00713596	6TERMINATED	2010-01-01	2008-07-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the effectiveness and safety of bortezomib in participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow causing numerous tumors and characterized by the presence of abnormal proteins in the blood) with limited kidney function.	This is an open label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), non-comparative, single arm study of bortezomib. The study consists of 3 phases: Screening phase (21 days before Day 1 of cycle 1); Treatment phase (consist of 8 cycles each cycle of 21 days or un...	Multiple Myeloma	Multiple Myeloma Velcade Bortezomib Dexamethasone	null	1	arm 1: Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and D...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Dexamethasone 20 mg per day will be administered orally on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-days cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline...	intervention 1: Dexamethasone intervention 2: Bortezomib	5	New Westminster \| British Columbia \| Canada \| -122.91092 \| 49.20678 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Greenfield Park \| Quebec \| Canada \| -73.46223 \| 45.48649 Saint John \| N/A \| Canada \| -66.05616 \| 45.27076	10	NCT00718640	6TERMINATED	2010-01-01	2007-10-01	Janssen-Ortho Inc., Canada	4INDUSTRY	false	false	false	null	0
[ 3 ]	11	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.	null	Anemia		null	1	arm 1: All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.	[ 0 ]	1	[ 0 ]	intervention 1: Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.	intervention 1: Venofer	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	11	NCT00721188	1COMPLETED	2010-01-01	2006-01-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of this study is to study the acute effects of angiotensin-converting enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional cavopulmonary connection (BCPC) patients.	The intermediate stage of the bi-directional cavopulmonary connection (BCPC) in the management algorithm of single ventricle palliation is a unique and extraordinary physiologic condition. It places the superior vena caval blood flow into series with the lungs i.e. pulmonary blood flow is partially dependent on cerebra...	Hypertension Congestive Cardiomyopathy	pediatric hypertension congestive cardiomyopathy angiotensin-converting enzyme inhibitor cardiac catheterization	null	1	arm 1: enalaprilat 0.005-0.01 mg/kg intravenous x 1 dose	[ 0 ]	1	[ 0 ]	intervention 1: Enalaprilat will be administered intravenously i.v. 0.005 - 0.01 mg/kg i.v. over 1 minute	intervention 1: Enalaprilat	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	12	NCT00741156	1COMPLETED	2010-01-01	2008-07-01	The Hospital for Sick Children	7OTHER	false	false	false	null	0
[ 3 ]	66	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone	null	Non Small Cell Lung Cancer Lung Cancer	NSCLC Phase II ZD4054 Pemetrexed Lung Cancer	null	2	arm 1: ZD4054 + Pemetrexed arm 2: ZD4054 matched placebo + pemetrexed	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 10mg oral tablet, once daily intervention 2: 500mg2/m IV infusion intervention 3: 10mg oral tablet, once daily	intervention 1: ZD4054 intervention 2: Pemetrexed intervention 3: Placebo	13	Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Jičín \| N/A \| Czechia \| 15.35162 \| 50.43723 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Cedex \| N/A \| France \| N/A \| N/A Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Bucharest \| N/A...	66	NCT00745875	1COMPLETED	2010-01-01	2008-08-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic deve...	This protocol involves an 8-week, open-label, pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in 4 and 5 year old children. The purpose of this study is to ascertain pilot data on the use of long-acting stimulants in preschool-...	Attention Deficit Hyperactivity Disorder	Attention Deficit Hyperactivity Disorder Stimulant Treatment Young Children	null	1	arm 1: open-label treatment with methylphenidate	[ 5 ]	1	[ 0 ]	intervention 1: Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tole...	intervention 1: methylphenidate	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	7	NCT00754208	1COMPLETED	2010-01-01	2008-09-18	University of Nebraska	7OTHER	false	false	false	null	0
[ 5 ]	226	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.	More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and ...	Hypertensive Urgency	hypertension emergency department Nicardipine Labetalol hypertensive emergency hypertensive urgency	null	2	arm 1: nicardipine intravenous arm 2: Labetalol	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour intervention ...	intervention 1: nicardipine intravenous intervention 2: Labetalol	2	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Houston \| Texas \| United States \| -95.36327 \| 29.76328	226	NCT00765648	1COMPLETED	2010-01-01	2008-10-01	The Cleveland Clinic	7OTHER	false	false	false	null	-0
[ 0 ]	2	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.	Specific Aim 1: To determine if, compared with current standard-of-care treatment, the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain. Hypothesis 1: Following upper or lower extremity amputation, phantom limb and/or stump pain will be significantly dec...	Amputation Phantom Limb Stump Pain	pain phantom limb stump pain catheter nerve block peripheral nerve block NMCSD Post-Amputation Phantom Limb or Stump Pain	null	2	arm 1: 3-7 days of perineural local anesthetic infusion arm 2: 3-7 days of perineural normal saline infusion	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: ropivacaine 0.4%; the basal rate will be set at 7 mL/h intervention 2: the basal rate will be set at 7 mL/h	intervention 1: perineural ropivacaine intervention 2: normal saline (placebo)	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	2	NCT00768248	6TERMINATED	2010-01-01	2008-10-01	University of California, San Diego	7OTHER	false	false	false	null	0
