Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_wilson_lower_bound float32
[ 3 ]	35	NA	SINGLE_GROUP	null	0NONE	false	0ALL	null	The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).	This Phase 2, multicenter study was conducted in HCV-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in Study M10-351 Substudy 2 (NCT0069...	HCV Infection	HCV Infection	null	1	arm 1: Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Participants received no treatment in this follow-up study.	[ 5 ]	2	[ 3, 0 ]	intervention 1: Approximately monthly collection of blood samples. intervention 2: Previous treatment in prior ABT-333 studies.	intervention 1: Blood sample collection only intervention 2: ABT-333	7	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 San Antoni...	35	NCT00726882	1COMPLETED	2010-05-01	2008-08-01	AbbVie (prior sponsor, Abbott)	4INDUSTRY	false	false	false	null	0
[ 2 ]	58	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.	First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.	Hepatitis C	Hepatitis C unresponsive to pegylated interferon and ribavirin therapy hepatitis C virus	null	7	arm 1: IMO-2125 given weekly at 0.04 mg/kg arm 2: IMO-2125 given weekly at 0.08 mg/kg arm 3: IMO-2125 given weekly at 0.16 mg/kg arm 4: IMO-2125 given weekly at 0.32 mg/kg arm 5: IMO-2125 given weekly at 0.48 mg/kg arm 6: Weekly saline placebo arm 7: IMO-2125 given twice a week at 0.16 mg/kg	[ 0, 0, 0, 0, 0, 2, 0 ]	2	[ 0, 0 ]	intervention 1: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system intervention 2: saline placebo given subcutaneously	intervention 1: IMO-2125 intervention 2: Saline placebo	7	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Novi \| Michigan \| United States \| -83.47549 \| 42.48059 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United Stat...	58	NCT00728936	1COMPLETED	2010-05-01	2007-09-01	Idera Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	31	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	true	2MALE	false	The original purpose of this research study was to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge would be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease, and to help in the development of a safe male hormonal c...	We will be administering three drugs: testosterone gel (T), anastrozole, and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress luteinizing hormone(LH) and follicle-stimulating hormone(FSH), which are hormones made by the pituitary gland, thus blocking the signal from ...	Healthy	HDL Insulin sensitivity testosterone estradiol cholesterol	null	3	arm 1: Acyline 300 µg/kg injections every two weeks (2 doses) + placebo (no active ingredients) gel daily for 28 days + oral placebo pill daily for 28 days arm 2: Acyline 300 µg/kg injections every two weeks (2 doses) + Testosterone gel 100 mg daily for 28 days + oral placebo pill daily for 28 days arm 3: Acyline 300 μ...	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days intervention 2: Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral ...	intervention 1: Acyline intervention 2: Acyline + Testosterone gel intervention 3: Acyline + testosterone gel + anastrozole	0	null	22	NCT00729859	1COMPLETED	2010-05-01	2008-12-01	University of Washington	7OTHER	false	false	false	null	0
[ 5 ]	491	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.	null	Hypertension	nebivolol Bystolic ™ lisinopril losartan Hypertension	null	2	arm 1: Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration arm 2: Matching placebo tablets, oral administration	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration intervention 2: Lisinopril 10mg, 20mg total daily dosage, oral administration Los...	intervention 1: nebivolol intervention 2: Placebo	75	Gulf Shores \| Alabama \| United States \| -87.70082 \| 30.24604 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Bell Gardens \| California \| U...	491	NCT00734630	1COMPLETED	2010-05-01	2008-08-01	Forest Laboratories	4INDUSTRY	false	false	false	null	-0
[ 5 ]	161	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	1FEMALE	true	This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.	This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary inco...	Stress Incontinence	Urinary tract infection (UTI) suburethral sling Prevention Nitrofurantoin Prophylaxis	null	2	arm 1: Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively arm 2: Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence intervention 2: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.	intervention 1: Nitrofurantoin intervention 2: Placebo	1	Temple \| Texas \| United States \| -97.34278 \| 31.09823	151	NCT00734968	1COMPLETED	2010-05-01	2008-05-01	University of Missouri-Columbia	7OTHER	false	false	false	null	0
[ 0 ]	3	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	1FEMALE	false	The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries. Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the heart do not function properl...	Endothelial function testing will be performed on women without significant coronary disease in order to help identify women who may be likely to develop coronary artery disease (CAD) and who would benefit from aggressive lifestyle (dietary counseling, exercise) or medical (treatment with aspirin and cholesterol and bl...	Chest Pain	coronary artery disease (CAD) chest pain myocardial ischemia endothelial function	null	2	arm 1: USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician. arm 2: TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therap...	[ 4, 1 ]	5	[ 0, 0, 0, 0, 5 ]	intervention 1: Aspirin 81 mg daily intervention 2: Lisinopril 10 mg every night intervention 3: Simvastatin 20 mg every night intervention 4: Lovaza 1 gram daily intervention 5: Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and w...	intervention 1: Aspirin intervention 2: Lisinopril intervention 3: Simvastatin intervention 4: Lovaza intervention 5: Therapeutic Lifestyle Changes	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	3	NCT00743197	6TERMINATED	2010-05-01	2008-05-01	Northwestern University	7OTHER	false	false	false	null	0
[ 3 ]	59	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the efficacy and safety of peginesatide injection for maintenance treatment of anemia in participants on peritoneal dialysis.	According to the International Federation of Renal Registries, in 1999 the prevalence of peritoneal dialysis in the United States as approximately 9.5% of patients receiving dialysis (2005 United States Renal Data Systems data indicates a prevalence of around 7.5%). Data from Europe in 1999 to 2000 (not including the U...	Anemia	Anemia Drug Therapy Peritoneal Dialysis.	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.	intervention 1: Peginesatide	23	Azusa \| California \| United States \| -117.90756 \| 34.13362 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Whittier \| California \| United States \| -118.03284 \| 33.97918 Naples \| Florida \| United States \| -81.79596 \| 26.14234 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Evergreen Park \| Illi...	59	NCT00752791	1COMPLETED	2010-05-01	2008-10-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 5 ]	36	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment.	Open-label single center trial to study improvements in symptom bother and quality of life in OAB patients self titrating solifenacin 5mg and 10 mg. The study was designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. After eligibility was confirmed, subjects complet...	Overactive Bladder		null	1	arm 1: Patients were given drug to self titrate	[ 5 ]	1	[ 0 ]	intervention 1: 5mg and 10 mg, oral once daily	intervention 1: Solifenacin	0	null	0	NCT00759577	6TERMINATED	2010-05-01	2008-09-01	NYU Langone Health	7OTHER	false	false	false	null	0
[ 3, 4 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous studies of GH use in...	1. Subjects. We will recruit 20 established Crohn patients from our gastroenterology (GI) referral practice at Nationwide Children's Hospital in Columbus, Ohio. Each will have previously undergone a complete diagnostic workup and classification of disease. Information on disease activity, location and behavior are rout...	Crohn Disease	poor growth inflammatory bowel disease	null	1	arm 1: Treatment with rhIGF (Increlex)	[ 0 ]	1	[ 0 ]	intervention 1: rhIGF will be administered as a subcutaneous injection per the following schema: First 2 weeks: 40 mcg/kg BID; Weeks 3 and 4: 80 mcg/kg BID; Subsequent weeks: 120 mcg/kg BID.	intervention 1: rhIGF (Increlex)	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	3	NCT00764699	6TERMINATED	2010-05-01	2008-10-01	Nationwide Children's Hospital	7OTHER	false	false	false	null	0
[ 3, 4 ]	192	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.	This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2...	Primary Insomnia	Primary insomnia	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 2, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted o...	intervention 1: Eszopiclone 1 mg intervention 2: Eszopiclone 2 mg intervention 3: Eszopiclone 3 mg intervention 4: Placebo intervention 5: Zolpidem Tartrate 10 mg	20	Toyohashi \| Aichi-ken \| Japan \| 137.38333 \| 34.76667 Akita \| Akita \| Japan \| 140.11667 \| 39.71667 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Kitakyushu \| Fukuoka \| Japan \| 130.85034 \| 33.85181 Kurume \| Fukuoka \| Japan \| 130.51667 \| 33.31667 Gifu \| Gifu \| Japan \| 136.76039 \| 35.42291 Hiroshima \| Hiroshima \| Japan \| 13...	348	NCT00770510	1COMPLETED	2010-05-01	2008-09-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	369	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.	This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.	Insomnia	insomnia primary insomnia insomnia associated with psychiatric or physical disorder(s)	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment. intervention 2: Elderly participants: Eszopiclone 2 mg...	intervention 1: Eszopiclone 1 mg- Elderly intervention 2: Eszopiclone 2 mg- Elderly intervention 3: Eszopiclone 3 mg- Non-elderly intervention 4: Eszopiclone 2 mg- Non-elderly	34	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Akita \| Akita \| Japan \| 140.11667 \| 39.71667 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Iizuka \| Fukuoka \| Japan \| 130.68678 \| 33.63654 Kitakyushu \| Fukuoka \| Japan \| 130.85034 \| 33.85181 Koga \| Fukuoka \| Japan \| 130.68709 \| 33.86429 Kurume \| Fukuoka \| Japan \| 130.516...	325	NCT00770692	1COMPLETED	2010-05-01	2008-10-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	287	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia	This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clini...	Schizophrenia		null	4	arm 1: At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of ar...	[ 1, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 150 mg/day armodafinil intervention 2: placebo intervention 3: 200 mg/day armodafinil intervention 4: 250 mg/day armodafinil	intervention 1: armodafinil intervention 2: placebo intervention 3: armodafinil intervention 4: armodafinil	39	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Escondido \| California \| United States \| -117.08642 \| 33.11921 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Pico R...	281	NCT00772005	1COMPLETED	2010-05-01	2008-09-01	Cephalon	4INDUSTRY	false	false	false	null	0
