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	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_count_Accidental overdose int64	METADATA_count_Medication error int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 4 ]	642	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.	null	Chronic Kidney Disease Dialysis Hyperphosphatemia Dyslipidemia	Chronic Kidney Disease Dialysis Hyperphosphatemia Dyslipidemia Phosphate binder	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study intervention 2: 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study	intervention 1: MCI-196 intervention 2: Placebo	73	Ajka \| N/A \| Hungary \| 17.55892 \| 47.10196 Baja \| N/A \| Hungary \| 18.95307 \| 46.18299 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Esztergom \| N/A \| Hungary \| 18.74148 \| 47.7928 Győr \| N/A \| Hungary \| 17.63512 \| 47.68333 Hatvan \| N/A \| Hungary \| 19.68333 \| 47.66667 Kisvárda \| N/A \| Hungary \| 22.08333 \| 48.21667 Lecco...	639	0	0	0	NCT00542386	1COMPLETED	2009-11-01	2007-12-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.	The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.	Acute Coronary Syndrome	Atherosclerosis	null	2	arm 1: VIA-2291 100mg arm 2: Matching placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 100 mg, oral dosing, 1 time daily for 24 weeks intervention 2: oral dosing, 1 time daily for 24 weeks	intervention 1: VIA-2291 intervention 2: Placebo	2	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Princeton \| New Jersey \| United States \| -74.65905 \| 40.34872	52	0	0	0	NCT00552188	1COMPLETED	2009-11-01	2007-10-01	Tallikut Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	112	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be fol...	null	Parkinson Disease		null	2	arm 1: patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -\> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID arm 2: patient to receive a tablet containing 0.125 mg Pramipexole IR ...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: titrated as individually needed (0.25 mg - 4.5 mg daily) intervention 2: titration as individually needed (0.375 mg -4.5 mg daily)	intervention 1: Pramipexole Immediate Release intervention 2: Pramipexole Extended Release	19	Akashi, Hyogo \| N/A \| Japan \| N/A \| N/A Akita, Akita \| N/A \| Japan \| N/A \| N/A Aomori, Aomori \| N/A \| Japan \| N/A \| N/A Asahikawa, Hokkaido \| N/A \| Japan \| 142.36489 \| 43.77063 Asahikawa, Hokkaido \| N/A \| Japan \| 142.36489 \| 43.77063 Bunkyo-ku, Tokyo \| N/A \| Japan \| N/A \| N/A Fuchu, Tokyo \| N/A \| Japan \| N/A \| N/A Fuku...	112	0	0	0	NCT00560508	1COMPLETED	2009-11-01	2007-11-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objective: * To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b. Secondary Objectives: * To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule...	THE STUDY DRUGS: Decitabine is designed to slow tumor growth and may cause death of cancer cells. Interferon alfa-2B is designed to activate your immune system, which may help keep tumors from growing, and may shrink tumors. STUDY TREATMENT: If you are found to be eligible to take part in this study, you will recei...	Renal Cell Carcinoma	Renal Cell Carcinoma Renal Cell Cancer Clear Cell Kidney Decitabine Dacogen 5-Aza-Deoxycytidine Interferon Alfa-2b Intron A® RCC	null	1	arm 1: Decitabine 15 mg/m\^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 15 mg/m\^2 IV Daily over one hour for 5 days intervention 2: 0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.	intervention 1: Decitabine intervention 2: Interferon Alfa-2b	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	1	0	0	0	NCT00561912	6TERMINATED	2009-11-01	2007-10-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	50	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy....	OBJECTIVES: Primary * To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer. Secondary * To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year. * To determine the short-term (1...	Breast Cancer	stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer male breast cancer recurrent breast cancer	null	1	arm 1: Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.	[ 0 ]	3	[ 0, 3, 4 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: capecitabine intervention 2: adjuvant therapy intervention 3: radiation therapy	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	39	0	0	0	NCT00562718	1COMPLETED	2009-11-01	2004-09-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	1,887	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	false	The purpose of this study is to determine whether the study drug is safe and effective.	The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.	Contraception Ovulation Inhibition Contraceptives, Oral	Oral Contraception Birth Control pill Healthy women requesting oral contraception Contraceptive efficacy	null	3	arm 1: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free in...	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone intervention 2: Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone intervention 3: Fixed package per cycle containing combination tablets containing 0.02...	intervention 1: EE20/DRSP (BAY86-5300) intervention 2: EE20/DRSP (BAY86-5300) intervention 3: EE20/DRSP (YAZ, BAY86-5300)	85	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tempe \| Arizona \| United States \|...	1,864	0	0	0	NCT00567164	1COMPLETED	2009-11-01	2007-10-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	48	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Cardiovascular disease is the major cause of death in the hemodialysis population and calcification of the major arteries (coronary, aorta, and carotid) are a play a central role in this process. The major causes of the calcification are many, including high levels of phosphorus, low levels of inhibitors of calcificati...	Hypothesis 1: The treatment of HD patients with high CAC scores with sodium thiosulfate for 5 months will decrease the amount of calcium in their coronary arteries. Patients who are at high risk for having coronary calcification (history of MI, ischemic heart disease, peripheral or carotid artery disease) will be sele...	Complication of Hemodialysis Cardiovascular Diseases	Coronary Calcification Dialysis Thiosulfate Cardiovascular	null	1	arm 1: This is the only arm and involves active treatment with sodium thiosulfate in those subjects with high coronary artery calcium scores.	[ 0 ]	1	[ 0 ]	intervention 1: sodium thiosulfate 12.5-25 gm/M2 after each thrice weekly hemodialysis treatments for 5 months.	intervention 1: sodium thiosulfate	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	37	0	0	0	NCT00568399	1COMPLETED	2009-11-01	2007-12-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	This study is designed to identify physiological, pharmacological and pathological circadian fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood flow in humans.	Glaucoma is a progressive optic neuropathy and a leading cause of blindness in the United States. In glaucoma, vision is lost through apoptosis (programmed cell death) of retinal ganglion cells, a type of cell in the retina that transmits visual information to the brain. Diagnosis of glaucoma is usually based on a comb...	Glaucoma	Glaucoma Ocular Hypertension Timolol®, Latanoprost® and Dorzolamide®	null	1	arm 1: The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.	[ 5 ]	3	[ 0, 0, 0 ]	intervention 1: prostaglandin intervention 2: carbonic anhydrase inhibitor intervention 3: beta blocker	intervention 1: Latanoprost intervention 2: Dorzolamide intervention 3: Timolol	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	90	0	0	0	NCT00572936	1COMPLETED	2009-11-01	2006-03-13	University of Nebraska	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery depending on your response t...	Primary Objective: \- Down-staging of the tumor Secondary Objectives: * Pathologic response rate * Tumor marker response * Incidence of sphincter sparing surgery * Progression-free survival * Overall Survival	Rectal Cancer		null	1	arm 1: FOLFOX4 + Cetuximab	[ 0 ]	2	[ 0, 0 ]	intervention 1: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle) intervention 2: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8...	intervention 1: FOLFOX4 intervention 2: Cetuximab	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	6	0	0	0	NCT00580073	6TERMINATED	2009-11-01	2007-12-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	155	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.	This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).	Rheumatoid Arthritis	Rheumatoid Arthritis RA	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: IV 10mg/kg Q28 days	intervention 1: belimumab	48	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Paradise Valley \| Arizona \| United States \| -111.94265 \| 33.53115 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles...	153	0	0	0	NCT00583557	6TERMINATED	2009-11-01	2005-01-01	Human Genome Sciences Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	15	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and breath by breath exercise response of sickle cell anemia patients The secondary purpose is to assess the effect of L-glutamine on incidence of painful crises; level of chronic pain, and amount of daily requirement for narcot...	This is a phase II, prospective, randomized, double-blind, placebo-controlled, parallel-group,study to evaluate the safety and efficacy of oral L-glutamine therapy for patients with sickle cell anemia or sickle β°-thalassemia who are at least 18 years old with focus on the aspect of exercise endurance. In this study, t...	Sickle Cell Anemia Thalassemia	sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle β°-Thalassemia	null	2	arm 1: L-glutamine group will be given at the following dosage: 17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily \>66.7 at 15 g 2X daily arm 2: Maltodextrin group will be given at the following dosage: 17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily \>66.7 at 15 g 2X daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (\>66.7 kg) intervention 2: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine	intervention 1: L-Glutamine intervention 2: Placebo	1	Torrance \| California \| United States \| -118.34063 \| 33.83585	15	0	0	0	NCT00586209	6TERMINATED	2009-11-01	2004-02-06	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.	This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life e...	Chronic Lymphocytic Leukemia	leukemia	null	1	arm 1: Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 w...	[ 5 ]	1	[ 0 ]	intervention 1: Campath 30 mg administered subcutaneously at varying intervals for up to 1 year	intervention 1: Campath	1	New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351	12	0	0	0	NCT00587847	6TERMINATED	2009-11-01	2005-08-01	Northwell Health	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	37	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	true	To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses t...	