[ 5 ]	258	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.	This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery. Hypothesis and Aims: We plan to test the null hypothesis that there is ...	Catheter-related Bladder Discomfort	Phenazopyrdine post operative bladder catheritization VAS scores Bladder pain related to indwelling foley catheters. Bladder irritaion related to indwelling foley catheters.	null	2	arm 1: Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has ...	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: Phenazopyrdine HCl 200 mg q8h x 24 intervention 2: Placebo tablet administered q8 hours for 24 hours postop.	intervention 1: phenazopyridine HCl intervention 2: Placebo	1	Maywood \| Illinois \| United States \| -87.84312 \| 41.8792	219	NCT00771173	1COMPLETED	2010-01-01	2008-08-01	Loyola University	7OTHER	false	false	false	null	0
[ 3, 4 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	HAM/TSP is a chronic disease of the spinal cord, caused by a virus called HTLV-I. Worldwide approximately 20 million persons are infected.Infection with HTLV-I is lifelong, and about 3% of infected persons will develop this chronic debilitating disease, of which half will become wheelchair dependent. We, and others, ha...	This is a proof of concept, open, observational study of Ciclosporin for the treatment of HTLV-I-associated myelopathy in patients with less than 2 years disease or new evidence of progression. After two baseline assessments patients will be commenced on ciclosporin in a weight dependent dose (2.5 - 5mg/kg/day) and the...	HTLV I Associated Myelopathy	HAM/TSP	null	1	arm 1: 48 weeks treatment with ciclosporin	[ 0 ]	1	[ 0 ]	intervention 1: Ciclosporin 2.5 - 5mg/kg/day in two equally divided doses. dose adjusted according to trough ciclosporin concentration	intervention 1: ciclosporin	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	7	NCT00773292	1COMPLETED	2010-01-01	2006-08-01	Imperial College London	7OTHER	false	false	false	null	0
[ 5 ]	860	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).	null	Hypertension Diabetes Mellitus	Hypertension, diabetes mellitus, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2	null	2	arm 1: Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks arm 2: Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks	[ 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks intervention 2: Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks intervention 3: Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks	intervention 1: Amlodipine intervention 2: Hydrochlorothiazide (HCTZ) intervention 3: Aliskiren	1	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201	859	NCT00787605	1COMPLETED	2010-01-01	2008-11-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	147	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.	null	Osteoarthritis Knee Pain		null	3	arm 1: Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. arm 2: Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID...	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: LY545694 placebo BID po for 5 weeks intervention 2: LY545694 49 mg BID po for 5 weeks. intervention 3: LY545694 105 mg BID po for 5 weeks.	intervention 1: Placebo intervention 2: LY545694 49 mg intervention 3: LY545694 105 mg	10	Spring Valley \| California \| United States \| -116.99892 \| 32.74477 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Edison \| New Jersey \| United States \| -74.4121 \| 40.51872 Hato Rey \| N/A \| Pue...	294	NCT00790790	1COMPLETED	2010-01-01	2008-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	230	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.	null	Rheumatoid Arthritis	Rheumatoid Arthritis Certolizumab Pegol Cimzia	null	2	arm 1: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks arm 2: Placebo of CDP870	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC) intervention 2: Placebo given every 2 weeks until Week22 (SC)	intervention 1: CDP870 intervention 2: Placebo of CDP870	7	Chube Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushuh Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A	230	NCT00791921	1COMPLETED	2010-01-01	2008-11-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	26	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	null	The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of ...	null	Wounds	burn wounds wound healing	null	3	arm 1: GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid arm 2: GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid arm 3: GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. intervention 2: Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. intervention 3: Topical administration to the laser-ablated area on days 1 (day of laser...	intervention 1: GLYC-101 Gel (0.1%) intervention 2: GLYC-101 Gel (1.0%) intervention 3: GLYC-101 Placebo	1	Beverly Hills \| California \| United States \| -118.40036 \| 34.07362	26	NCT00792688	1COMPLETED	2010-01-01	2008-10-01	TR Therapeutics	4INDUSTRY	false	false	false	null	0
[ 4 ]	364	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.	null	Fibromyalgia	fibromyalgia milnacipran pregabalin treatment Forest Research Institute	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: No added treatment intervention 2: Milnacipran 100 mg/d added	intervention 1: No Treatment Added intervention 2: Milnacipran Added	60	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Sacramento \| California \| Un...	362	NCT00797797	1COMPLETED	2010-01-01	2008-11-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.	Non-alcoholic fatty liver disease (NAFLD) steatohepatitis represents a spectrum of disease occurring in the absence of alcohol abuse. It is characterized by the presence of steatosis and may represent a hepatic manifestation of the metabolic syndrome (including obesity, diabetes and hypertriglyceridemia). NAFLD is link...	Fatty Liver	NASH, NAFLD,nonalcoholic steatohepatitis	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Drug is in enteric-coated capsule form. The dosage will begin at 1g/m-squared body surface area with a maximum dose of 1000mg twice daily. Treatment period is 3-6 months.	intervention 1: Cysteamine	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	13	NCT00799578	1COMPLETED	2010-01-01	2008-10-01	Joel Lavine	7OTHER	false	false	false	null	0