[ 3 ]	58	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney and liver. LCP-Tacro...	This was a randomized, parallel-group, open-label, multicenter study in adult de novo liver transplant patients to demonstrate the pharmacokinetics and safety of once-daily treatment of LCP-Tacro tablets and twice-daily Prograf capsules in the first 2 weeks after live transplantation. The study also compared the effica...	Liver Failure	Liver Hepatic Transplantation Immunosuppression Tacrolimus Prograf	null	2	arm 1: LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) arm 2: Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL. ...	intervention 1: LCP -Tacro intervention 2: Prograf	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	58	NCT00772148	1COMPLETED	2010-05-01	2008-10-01	Veloxis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	440	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) ...	null	Hypercholesterolemia		null	4	arm 1: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. arm 2: Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg onc...	[ 0, 1, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. intervention 2: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then re...	intervention 1: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg intervention 2: Comparator: rosuvastatin 10 mg intervention 3: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg intervention 4: Comparator: rosuvastatin 20 mg	0	null	440	NCT00783263	1COMPLETED	2010-05-01	2008-11-01	Organon and Co	4INDUSTRY	false	false	false	null	0
[ 2 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.	null	Arthritis, Psoriatic		null	3	arm 1: Lowest dose PG102 arm 2: Second dose PG102 arm 3: Control	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: A single intravenous infusion intervention 2: Phosphate-buffered saline	intervention 1: PG102 intervention 2: Placebo comparator	1	Belgrade \| N/A \| Serbia \| 20.46513 \| 44.80401	17	NCT00787137	6TERMINATED	2010-05-01	2008-12-01	PanGenetics UK Limited	4INDUSTRY	false	false	false	null	0
[ 3 ]	63	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerat...	null	Fragile X Syndrome	fragile X syndrome irritability behavior problems	null	2	arm 1: STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks arm 2: variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks intervention 2: variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks	intervention 1: STX209 intervention 2: Placebo	12	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Boston \| Massa...	126	NCT00788073	1COMPLETED	2010-05-01	2008-11-01	Seaside Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	3,235	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.	Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography (ideally within 72 hours) will be assessed for eligibility and consented. Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5 milligram (mg), subcutaneous (s.c.), once daily. Fol...	Acute Coronary Syndrome	Unstable angina Non ST elevation myocardial infarction PCI unfractionated heparin fondaparinux acute coronary syndrome	null	3	arm 1: Subjects indicated for PCI and randomized to receive standard dose UFH arm 2: Subjects indicated for PCI and randomized to receive low dose UFH arm 3: Subjects not indicated for PCI and not randomized	[ 0, 0, 5 ]	3	[ 0, 0, 0 ]	intervention 1: Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein \[GP\] IIb/IIIa inhibitor use...	intervention 1: fondaparinux background and standard dose UFH intervention 2: Fondaparinux background and low dose heparin intervention 3: Open label fondaparinux	203	Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Adrogué \| Buenos Aires \| Argentina \| -58.38384 \| -34.80041 Bahía Blanca \| Buenos Aires \|...	3,235	NCT00790907	1COMPLETED	2010-05-01	2009-02-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	15	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	true	0ALL	false	The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.	null	Allergic Rhinitis		null	2	arm 1: fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week arm 2: placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 2 puffs in each nostril once daily for 1 week intervention 2: 2 puffs in each nostril once daily for 1 week	intervention 1: fluticasone furoate intervention 2: Placebo	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	30	NCT00791973	1COMPLETED	2010-05-01	2008-11-01	University of Chicago	7OTHER	false	false	false	null	0
[ 0 ]	8	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Schizophrenia patients treated with clozapine have a high prevalence of obesity-related metabolic syndrome. The condition is often poorly treated and may lead to the emergence of coronary heart disease and type 2 diabetes. The study will investigate whether structured treatment provided at the site of the outpatient ps...	Background Compared with the general population, patients with schizophrenia have an increased risk of death from atherosclerotic cardiovascular diseases (ASCVD) that reflect coronary heart disease, stroke and peripheral vascular disease (Newcomer, 2007). Among the factors contributing to the increased prevalence of A...	Metabolic Syndrome		null	2	arm 1: Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic arm 2: Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community	[ 0, 5 ]	2	[ 0, 10 ]	intervention 1: The intervention in the 4 patients consisted in dietary recommendations, advice regarding increasing physical activity, and use of Orlistat 60 mg three times daily. No other drugs were prescribed. intervention 2: As selected by community physician	intervention 1: Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan intervention 2: As selected by community physician	1	Glen Oaks \| New York \| United States \| -73.71152 \| 40.74705	8	NCT00794963	6TERMINATED	2010-05-01	2008-11-01	Northwell Health	7OTHER	false	false	false	null	0
[ 3, 4 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.	The methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. Evaluations of hemoglobin A1C (A1C) -- A measurement of blood glucose over the past 3 months -- will be done at baseline \[before placebo ...	Type 2 Diabetes	Herbal Supplement Type 2 Diabetes Mulberry Hemoglobin A1C	null	2	arm 1: Control Group arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months intervention 2: Placebo 500 mg #2 capsules by mouth three times daily	intervention 1: Mulberry Leaf Extract intervention 2: Placebo	1	Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876	24	NCT00795704	1COMPLETED	2010-05-01	2008-04-01	University of Mississippi Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	857	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For...	null	Diabetes Mellitus, Type 2		null	6	arm 1: BI 1356 low dose + metformin 500 mg, twice daily arm 2: matching placebo arm 3: BI 1356 low dose + metformin 1000 mg, twice daily arm 4: Metformin 500 mg, twice daily arm 5: Metformin 1000 mg, twice daily arm 6: BI 1356 high dose, once daily	[ 0, 2, 0, 1, 1, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: BI 1356 high dose tablet, once daily intervention 2: BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily intervention 3: BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily intervention 4: Metformin 500 mg tablet, twice daily intervention 5: metformin 1000 mg tablet, twice daily i...	intervention 1: BI 1356 intervention 2: BI 1356 + metformin intervention 3: Bi 1356 + metformin intervention 4: Metformin intervention 5: metformin intervention 6: matching placebo	138	Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Red Deer \| Alberta \| Canada \| -113.802 \| 52.26682 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Oak...	857	NCT00798161	1COMPLETED	2010-05-01	2008-12-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	252	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection	null	Leukopenia	high-risk leukopenic patients	null	2	arm 1: Posaconazole oral suspension 200 mg three times a day (TID) arm 2: Fluconazole 400 mg once daily (QD)	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 40 mg/mL; 200 mg (5 mL) TID Treatment was continued with each cycle of chemotherapy until: * The onset of a proven or probable diagnosis of invasive fungal infection (IFI) * 3 chemotherapy cycles or * Total treatment duration up to 12 weeks (84 days) intervention 2: 50 mg/capsule (2 capsules), 150 mg/...	intervention 1: Posaconazole intervention 2: Fluconazole	0	null	245	NCT00811928	1COMPLETED	2010-05-01	2008-11-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	179	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.	null	Acne Vulgaris	Moderate Acne Vulgaris Oral contraceptive Female	null	2	arm 1: In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). arm 2: The participants of the placebo group received inert but identical-appearing,...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd intervention 2: Inert tablet	intervention 1: EE20/Drospirenone (YAZ, BAY86-5300) intervention 2: Placebo	7	Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Changsha \| Hunan \| China \| 112.97087 \| 28.19874 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Chengdu \| Sichuan \| China \| 104.06667 \| 30.66667 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Shanghai \| N/A \| China \| 121.45806 \|...	173	NCT00818519	1COMPLETED	2010-05-01	2008-12-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 5 ]	41	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	The design of the study will be randomized, double blind trial, which will examine the effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and C-III as compared to Fenofibrate and placebo. This...	Treatment of patients with type 2 Diabetes Mellitus (DM) consists of reducing hyperglycemia through diet, exercise, oral drug therapy or insulin (1). The Thiazolidinedione (TZDs), which include Troglitazone (withdrawn by the FDA), Rosiglitazone, and Pioglitazone, correct hyperglycemia by increasing insulin sensitivity ...	Hypertriglyceridemia in Type 4 Hyperlipidemia Non Diabetic Subjects With Normoglycemia	Type 4 hyperlipidemia Rosiglitazone Fenofibrate	null	4	arm 1: Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks arm 2: Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks arm 3: Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks arm 4: Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 week...	[ 1, 1, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Rosiglitazone 8mg daily for 12 weeks intervention 2: Placebo (Rosiglitazone) 8mg daily for 12 weeks intervention 3: Placebo (Fenofibrate) 145 mg daily for 12 weeks intervention 4: Fenofibrate 145 mg daily for 12 weeks	intervention 1: Rosiglitazone intervention 2: Placebo (Rosiglitazone) intervention 3: Placebo (Fenofibrate) intervention 4: Fenofibrate	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	41	NCT00819910	6TERMINATED	2010-05-01	2008-09-01	Ahmad Slim	1FED	false	false	false	null	0