This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their stud...	Smoking Cessation	therapeutic effects	null	2	arm 1: Subjects received a Placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7 mg per 70 kg).After a minimum of a 5 day washout subjects then received varenicline tablet (1mg). once per day for 4 days and then received a labo...	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Varenicline (1 mg per day) given for 4 days prior to laboratory session intervention 2: Sugar Pill intervention 3: IV Nicotine given during the laboratory session following 4 days of exposure to the study medication (varenicline or placebo). This nicotine was given during each laboratory session which f...	intervention 1: Varenicline intervention 2: Placebo intervention 3: IV Nic	1	West Haven \| Connecticut \| United States \| -72.94705 \| 41.27065	46	0	0	0	NCT00606892	1COMPLETED	2009-11-01	2007-08-01	Yale University	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	68	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating patients with locally advanced or metastatic s...	OBJECTIVES: Primary * To evaluate the safety and tolerability of escalating doses of systemic Hedgehog antagonist GDC-0449 in patients with locally advanced or metastatic solid tumors. * To estimate the maximum tolerated dose of GDC-0449 in these patients. * To define the dose-limiting toxicities of GDC-0449 in these...	Unspecified Adult Solid Tumor, Protocol Specific	unspecified adult solid tumor, protocol specific	null	7	arm 1: Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-relate...	[ 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: GDC-0449	0	null	68	0	0	0	NCT00607724	1COMPLETED	2009-11-01	2007-04-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	709	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.	null	Primary Insomnia	sleeplessness orexin receptor antagonist almorexant insomnia	null	4	arm 1: almorexant 200 mg arm 2: almorexant 100 mg arm 3: Placebo arm 4: zolpidem 10 mg	[ 0, 0, 2, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem intervention 2: 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem intervention 3: 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated...	intervention 1: almorexant intervention 2: almorexant intervention 3: Placebo intervention 4: zolpidem	91	Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Clayton \| Victoria \| Australia \| 145.11667 \| -37.91667 Footscray \| Victoria \| Australia \| 144.9 \| -37.8 Heidelburg \| Victoria \| Australia \| N/A \| N/A Glebe \| N/A \| Australia \| 151.18426 \| -33.87884 Kippa-Ring \| N/A \| Australia \| 153.0835 \| -27.22586 Melbour...	707	0	0	0	NCT00608985	1COMPLETED	2009-11-01	2008-03-01	Midnight Pharma, LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	21	NA	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic ...	Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our research question is: Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening disease such as Atopic Kera...	Allergic Conjunctivitis	tears conjunctival epithelial cells olopatadine eosinophils	null	1	arm 1: one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week	[ 0 ]	1	[ 0 ]	intervention 1: olopatadine one drop in one eye for one week	intervention 1: olopatadine	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	21	0	0	0	NCT00609128	1COMPLETED	2009-11-01	2000-09-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	57	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	2DOUBLE	true	1FEMALE	true	Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies suggest that stimulation of bone marrow stem c...	null	Change in Bone Mineral Density Change in Bone Marrow Fat Content	BMD Rosiglitazone Bone marrow fat	null	2	arm 1: 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day arm 2: 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: one tablet of rosiglitazone 8 milligrams per day for 14 weeks intervention 2: One encapsulated placebo pill a day for 14 weeks	intervention 1: Rosiglitazone intervention 2: Placebo pill	1	Aarhus \| N/A \| Denmark \| 10.21076 \| 56.15674	53	0	0	0	NCT00609362	1COMPLETED	2009-11-01	2008-01-01	University of Aarhus	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	28	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus slow dose titration of ziprasidone in PBD. The inv...	This study will enroll approximately 60 children and adolescents aged 10-17 years who have been diagnosed with bipolar disorder. Their participation will last about 8 weeks (2 weeks of screening and 6 weeks of medication management) and enrollment will last for two years. After the screening period, all subjects who me...	Bipolar Disorder	Bipolar Disorder Children Adolescents Treatment	null	2	arm 1: Rapid Dose Titration Group arm 2: Slow Dose Titration Group	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reductio...	intervention 1: Ziprasidone intervention 2: Ziprasidone	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	28	0	0	0	NCT00622739	1COMPLETED	2009-11-01	2007-02-01	Baylor College of Medicine	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	467	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.	null	Type 2 Diabetes Mellitus	diabetes exenatide exenatide once weekly metformin sulfonylurea insulin glargine Amylin Lilly	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: subcutaneous injection, 2.0mcg, once weekly intervention 2: subcutaneous injection, variable dose, QD	intervention 1: Exenatide Once Weekly intervention 2: Insulin Glargine	75	Escondido \| California \| United States \| -117.08642 \| 33.11921 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Idaho Falls \| I...	456	0	0	0	NCT00641056	1COMPLETED	2009-11-01	2008-04-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	11	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a phosphate binding agent, works by releasing lanthanum ion...	Study subjects Men and women at least 18 years of age, receiving HD for at least 3 months, with serum P concentrations 45.5 mg/dL at the end of the washout period, and on a stable dose of P binder and/or active vitamin D (if prescribed previously) for at least 1 month before the study were eligible for study participat...	Hyperphosphatemia Kidney Disease	stage 5 chronic hemodialysis	null	2	arm 1: One week before the administration of crushed or chewed lanthanum, the subjects were instructed to discontinue their P-binding agents, if prescribed previously. At the end of the 1-week washout period, subjects whose serum P exceeded 5.5 mg/dL were randomized to receive, in a crossover fashion, lanthanum 1000 mg...	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Lanthanum carbonate 1 g to be chewed, three times daily with meals intervention 2: Lanthanum carbonate (Fosrenol) 1 g crushed into a fine powder, three times daily with meal	intervention 1: Lanthanum Carbonate Chewable Product intervention 2: Lanthanum carbonate crushed powder	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	22	0	0	0	NCT00660530	1COMPLETED	2009-11-01	2008-01-01	University of Illinois at Chicago	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	99	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when both control and intervention groups are given free antihypertensive medications and are involved in usual versus intensive intervention strategies. Because of this, it has not yet been determined whether the method of prescribi...	null	Hypertension	African American	null	2	arm 1: Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs). arm 2: No intervention	[ 0, 1 ]	12	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Hydrochlorothiazide 25 mg tablets intervention 2: Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet intervention 3: L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets intervention 4: 30 mg extended release tablets, 60 mg extended release tablets intervention 5: 50 ...	intervention 1: Hydrochlorothiazide intervention 2: Lisinopril intervention 3: Lisinopril and Hydrochlorothiazide intervention 4: Nifedipine XL intervention 5: Metoprolol tartrate intervention 6: Atenolol intervention 7: Valsartan intervention 8: Doxazosin intervention 9: Clonidine intervention 10: Hydralazine interven...	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	99	0	0	0	NCT00661895	1COMPLETED	2009-11-01	2005-08-01	Creighton University	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	85	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	1FEMALE	true	One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most b...	The primary purpose of this randomized, blinded placebo controlled trial is to quantify and compare measurements of pulmonary function (including respiratory compliance and lung volumes/functional residual capacity) of hospitalized preterm infants whose mothers received an initial course of antenatal corticosteroids, r...	Respiratory Compliance Functional Residual Capacity Pulmonary Function Testing	premature delivery respiratory distress syndrome	null	2	arm 1: Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses arm 2: Placebo dose intramuscular q 24 hours x 2 doses	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 12 mg IM q 24 hours x 2 doses intervention 2: Placebo IM q 24 hours x 2 doses	intervention 1: betamethasone intervention 2: placebo	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	112	0	0	0	NCT00669383	1COMPLETED	2009-11-01	2001-06-01	Oregon Health and Science University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Primary objective: To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at d...	null	AMI		null	2	arm 1: In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL. arm 2: In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Subcutaneous insulin glargine was initiated 90 prior to the insulin glulisine infusion discontinuation (i.e. 48 hours after randomization) and titrated as per physician preference to maintain the plasma glucose between 90-130 mg/dL intervention 2: Prior PCI, subjects received a single IV bolus of insuli...	intervention 1: Insulin Glargine (LANTUS) intervention 2: Insulin Glulisine (Apidra) intervention 3: Standard Therapy	5	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Col. Coyoacan \| N/A \| Mexico \| N/A \| N/A	29	0	0	0	NCT00670228	6TERMINATED	2009-11-01	2008-04-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	120	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fo...	Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsilla...	Postoperative Pain	Tonsillectomy Postoperative Pain Clonidine Anesthetics, Local	null	3	arm 1: 1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy arm 2: Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy arm 3: Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-to...	