[ 5 ]	173	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles	This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study ce...	Infertility	Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF	null	4	arm 1: Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10...	[ 0, 0, 1, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met. intervention 2: 100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirm...	intervention 1: Menotropin intervention 2: Progestrone vaginal insert intervention 3: follitropin beta intervention 4: Progesterone in oil intervention 5: Ganirelix	7	Pasadena \| California \| United States \| -118.14452 \| 34.14778 San Diego \| California \| United States \| -117.16472 \| 32.71571 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Naperville \| Illinois \| United States \| -88.14729 \| 41.78586 Baton Rouge \| ...	165	NCT00802360	1COMPLETED	2010-01-01	2008-12-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	-0
[ 4 ]	381	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.	To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: \- The Average Adjusted Symptom Score (AASS). To document the safety of the treatment.	Primary Disease	allergic rhinoconjunctivitis	null	2	arm 1: 300 IR grass pollen allergen extract tablet arm 2: Placebo tablet	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season intervention 2: Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season	intervention 1: 300 IR intervention 2: Placebo	6	Antony \| N/A \| France \| 2.29668 \| 48.75329 Montauban \| N/A \| France \| 1.3542 \| 44.01759 Orange \| N/A \| France \| 4.81025 \| 44.13806 Parma \| N/A \| Italy \| 10.32618 \| 44.79935 Cáceres \| N/A \| Spain \| -6.37224 \| 39.47649 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165	381	NCT00803244	1COMPLETED	2010-01-01	2009-01-01	Stallergenes Greer	4INDUSTRY	false	false	false	null	0
[ 4 ]	210	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder	null	Generalized Anxiety Disorder	anxiety	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 to 120 mg, capsules, oral, once a day for 15 weeks intervention 2: placebo capsules, oral, once a day for 15 weeks	intervention 1: Duloxetine intervention 2: Placebo	7	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Kunming \| N/A \| China \| 102.71833 \| 25.03889 Nanjing \| N/A \| China \| 118.77778 \| 32.06167 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Xi'an \| N/A \| China \| 108.92861 \| 34.25833	210	NCT00803361	1COMPLETED	2010-01-01	2008-12-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	247	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis tha...	null	Diabetes Mellitus, Type 2		null	6	arm 1: Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. arm 2: Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personne...	[ 0, 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Once weekly for 12 weeks as a subcutaneous injection. intervention 2: 1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.	intervention 1: LY2428757 intervention 2: Placebo	60	Bermuda Dunes \| California \| United States \| -116.28918 \| 33.7428 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Pomona \| California \| United States \| -117.75228 \| 34.055...	244	NCT00804986	1COMPLETED	2010-01-01	2008-12-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	331	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To explore the effects of fesoterodine when used in a flexible dose manner	null	Urinary Bladder, Overactive	Fesoterodine Open Label Flexible Dose OAB	null	1	arm 1: Fesoterodine 4mg, escalating to 8mg as required	[ 0 ]	1	[ 0 ]	intervention 1: Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated	intervention 1: Fesoterodine	39	Ely \| Cambridgeshire \| United Kingdom \| 0.26196 \| 52.39964 Crewe \| Cheshire \| United Kingdom \| -2.44161 \| 53.09787 Fowey \| Cornwall \| United Kingdom \| -4.6386 \| 50.33634 Penzance \| Cornwall \| United Kingdom \| -5.53715 \| 50.11861 Chesterfield \| Derbyshire \| United Kingdom \| -1.41667 \| 53.25 Chesterfield \| Derbyshire \| U...	331	NCT00806494	1COMPLETED	2010-01-01	2009-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	148	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	null	A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects	null	Glaucoma Ocular Hypertension		null	2	arm 1: Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution arm 2: Latanoprost 0.005% ophthalmic solution	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day intervention 2: 1 drop of study medication taken once daily	intervention 1: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution intervention 2: latanoprost 0.005%	1	Slingerlands \| New York \| United States \| -73.86457 \| 42.62925	148	NCT00811564	1COMPLETED	2010-01-01	2008-12-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 4 ]	213	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	null	Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid tolerant patients with chronic pain.	null	Chronic Pain	Breakthrough Pain Opioid-tolerant Chronic Pain	null	2	arm 1: This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain. The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets). For the subsequent 12-week open-label treatment period, ...	intervention 1: Fentanyl Buccal Tablet intervention 2: Immediate release oxycodone	50	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Chino \| California \| United States \| -117.68894 \| 34.01223 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Loma Linda \|...	403	NCT00813488	1COMPLETED	2010-01-01	2008-12-01	Cephalon	4INDUSTRY	false	false	false	null	0