[ 3 ]	68	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.	null	Type 2 Diabetes Mellitus		null	2	arm 1: Participants receiving placebo tablets three times daily plus insulin injection once daily arm 2: Participants receiving MK-0941 tablets three times daily plus insulin injection once daily	[ 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose. intervention 2: Placebo tablets, taken 3 times daily. intervention 3: Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.	intervention 1: MK-0941 intervention 2: Placebo intervention 3: Insulin	0	null	68	NCT00824616	1COMPLETED	2010-05-01	2009-01-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to evaluate 1) the incidence of insulin resistance (a pre-diabetic state) in patients with pulmonary hypertension, and 2) test the utility of a validated PH therapy (Tracleer) versus Pioglitazone in the treatment of those patients found to have insulin resistance.	The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension ,is a study evaluating the incidence of insulin resistance in patients with pulmonary hypertension and testing the utility of a validated PH therapy(Tracleer) versus Pioglitazone in the treatment of those patients found to ...	Hypertension, Pulmonary	pulmonary hypertension & insulin resistance	null	2	arm 1: Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily. arm 2: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study. intervention 2: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.	intervention 1: bosentan intervention 2: Pioglitazone	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	2	NCT00825266	6TERMINATED	2010-05-01	2008-09-01	Stanford University	7OTHER	false	false	false	null	0
[ 5 ]	21	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is: To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities. This investigation w...	Methods: Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia (\<500) APACHE II scores \> 20, or significant liver disease will be excluded. All will give written informed consent (Pappas et al. CID. Oct 1, 2007). Drugs - Patients will receive either CFG: 70 mg loading dose (LD) fol...	Candidemia	candidemia echinocandin micafungin caspofungin	null	3	arm 1: Patients receive Micafungin 100 mg qd arm 2: Patients receive 200 mg Micafungin qd arm 3: Patients receive caspofungin 70 mg LD followed by 50 mg qd	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 100 mg qd by slow IV infusion for 24 h intervention 2: 200 mg qd by slow IV infusion for 24 h intervention 3: 70 mg LD followed by 50 mg qd by slow IV infusion for 24 h	intervention 1: micafungin intervention 2: Micafungin intervention 3: Caspofungin	1	Lansing \| Michigan \| United States \| -84.55553 \| 42.73253	21	NCT00839540	1COMPLETED	2010-05-01	2008-12-01	Gary E. Stein, Pharm.D.	7OTHER	false	false	false	null	0
[ 5 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	1FEMALE	true	A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discha...	This is a randomized controlled trial. Participants will be assigned with equal probability to 1 of the 2 test groups using computer-generated random numbers in blocks of varying sizes. Allocation concealment will be assured by enclosing assignments in sequentially numbered, opaque, sealed envelopes. Envelopes will be ...	Complications; Contraceptive Female Lactation	Contraceptive Implant Postpartum period etonogestrel-releasing lactogenesis Breastfeeding	null	2	arm 1: Early postpartum insertion arm 2: Standard postpartum insertion	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Implant insertion postpartum prior to hospital discharge intervention 2: Standard insertion at 4-8 weeks postpartum	intervention 1: Etonogestrel contraceptive implant intervention 2: Etonogestrel contraceptive implant	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	69	NCT00847587	1COMPLETED	2010-05-01	2009-01-01	University of Utah	7OTHER	false	false	false	null	0
[ 4 ]	28	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.	null	Schizophrenia	Quetiapine efficacy in schizophrenia	null	0	null	null	1	[ 0 ]	intervention 1: 600mg Extended release tablet, oral, once daily	intervention 1: Quetiapine fumarate (Seroquel)	3	Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398 Chiang Mai \| N/A \| Thailand \| 98.98468 \| 18.79038 Songkhla \| N/A \| Thailand \| 100.5951 \| 7.19882	28	NCT00852631	6TERMINATED	2010-05-01	2009-02-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 2 ]	131	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Test the safety, tolerability and improvement of blood sugar control with combination therapy in individuals with Type 2 Diabetes.	null	Diabetes Mellitus, Type 2		null	4	arm 1: Weekly LY2428757 plus 3 milligrams (mg) daily TT223 arm 2: Weekly LY2428757 plus 2 mg daily TT223 arm 3: Weekly LY2428757 plus daily TT223 placebo arm 4: Weekly LY2428757 placebo plus daily TT223 placebo	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 14 mg subcutaneous injection 1 time a week for 5 weeks intervention 2: subcutaneous injection once a day for 4 weeks intervention 3: subcutaneous injection 1 time a week for 5 weeks intervention 4: subcutaneous injection once a day for 4 weeks	intervention 1: LY2428757 intervention 2: TT223 intervention 3: Placebo for LY2428757 intervention 4: Placebo for TT223	29	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Artesia \| California \| United States \| -118.08312 \| 33.86585 Fresno \| California \| United States \| -119.77237 \| 36.74773 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Norwalk \| Califor...	131	NCT00853151	1COMPLETED	2010-05-01	2009-02-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	226	NON_RANDOMIZED	SINGLE_GROUP	2DIAGNOSTIC	1SINGLE	true	0ALL	false	The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).	There will be two primary analyses: * The first primary analysis will evaluate the correlation between the blinded readers' rating of amyloid plaque density on the PET scan and the cortical amyloid plaque density at autopsy. * The second primary analysis will evaluate the specificity of the blinded readers' rating of ...	Alzheimer's Disease	florbetapir F 18 PET amyloid imaging Amyloid pathology in the brain	null	2	arm 1: End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. arm 2: Younger healthy controls presumed to be devoid of beta-amyloid plaques.	[ 0, 0 ]	1	[ 0 ]	intervention 1: Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration	intervention 1: florbetapir F 18	25	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Irvine \| California \| United States \| -117.82311 \| 33.66946 San Francisco \| Cali...	226	NCT00857415	1COMPLETED	2010-05-01	2008-12-01	Avid Radiopharmaceuticals	4INDUSTRY	false	false	false	null	-0
[ 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.	Smoking rates are elevated among drinkers compared to non-drinkers (Marks et al., 1997). Moreover, there is some evidence that both smokers who drink alcohol are less successful quitting smoking (Leeman, Huffman, \& O'Malley, 2007). Thus, identifying interventions that are effective in reducing both smoking and heavy d...	Nicotine Dependence Smoking Heavy Drinking	Smoking cessation Smoking Tobacco Varenicline Alcohol	null	2	arm 1: Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment. arm 2: Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varen...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment. intervention 2: 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twic...	intervention 1: Extended Varenicline Pretreatment intervention 2: Short-term Varenicline Pretreatment	0	null	30	NCT00860028	1COMPLETED	2010-05-01	2008-10-01	Yale University	7OTHER	false	false	false	null	0
[ 2, 3 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	This trial is designed to determine the proper doses of Docetaxel and Imatinib mesylate to be used to treat hormone refractory prostate cancer and to evaluate the safety and efficacy of the treatment.	Androgen-independent prostate cancer is the second most common cause of cancer death in men. These patients have limited treatment options. Docetaxel(Taxotere) is the single most active agent for the treatment of hormone refractory prostate cancer. Phase II clinical trials including docetaxel combinations with other mi...	Prostate Cancer Prostatic Neoplasms	hormone refractory prostate cancer tyrosine kinase inhibitor Gleevec PSA prostate specific antigen growth factor receptor inhibitor androgen independent	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: One treatment cycle is defined as 21 days. Docetaxel: 70 mg/m\^2 (60 mg/m\^2 was tested in Phase I as well), Intravenous, every 21 days. intervention 2: One treatment cycle is defined as 21 days. Imatinib Mesylate: 24-36 hours after Docetaxel, 600 mg (400 mg was tested in Phase I as well), orally, dai...	intervention 1: Docetaxel intervention 2: Imatinib Mesylate	3	New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427	12	NCT00861471	6TERMINATED	2010-05-01	2005-05-01	NYU Langone Health	7OTHER	false	false	false	null	0