[ 2, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. B - lidocaine (1%) + bupivacaine (0.5%) intervention 2: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy. A - normal saline intervention 3: Submucosal injection of 1.5 ...	intervention 1: lidocaine (1%) + bupivacaine (0.5%) intervention 2: Normal saline intervention 3: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	120	0	0	0	NCT00678379	1COMPLETED	2009-11-01	2008-04-01	Vanderbilt University Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	136	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing e...	Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel prepa...	Colon Cancer	Afternoon colonoscopy Morning Evening Bowel Preparation Efficacy Satisfaction	null	2	arm 1: Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon' arm 2: Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning'	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM intervention 2: Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, be...	intervention 1: Polyethylene Glycol afternoon intervention 2: Polyethylene Glycol morning	1	Weston \| Florida \| United States \| -80.39977 \| 26.10037	136	0	0	0	NCT00687830	1COMPLETED	2009-11-01	2008-02-01	Cleveland Clinic Florida	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.	To assess the efficacy of a desonide hydrogel 0.05% in both young children (age \<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis	Atopic Dermatitis		null	1	arm 1: Approximately 40 male and female subjects (about 20 age 3 months to \<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD	[ 0 ]	1	[ 0 ]	intervention 1: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions	intervention 1: topical desonide hydrogel 0.05%	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	41	0	0	0	NCT00690833	1COMPLETED	2009-11-01	2007-08-01	Wake Forest University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	139	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.	null	Glaucoma		null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Timolol 0.5% dosed twice-daily intervention 2: Latanoprost 0.005% ophthalmic solution dosed once-daily	intervention 1: Timolol intervention 2: latanoprost	48	Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Henderson \| Nevada...	137	0	0	0	NCT00716859	1COMPLETED	2009-11-01	2008-07-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).	This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects...	Methamphetamine Dependence	Methamphetamine Dependency Addiction vigabatrin	null	2	arm 1: CPP-109 vigabatrin tablets arm 2: Matching Placebo Tablets	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: tablets, bid for 12 weeks intervention 2: tablets, bid, 12 weeks	intervention 1: CPP-109 vigabatrin intervention 2: Matching Placebo	8	Oceanside \| California \| United States \| -117.37948 \| 33.19587 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Albuquerq...	55	0	0	0	NCT00730522	6TERMINATED	2009-11-01	2008-07-01	Catalyst Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2, 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive act...	Background: Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain. Treatment modalities include adjunctive comfort measures (primarily irrigation), mechani...	Empty Nose Syndrome Atrophic Rhinitis	Empty nose syndrome Over resection of turbinate Atrophic rhinitis	null	1	arm 1: Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.	[ 0 ]	1	[ 0 ]	intervention 1: 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.	intervention 1: Botulinum Toxin Type A	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	9	0	0	0	NCT00732680	6TERMINATED	2009-11-01	2008-12-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.	null	Neoplasm, Malignant	Solid tumor malignancy sunitinib pemetrexed phase 1 neoplasms	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity. intervention 2: Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable tox...	intervention 1: Sunitinib, Pemetrexed intervention 2: Sunitinib, Pemetrexed	1	Osakasayama-shi \| Osaka \| Japan \| N/A \| N/A	12	0	0	0	NCT00732992	1COMPLETED	2009-11-01	2008-08-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	219	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) with long term administration in participants with chronic pain.	This is an open-label (both physician and participant know the name of the study drug), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study) and long-term efficacy and safety study of JNS013 (combination of tramadol hydrochloride (TRAM) with acetaminophen \[A...	Chronic Pain	Chronic Pain Acetaminophen Tramadol JNS013	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment ...	intervention 1: Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)	25	Chikushi \| N/A \| Japan \| 130.78718 \| 33.56055 Chūō \| N/A \| Japan \| 139.77544 \| 35.67004 Fukui \| N/A \| Japan \| 135.54836 \| 34.84214 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hiratsuka \| N/A \| Japan \| 139.33735 \| 35.32785 Ichikawa \| N/A \| Japan \| 139.9065 \| 35.73413 Kashiwa \| N/A \| Japan \| 139.97732 \| 35.86224 Komatsu \| N...	190	0	0	0	NCT00736957	1COMPLETED	2009-11-01	2008-05-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.	null	Paroxysmal Atrial Fibrillation		null	2	arm 1: Ablation with HD Mesh Ablation System arm 2: Treatment with anti-arrhythmic drugs	[ 0, 1 ]	2	[ 1, 0 ]	intervention 1: Ablation using the HD Mesh Ablation System intervention 2: 5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation	intervention 1: HD Mesh Ablation System intervention 2: Anti-arrhythmic drugs	13	San Diego \| California \| United States \| -117.16472 \| 32.71571 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| U...	36	0	0	0	NCT00741611	6TERMINATED	2009-11-01	2008-07-01	C. R. Bard	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	508	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) ou...	To assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF). This is a Phase 2, exploratory, randomized, parallel group, multicenter, active comparator, dos...	Atrial Fibrillation	Atrial Fibrillation Betrixaban Factor Xa inhibitor Warfarin	null	4	arm 1: Betrixaban, 40 mg, orally, once daily for at least 3 months. arm 2: Betrixaban, 60 mg, orally, once daily for at least 3 months arm 3: Betrixaban, 80 mg, orally, once daily for at least 3 months arm 4: Warfarin will be prescribed by investigators according to the standard of care.	[ 0, 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: orally, once daily for at least 3 months intervention 2: Warfarin will be prescribed by the investigator according to the standard of care.	intervention 1: betrixaban intervention 2: Warfarin	21	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Melbourne \| Florida \| United States \| -80.60811 \| 28.08363 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Ormond Beach \| Florida \| United States \| -81.05589 \| 29.28581 Pensacola \| Flor...	508	0	0	0	NCT00742859	1COMPLETED	2009-11-01	2008-10-01	Portola Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	300	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit	Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral...	Tobacco Dependence	nicotine dependence, smoking cessation, NRT	null	3	arm 1: Nicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks arm 2: Nicoti...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks intervention 2: Each will use 15 mg/16 h patch for the first 8 weeks...	intervention 1: Nicotine Gum intervention 2: Nicotine Patch	6	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Shanghai \| Shanghai Municipality \| China \| 121.45806 \| 31.22222 Shanghai \| Shanghai Municipality \|...	300	0	0	0	NCT00749463	1COMPLETED	2009-11-01	2009-02-01	McNeil AB	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	134	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134 patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination with metformin. Patients are expected to be treated with exenatide once weekly for at least 52 weeks.	null	Type 2 Diabetes	Amylin Lilly exenatide once weekly thiazolidinedione metformin	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: subcutaneous injection, 2.0mcg, once weekly	intervention 1: exenatide	26	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Concord \| California \| United States \| -122.03107 \| 37.97798 Fresno \| California \| United States \| -119.77237 \| 36.74773 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Atlanta \| Georgia \| United ...	134	0	0	0	NCT00753896	1COMPLETED	2009-11-01	2008-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	277	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension	null	Hypertension	nebivolol Bystolic ™ Hypertension Hispanic Hypertension in Hispanic patients	null	2	arm 1: Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration arm 2: Matching place...	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration intervention 2...	intervention 1: Nebivolol intervention 2: Placebo	32	Buena Park \| California \| United States \| -117.99812 \| 33.86751 Chino \| California \| United States \| -117.68894 \| 34.01223 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 National City \| California \| United States \| -117.0992 \| 32.67811 Sa...	277	0	0	0	NCT00770861	1COMPLETED	2009-11-01	2008-09-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	10	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	Sildenafil (Viagra) is known to reduce pulmonary hypertension. Heart failure patients also have pulmonary hypertension and several recent reports have shown that sildenafil leads to an improvement in their exercise capacity. In these studies sildenafil caused a reduction in the pulmonary and systemic vascular resistanc...	Sildenafil (Viagra) has been extensively studied in patients with idiopathic pulmonary hypertension. It reduces pulmonary vascular resistance, improves exercise capacity and is now an approved therapy for this condition. Heart failure (HF) patients also have pulmonary hypertension and several recent reports have shown ...	Heart Failure Left Ventricular Dysfunction	heart failure, left sided ventricular dysfunction diastolic dysfunction sildenafil	null	2	arm 1: Effect of oral administration of a single dose of sildenafil 50 mg on left ventricular filling pressures as evaluated 1 hr after sildenafil administration in patients with heart failure arm 2: Inactive placebo prepared to mimic the appearance of sildenafil.	