[ 3 ]	276	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.	null	Bloodloss Surgical Procedures, Operative		null	4	arm 1: target steady state concentration of 0.15 mg/L arm 2: target steady state concentration of 0.75 mg/L arm 3: target steady state concentration of 2.25 mg/L arm 4: placebo	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: infusion administered IV over the duration of the surgical procedure intervention 2: solution for IV infusion over the duration of the surgical\>\> procedure	intervention 1: ecallantide intervention 2: placebo	29	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Lexington \| Kentucky \| Unite...	249	NCT00816023	1COMPLETED	2010-01-01	2009-03-01	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	4INDUSTRY	false	false	false	null	-0
[ 4 ]	245	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.	null	Diabetes Mellitus, Type 2		null	2	arm 1: 5 mg orally (po) once daily arm 2: one tablet once daily	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 5mg orally (po) tablet qd intervention 2: Placebo matching BI 1356 5mg one tablet daily	intervention 1: BI 1356 intervention 2: Placebo	45	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 National City \| California \| United States \| -117.0992 \| 32.67811 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231...	245	NCT00819091	1COMPLETED	2010-01-01	2008-12-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	5	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	false	The purpose of the study is to examine the effects of Eszopiclone, a sleep aid, on inflammatory mediators and coagulability in patients with a recent myocardial infarction.	Abnormalities of sleep are common in hospitalized patients, but the mechanisms and consequences are not well understood. In many of these patients, sleep is very disrupted, occurs during the daytime, and circadian rhythm is diminished or lost. Hospitalized patients experience more frequent arousals and awakenings than ...	Acute Coronary Syndrome Sleep Disorder	Acute Coronary Syndrome cytokines pro-coagulant mediators sleep disorders	null	2	arm 1: Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors arm 2: Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older. intervention 2: Subjects are given placebo for 3 consecutive nights	intervention 1: Eszopiclone intervention 2: Placebo	1	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174	0	NCT00822679	1COMPLETED	2010-01-01	2007-10-01	University of Arizona	7OTHER	false	false	false	null	0
[ 5 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GO...	null	Infertility	Infertility Assisted reproductive technology	null	2	arm 1: GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator arm 2: GONAL-f® at a standard dose of 150 IU per day	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only intervention 2: GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to ...	intervention 1: GONAL f® prefilled pen intervention 2: GONAL f® prefilled pen	1	Geneva \| N/A \| Switzerland \| 6.14569 \| 46.20222	200	NCT00829244	1COMPLETED	2010-01-01	2008-08-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.	null	Hypertension	aliskiren pediatric hypertension pharmacokinetics (PK) pharmacodynamics (PD) plasma renin activity mini-tablet formulation	null	2	arm 1: Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning arm 2: Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning	[ 0, 0 ]	1	[ 0 ]	intervention 1: Oral mini-tablets (3.125 mg) of aliskiren once each morning	intervention 1: Aliskiren 3.125 mini-tablets	5	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977	39	NCT00834041	1COMPLETED	2010-01-01	2009-04-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 0 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to investigate whether enoxaparin, minocycline, or both medications in combination may help in recovery from acute stroke. Enoxaparin (brand name Lovenox®) is a medication approved for use in humans to prevent and to treat blood clots in deep veins in certain specific medical situations. M...	Enoxaparin is a low molecular weight heparin (average molecular weight 4,500 daltons, vs. 12,000 to 15,000 daltons for unfractionated heparin) administered subcutaneously and intravenously. It is a marketed drug FDA-approved in various clinical situations for: the prevention and treatment of deep vein thrombosis; and i...	Acute Ischemic Stroke	stroke magnetic resonance imaging enoxaparin minocycline NIH stroke scale modified Rankin scale neuroprotection	null	4	arm 1: None arm 2: Minocycline 200 mg orally once daily for 5 days arm 3: None arm 4: None	[ 0, 0, 0, 4 ]	2	[ 0, 0 ]	intervention 1: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later intervention 2: 200 mg orally once daily for 5 days	intervention 1: Enoxaparin intervention 2: Minocycline	2	New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427	6	NCT00836355	6TERMINATED	2010-01-01	2009-04-01	NYU Langone Health	7OTHER	false	false	false	null	0
[ 4 ]	217	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.	null	Erectile Dysfunction	Erectile Dysfunction	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 5 milligrams (mg) administered orally once a day for 12 weeks intervention 2: tablet administered orally once a day for 12 weeks.	intervention 1: tadalafil intervention 2: placebo	21	Bad Wiessee \| N/A \| Germany \| 11.71667 \| 47.71667 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Koblenz \| N/A \| Germany \| 7.57883 \| 50.35357 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Pátrai \| N/A \| Greece \| 21.73444 \| 38.24444 T...	217	NCT00836693	1COMPLETED	2010-01-01	2009-01-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	-0