[ 2, 3 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in patients with hepatocellular carcinoma. These include: * Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition, in p...	A randomized phase I/II, multi-center, open-label, study with a single arm phase I portion to determine the appropriate dose of PR104 combined with sorafenib, followed by a phase II portion with randomization between sorafenib and sorafenib/PR104. Following informed consent, subjects will undergo baseline evaluation w...	Hepatocellular Carcinoma		null	1	arm 1: PR104 will be administered IV once every four weeks, in addition to 400mg sorafenib PO twice daily	[ 0 ]	2	[ 0, 0 ]	intervention 1: 550 mg/m\^2 PR104 IV on day 1 of each 28 day cycle + 400 mg sorafenib PO twice daily. Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: 770 mg/m\^2 PR104 IV on day 1 of each 28 day cycle + 400 mg sorafenib PO twice daily. Number of Cycles: until progression or unacce...	intervention 1: PR104 550 mg/m^2 + sorafenib intervention 2: PR104 770 mg/m^2 + sorafenib	17	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Orange \| California \| United States \| -117.85311 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Chicago \| Il...	14	NCT00862082	6TERMINATED	2010-05-01	2009-03-01	Proacta, Incorporated	4INDUSTRY	false	false	false	null	0
[ 3 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The current understanding of PR104 justifies the evaluation of PR104 with docetaxel in subjects with Non Small Cell Lung Cancer (NSCLC). These include: * Aldo-keto reductase 1C3 (AKR1C3). NSCLC has been shown to express high levels of AKR1C3 in about one half of tumors tested. Subjects with high levels of AKR1C3 shoul...	A randomized phase II, multi-center, open-label, study of docetaxel versus docetaxel/PR104. Following informed consent, subjects will undergo baseline evaluation with history, physical exams, blood work and disease assessment. Selected subjects will undergo PET imaging with F18 fluoromisonidazole (F18-FMISO) and Flude...	Non-Small Cell Lung Cancer		null	2	arm 1: Subjects randomized to the docetaxel arm will be administered 75 mg/m\^2, IV, every 21 days (an approved dose and schedule) arm 2: Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.	[ 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 770 mg/m\^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: 75 mg/m\^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops. intervention 3: 60 mg/m\^2, IV, every 21 days. Number of Cycles: until progression ...	intervention 1: PR104 intervention 2: docetaxel intervention 3: docetaxel intervention 4: Granulocyte colony-stimulating factor	27	San Diego \| California \| United States \| -117.16472 \| 32.71571 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Skokie \| Illinois \| United States \| -87.73339 \| 42.03336 Zion \| Illinois \| United States \| -87.83285 \| 42.44613 Beech Grove \| Indiana \| United S...	40	NCT00862134	6TERMINATED	2010-05-01	2009-03-01	Proacta, Incorporated	4INDUSTRY	false	false	false	null	0
[ 5 ]	14	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	null	The primary objective of this study is to determine the average bioequivalence of tenofovir, emtricitabine and efavirenz in an extemporaneously prepared oral liquid formulation (test formulation) compared with the commercially available tablet formulation (reference formulation). The study is designed as an open-label,...	null	Healthy	Healthy Volunteers	null	2	arm 1: Drug exposure after administration of Atripla Tablet arm 2: Drug exposure after administration of an extemporaneously prepared liquid formulation of Atripla	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Atripla contains 300mg of tenofovir, 200mg of emtricitabine and 600mg of efavirenz intervention 2: Atripla contains 300mg of tenofovir, 200mg of emtricitabine and 600mg of efavirenz	intervention 1: tenofovir, emtricitabine and efavirenz fixed dose tablet intervention 2: tenofovir, emtricitabine and efavirenz tablet added to solution	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	16	NCT00862823	1COMPLETED	2010-05-01	2009-02-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0
[ 5 ]	125	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus i...	null	Primary Hypercholesterolemia		null	3	arm 1: Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg arm 2: Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 m...	[ 0, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) intervention 2: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) intervention 3: 2 tablets of 10 mg daily for 12 weeks (Weeks 5-16) intervention 4: 1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)	intervention 1: Ezetimibe intervention 2: Atorvastatin intervention 3: Atorvastatin intervention 4: Rosuvastatin	0	null	125	NCT00871351	1COMPLETED	2010-05-01	2009-02-01	Organon and Co	4INDUSTRY	false	false	false	null	0
[ 4 ]	706	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.	null	Hypertension		null	2	arm 1: Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination arm 2: Amlodipine 5 for two weeks, then forced titration to Amlodipine 10	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Telmisartan 80 mg intervention 2: Amlodipine 5 for two weeks, then forced titration to Amlodipine 10 intervention 3: Amlodipine 5 for two weeks, then forced titration to Amlodipine 10	intervention 1: Telmisartan 80 intervention 2: Amlodipine 10 intervention 3: Amlodipine 10	65	Long Beach \| California \| United States \| -118.18923 \| 33.76696 Tustin \| California \| United States \| -117.82617 \| 33.74585 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Tucker \| ...	706	NCT00877929	1COMPLETED	2010-05-01	2009-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	-0
[ 4 ]	324	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Ps...	null	Cystic Fibrosis	cystic fibrosis P. aeruginosa tobramycin	null	2	arm 1: tobramycin / Bramitob administered 300mg twice a day for 4 weeks arm 2: tobramycin / TOBI administered 300mg twice a day for 4 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen intervention 2: 300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen	intervention 1: tobramycin / Bramitob intervention 2: tobramycin / TOBI	44	Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Caen \| N/A \| France \| -0.35912 \| 49.18585 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Paris \| N/A \| France \| 2.3488 \| 48.85341 GieBen \| N/A \| Germany \| N/A \| N/A Krefeld \| N/A \| Germany \| 6.55381 \| 51.33645 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Mosdós \| N/A \| Hu...	324	NCT00885365	1COMPLETED	2010-05-01	2009-04-01	Chiesi Farmaceutici S.p.A.	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	20	NON_RANDOMIZED	SEQUENTIAL	0TREATMENT	1SINGLE	false	0ALL	false	This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.	This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.	Chronic Kidney Disease	metabolic acidosis chronic kidney disease Estimated GFR 15-45	null	2	arm 1: Sequential design. Participants will be getting different doses of sodium bicarbonate during the study. arm 2: Sequential design. Participants will be getting either placebo of different doses during the study.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight intervention 2: Placebo at 3 different doses to match Sodium bicarbonate dosing	intervention 1: Sodium bicarbonate intervention 2: Placebos	1	The Bronx \| New York \| United States \| -73.86641 \| 40.84985	40	NCT00888290	1COMPLETED	2010-05-01	2009-03-01	Albert Einstein College of Medicine	7OTHER	false	false	false	null	0
[ 3 ]	415	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.	null	Cataract Inflammation	Surgery	null	2	arm 1: BOL-303242-X (Mapracorat) arm 2: Vehicle for BOL-303242-X (Mapracorat)	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules. intervention 2: Medication instilled into the study eye, subjects randomized to various drug dose schedules.	intervention 1: BOL-303242-X intervention 2: Vehicle for BOL-303242-X	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	415	NCT00905450	1COMPLETED	2010-05-01	2009-06-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0
[ 5 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to learn about the efficacy of a medication called varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be improved with varenicline treatment. The inv...	null	Attention Deficit/Hyperactivity Disorder Smoking Cessation	ADHD Attention Deficit Hyperactivity Disorder ADHD medication Chantix varenicline smoking smoking cessation quit smoking	null	1	arm 1: Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.	[ 0 ]	1	[ 0 ]	intervention 1: Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start...	intervention 1: Varenicline (Chantix)	0	null	2	NCT00907218	6TERMINATED	2010-05-01	2009-04-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 4 ]	219	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.	null	Type 2 Diabetes		null	2	arm 1: (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) arm 2: (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)	[ 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Tablets, Oral, 5 mg, once daily, 4 weeks intervention 2: Tablets, Oral, 1500 mg, once daily, 4 weeks intervention 3: Tablets, Oral, 0 mg, once daily, 4 weeks intervention 4: Tablets, Oral, 500 mg, once daily, 4 weeks intervention 5: Tablets, Oral, 0 mg, once daily, 4 weeks	intervention 1: Saxagliptin intervention 2: Metformin XR intervention 3: Placebo matching Metformin XR intervention 4: Metformin XR intervention 5: Placebo matching Saxagliptin	21	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Redlands \| California \| United States \| -117.18254 \| 34.05557 Tustin \| California \| United States \| -117.82617 \| 33.74585 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Hialeah \| Florida \| United States \| -80.27811 \| 25.8576 North Miami \| Florida ...	93	NCT00918138	1COMPLETED	2010-05-01	2009-08-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	116	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.	Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical ...	Depression	Depression	null	1	arm 1: 12-week open label with 2 week placebo period (14 weeks total)	[ 0 ]	1	[ 0 ]	intervention 1: 10mg tab daily	intervention 1: Escitalopram	0	null	90	NCT00918684	1COMPLETED	2010-05-01	2002-12-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0