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Changes in left ventricular filling pressure 1 hour after the administration of a single oral dose of sildenafil 50 mg. intervention 2: Changes in left ventricular filling pressure 1 hour after oral administration of placebo	intervention 1: sildenafil intervention 2: Placebo	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	10	0	0	0	NCT00781508	1COMPLETED	2009-11-01	2006-12-01	MetroHealth Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	407	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.	null	Migraine Disorders	sumatriptan and naproxen sodium migraine with or without aura naproxen sodium sumatriptan blood pressure migraine headaches	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: sumatriptan 85mg and naproxen sodium 500mg intervention 2: sumatriptan 85mg intervention 3: Naproxen sodium 500mg	intervention 1: sumatriptan and naproxen sodium combination tablet intervention 2: sumatriptan tablet intervention 3: naproxen sodium tablet	49	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Little Rock \| Arkansas ...	374	0	0	0	NCT00792636	1COMPLETED	2009-11-01	2008-11-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	400	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	false	The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is to administer the antibiotic immediately after the umbilical cord is clamped. This study will compare the incidence of post partum infec...	Some studies suggest that administering the antibiotics prior to skin incision decrease the incidence of post partum infectious morbidities without increasing the risks to the baby from the exposure to the antibiotics. Our investigation will validate these findings in a larger series of patients. We will be conducting ...	Infection		null	2	arm 1: Group of patients that will receive antibiotics 30-60 minutes prior to incision arm 2: Group of patients that will receive antibiotics immediately after clamping the umbilical cord	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously intervention 2: Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously	intervention 1: Antibiotic intervention 2: Antibiotic	1	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163	400	0	0	0	NCT00805545	1COMPLETED	2009-11-01	2008-11-01	University of Florida	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	22	NA	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	false	The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.	All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and sym...	Atopic Dermatitis	Atopic Dermatitis Prevention Skin Barrier	null	1	arm 1: Skin barrier protection from birth	[ 0 ]	1	[ 0 ]	intervention 1: Cetaphil cream applied daily from birth	intervention 1: emollient (Cetaphil cream)	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	22	0	0	0	NCT00806221	1COMPLETED	2009-11-01	2006-11-01	Oregon Health and Science University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	234	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be adminis...	null	Atrial Fibrillation Stroke		null	3	arm 1: DU-176b tablets: high-dose arm 2: Warfarin tablets arm 3: DU-176b tablets: low-dose	[ 0, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: DU-176b tablets taken once daily for up to 3 months intervention 2: DU-176b tablets taken once daily for up to 3 months intervention 3: Warfarin tablets taken once daily for up to 3 months	intervention 1: DU-176b tablets intervention 2: DU-176b tablets intervention 3: Warfarin tablets	4	Hong Kong \| N/A \| China \| 114.17469 \| 22.27832 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	234	0	0	0	NCT00806624	1COMPLETED	2009-11-01	2007-10-01	Daiichi Sankyo Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	37	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.	This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants will be divided in 5 groups as per the ge...	Hepatitis C	Hepatitis C TMC435	null	5	arm 1: Participants with chronic genotype 2 hepatitis C virus (HCV) infection arm 2: Participants with chronic genotype 3 HCV infection arm 3: Participants with chronic genotype 4 HCV infection arm 4: Participants with chronic genotype 5 HCV infection arm 5: Participants with chronic genotype 6 HCV infection	[ 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.	intervention 1: TMC435	10	Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9...	37	0	0	0	NCT00812331	1COMPLETED	2009-11-01	2009-03-01	Tibotec Pharmaceuticals, Ireland	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	609	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare the antihypertensive effect of chlorthalidone vs hydrochlorothiazide when each is used with azilsartan medoxomil, once daily (QD), in participants with moderate to severe essential hypertension.	According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive agents, hy...	Essential Hypertension	Essential Hypertension Hypertensive Blood Pressure, High Vascular Disease Cardiovascular Disease Drug Therapy	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks. For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the...	intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Azilsartan medoxomil and hydrochlorothiazide	53	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Gulf Shores \| Alabama \| United States \| -87.70082 \| 30.24604 Scottsboro \| Alabama \| United States \| -86.03415 \| 34.67231 Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Sierra Vista \| Arizona \| United States \| -110.30369 \| 31.55454 Paramount \| Califo...	605	0	0	0	NCT00818883	1COMPLETED	2009-11-01	2009-02-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	2	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine the best dose of nebulized arformoterol, a quick onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics presenting to the the Emergency Department. Also this study will evaluate the side effect and safety profile of arformoterol when used in th...	Acute bronchospasm associated with exacerbations of asthma is a common problem. Currently the mainstay of treatment is inhalation albuterol, either levalbuterol or racemic mixture, in repetitive fashion depending on the resolution of the airways obstruction. Formoterol is a long-acting (\>12 hours) selective beta2-agon...	Acute Asthma	Acute asthma Arformoterol Long acting beta agonists	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Group 1 will receive nebulized arformoterol 15 ug every 20 minutes for 3 doses. Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses. intervention 2: Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for ...	intervention 1: arformoterol (RR formoterol) intervention 2: placebo intervention 3: levalbuterol	1	Detroit \| Michigan \| United States \| -83.04575 \| 42.33143	2	0	0	0	NCT00819637	6TERMINATED	2009-11-01	2009-01-01	Henry Ford Health System	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	433	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken o...	null	Diabetes Diabetes Mellitus, Type 2		null	2	arm 1: Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times dail...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times da...	intervention 1: repaglinide intervention 2: metformin intervention 3: repaglinide	17	Fuzhou \| Fujian \| China \| 119.30611 \| 26.06139 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Suzhou \| Jiangsu \| China \| 120.59538 \| 31.30408 Wuxi \| Jiangsu \| China \| 120.28857 \| 31.56887 Nanchang \| Jiangxi \| China \| 115...	432	0	0	0	NCT00819741	1COMPLETED	2009-11-01	2009-02-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	126	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	false	Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.	null	Cold Sore	cold sore	null	2	arm 1: Penciclovir arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Penciclovir every 2 hours during waking hours for 96 hours intervention 2: Placebo every 2 hous during waking hours for 96 hours	intervention 1: Penciclovir intervention 2: Placebo	1	Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682	126	0	0	0	NCT00820534	1COMPLETED	2009-11-01	2008-12-01	Novartis	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	123	RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	false	0ALL	true	Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information o...	Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second br...	Helicobacter Pylori Infection	HP UBT PPI	null	4	arm 1: Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning arm 2: Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning arm 3: Patients with H.pylori infection will take one tablet a day of 40 ...	[ 1, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection intervention 2: Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection intervention 3: Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection intervention ...	intervention 1: Lansoprazole (Lanton) intervention 2: Omeprezole (Losec) intervention 3: Pantoprazole(Controloc) intervention 4: Esomeprazole (Nexium)	1	Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707	123	0	0	0	NCT00825630	1COMPLETED	2009-11-01	2008-11-01	Meridian Bioscience, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells ...	OBJECTIVES: Primary * To evaluate the 100-day transplant-related (non-relapse) mortality in patients with hematologic malignancies undergoing reduced-intensity conditioning comprising fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential umbilical cord blood transplantation (UCBT) from ...	Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes	accelerated phase cml adult ALL in remission adult AML in remission adult AML with 11q23 (MLL) abnormalities adult AML with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) blastic phase chronic my...	null	0	null	null	6	[ 2, 0, 0, 0, 0, 3 ]	intervention 1: anti-thymocyte globulin intervention 2: fludarabine phosphate intervention 3: melphalan intervention 4: mycophenolate mofetil intervention 5: tacrolimus intervention 6: umbilical cord blood transplantation	intervention 1: anti-thymocyte globulin intervention 2: fludarabine phosphate intervention 3: Melphalan intervention 4: mycophenolate mofetil intervention 5: tacrolimus intervention 6: umbilical cord blood transplantation	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	5	0	0	0	NCT00827099	6TERMINATED	2009-11-01	2006-06-01	Northside Hospital, Inc.	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	325	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)	null	Benign Prostatic Hyperplasia	Signs and Symptoms Prostatic Hyperplasia Hyperplasia Genital Diseases, Male Prostatic Diseases BPH-LUTS	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period. intervention 2: Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.	intervention 1: Placebo intervention 2: tadalafil	27	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Bay Shore \| New York \| U...	325	0	0	0	NCT00827242	1COMPLETED	2009-11-01	2009-01-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatmen...	