[ 4 ]	742	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks Aft...	null	Alzheimer's Disease	Alzheimer's Disease Dimebon Safety Tolerability	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 2, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 10 mg TID for week 1 followed by 20 mg TID through Week 26 intervention 2: 10 mg TID for week 1 followed by 20 mg TID through Week 26 intervention 3: 10 mg TID for week 1 followed by 20 mg TID through Week 12 intervention 4: 20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID thr...	intervention 1: Dimebon intervention 2: Placebo intervention 3: Dimebon intervention 4: Placebo	118	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Northport \| Alabama \| United States \| -87.57723 \| 33.22901 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Oceanside \| California \| United States \| -117.37948 \| 33.19587 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Rosa \| Cali...	741	NCT00838110	1COMPLETED	2010-01-01	2009-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	240	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to compare the efficacy of rabeprazole extended release 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, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily). Please note that this study is not a duplicate of E38...	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	226	NCT00839306	1COMPLETED	2010-01-01	2008-08-01	Eisai Inc.	4INDUSTRY	false	false	false	null	-0
[ 4 ]	371	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension	null	Open Angle Glaucoma Ocular Hypertension	OAG OHT	null	2	arm 1: One drop once daily in the evening for 3 months arm 2: One drop once daily in the evening for 3 months	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: One drop once daily in the evening for 3 months intervention 2: One drop once daily in the evening for 3 months	intervention 1: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution intervention 2: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution	0	null	371	NCT00848536	1COMPLETED	2010-01-01	2009-03-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 3 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be in...	null	Methamphetamine Dependence		null	2	arm 1: None arm 2: Placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 400 mg/day intervention 2: inactive substance	intervention 1: Modafinil intervention 2: Placebo	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	9	NCT00859573	6TERMINATED	2010-01-01	2009-04-01	University of Arkansas	7OTHER	false	false	false	null	0
[ 3 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU ...	null	Chronic Idiopathic Urticaria	Xolair CIU	null	4	arm 1: Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed b...	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Administered by subcutaneous injection intervention 2: Participants received a single subcutaneous placebo injection on Day 0 of the study. intervention 3: Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day...	intervention 1: omalizumab intervention 2: placebo intervention 3: H1 antihistamines intervention 4: Diphenhydramine	0	null	90	NCT00866788	1COMPLETED	2010-01-01	2009-03-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	7	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD	null	Influenza	Influenza Immunocompromised Antiviral	null	3	arm 1: TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate) arm 2: Zanamivir or Oseltamivir arm 3: TCAD for subjects who cannot tolerate or are ineligible to receive zanamivir	[ 0, 1, 5 ]	3	[ 0, 0, 10 ]	intervention 1: TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate) intervention 2: Zanamivir or Oseltamivir intervention 3: TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)	intervention 1: TCAD intervention 2: Zanamivir or Oseltamivir intervention 3: Open label treatment with TCAD	2	Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	7	NCT00867139	1COMPLETED	2010-01-01	2009-03-01	Fred Hutchinson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	114	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	false	The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery. The study protocol was divided into two parts with subjects either dosed with study drug the day follow...	Currently, the most widely used drugs to treat pain after surgery are opiates, such as morphine. Morphine works mainly by activating one of several types of opiate receptors that control some of our pain sensation - the so-called mu opiate receptors. These receptors are located in many areas of the brain and also outsi...	Acute Pain	pain acute pain visceral pain kappa agonist opioid analgesics peripheral nervous system agents physiological effects of drugs surgery hysterectomy post-operative post-operative complications	null	2	arm 1: CR845 administered as a single 15-min i.v. infusion at doses of 0.008 or 0.024 mg/kg on the day after surgery (Cohort 1), or at a dose of 0.040 mg/kg immediately after surgery (Cohort 2) arm 2: Matched placebo administered as a single 15-min i.v. infusion on the day after surgery (Cohort 1), or the immediately a...	[ 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: CR845 (0.024 mg/kg) administered the day after surgery (Day 1) intervention 2: CR845 (0.008 mg/kg) administered the day after surgery (Day 1) intervention 3: CR845 (0.040 mg/kg) administered immediately after surgery (Day 0) intervention 4: Matched placebo administered the day after surgery (Day 1) inte...	intervention 1: CR845 intervention 2: CR845 intervention 3: CR845 intervention 4: Placebo intervention 5: Placebo	12	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Sheffield \| Alabama \| United States \| -87.69864 \| 34.76509 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Glendale \| California \| United States \| -118.25508 \| 34.14251 Laguna Hills \| California \| U...	114	NCT00877799	1COMPLETED	2010-01-01	2009-03-01	Cara Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	254	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.	null	Type 2 Diabetes Mellitus	diabetes exenatide once weekly Byetta Amylin Lilly Bydureon	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: subcutaneous injection, 2.0mg, once a week intervention 2: subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day	intervention 1: exenatide once weekly intervention 2: exenatide twice daily	41	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Artesia \| California \| United States \| -118.08312 \| 33.86585 Concord \| California \| United States \| -122.03107 \| 37.97798 Encino \| California \| Unite...	252	NCT00877890	1COMPLETED	2010-01-01	2009-03-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus...	null	Atopic Dermatitis Pruritus	Itching Atopic Dermatitis	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One tablet 5 mg taken orally at night for 28 days intervention 2: One tablet taken orally at night for 28 days	intervention 1: Levocetirizine dihydrochloride (Xyzal) intervention 2: placebo	1	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	40	NCT00884325	1COMPLETED	2010-01-01	2009-02-01	Derm Research, PLLC	7OTHER	false	false	false	null	0