[ 4 ]	100	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.	null	Pulmonary Disease, Chronic Obstructive		null	4	arm 1: Medium Dose once Daily arm 2: Low Dose once Daily arm 3: Placebo once Daily arm 4: 12 mcg twice daily	[ 0, 0, 2, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: BI1744 Respimat low dose once daily and placebo Foradil intervention 2: BI1744 Respimat medium dose once daily and placebo Foradil intervention 3: Placebo Respimat once daily and placebo Foradil intervention 4: 12 mcg twice daily and placebo Respimat	intervention 1: BI 1744 (Olodaterol) Low Dose intervention 2: BI 1744 (Olodaterol) Medium Dose intervention 3: Placebo intervention 4: Foradil	13	Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Austell \| Georgia \| United States \| -84.63438 \| 33.81261 Albuquerque \| New Mexico \| United S...	375	NCT00932646	1COMPLETED	2010-05-01	2009-06-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	7	NON_RANDOMIZED	SINGLE_GROUP	null	0NONE	true	0ALL	false	The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).	BACKGROUND: Infection is a leading cause of morbidity and mortality in end-stage renal disease (ESRD) patients.\[1, 2\] Ertapenem is an antibiotic used for the treatment of infections caused by several organisms, including both Gram positive and negative infections.3 Although ertapenem pharmacokinetic (PK) parameters ...	Continuous Ambulatory Peritoneal Dialysis End Stage Renal Disease	ertapenem CAPD dialysis	null	1	arm 1: All patients will receive ertapenem 500 mg IV once.	[ 1 ]	1	[ 0 ]	intervention 1: 500 mg IV once	intervention 1: ertapenem	1	Clifton Park \| New York \| United States \| -73.77095 \| 42.86563	7	NCT00939952	1COMPLETED	2010-05-01	2009-06-01	Albany College of Pharmacy and Health Sciences	7OTHER	false	false	false	null	0
[ 4 ]	142	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.	null	Dental Pain		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1 single injection at day of dental surgical extraction intervention 2: 1 single injection at day of dental surgical extraction	intervention 1: Diclofenac HPBCD s.c. 75mg/ml intervention 2: Voltarol 75mg/3ml i.m.	3	Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Cardiff \| N/A \| United Kingdom \| -3.18 \| 51.48 Sheffield \| N/A \| United Kingdom \| -1.4659 \| 53.38297	142	NCT00943098	1COMPLETED	2010-05-01	2009-09-01	IBSA Institut Biochimique SA	4INDUSTRY	false	false	false	null	0
[ 3 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.	The planned sample size of 15 participants per treatment group is in keeping with other Phase II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate.	Pulmonary Tuberculosis	Early Bactericidal Activity EBA Pulmonary Tuberculosis PA-824 pretomanid	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 50mg intervention 2: 100mg intervention 3: 150 mg intervention 4: 275 mg intervention 5: 200 mg	intervention 1: PA-824 intervention 2: PA-824 intervention 3: PA-824 intervention 4: Rifafour e-275 mg intervention 5: PA-824	0	null	69	NCT00944021	1COMPLETED	2010-05-01	2009-08-01	Global Alliance for TB Drug Development	7OTHER	false	false	false	null	0
[ 4 ]	424	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.	null	Osteoarthritis Knee Pain	Osteoarthritis, Knee Pain	null	2	arm 1: Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labe...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: dose daily by mouth intervention 2: Placebo Comparator daily by mouth	intervention 1: Duloxetine (DLX) intervention 2: Placebo (PLA)	26	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Spring Valley \| California \| United States \| -116.99892 \| 32.74477 Morton Grove \| Illinois \| United States \| -87.78256 \| 42.04059 Prairie Village \| Kansas \| United States \| -94.63357 \| 38.99167 Toledo \|...	424	NCT00945945	1COMPLETED	2010-05-01	2009-07-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design).	null	Neuroendocrine Tumors Carcinoid Tumors Adrenal Gland Tumors Neuroblastoma Pancreatic Neuroendocrine Tumors Multiple Endocrine Neoplasia		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 840 mg, 420 mg, iv intervention 2: 150 mg, PO	intervention 1: pertuzumab intervention 2: erlotinib	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	4	NCT00947167	6TERMINATED	2010-05-01	2009-03-01	Pamela L. Kunz	7OTHER	false	false	false	null	0
[ 5 ]	425	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	true	Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerabilit...	null	Colonoscopy	Efficacy of bowel cleansing Patient tolerability Amitiza Dulcolax Miralax Colonoscopy preparation Bowel preparation Screening colonoscopy	null	4	arm 1: 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution wil...	[ 1, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Miralax 255gm bottle intervention 2: Amitiza 24mcg gelcap intervention 3: Bisacodyl 5mg tab x2 intervention 4: Golytely 1 gallon	intervention 1: Miralax (PEG 3350) intervention 2: Amitiza (Lubiprostone) intervention 3: Dulcolax (Bisacodyl) intervention 4: Golytely (polyethylene glycol)	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	403	NCT00953017	1COMPLETED	2010-05-01	2009-07-01	Brooke Army Medical Center	1FED	false	false	false	null	0
[ 3 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	Heart failure (HF) is a complex condition resulting from structural or functional heart diseases that impair the ability of the heart to fill with or pump out blood. The main manifestations of HF are shortness of breath and tiredness which may limit the ability to exercise or perform simple daily physical activities su...	null	Heart Failure		null	3	arm 1: placebo patch arm 2: 300 micrograms/day transdermal testosterone patch arm 3: 450 micrograms/day transdermal testosterone patch	[ 2, 0, 0 ]	2	[ 0, 0 ]	intervention 1: placebo patch intervention 2: 300 or 450 micrograms/day transdermal testosterone patch	intervention 1: placebo intervention 2: testosterone	16	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Lakewood \| California \| United States \| -118.13396 \| 33.85363 Riverside \| California \| United States \| -117.39616 \| 33.95335 Stamford \| Connecticut \| United States \| -73.53873 \| 41.05343 Melbourne \| Florid...	17	NCT00957034	6TERMINATED	2010-05-01	2009-07-01	Warner Chilcott	4INDUSTRY	false	false	false	null	0
[ 5 ]	1,034	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.	In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed ...	Variceal Bleeding, Cirrhosis	Cirrhosis, Esophagus Disorders, Varicose Veins	null	3	arm 1: treat with terlipressin IV for 5 days and endoscopic treatment arm 2: treat with somatostatin IV for 5 days and endoscopic treatment arm 3: treat with octreotide IV for 5 days and endoscopic treatment	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days intervention 2: loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days intervention 3: loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	intervention 1: Terlipressin intervention 2: Somatostatin intervention 3: Octreotide	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	780	NCT00966355	1COMPLETED	2010-05-01	2006-09-01	Korea University	7OTHER	false	false	false	null	0
[ 3 ]	417	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.	null	Type 2 Diabetes Mellitus	Type 2 diabetes mellitus Japanese phase 2 efficacy safety dapagliflozin	null	5	arm 1: 1mg dapagliflozin arm 2: 2.5mg dapagliflozin arm 3: 5mg dapagliflozin arm 4: 10mg dapagliflozin arm 5: Placebo	[ 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: once daily, 12 weeks intervention 2: once daily, 12 weeks	intervention 1: Dapagliflozin intervention 2: Placebo	20	Anjyo \| N/A \| Japan \| N/A \| N/A Bunkyō City \| N/A \| Japan \| 139.4217 \| 35.5331 Chūōku \| N/A \| Japan \| 130.67068 \| 33.63867 Daitō \| N/A \| Japan \| 135.62033 \| 34.71378 Kamagaya \| N/A \| Japan \| 140.00238 \| 35.76971 Kashiwara \| N/A \| Japan \| 135.76667 \| 34.45 Matsuyama \| N/A \| Japan \| 132.76574 \| 33.83916 Nagoya \| N/A \| Ja...	279	NCT00972244	1COMPLETED	2010-05-01	2009-08-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	57	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	2MALE	false	This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.	Primary Objective: The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it t...	Hypogonadism	Primary Hypogonadism Secondary Hypogonadism	null	4	arm 1: Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; arm 2: Treatment B: 11.0 mg Nasobol® (2 syringes), ...	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Intra-nasal Testosterone (2 syringes), b.i.d. intervention 2: QD administration	intervention 1: Nasobol® intervention 2: Androderm® (Positive Control)	6	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Burbank \| California \| United States \| -118.30897 \| 34.18084 Miami Gardens \| Florida \| United States \| -80.2456 \| 25.94204 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 San Antonio \| Texas \| ...	222	NCT00975650	1COMPLETED	2010-05-01	2009-08-01	Acerus Pharmaceuticals Corporation	4INDUSTRY	false	false	false	null	0