OBJECTIVES: Primary * To assess the complete pathologic response rate in patients with rectal cancer treated with radiation, modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy. Secondary * To observe the overall pathologic response rate in th...	Colorectal Cancer	stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum	null	1	arm 1: Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and 5-FU / leucovorin (FOLFOX 6)	[ 0 ]	4	[ 0, 0, 0, 3 ]	intervention 1: 5-FU: continuous infusion via portable pump during all RT (approximately 33 days) intervention 2: Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1) intervention 3: Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin intervention 4: mesorectal excision	intervention 1: 5-FU intervention 2: Oxaliplatin intervention 3: leucovorin intervention 4: mesorectal excision	2	New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427	27	0	0	0	NCT00831181	1COMPLETED	2009-11-01	2004-07-01	Beth Israel Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	62	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a mechanomyographic TOF ratio of 0.9 is mandatory....	null	Anesthesia	neostigmine neuromuscular blocking agent train of four anesthesia	null	4	arm 1: neostigmine 0.04 mg.kg associated with atropine 0.02 mg/kg arm 2: neostigmine 0.02 mg.kg associated with atropine 0.01 mg/kg arm 3: neostigmine 0.1 mg.kg associated with atropine 0.05 mg/kg arm 4: no injection of neostigmine	[ 1, 1, 1, 4 ]	3	[ 0, 0, 0 ]	intervention 1: 0.04 mg/kg IV bolus, injection when the of train of four is \> or = to 40 % intervention 2: 0.02 mg/kg IV bolus, injection when the of train of four is \> or = to 40 % intervention 3: 0.01 mg/kg IV bolus, injection when the of train of four is \> or = to 40 %	intervention 1: neostigmine intervention 2: neostigmine intervention 3: neostigmine	1	La Roche-sur-Yon \| N/A \| France \| -1.42757 \| 46.66974	60	0	0	0	NCT00847938	1COMPLETED	2009-11-01	2009-03-01	Centre Hospitalier Departemental Vendee	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day). The dose of E2007 will be adjusted during...	null	Refractory Partial Seizures	Seizures epilepsy	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at We...	intervention 1: E2007	9	Kitakyushu \| Fukuoka \| Japan \| 130.85034 \| 33.85181 Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Kyoto \| Kyoto \| Japan \| 135.75385 \| 35.02107 Sendai \| Miyagi \| Japan \| 140.86667 \| 38.26667 Nagasaki \| Nagasaki \| Japan \| 129.88333 \| 32.75 Niigata \| Niigata \| Japan \| 139.04125 \| 37.92259 Shizuoka \| Shizuoka \| Japan \| 138.3833...	30	0	0	0	NCT00849212	1COMPLETED	2009-11-01	2009-04-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion. Recent clinical trials in adults with other anxiety disorders (acrophobia and social phobia...	Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion. The behavioral theory that underlies CBT is based on two components, namely fear conditioni...	Obsessive-compulsive Disorder	Obsessive-compulsive disorder	null	2	arm 1: Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules). arm 2: Involves receiving cognitive-behav...	[ 1, 0 ]	3	[ 5, 0, 0 ]	intervention 1: All patients will receive 10 sessions of therapy over 8 weeks that is based on the protocol used in POTS (2004). Sessions 1-4 will be held twice weekly; thereafter sessions will be held on a weekly basis. This evidence-based E/RP intervention (POTS, 2004) includes psychoeducation, cognitive training, an...	intervention 1: Cognitive-behavioral therapy intervention 2: D-cycloserine intervention 3: Placebo pill	1	St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086	30	0	0	0	NCT00864123	1COMPLETED	2009-11-01	2008-01-01	University of South Florida	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	49	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).	This is a multicenter, explorative, phase IIIb, open-label study in patients with CF and PI. The study consists of a screening visit (visit 1), followed by a baseline phase of 9 days (plus a 5-day window if necessary) during which the regular pancreatic enzyme will be maintained and 10 stool samples will be collected o...	Cystic Fibrosis Pancreatic Insufficiency	Steatorrhea Malabsorption of fat Pancreatic enzymes Abdominal pain Greasy stools	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.	intervention 1: Ultrase® MT12	15	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cleveland \| Ohio ...	48	0	0	0	NCT00880100	1COMPLETED	2009-11-01	2009-04-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	High blood pressure, also referred to as hypertension, is a blood pressure level of 140/90 mm Hg or higher. Along with lifestyle changes, various medications are currently used to treat people with hypertension. Some of these medications, however, may affect the way the body handles sugar, essentially preventing the bo...	Treatment for hypertension includes lifestyle changes and medications. Examples of some antihypertensive medications include diuretics, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and vasodilators. Mounting research suggests that certain antihypertensive medicati...	Hypertension	Metabolic Syndrome High Blood Pressure Abdominal Obesity Impaired Glucose Tolerance	null	2	arm 1: Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks. arm 2: Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg ...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 25 mg tablet once daily for 6 weeks Other Names: HCTZ intervention 2: 4 mg tablet once daily for 6 weeks	intervention 1: Hydrochlorothiazide intervention 2: Trandolapril	1	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163	24	0	0	0	NCT00887510	1COMPLETED	2009-11-01	2007-05-01	University of Florida	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	193	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.	Following drug study administration, safety and efficacy assessments were conducted	Bunion Hallux Valgus	Bunion Bunionectomy Osteotomy	null	2	arm 1: Injection of Study Drug arm 2: Injection of study drug	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Local infiltration of 8cc SKY0402 intervention 2: Local infiltration of 8cc Placebo	intervention 1: SKY0402 intervention 2: Placebo	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	193	0	0	0	NCT00890682	1COMPLETED	2009-11-01	2009-04-01	Pacira Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	189	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.	null	Hemorrhoid	Hemorrhoid Hemorrhoidectomy Postoperative pain Analgesia	null	2	arm 1: During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound. arm 2: During the hemorrhoidectomy, 30cc Placebo injected into the wound.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: During the operation, 30cc of SKY0402 are injected into the wound. intervention 2: During the hemorrhoidectomy, 30cc Placebo injected into the wound.	intervention 1: SKY0402 intervention 2: Placebo	1	Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227	187	0	0	0	NCT00890721	1COMPLETED	2009-11-01	2009-05-01	Pacira Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	257	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical t...	null	Postoperative Nausea and Vomiting		null	5	arm 1: None arm 2: 0.3mg dose level arm 3: 1mg dose level arm 4: 2mg dose level arm 5: 3mg dose level	[ 2, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: IV intervention 2: IV	intervention 1: APD405 intervention 2: Placebo	18	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Bron \| N/A \| France \| 4.91303 \| 45.73865 Lille \| N/A \| France \| 3.05858 \| 50.63297 Nancy \|...	257	0	0	0	NCT00895830	1COMPLETED	2009-11-01	2009-05-01	Acacia Pharma Ltd	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	22	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.	null	Type 2 Diabetes Mellitus		null	2	arm 1: Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a ...	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Single dose of MK0893 1000 mg (ten 100 mg tablets) intervention 2: Single dose of placebo to MK0893 (ten tablets) intervention 3: Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.	intervention 1: MK0893 intervention 2: MK0893-matched Placebo intervention 3: Propranolol Hydrochloride (HCL)	0	null	66	0	0	0	NCT00902161	1COMPLETED	2009-11-01	2009-05-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-l...	null	Thrombosis, Venous	Pulmonary thromboembolism contrast-enhanced MDCT Deep Vein Thrombosis Fondaparinux sodium	null	2	arm 1: None arm 2: None	[ 0, 5 ]	2	[ 0, 0 ]	intervention 1: The dose of Fondaparinux will be determined based on a subject's body weight (\< 50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection. intervention 2: UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPT...	intervention 1: Fondaparinux sodium intervention 2: unfractionated heparin (UFH)	24	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Gunma \| N/A \| Japan \| N/A \| N/A Gunma \| N/A \| Japan \| N/A \| N/A Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Hokkaido \| N/A \| Japan \| N/A \| N/A Hokkaido \| N/A \| Japan \| N/A \| N/A Hokkaido \| N/A \| Japan...	39	0	0	0	NCT00911157	1COMPLETED	2009-11-01	2008-06-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	23	RANDOMIZED	CROSSOVER	null	2DOUBLE	false	0ALL	false	This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), a...	This study design was chosen to assess the differences between pharmacokinetic (PK) and pharmacodynamic (PD) parameters, including postprandial glycemic response, of Humalog + recombinant human hyaluronidase PH20 (rHuPH20), Humalog alone, and Humulin-R + rHuPH20 at optimal doses following a liquid meal.	Diabetes Mellitus, Type 2	recombinant human hyaluronidase PH20 (rHuPH20) Insulin lispro Regular human insulin	null	6	arm 1: A subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of...	[ 1, 1, 1, 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Humalog intervention 2: Humulin-R intervention 3: Recombinant human hyaluronidase PH20 (rHuPH20)	1	Chula Vista \| California \| United States \| -117.0842 \| 32.64005	66	0	0	0	NCT00916357	1COMPLETED	2009-11-01	2009-07-01	Halozyme Therapeutics	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	50	RANDOMIZED	PARALLEL	9OTHER	4QUADRUPLE	false	0ALL	false	This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.	null	Cataract Extraction		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Administer moxifloxacin study drug prior to cataract surgery. intervention 2: Administer besifloxacin study drug prior to cataract surgery.	intervention 1: Moxifloxacin 0.5% ophthalmic solution intervention 2: Besifloxacin 0.6% ophthalmic suspension	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	50	0	0	0	NCT00924729	1COMPLETED	2009-11-01	2009-09-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.	