[ 3 ]	243	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding	null	Bloodloss Surgical Procedures, Operative		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion intervention 2: 1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime	intervention 1: Ecallantide intervention 2: Cyklokapron(R)	34	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Aachen \| N/A \| Germany \| 6.08342 \| 50.77664 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Bad Bevensen \| N/A \| Germany \| 10.58129 \| 53.07923 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Dortmund \| N/A \| Germany \| 7.466 \|...	218	NCT00888940	1COMPLETED	2010-01-01	2009-06-01	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	4INDUSTRY	false	false	false	null	0
[ 5 ]	161	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia	To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .	Hypercholesterolemia With Type2DM	pitavastatin PWV ESPRIT Pitavastatin and Atorvastatin Adiponectin fasting insulin hs-CRP baPWV	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks intervention 2: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wk...	intervention 1: Pitavastatin intervention 2: Atorvastatin	0	null	151	NCT00889226	1COMPLETED	2010-01-01	2008-04-01	JW Pharmaceutical	4INDUSTRY	false	false	false	null	0
[ 5 ]	147	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	Many clinical trials may not fully explore criteria that are important to some migraine patients' definition of "complete response." This study offers the opportunity to evaluate the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck pain, irritability or fatigue). Subjects enrolled a...	At the screening visit (Visit 1), following written informed consent, subjects will provide a medical, medication and migraine history. A physical and neurological exam and pregnancy test (if appropriate) will be performed. Vital signs will be recorded for all subjects. The Headache Impact Test (HIT-6) and Baseline Pat...	Migraine	Migraine Headache, Migraine	null	1	arm 1: Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.	[ 0 ]	1	[ 0 ]	intervention 1: Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.	intervention 1: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)	8	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Plainview \| New York \| United States \| -73.46735 \| 40.77649 Pittsburgh \|...	147	NCT00893737	1COMPLETED	2010-01-01	2009-06-01	Cady, Roger, M.D.	3INDIV	false	false	false	null	0
[ 5 ]	8	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident	On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.	Pain	Treatment of the acute pain due to cervical sprain Celecoxib NSAID Diclofenac	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg intervention 2: diclofenac 75 mg tablet BID (twice a day)	intervention 1: Celecoxib intervention 2: oral Diclofenac	2	Mexico \| D.F. \| Mexico \| -98.43784 \| 18.88011 Mexico \| D.F. \| Mexico \| -98.43784 \| 18.88011	8	NCT00894790	6TERMINATED	2010-01-01	2009-11-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 0 ]	63	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	The goal of this study is to find out if giving intravenous B-vitamins before general anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has been linked to cardiovascular complications.	Patients will be randomized into the following arms: * Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and folate, 5 mg) before surgery. * Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery a...	Cardiovascular Abnormalities	Nitrous oxide cobalamin homocysteine vitamin B12 folate No specific diseases targeted	null	3	arm 1: B12-Folic acid, nitrous oxide arm 2: Nitrous oxide (NO) and placebo arm 3: oxygen nitrogen	[ 0, 1, 2 ]	4	[ 0, 0, 10, 10 ]	intervention 1: IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min. IV folic acid, 5 mg, single administration over 30 min. Both diluted in 250 ml normal saline. intervention 2: 60% nitrous oxide anesthesia plus saline intervention 3: Saline intervention 4: 60% air and oxygen mix.	intervention 1: B12-Folic Acid, nitrous oxide intervention 2: Nitrous oxide (NO) and placebo intervention 3: Placebo intervention 4: oxygen nitrogen	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	59	NCT00901394	1COMPLETED	2010-01-01	2009-03-01	Washington University School of Medicine	7OTHER	false	false	false	null	0
[ 4 ]	232	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, ...	Idebenone, a short-chain analogue of Co-enzyme Q10 (CoQ10), has the potential to moderate underlying causes of Friedreich's Ataxia through its antioxidant activity and its role as an electron carrier in the respiratory chain promoting mitochondrial ATP production. The current 12-month placebo-controlled treatment stud...	Friedreich's Ataxia	FRDA idebenone FRDA disease	null	4	arm 1: Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day arm 2: Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day arm 3: Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day arm 4: placebo	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals. intervention 2: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.	intervention 1: idebenone intervention 2: Placebo	13	Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Göttingen \| N/A \| Germany \| 9.93228 \| 51....	