[ 2 ]	14	RANDOMIZED	CROSSOVER	null	2DOUBLE	true	0ALL	false	This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rH...	null	Healthy	insulin recombinant human hyaluronidase Healthy volunteers	null	1	arm 1: All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout. Intervention A: Participants received a single, subcutaneous (SC) injection of 95 un...	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: Recombinant human hyaluronidase PH20 (rHuPH20) intervention 2: Insulin lispro intervention 3: Insulin glulisine intervention 4: Insulin aspart	1	Chula Vista \| California \| United States \| -117.0842 \| 32.64005	84	NCT00979875	1COMPLETED	2010-05-01	2009-09-01	Halozyme Therapeutics	4INDUSTRY	false	false	false	null	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a medication called erlot...	null	Lung Cancer	AT-101 erlotinib Unresectable Stage IIIB 09-026	null	1	arm 1: This will be an open-label, single institution, phase II trial. The study will assess the efficacy of the combination of the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, and the novel pan-Bcl-2 inhibitor, AT-101, in treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGF...	[ 0 ]	1	[ 0 ]	intervention 1: Patients will receive oral erlotinib 100 mg daily and pulsed doses of oral AT-101 given 40 mg twice daily on days 1-3 of a 21-day cycle. If the initial combination of erlotinib and AT-101 is tolerated, dose escalation of erlotinib to 150 mg daily will be allowed at the discretion of the treating investi...	intervention 1: oral erlotinib and pulsed doses of oral AT-101	1	New York \| New York \| United States \| -74.00597 \| 40.71427	5	NCT00988169	6TERMINATED	2010-05-01	2009-09-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	47	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.	null	Secondary Hyperparathyroidism Hemodialysis	Secondary hyperparathyroidism Hemodialysis paricalcitol maxacalcitol	null	2	arm 1: 2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis arm 2: 5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completi...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Intravenous administration 3 times a week immediately before completion of dialysis intervention 2: Intravenous administration 3 times a week immediately before completion of dialysis	intervention 1: paricalcitol intervention 2: maxacalcitol	14	Anjo \| N/A \| Japan \| 137.08054 \| 34.95828 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Kumagaya \| N/A \| Japan \| 139.39004 \| 36.13497 Matsumoto \| N/A \| Japan \| 137.96667 \| 36.23333 Mito \| N/A \| Japan \| 140.45 \| 36.35 Nagasaki \| N/A \| Japan \| 129.88333 \| 32.75 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Sapporo \| N/A \| Japan \| ...	47	NCT00990704	1COMPLETED	2010-05-01	2009-10-01	Abbott	4INDUSTRY	false	false	false	null	0
[ 0 ]	22	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	true	2MALE	false	The purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.	This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-...	Hyperalgesia	opioid induced hyperalgesia	null	2	arm 1: Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals. arm 2: Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 15 mcg/kg IM intervention 2: 25 mg IM	intervention 1: Alfentanil intervention 2: Diphenhydramine	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	22	NCT00991809	1COMPLETED	2010-05-01	2009-02-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 4 ]	932	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.	null	Essential Hypertension	Blood pressure hypertension Exforge valsartan/amlodipine	null	3	arm 1: One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks arm 2: One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks arm 3: Single-Blind Ru...	[ 1, 0, 5 ]	3	[ 0, 0, 0 ]	intervention 1: Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily. intervention 2: Valsartan 160 mg capsule taken orally once daily. intervention 3: 1 capsule or tablet taken orally once daily	intervention 1: Valsartan/amlodipine 160/5 mg intervention 2: Valsartan 160 mg intervention 3: Placebo	2	N/A \| N/A \| N/A \| N/A \| N/A N/A \| N/A \| N/A \| N/A \| N/A	654	NCT01001572	1COMPLETED	2010-05-01	2009-09-01	Novartis	4INDUSTRY	false	false	false	null	-0
[ 2, 3 ]	50	NON_RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	true	0ALL	true	This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characteri...	null	Healthy	CECT - Contrast-enhanced computed tomography HCG - Human Chorionic Gonadotropin HU - Hounsfield Units Patient Safety Tolerance Pharmacokinetic	null	2	arm 1: None arm 2: An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration. intervention 2: An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.	intervention 1: GE-145 (AN113111) Injection intervention 2: Visipaque (iodixanol) Injection	1	Princeton \| New Jersey \| United States \| -74.65905 \| 40.34872	50	NCT01004770	1COMPLETED	2010-05-01	2009-10-01	GE Healthcare	4INDUSTRY	false	false	false	null	0
[ 5 ]	32	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once ev...	null	Rheumatoid Arthritis		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: tocilizumab 8 mg/kg intravenous infusion once in 4 weeks	intervention 1: tocilizumab [RoActemra/Actemra]	1	Piešťany \| N/A \| Slovakia \| 17.82591 \| 48.59479	32	NCT01010503	1COMPLETED	2010-05-01	2009-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is responsible for significant public health complications, including HIV infection. As a result effective treatments for MA dependence are urgently needed. There are currently no efficacious medications for MA dependence, although ...	Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is responsible for significant public health complications, including HIV infection1. As a result effective treatments for MA dependence are urgently needed. There are currently no efficacious medications for MA dependence, although...	Methamphetamine Dependence Substance Abuse Methamphetamine Abuse	methamphetamine crystal meth addiction los angeles medication meth	null	2	arm 1: Varenicline: 0.5 mg daily for days 1-3 0.5 mg twice daily for days 4-7 1 mg twice daily from day 8 until end of week 8. arm 2: 8 weeks of daily matching oral placebo in tablet form	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week ...	intervention 1: Varenicline intervention 2: Placebo	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	20	NCT01011829	1COMPLETED	2010-05-01	2009-11-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 5 ]	340	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuati...	null	Fibromyalgia	Milnacipran Pain Durability of Effect Loss of Therapeutic Response Fatigue Forest Research Institute Savella ®	null	2	arm 1: Placebo tablets administered orally twice daily arm 2: Milnacipran tablets administered orally twice daily	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Placebo tablets administered orally twice daily intervention 2: Milnacipran tablets administered orally twice daily	intervention 1: Placebo intervention 2: Milnacipran	58	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Fresno \| California \| United States \| -119.77237 \| 36.74773 Pismo Beach \| California \| United States \| -120.64128 \| 35.14275 Sacramento \| Calif...	338	NCT01014585	1COMPLETED	2010-05-01	2009-11-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 4 ]	378	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face. The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalen...	null	Acne Vulgaris	acne vulgaris	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning intervention 2: Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning	intervention 1: Adapalene/ BPO gel with Lymecycline capsules intervention 2: Adapalene/ BPO vehicle gel with Lymecycline capsules	28	Canberra \| N/A \| Australia \| 149.12807 \| -35.28346 Kogarah \| N/A \| Australia \| 151.13564 \| -33.9681 Melbourne \| N/A \| Australia \| 144.96332 \| -37.814 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| ...	378	NCT01014689	1COMPLETED	2010-05-01	2009-08-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 3 ]	30	RANDOMIZED	SINGLE_GROUP	0TREATMENT	1SINGLE	false	1FEMALE	false	Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles. One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation o...	There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical res...	Wrinkles	Forehead Wrinkles Toxin	null	1	arm 1: None	[ 5 ]	2	[ 0, 0 ]	intervention 1: One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized. intervention 2: One botulinum toxin type A will be injected in one side of ...	intervention 1: Botulinum Toxin Type A - Azzalure intervention 2: Botulinum Toxin Type A - Vistabel	1	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437	60	NCT01014871	1COMPLETED	2010-05-01	2009-07-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 3 ]	151	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.	null	Psoriasis	Psoriasis Topical corticosteroids Plaque psoriasis	null	6	arm 1: Desoximetasone topical spray 0.05% administered once daily to affected area arm 2: Desoximetasone topical spray 0.05% administered twice daily to affected area arm 3: Desoximetasone topical spray 0.25% administered once daily to affected area arm 4: Desoximetasone topical spray 0.25% administered twice daily to ...	[ 0, 0, 0, 0, 2, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days intervention 2: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days intervention 3: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days interve...	intervention 1: Desoximetasone 0.05% once daily intervention 2: Desoximetasone 0.05% twice daily intervention 3: Desoximetasone 0.25% once daily intervention 4: Desoximetasone 0.25% once daily intervention 5: Vehicle once daily intervention 6: Vehicle twice daily	7	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Martinez \| Georgia \| United States \| -82.07567 \| 33.51736 Olathe \| Kansas \| United States \| -94.81913 \| 38.8814 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Cincinnati \| Ohio \| United State...	150	NCT01018134	1COMPLETED	2010-05-01	2009-11-01	Sun Pharmaceutical Industries, Inc.	4INDUSTRY	false	false	false	null	0