null	Asthma	QAB149 asthma indacaterol salts (acetate, maleate, and xinafoate) orally inhaled indacaterol salts persistent asthma	null	4	arm 1: In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment on...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. intervention 2: Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The ...	intervention 1: Indacaterol maleate 400 μg intervention 2: Indacaterol acetate 400 μg intervention 3: Indacaterol xinafoate 400 μg intervention 4: Placebo to indacaterol	3	Poitiers \| N/A \| France \| 0.34348 \| 46.58261 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Verona \| N/A \| Italy \| 10.9938 \| 45.43854	117	0	0	0	NCT00927901	1COMPLETED	2009-11-01	2009-06-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under ...	Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for o...	Chronic Pain	opioid tolerant chronic pain	null	2	arm 1: Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal arm 2: Participants received 40 mg oxymorphone ER after fasting for 8-12 hours	[ 0, 0 ]	1	[ 0 ]	intervention 1: 40 mg qd twice	intervention 1: Oxymorphone ER	1	Wellesley Hills \| Massachusetts \| United States \| -71.27867 \| 42.30843	60	0	0	0	NCT00930943	1COMPLETED	2009-11-01	2009-05-01	MedVadis Research Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	25	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of A...	null	Chronic Obstructive Pulmonary Disease	Chronic Obstructive Pulmonary Disease (COPD) efficacy safety inhalation long-acting muscarinic receptor antagonist (LAMA)	null	5	arm 1: 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 2: 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation arm 3: 1 x AZD9164 solution ...	[ 0, 0, 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Solution for inhalation through nebulization, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Placebo	intervention 1: AZD9164 intervention 2: Tiotropium intervention 3: Placebo	3	Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Luleå \| N/A \| Sweden \| 22.15465 \| 65.58415 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584	140	0	0	0	NCT00939211	1COMPLETED	2009-11-01	2009-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	153	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.	null	Dental Pain		null	5	arm 1: Oxycodone 5-mg oral capsule and 2 buccal placebo films arm 2: Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule arm 3: Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule arm 4: Buprenorphine HCl bucca...	[ 1, 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Single-dose of over-encapsulated oral 5-mg oxycodone capsule intervention 2: Single-dose of buprenorphine HCl buccal film intervention 3: Single-dose of placebo buccal film intervention 4: Single-dose of oral placebo capsule	intervention 1: Oxycodone intervention 2: Buprenorphine intervention 3: Placebo Film intervention 4: Placebo Capsule	3	Austin \| Texas \| United States \| -97.74306 \| 30.26715 San Marcos \| Texas \| United States \| -97.94139 \| 29.88327 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	153	0	0	0	NCT00941304	1COMPLETED	2009-11-01	2009-08-01	BioDelivery Sciences International	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	147	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.	null	Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis Relapsing Remitting Multiple Sclerosis (RRMS) Glatiramer Acetate (GA)	null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary. intervention 2: GA 20 mg/0.5 mL	intervention 1: Glatiramer Acetate intervention 2: Experimental Glatiramer Acetate	0	null	294	0	0	0	NCT00947752	1COMPLETED	2009-11-01	2009-07-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	28	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly a...	Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilater...	Acne Vulgaris	Acne vulgaris	null	2	arm 1: Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. arm 2: Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire f...	intervention 1: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) intervention 2: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)	2	Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Warren \| Michigan \| United States \| -83.01304 \| 42.49044	28	0	0	0	NCT00964223	1COMPLETED	2009-11-01	2009-07-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	331	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	false	This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhini...	null	Vasomotor Rhinitis Seasonal Allergic Rhinitis		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days. intervention 2: Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.	intervention 1: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg intervention 2: Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg	0	null	651	0	0	0	NCT00976209	1COMPLETED	2009-11-01	2009-08-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	80	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.	null	Pain	posttraumatic pain	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Day 1 * The first dose: Celecoxib 400mg * The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8) \- Celecoxib 200mg twice daily	intervention 1: Celecoxib	11	Funabashi \| Chiba \| Japan \| 139.98648 \| 35.70129 Ichikawa \| Chiba \| Japan \| 139.9065 \| 35.73413 Matsudo \| Chiba \| Japan \| 139.90144 \| 35.77995 Sagamihara \| Kanagawa \| Japan \| 139.24167 \| 35.56707 Ageo \| Saitama \| Japan \| 139.61382 \| 35.97145 Saitama-shi \| Saitama \| Japan \| N/A \| N/A Edogawaku \| Tokyo \| Japan \| N/A \| N/...	80	0	0	0	NCT00976716	1COMPLETED	2009-11-01	2009-09-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	129	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).	null	Vasomotor Rhinitis	vasomotor rhinitis chronic non-allergic rhinitis VMR	null	2	arm 1: Olopatadine HCL Nasal Spray, 0.6% arm 2: Azelastine HCl Nasal Spray, 137 mcg	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 2 sprays/ nostril BID intervention 2: 2 sprays/ nostril BID	intervention 1: Olopatadine HCL (Patanase) Nasal Spray, 0.6% intervention 2: Azelastine HCl (Astelin) Nasal Spray, 137 mcg	1	Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541	129	0	0	0	NCT00979615	1COMPLETED	2009-11-01	2009-09-01	Alcon Research	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	44	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	null	The purpose of this study is to investigate the safety and tolerability of trospium chloride (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.	null	Healthy	Adults	null	2	arm 1: Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days. arm 2: Treatment Period 1...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: extended release, 60 mg, oral daily intervention 2: immediate release, 500mg	intervention 1: Trospium Chloride (Sanctura XR®) intervention 2: Metformin hydrochloride (Glucophage®)	1	Tempe \| Arizona \| United States \| -111.90931 \| 33.41477	131	0	0	0	NCT00986401	1COMPLETED	2009-11-01	2009-10-01	Allergan	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.	null	Head Lice	Head Lice Pediculus	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Topical 0.5% ivermectin cream applied to scalp and hair on day 1	intervention 1: 0.5% Ivermectin Cream	5	Bentonville \| Arkansas \| United States \| -94.20882 \| 36.37285 Dinuba \| California \| United States \| -119.38707 \| 36.54328 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Picayune \| Mississippi \| United States \| -89.67788 \| 30.52556	30	0	0	0	NCT00988533	1COMPLETED	2009-11-01	2009-09-01	Topaz Pharmaceuticals Inc	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	25	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.	null	Asthma	asthmatic children	null	6	arm 1: Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 arm 2:...	[ 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol intervention 2: 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol intervention 3: 21ug of unit dose budesonide inhalation suspension delivered by Aero...	intervention 1: 84ug MAP0020 intervention 2: 42ug MAP0020 intervention 3: 21ug MAP0020	2	Cypress \| California \| United States \| -118.03729 \| 33.81696 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	73	0	0	0	NCT00995904	1COMPLETED	2009-11-01	2009-09-01	Allergan	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	239	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.	Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern. After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to...	Pain	pain after cesarean visual analog scale oxycodon piritramid	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. intervention 2: Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9...	intervention 1: Oral Oxycodon intervention 2: Piritramid	1	Rostock \| Mecklenburg-Vorpommern \| Germany \| 12.14049 \| 54.0887	239	0	0	0	NCT01115101	1COMPLETED	2009-11-01	2009-07-01	Max Dieterich	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	89	RANDOMIZED	CROSSOVER	4SUPPORTIVE_CARE	1SINGLE	false	0ALL	false	The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.	A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Gro...	COPD Sepsis Shock	Tachycardia tachyarrhythmias bronchodilator therapy Critically ill patients	null	2	arm 1: Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. arm 2: Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg intervention 2: Nebulized albuterol 2.5mg	intervention 1: Levalbuterol intervention 2: Albuterol	1	Grand Blanc \| Michigan \| United States \| -83.62995 \| 42.92753	89	0	0	0	NCT01151579	1COMPLETED	2009-11-01	2008-12-01	Fahim Khorfan, MD	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	3,879	RANDOMIZED	CROSSOVER	1PREVENTION	2DOUBLE	false	0ALL	false	Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially...	A group-randomized crossover trial was conducted to test the null hypothesis of no difference in blood culture contamination rates among 3 antiseptic skin preparations. The sequence of 3 different antiseptic treatments was randomly assigned to 3 separate hospital floors, therefore in this trial cross-over occurred at t...	Bacteremia	Bacteremia Blood culture Contamination Antiseptic agents	null	3	arm 1: Skin antisepsis prior to any peripheral blood culture collection on Floor A was performed with CHG for 3 months, followed by PI for 3 months, followed by IT for 3 months. Each 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collect...	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) intervention 2: 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) intervention 3: 10% povidone iod...	intervention 1: Iodine tincture intervention 2: Chlorhexidine gluconate intervention 3: Povidone iodine	0	null	4,210	0	0	0	NCT01216761	1COMPLETED	2009-11-01	2008-05-01	University of Michigan	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achie...	