232	NCT00905268	1COMPLETED	2010-01-01	2006-04-01	Santhera Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	107	RANDOMIZED	PARALLEL	null	2DOUBLE	true	0ALL	true	The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety tri...	This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety...	Orthopoxviral Disease	Orthopoxvirus Smallpox This is a safety study only ST-246 is being studied for treatment of Orthopoxviruses	null	3	arm 1: ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days arm 2: ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days arm 3: Matching Placebo capsules, Orally Once Daily for 14 days	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Capsules, 400 mg daily for 14 days intervention 2: Capsules, 600 mg daily for 14 days intervention 3: Capsules, once daily for 14 days	intervention 1: ST-246 400 mg intervention 2: ST-246 600 mg intervention 3: Placebo	3	Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694	107	NCT00907803	1COMPLETED	2010-01-01	2009-06-01	SIGA Technologies	4INDUSTRY	false	false	false	null	0
[ 5 ]	170	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).	null	Dry Eye	Post LASIK dry eye Pre LASIK dry eye Hypromellose	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery. intervention 2: Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surger...	intervention 1: Pre-LASIK 0.3% hypromellose intervention 2: Post-LASIK 0.3% hypromellose	1	Delhi \| N/A \| India \| 77.23149 \| 28.65195	162	NCT00909324	1COMPLETED	2010-01-01	2009-08-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.	Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-...	Male Hypogonadism Primary Hypogonadism Secondary Hypogonadism		null	1	arm 1: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Testosterone undecanoate	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	15	NCT00911586	1COMPLETED	2010-01-01	2009-07-01	Clarus Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	16	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To determine the effect and safety of Varisolve® 0.125% \[0.2%\]	In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% \[0.2%\] as assessed by the elimination of SFJ reflux and/or o...	Varicose Veins	Varicose Veins	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Polidocanol Endovenous Microfoam 0.125%, single dose	intervention 1: Polidocanol Endovenous Microfoam 0.125%	1	Bellevue \| Washington \| United States \| -122.20068 \| 47.61038	16	NCT00928421	1COMPLETED	2010-01-01	2009-06-01	Boston Scientific Corporation	4INDUSTRY	false	false	false	null	0
[ 5 ]	488	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).	null	Stage 2 Systolic Hypertension	Hypertension combination therapy valsartan cardiovascular diseases	null	2	arm 1: Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/H...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study intervention 2: losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCT...	intervention 1: valsartan, amlodipine, HCTZ intervention 2: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ	1	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201	488	NCT00931710	1COMPLETED	2010-01-01	2009-07-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 5 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours....	null	Pain, Postoperative	mastectomy pain, postoperative pregabalin	null	2	arm 1: Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later arm 2: Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Pregabalin 75 mg orally intervention 2: Vitamin Complex orally	intervention 1: Pregabalin intervention 2: Vitamin Complex (placebo)	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	70	NCT00938548	1COMPLETED	2010-01-01	2009-06-01	Severance Hospital	7OTHER	false	false	false	null	0
[ 5 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the patients and treating physicians. The investigators are interested to see if the study product is effective in treating moderate to severe KP.	Keratosis pilaris (KP) is a benign, inherited skin disorder that presents as grouped, rough, horny follicular papules. It is estimated that 40-50% of the adult population and 50-80% of adolescents suffer from KP. Both men and women are affected, with a possible female predominance. It is noted worldwide and shows no ra...	Keratosis Pilaris	keratosis pilaris	null	1	arm 1: All participants will receive this intervention.	[ 0 ]	1	[ 0 ]	intervention 1: application of the Salkera emollient foam twice a day during the 12 week study period.	intervention 1: Salkera Emollient Foam	1	Dayton \| Ohio \| United States \| -84.19161 \| 39.75895	1	NCT00944216	6TERMINATED	2010-01-01	2009-06-01	Wright State University	7OTHER	false	false	false	null	0
[ 5 ]	941	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.	null	Hypertension		null	3	arm 1: Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. arm 2: Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks arm 3: Losartan 50 mg once daily for four weeks, followed by losartan ...	[ 0, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Oral tablets, once daily, at either 20mg or 40mg daily. intervention 2: placebo oral tablets once daily for two weeks intervention 3: losartan potassium oral tablet at either 50mg or 100 mg daily dose.	intervention 1: olmesartan medoxomil intervention 2: Placebo intervention 3: losartan potassium	20	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Harbor City \| California \| United States \| -118.29785 \| 33.79002 Tustin \| California \| United States \| -117.82617 \| 33.74585 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Pueblo \| Col...	941	NCT00949884	1COMPLETED	2010-01-01	2009-08-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0