[ 2 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	2MALE	false	This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hy...	null	Hypertension		null	10	arm 1: Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. arm 2: 1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Perio...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg. intervention 2: Single dose administration of candesartan, 32 mg oral tablet intervention 3: Placebo	intervention 1: MK-5478 intervention 2: Comparator: Candesartan cilexetil intervention 3: Comparator: Pbo	0	null	88	NCT01025843	1COMPLETED	2010-05-01	2009-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 2 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in subjects will mild to moderate Alzheimer's disease.	null	Alzheimer's Disease	Phase 1 Alzheimer's disease Safety Tolerability Pharmacokinetics	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: PF-03654746 capsule of 0.25 mg, 0.5 mg, and 1.0 mg strength. Drug is dosed orally once a day. Forced titration dosing for the first 15 days of the study being at 0.25 mg for 5 days, then 0.5 mg for days 6-10, then 1.0 mg for days 11-15. Flexible dosing for the next 15 days depending on tolerability and ...	intervention 1: PF-03654746 intervention 2: Placebo	2	Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224	9	NCT01028911	6TERMINATED	2010-05-01	2009-12-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	10	RANDOMIZED	CROSSOVER	6HEALTH_SERVICES_RESEARCH	0NONE	true	0ALL	false	Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole compared to normal weight subjects to achieve comparable plasma exposures. The current study is designed to address this issue.	The prevalence of obesity has increased tremendously in the past two decades. An estimated 1 out of 5 persons in the United States are classified as obese. Under representation of obese patients in pharmacokinetic trials grossly limit generalizability of drug dosing recommendations in this emerging population. No publi...	Healthy	Voriconazole Pharmacokinetics Obese Healthy Volunteer	null	2	arm 1: Voriconazole administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg Every 12 Hours x 7 Doses) followed by 7 day washout followed by Loading Dose (400 mg x 2 Doses, Day 1) and a Maintenance Doses (300 mg Every 12 Hours x 7 Doses) arm 2: Voriconazole administered by Mout...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Voriconazole 400 mg po x 2 doses (loading dose)then 200 mg po twice daily x 7 doses intervention 2: Voriconazole 400 mg po x 2 doses (loading dose)then 300 mg po twice daily x 7 doses	intervention 1: Voriconazole low dose intervention 2: Voriconazole high dose	1	Paramus \| New Jersey \| United States \| -74.07542 \| 40.94454	16	NCT01030653	1COMPLETED	2010-05-01	2009-11-01	Manjunath Prakash Pai	7OTHER	false	false	false	null	0
[ 3 ]	250	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.	The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. After an appropriate period of time following ...	Pain	Postoperative Pain	null	5	arm 1: 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). arm 2: 1...	[ 2, 1, 1, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: Hydrocodone/Acetaminophen Extended Release intervention 2: Acetaminophen intervention 3: Morphine Extended Release intervention 4: Placebo	4	Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Austin \| Texas \| United States \| -97.74306 \| 30.26715 San Marcos \| Texas \| United States \| -97.94139 \| 29.88327 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967	250	NCT01038609	1COMPLETED	2010-05-01	2009-12-01	AbbVie (prior sponsor, Abbott)	4INDUSTRY	false	false	false	null	0
[ 5 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and saf...	null	Acne Vulgaris Post Inflammatory Hyperpigmentation		null	1	arm 1: Open label pilot study, Topical gel to be appiled twice daily for 16 weeks	[ 0 ]	1	[ 0 ]	intervention 1: Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.	intervention 1: Azelaic acid	1	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	20	NCT01038869	1COMPLETED	2010-05-01	2009-12-01	Derm Research, PLLC	7OTHER	false	false	false	null	0
[ 3 ]	27	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.	null	Gastroesophageal Reflux Disease	GERD lesogaberan impedance pH pharmacokinetics safety tolerability	null	5	arm 1: AZD3355 30 mg arm 2: AZD3355 90 mg arm 3: AZD3355 120 mg arm 4: AZD3355 240 mg arm 5: Placebo	[ 0, 0, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 30 mg orally in the morning and 30 mg in the evening for 1 day intervention 2: 90 mg orally in the morning and 90 mg in the evening for 1 day intervention 3: 120 mg orally in the morning and 120 mg in the evening for 1 day intervention 4: 240 mg orally in the morning and 240 mg in the evening for 1 day ...	intervention 1: AZD3355 intervention 2: AZD3355 intervention 3: AZD3355 intervention 4: AZD3355 intervention 5: placebo	1	Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756	107	NCT01043185	1COMPLETED	2010-05-01	2009-12-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 2 ]	50	RANDOMIZED	PARALLEL	9OTHER	3TRIPLE	false	0ALL	false	The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).	The purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM.	Type 2 Diabetes Mellitus	phase 1 safety and tolerability PK PD type 2 diabetes mellitus T2DM	null	2	arm 1: In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. arm 2: In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. There will be approximately 6 dosing levels of PF-04937319	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Placebo to match PF-04937319 will be provided. intervention 2: The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a s...	intervention 1: Placebo intervention 2: PF-04937319	3	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Cypress \| California \| United States \| -118.03729 \| 33.81696 Miami \| Florida \| United States \| -80.19366 \| 25.77427	50	NCT01044537	1COMPLETED	2010-05-01	2010-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	109	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose. * Secondary efficacy variables: Average FEV1 during the first 15 m...	null	Chronic Obstructive Pulmonary Disease	Chronic Obstructive Pulmonary Disease Onset of effect COPD Oxis Turbuhaler	null	6	arm 1: Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler arm 2: Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus arm 3: P...	[ 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Formoterol Turbuhaler 9 μg and Placebo Diskus intervention 2: Salmeterol Diskus 50 μg and Placebo Turbuhaler intervention 3: Placebo Diskus and Placebo Turbuhaler	intervention 1: Formoterol intervention 2: Salmeterol intervention 3: Placebo	17	Bussolengo \| N/A \| Italy \| 10.85371 \| 45.46903 Cassano delle Murge \| N/A \| Italy \| 16.76531 \| 40.89112 Catanzaro \| N/A \| Italy \| 16.60086 \| 38.88247 Cava de' Tirreni \| N/A \| Italy \| 14.70773 \| 40.69954 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Parma \| N/A \| Italy \| 10.32618 \| 4...	326	NCT01048333	1COMPLETED	2010-05-01	2010-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This pilot trial has the goal to demonstrate the feasibility of a study to test the effects of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration paradigms in non-treatment seeking alcohol-dependent subjects.	null	Alcoholism	baclofen alcoholism urge craving alcohol drinking biobehavioral mechanisms of baclofen in alcoholism	null	2	arm 1: Baclofen 10 mg three times a day (t.i.d.) for 8-10 days arm 2: Cyproheptadine 2 mg t.i.d. for 8-10 days	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Baclofen 10mg t.i.d. intervention 2: 'active' placebo	intervention 1: Baclofen intervention 2: Cyproheptadine	1	Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	14	NCT01076283	1COMPLETED	2010-05-01	2009-12-01	Brown University	7OTHER	false	false	false	null	0
[ 5 ]	240	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxici...	The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadr...	Helicobacter Pylori Infection	Helicobacter pylori infection	null	2	arm 1: One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. arm 2: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and m...	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: * 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days * 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esom...	intervention 1: 14-day sequential treatment intervention 2: 14-day hybrid treatment	2	Kaohsiung \| Taiwan \| Taiwan \| N/A \| N/A Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626	240	NCT01085786	1COMPLETED	2010-05-01	2008-08-01	Kaohsiung Veterans General Hospital.	7OTHER	false	false	false	null	0
[ 2 ]	16	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	false	0ALL	false	Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed to inform exploratory clinical trial design in support of programs to develop new inhaled therapies for CF. We hypothesize that MCC/CC ...	A reduction in epithelial lining fluid height in cystic fibrosis (CF) as a consequence of decreased function of the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) chloride channel and related increased activity of the Epithelial sodium (Na) Channel (ENaC) results in impaired mucociliary clearance (MCC), muc...	Cystic Fibrosis	cystic fibrosis mucociliary clearance hypertonic saline	null	2	arm 1: sodium chloride (7%); mucociliary clearance measured 1 hour post dose arm 2: sodium chloride (7%); mucociliary clearance measured four hours post-dose.	[ 0, 0 ]	1	[ 0 ]	intervention 1: 4mL nebulized 7% sodium chloride	intervention 1: sodium chloride (7%)	2	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132	16	NCT01094704	1COMPLETED	2010-05-01	2009-11-01	University of North Carolina, Chapel Hill	7OTHER	false	false	false	null	0
[ 1 ]	17	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	3TRIPLE	false	0ALL	false	The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people...	Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as...	Obstructive Sleep Apnea	Obstructive sleep apnea Arousal threshold Sedative medication upper airway	null	2	arm 1: Eszopiclone 3mg prior to sleep (1 night) arm 2: Sugar Pill (placebo) prior to sleep (1 night)	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 3mg tablet once prior to sleep intervention 2: 1 placebo capsule prior to sleep	intervention 1: Eszopiclone intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	34	NCT01102270	1COMPLETED	2010-05-01	2009-01-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0
[ 5 ]	17	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	This study has been designed to provide a substantial evidence of acute bronchodilator responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative bronchiolitis after hematopoietic stem cell tran...	Obliterative bronchiolitis is a life-threatening non-infectious pulmonary complication of allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by the development of an obstructive abnormality which has been considered to be insensitive to bronchodilator treatments. However, this knowledge stem...	Obliterative Bronchiolitis	Obliterative bronchiolitis Bronchodilator responsiveness Partial forced expiratory flow Lung volumes	null	1	arm 1: At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide \[Spiriva®\] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhal...	[ 0 ]	1	[ 0 ]	intervention 1: Four separate doses of 100 μg of albuterol and 18 μg of tiotropium bromide. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber and tiotropium by a dry-powder device.	intervention 1: albuterol plus tiotropium	1	Genoa \| N/A \| Italy \| 8.94439 \| 44.40478	17	NCT01112241	1COMPLETED	2010-05-01	2010-04-01	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	7OTHER	false	false	false	null	0