null	Acromegaly	Sandostatin LAR High Dose GH-receptor antagonist combination with dopamine-agonist acromegalic patients octreotide acetate Somavert Dostinex pegvisomant cabergoline not adequately controlled active acromegaly	null	3	arm 1: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. arm 2: All patients...	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 40 mg intramuscular (i.m.) every 28 days for 3 months intervention 2: Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months intervention 3: Weekly cabergoline for 4 months, with weekly doses of Sandostatin LA...	intervention 1: Sandostatin LAR intervention 2: pegvisomant intervention 3: cabergoline	20	Brest \| N/A \| France \| -4.48628 \| 48.39029 Bron \| N/A \| France \| 4.91303 \| 45.73865 Le Kremlin-Bicêtre \| N/A \| France \| 2.36073 \| 48.81471 Nice \| N/A \| France \| 7.26608 \| 43.70313 Nîmes \| N/A \| France \| 4.35788 \| 43.83665 Pessac \| N/A \| France \| -0.6324 \| 44.80565 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Genova \| N...	70	0	0	0	NCT01278342	1COMPLETED	2009-11-01	2006-09-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	96	RANDOMIZED	PARALLEL	null	1SINGLE	true	2MALE	false	The study objective is to investigate the pharmacodynamics (effects of a drug product) when switching the treatment from warfarin to rivaroxaban. 84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and sing...	null	Venous Thrombosis	Rivaroxaban Xa-Factors Warfarin Thrombosis Embolism	null	3	arm 1: Days -6 and -5: 10 mg warfarin once daily or lower depending on international normalized ratio (INR); Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily arm 2: Days -6 and -5:...	[ 0, 2, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR intervention 2: Days 0 to 3: 20 mg rivaroxaban once daily interventio...	intervention 1: Warfarin (Coumadin) intervention 2: Rivaroxaban (Xarelto, BAY59-7939) intervention 3: Placebo intervention 4: Vitamin K (Konakion)	2	Cologne \| North Rhine-Westphalia \| Germany \| 6.95 \| 50.93333 Mönchengladbach \| North Rhine-Westphalia \| Germany \| 6.44172 \| 51.18539	147	0	0	0	NCT01507051	1COMPLETED	2009-11-01	2008-11-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	95	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.	This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on ...	Schizophrenia	Schizophrenia Paliperidone extended-release (ER) Antipsychotic agents	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.	intervention 1: Paliperidone ER	5	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Rosario \| N/A \| Argentina \| -60.63932 \| -32.94682 Bogotá \| N/A \| Colombia \| -74.08175 \| 4.60971 Medellín \| N/A \| Colombia \| -75.57151 \| 6.245 Santiago de Cali \| N/A \| Colombia \| -76.5199 \| 3.43054	95	0	0	0	NCT01724359	1COMPLETED	2009-11-01	2008-02-01	Janssen-Cilag, S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	296	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting and constipation or diarrhea) who completed the JNS019-JPN-02 study.	This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than one center), dose-titration (dose escalation/reduction) study of topiramate in participants with migraine. This study is a continuous study for the participants who were enrolled in the JNS019-JPN-02 study. Par...	Migraine	Migraine Topiramate	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.	intervention 1: Topiramate	25	Chitose \| N/A \| Japan \| 141.65222 \| 42.81944 Hachiōji \| N/A \| Japan \| 139.32389 \| 35.65583 Isehara \| N/A \| Japan \| 139.31019 \| 35.39932 Kagoshima \| N/A \| Japan \| 130.55 \| 31.56667 Kamogawa \| N/A \| Japan \| 140.1003 \| 35.0969 Kitakyushu \| N/A \| Japan \| 130.85034 \| 33.85181 Kobe \| N/A \| Japan \| 135.183 \| 34.6913 Kumamoto ...	296	0	0	0	NCT01799590	1COMPLETED	2009-11-01	2007-08-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	43	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.	Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximat...	Epilepsy		null	2	arm 1: Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily arm 2: Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 3...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: BIA 2-093 intervention 2: Carbamazepine	0	null	243	0	0	0	NCT02284854	1COMPLETED	2009-11-01	2009-07-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	2MALE	false	The study will measure the early and late asthamtic response using an allergen challenge. This study will evaluate the safety and patients tolerance to repeat inhaled doses of GW870086X using a number of clinical and biological markers.	null	Asthma	asthma late phase response allergen challenge GW870086X	null	1	arm 1: None	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Investigational product intervention 2: Positive control intervention 3: Placebo control	intervention 1: GW870086X intervention 2: FP intervention 3: Placebo	4	Wiesbaden \| Hesse \| Germany \| 8.24932 \| 50.08258 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Großhansdorf \| Schleswig-Holstein \| Germany \| 10.28333 \| 53.66667 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437	72	0	0	0	NCT00857857	1COMPLETED	2009-11-03	2009-02-16	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	8	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	Objective: To establish which combination of diuretics is the most effective in promoting diuresis in congestive heart failure patients. Secondary Objectives: To determine the duration of action of furosemide as monotherapy and in combination hydrochlorothiazide with metolazone. To determine the effect of diuretic comb...	null	Congestive Heart Failure	congestive heart failure diuretics combination	ICF_001.pdf: Page 1 of 6 HRRC #:03-477 Version: 05/25/07 OFFICIAL USE ONLY Approved: 06/09/09 Expires: 06/12/10 The University of New Mexico Human Research Review Committee UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER CONSENT TO PARTICIPATE IN RESEARCH A COMPARISON OF HYDROCHLOROTHIAZIDE A...	2	arm 1: A randomized, double-blind, crossover study designed to compare the efficacy of hydrochlorothiazide in combination with stable doses of furosemide in congestive heart failure patients. arm 2: A randomized, double-blind, crossover study designed to compare the efficacy of metolazone in combination with stable dos...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: A randomized, double-blind, crossover study designed to compare the efficacy of hydrochlorothiazide in combination with stable doses of furosemide in congestive heart failure patients. intervention 2: A randomized, double-blind, crossover study designed to compare the efficacy of metolazone in combinati...	intervention 1: Treatment of Furosemide + Hydrochlorothiazide intervention 2: Treatment of Furosemide + Metolazone	1	Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449	16	0	0	0	NCT00690521	1COMPLETED	2009-11-10	2004-10-26	University of New Mexico	7OTHER	true	false	true	https://cdn.clinicaltrials.gov/large-docs/21/NCT00690521/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/21/NCT00690521/ICF_001.pdf	0	0	0	0
[ 2 ]	60	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	false	The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).	Title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline...	Depressive Disorder	Bioequivalence Paroxetine reference/test healthy volunteers Fed condition	null	2	arm 1: Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline ...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation) intervention 2: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactu...	intervention 1: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico intervention 2: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada	1	Belo Horizonte \| Minas Gerais \| Brazil \| -43.93778 \| -19.92083	120	0	0	0	NCT01339247	1COMPLETED	2009-11-16	2009-10-20	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	140	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A P...	null	Parkinson Disease Neurodegenerative Diseases Central Nervous System Diseases Movement Disorders Brain Diseases		null	1	arm 1: Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 5 mg BID capsules intervention 2: Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa). intervention 3: Participants may also receive other drugs as part of thei...	intervention 1: Preladenant intervention 2: L-dopa intervention 3: Other Parkinson's Disease treatments	0	null	140	0	0	0	NCT00537017	1COMPLETED	2009-11-19	2007-11-23	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,512	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.	null	Diabetes Mellitus, Non-Insulin-Dependent		null	3	arm 1: Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet. arm 2: Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary arm 3: Sub...	[ 0, 0, 0 ]	3	[ 0, 5, 5 ]	intervention 1: sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks intervention 2: Diet intervention 3: Physical Activity	intervention 1: sitagliptin phosphate intervention 2: Comparator: Diet intervention 3: Comparator: Physical Activity	0	null	1,131	0	0	0	NCT00545584	1COMPLETED	2009-11-19	2007-04-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	460	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).	Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. The maleic ...	Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorder, Intrinsic	placebo controlled randomized double blind	null	2	arm 1: Participants receive esmirtazapine 4.5 mg tablets, administered once a day for 6 months arm 2: Participants receive placebo tablets, administered once a day for 6 months	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One esmirtazapine 4.5 mg tablet once a day intervention 2: One placebo tablet once a day	intervention 1: Esmirtazapine intervention 2: Placebo	0	null	457	0	0	0	NCT00631657	1COMPLETED	2009-11-19	2008-03-04	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	80	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.	null	Pancreatic Cancer		null	1	arm 1: Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily. intervention 2: Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m\^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on ...	intervention 1: Erlotinib intervention 2: Gemcitabine	11	Bari \| Apulia \| Italy \| 16.86982 \| 41.12066 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Bologna \| Emilia-Romagna \| Italy \| 11.33875 \| 44.49381 Pordenone \| Friuli Venezia Giulia \| Italy \| 12.66051 \| 45.95689 Rome \| Lazio \| Italy \| 12.51133 \| 41.89193 Pavia \| Lombardy \| Italy \| 9.15917 \| 45.19205 Catania \| Sicily \| It...	80	0	0	0	NCT02694536	1COMPLETED	2009-11-19	2006-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	28	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dr...	