[ 3 ]	75	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.	The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility ...	Asthma	GW642444 once daily dosing asthma efficacy safety FEV1	null	5	arm 1: GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD arm 2: GW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD arm 3: placebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD arm 4: GW642444 Dose 1 BD/placebo/GW642444 Dose...	[ 0, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: QD once daily intervention 2: QD once daily intervention 3: placebo intervention 4: QD once daily intervention 5: BD twice daily	intervention 1: Dose 4 QD intervention 2: Dose 3 QD intervention 3: placebo intervention 4: Dose 2 QD intervention 5: Dose 1 BD	9	Cypress \| California \| United States \| -118.03729 \| 33.81696 Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Rolla \| Missouri \| United States \| -91.77127 \| 37.95143 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Oklahoma Cit...	367	NCT00980200	1COMPLETED	2010-01-01	2009-09-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 2 ]	22	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval, following administration to male and female HIV-negative healthy volunteers of: 1. Lopinavir/ritonavir 400/100 mg twice daily 2. Lopinavir/ritonavir 200/150 mg twice daily 3. Lopinavir/ritonavir 20...	Data during the development of lopinavir/ritonavir showed that lower drug doses had similar efficacy to the standard dose of 400/100mg twice daily. Lower drug doses are also associated with limited toxicity and cost. The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir following ad...	Acquired Immunodeficiency Syndrome	HIV ART HAART Pharmacokinetics Lopinavir/ritonavir Lower dose selection	null	3	arm 1: Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID)) arm 2: Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID) arm 3: Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)	[ 1, 0, 0 ]	1	[ 0 ]	intervention 1: Each participant received three sequential doses of lopinavir/ritonavir: 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID), and 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID). Each dos...	intervention 1: lopinavir/ritonavir	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	22	NCT00985543	1COMPLETED	2010-01-01	2009-10-01	Kirby Institute	2OTHER_GOV	false	false	false	null	0
[ 5 ]	126	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of ...	null	Cataracts		null	3	arm 1: Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery arm 2: Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery arm 3: One day before surgery 1 drop 2 times daily (BID), then 3 d...	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery intervention 2: One day pre operative 1 drop BID then 3 doses pre op day of surgery intervention 3: One drop BID, 1 day pre operative and then 3 doses the day of surgery	intervention 1: Ketorolac Tromethamine 0.45% intervention 2: bromfenac 0.09% intervention 3: nepafenac 0.1%	1	Wilkes-Barre \| Pennsylvania \| United States \| -75.88131 \| 41.24591	126	NCT01001806	1COMPLETED	2010-01-01	2009-10-01	Frank A. Bucci, Jr., M.D.	7OTHER	false	false	false	null	0
[ 4 ]	63	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.	null	Human Experimentation		null	3	arm 1: Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participan...	[ 0, 1, 4 ]	2	[ 0, 0 ]	intervention 1: Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days. intervention 2: Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.	intervention 1: Zegerid intervention 2: Prevacid®	0	null	183	NCT01005719	1COMPLETED	2010-01-01	2009-09-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 5 ]	126	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of s...	null	Cataracts		null	3	arm 1: Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery arm 2: Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery arm 3: Acuvail to be given preoperatively. One drop 2 times (BID), 1 ...	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery intervention 2: Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery intervention 3: drug to be given 1 drop BID the day before surgery and ...	intervention 1: Ketorolac Tromethamine intervention 2: Bromfenac intervention 3: nepafenac	0	null	126	NCT01021761	1COMPLETED	2010-01-01	2009-10-01	Frank A. Bucci, Jr., M.D.	7OTHER	false	false	false	null	0
[ 3 ]	120	RANDOMIZED	FACTORIAL	0TREATMENT	3TRIPLE	false	0ALL	null	This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.	null	Heartburn	Heartburn antacid PPI Lansoprazole calcium carbonate magnesium hydroxide Relief of heartburn following ingestion of a heartburn-inducing meal	null	4	arm 1: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet arm 2: Lansoprazole arm 3: Calcium carbonate/magnesium hydroxide arm 4: Placebo	[ 0, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tablet intervention 2: Tablet intervention 3: Tablet intervention 4: Tablet	intervention 1: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg intervention 2: Lansoprazole intervention 3: Calcium carbonate/magnesium hydroxide intervention 4: Placebo	1	Anaheim \| California \| United States \| -117.9145 \| 33.83529	120	NCT01037452	1COMPLETED	2010-01-01	2009-12-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 2 ]	50	NON_RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	2MALE	false	Primary Trial objectives: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose level, 10 subjects receiving placebo) Secondary objectives: To evaluate safety and tolerab...	Primary Trial objective: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in healthy, male volunteers after single intravenous administration Secondary objectives: To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressur...	Heart Failure	anti-beta1 adrenergic receptor autoantibody cyclic peptide heart failure	null	2	arm 1: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 arm 2: intravenous 0.9 % NaCl	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 intervention 2: intravenous 0.9 % NaCl	intervention 1: COR-1 intervention 2: placebo	1	Görlitz \| Saxony \| Germany \| 14.98853 \| 51.15518	50	NCT01043146	1COMPLETED	2010-01-01	2009-10-01	Corimmun GmbH	4INDUSTRY	false	false	false	null	0

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