Acne vulgaris is an extremely common dermatological disease that is found typically in adolescence and young adulthood. Acne vulgaris manifests with open and closed comedones (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and trunk. Scarring can occur, particularly if the lesions ...	Acne Vulgaris		null	1	arm 1: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over-the-counter.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Available over the counter. intervention 2: Available over the counter. intervention 3: Available over the counter.	intervention 1: MAXCLARITY II (2.5% BPO) Foam Cleanser intervention 2: MAXCLARITY II (2.5% BPO) Foam Treatment intervention 3: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam	0	null	28	0	0	0	NCT01706263	1COMPLETED	2009-11-20	2009-08-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	113	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML	Other objectives of this study include: 1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality 2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR). 3. Characterize the pharmacokinetic (PK) profile of vosarox...	Leukemia Acute Disease Acute Myeloid Leukemia Nonlymphocytic Leukemia Myelodysplastic Syndromes	Leukemia Myeloid Elderly Hematologic Blood Cancer Malignancy SNS-595 Sunesis Hematologic Diseases Myelodysplastic Syndromes Older voreloxin reveal-1	null	1	arm 1: * Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4	[ 0 ]	1	[ 0 ]	intervention 1: Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 day...	intervention 1: vosaroxin	20	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| Unit...	113	0	0	0	NCT00607997	1COMPLETED	2009-11-23	2008-05-15	Sunesis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The addition of entinostat to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor. It is hypothesized that entinostat with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an accept...	null	ER+ Breast Cancer	breast cancer estrogen receptor positive	null	1	arm 1: Entinostat 5 mg tablet orally every week on Days 1, 8. 15 and 22 of each 28-day treatment cycle in combination with continued treatment with AI therapy at labeled dose and schedule until disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Entinostat 5 mg PO every week intervention 2: AI therapy at labeled dose and schedule as prescribed in clinical practice. AI therapies include: Arimidex® (anastrozole) 1 mg/day by mouth (PO), Fermara® (letrozole) 2.5 mg/day PO , Aromasin® (exemestane) 25 mg/day PO.	intervention 1: Entinostat intervention 2: Aromatase Inhibitor (AI) Therapy	6	Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Cardiff \| N/A \| United Kingdom \| -3.18 \| 51.48 Liverpool \| N/A \| United Kingdom \| -2.97794 \| 53.41058 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095	27	0	0	0	NCT00828854	1COMPLETED	2009-11-24	2008-10-01	Syndax Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	8	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty treatment-naïve subjects infected with HIV-1. GSK2...	null	Infection, Human Immunodeficiency Virus	IDX12899 adaptive monotherapy pharmacokinetics Treatment-naive HIV-1 GSK2248761 NNRTI HIV Infections treatment naive	null	2	arm 1: In Cohort 1 subjects will receive either GSK2248761 30 mg or placebo once a day for 7 days. On Day 8 subjects will receive either Kaletra or HAART for 28 days. The doctor will choose the most appropriate medications for HAART. arm 2: In Cohort 2 subjects will receive either GSK2248761 in the range of 10 mg - 20 ...	[ 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: GSK2248761 30 mg capsule once a day for 7 days. GSK2248761 is an investigational (not approved by the FDA) HIV drug in the class of non-nucleoside reuptake inhibitor class. intervention 2: Lopinavir 400 mg and ritonovir 100 mg every 12 hours for 28 days. Lopinavir/ritonavir is approved by the FDA as an ...	intervention 1: GSK2248761 intervention 2: Lopinavir/ritonavir intervention 3: HAART intervention 4: Placebo intervention 5: GSK2248761	1	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315	8	0	0	0	NCT00945282	1COMPLETED	2009-11-28	2009-10-20	ViiV Healthcare	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	74	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in metastatic gastric carcinoma.	null	Neoplasms, Gastrointestinal Tract	c-Met Metastatic Gastric Carcinoma adenocarcinoma Gastric cancer GSK1363089 XL880 MET inhibitor	null	2	arm 1: Dosing for first 5 days in every 14-day period. arm 2: dosed every day	[ 0, 0 ]	1	[ 0 ]	intervention 1: c-MET tyrosine kinase inhibitor	intervention 1: GSK1363089 (formerly XL880)	17	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Stanford \| California \| United States \| -122.16608 \| 37.42411 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38....	74	0	0	0	NCT00725712	1COMPLETED	2009-11-30	2007-03-31	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	313	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this trial is to demonstrate whether valproate therapy delays the emergence of agitation and/or psychosis in outpatients with probable Alzheimer's disease (AD) who have not experienced agitation and psychosis in their illness. A secondary aim is to determine whether valproate therapy delays the progressi...	This study represents a novel clinical trial strategy designed to assess both prospective "prophylactic" therapy for psychopathology in Alzheimer's disease (AD) and to assess an approach that may alter several aspects of the pathophysiology of AD, and perhaps result in alteration of clinical progression of illness. Int...	Alzheimer Disease	Alzheimer disease Agitation Psychosis	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout intervention 2: Placebo tablets beginning with one daily and increasing according to weight an...	intervention 1: Valproate intervention 2: Placebo	46	Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Irvine \| California \| United States \| -117.82311 \| 33.66946 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| Calif...	313	1	0.003195	1	NCT00071721	1COMPLETED	2009-12-01	2003-10-01	Alzheimer's Disease Cooperative Study (ADCS)	7OTHER	false	false	false	null	1	0	0	0.000564
[ 4 ]	1,228	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin...	null	Anemia		null	2	arm 1: Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or e...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the foll...	intervention 1: Methoxy Polyethylene Glycol-Epoetin Beta intervention 2: Epoetin alfa intervention 3: Epoetin beta intervention 4: Darbepoetin alfa	249	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Covina \| California \| United States \| -117.89034 \| 34.09001 Encino \| California \| U...	1,228	3	0.002443	1	NCT00090753	1COMPLETED	2009-12-01	2004-10-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	3	0.000831
[ 5 ]	220	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .	Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regiment. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. Tradi...	Schizophrenia	Schizophrenia intramuscular injection antipsychotic agents long-acting risperidone	null	2	arm 1: early initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the ...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. intervention 2: 25 mg to 50 mg...	intervention 1: early initiation of treatment with Risperdal Consta intervention 2: routine initiation of treatment with Risperdal Consta	31	Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Glostrup Municipality \| N/A \| Denmark \| 12.40377 \| 55.6666 Hjørring \| N/A \| Denmark \| 9.98229 \| 57.46417 Kolding \| N/A \| Denmark \| 9.47216 \| 55.4904 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Vantaa \| N/A \| Finland \| 25.04099 \| 60.29414 Bar-le-Duc \| N/A \| France \| 5....	220	4	0.018182	1	NCT00216671	1COMPLETED	2009-12-01	2005-11-01	Janssen Pharmaceutica N.V., Belgium	4INDUSTRY	false	false	false	null	0	0	4	0.007093
[ 3 ]	384	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as disco...	null	Breast Cancer	Early Breast Cancer	null	2	arm 1: None arm 2: None	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks intervention 2: Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks intervention 3: Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks intervention 4: Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 ...	intervention 1: Ixabepilone intervention 2: Paclitaxel intervention 3: Cyclophosphamide intervention 4: Doxorubicin	49	Palm Springs \| California \| United States \| -116.54529 \| 33.8303 Coral Spring \| Florida \| United States \| N/A \| N/A Davie \| Florida \| United States \| -80.2331 \| 26.06287 Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Louisville \| Kentucky \| United Stat...	289	4	0.013841	1	NCT00455533	1COMPLETED	2009-12-01	2007-10-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	1	3	0.005395
[ 5 ]	392	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The...	ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.	Infection, Human Immunodeficiency Virus I HIV Infection	tenofovir HIV efavirenz naive lamivudine abacavir emtricitabine renal	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Abacavir/lamivudine and efavirenz intervention 2: Tenofovir/Emtricitabine and efavirenz	68	Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Charleroi \| N/A \| Belgium \| 4.44448 \| 50.4113...	385	1	0.002597	1	NCT00549198	1COMPLETED	2009-12-01	2007-06-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	1	0	0	0.000459
[ 4 ]	108	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropr...	This is a randomized (study drug assigned by chance), multicenter, double-blind (neither the patient nor the physician know the study drug administered) study to determine the efficacy and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in approximately 625 patients with acute pain...	Back Pain	Vertebral compression fracture Osteoporosis Acute pain Analgesic Oxycodone Tapentadol	null	3	arm 1: tapentadol IR 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days maximum daily dose 450 mg arm 2: oxycodone IR 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days maximum daily dose 60 mg arm 3: placebo 1 capsule every 4 - 6 hr as needed for up to 10 days	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: maximum daily dose 450 mg intervention 2: 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days intervention 3: 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days	intervention 1: oxycodone IR intervention 2: placebo intervention 3: tapentadol IR	37	Haleyville \| Alabama \| United States \| -87.62141 \| 34.22649 Tallassee \| Alabama \| United States \| -85.89329 \| 32.53597 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Los Gatos \| California \| ...	108	1	0.009259	1	NCT00771758	1COMPLETED	2009-12-01	2008-09-01	Ortho-McNeil Janssen Scientific Affairs, LLC	4INDUSTRY	false	false	false	null	1	0	0	0.001636

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