[ 3 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.	null	Open-angle Glaucoma (OAG) Ocular Hypertension		null	5	arm 1: TRAVATAN 0.004% once daily arm 2: Travoprost Vehicle arm 3: Travoprost Group A arm 4: Travoprost Group B arm 5: Travoprost Group C	[ 1, 2, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days intervention 2: 1 drop in each eye 8 times daily for 5 days intervention 3: 1 drop in each eye 8 times daily for 5 days	intervention 1: Travoprost 0.004% intervention 2: Travoprost Vehicle intervention 3: Travoprost (Groups A, B and C)	1	Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541	67	NCT01114893	1COMPLETED	2010-05-01	2010-04-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 3 ]	23	RANDOMIZED	CROSSOVER	1PREVENTION	1SINGLE	true	0ALL	false	A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth	null	Healthy Subjects	tooth plaque	null	3	arm 1: Commercially available 0.12% Chlorhexidine mouthrinse arm 2: Commercially available cosmetic mouthrinse arm 3: Sterile Water	[ 1, 1, 2 ]	3	[ 0, 10, 10 ]	intervention 1: commercially available 0.12% chlorhexidine mouthrinse intervention 2: Commerically available cosmetic mouthrinse intervention 3: Sterile water	intervention 1: 0.12% chlorhexidine mouthrinse intervention 2: Cosmetic mouthrinse intervention 3: Sterile water	1	Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306	66	NCT01122862	1COMPLETED	2010-05-01	2010-04-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 0 ]	18	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve function.	This is a randomized double blind placebo controlled prospective study in which botulinum toxin A (Botox®) or normal saline will be intraoperatively injected into the muscles surrounding the elbow following the surgical treatment of an elbow fracture or elbow fracture dislocation. Eligible patients will be identified ...	Post Traumatic Stiffness	Botulinum Toxin Elbow Stiffness	null	2	arm 1: 100 U injected into biceps, 100 U into brachialis arm 2: 100 U injected into biceps, 100 U into brachialis	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Injection into the biceps brachii and brachialis immediately following the initial fracture surgery intervention 2: Injection into the biceps brachii and brachialis immediately following the initial fracture surgery	intervention 1: Botulinum Toxin Type A intervention 2: Saline	1	New York \| New York \| United States \| -74.00597 \| 40.71427	18	NCT01129583	1COMPLETED	2010-05-01	2003-11-01	Columbia University	7OTHER	false	false	false	null	0
[ 5 ]	15	NA	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	false	0ALL	false	The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysi...	null	Iron Deficiency Anemia		null	1	arm 1: FDA approved drug	[ 5 ]	1	[ 0 ]	intervention 1: 510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)	intervention 1: ferumoxytol	1	North Brunswick \| New Jersey \| United States \| -74.482 \| 40.454	15	NCT01148745	1COMPLETED	2010-05-01	2010-03-01	Dialysis Clinic, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	54	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.	null	Colorectal Cancer		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen	intervention 1: bevacizumab [Avastin]	16	Angers \| N/A \| France \| -0.55202 \| 47.47156 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Boulogne-Billancourt \| N/A \| France \| 2.24128 \| 48.83545 Colmar \| N/A \| France \| 7.35584 \| 48.08078 Dijon \| N/A \| France \| 5.01667 \| 47.31667 La Roche-sur-Yon \| N/A \| France \| -1.42757 \| 46.66974 Marseille \| N/A \| France \| 5.38107 ...	53	NCT01181609	1COMPLETED	2010-05-01	2005-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	26	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM patients, gabapenti...	null	Opioid-Induced Hyperalgesia	opioid-induced hyperalgesia methadone gabapentin opioid addiction	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks. intervention 2: Placebo titrated over 1 week with established dose taken daily for 5 weeks.	intervention 1: Gabapentin; intervention 2: Placebo	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	26	NCT01210079	1COMPLETED	2010-05-01	2002-09-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 5 ]	102	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed "PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to persistent acid reflux. Recently, heart...	null	Gastroesophageal Reflux Disease Eosinophilic Esophagitis	Gastroesophageal reflux Proton pump inhibitor Eosinophilic esophagitis	null	0	null	null	1	[ 0 ]	intervention 1: Treat with lansoprazole 30 mg BID for 2 weeks, perform endoscopic examination with esophageal biopsy	intervention 1: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	21	NCT01404832	6TERMINATED	2010-05-01	2007-10-01	Dallas VA Medical Center	1FED	false	false	false	null	0
[ 4 ]	324	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a traditional Chinese herbal medicine, on cognition, function and memory in patients with amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's disease, in a 6-month supervised protocol of a t...	Mild cognitive impairment (MCI) refers to a group of individuals who have some cognitive impairment but of insufficient severity to constitute dementia1,which is a transitional stage between normal aging and dementia. Amnestic MCI is the most common subtype of MCI, which shows the least reversion to normal, and is defi...	Mild Cognitive Impairment	Mild cognitive impairment	null	2	arm 1: Shenwu Capsule:1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months. Placebo: Placebo identical to donepezil tablets,1 placebo tablet/time, 1 time/day for 6 months. arm 2: Donepezil: 1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months. Placebo: Placebo ...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1 shenwu capsule contains 451 mg extract from herbs.5 capsules/time, 3 times/day for 6 months. Placebo identified to donepezil: 1 tablet per time, 1 time per day for 6 months. intervention 2: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months. Placebo identical to shenwu...	intervention 1: Shenwu Capsule intervention 2: Donepezil	1	Beijing \| N/A \| China \| 116.39723 \| 39.9075	324	NCT01451749	1COMPLETED	2010-05-01	2008-09-01	North China Pharmaceutical Group Corporation	4INDUSTRY	false	false	false	null	0
[ 0 ]	41	NA	SINGLE_GROUP	2DIAGNOSTIC	1SINGLE	true	0ALL	false	This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.	null	Alzheimer's Disease	Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging	null	0	null	null	1	[ 0 ]	intervention 1: IV injection, 111 or 370MBq (3 or 10mCi), single dose	intervention 1: florbetapir F 18	0	null	0	NCT01565356	1COMPLETED	2010-05-01	2010-03-01	Avid Radiopharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 2 ]	16	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.	This was an open-label, single-dose, parallel-group, in-patient, nonrandomized study conducted in 8 patients with moderate chronic hepatic impairment and in 8 healthy matched subjects matched by origin, age, sex, weight, and smoking habits. Each hepatic impaired patient and matched healthy subject participated in the ...	Parkinson's Disease	BIA 9-1067 Opicapone catechol-O-methyltransferase (COMT)	null	2	arm 1: Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067 arm 2: Group 2 - healthy subjects treated with BIA 9-1067	[ 0, 0 ]	1	[ 0 ]	intervention 1: Opicapone, OPC	intervention 1: BIA 9-1067	3	Rennes \| N/A \| France \| -1.67429 \| 48.11198 Moscow \| Moscow \| Russia \| 37.61556 \| 55.75222 Moscow \| Moscow \| Russia \| 37.61556 \| 55.75222	16	NCT02101190	1COMPLETED	2010-05-01	2010-03-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	84	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Bart...	null	Acute Cerebral Stroke Within 12 Hours for the First Time	Acute ischemic stroke Dl-3-n-butylphthalide Cerebrolysin	null	3	arm 1: Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days arm 2: Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days arm 3: Intravenous infusion of 100 ml saline intravenous q.d. for 10 days	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily. intervention 2: Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days. intervention 3: 100 ml saline intravenous infusion once daily for 10 days.	intervention 1: Dl-3-n-butylphthalide intervention 2: Cerebrolysin intervention 3: Placebo	1	Shanghai \| N/A \| China \| 121.45806 \| 31.22222	60	NCT02149875	1COMPLETED	2010-05-01	2010-01-01	Shanghai 6th People's Hospital	7OTHER	false	false	false	null	0
[ 2 ]	99	RANDOMIZED	PARALLEL	null	2DOUBLE	true	0ALL	null	This multi-center, randomized, double-blind, multiple-dose, placebo-controlled, parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its carboxylate metabolite, RO0640802 in healthy participants. Participants will be randomized to receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, o...	null	Healthy Volunteer		null	3	arm 1: Participants will receive 100 mg oseltamivir intravenous BID for 5 days. arm 2: Participants will receive 200 mg oseltamivir intravenous BID for 5 days. arm 3: Participants will receive oseltamivir matched placebo intravenous BID for 5 days.	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days. intervention 2: Oseltamivir matched placebo will be administered intravenous for 5 days.	intervention 1: Oseltamivir intervention 2: Placebo	2	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Austin \| Texas \| United States \| -97.74306 \| 30.26715	99	NCT02717754	1COMPLETED	2010-05-01	2009-12-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 2 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib	null	Osteoporosis		null	4	arm 1: Panel A - Healthy male subjects receiving Odanacatib arm 2: Panel A - Healthy male subjects receiving placebo arm 3: Panel B - Healthy female subjects receiving Odanacatib arm 4: Panel B - Healthy female subjects receiving placebo	[ 0, 2, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks intervention 2: Oral Placebo tablet administered once weekly for 4 consecutive weeks	intervention 1: Odanacatib intervention 2: Comparator: Placebo	0	null	44	NCT01068262	1COMPLETED	2010-05-02	2009-12-08	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.	The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world s...	Obesity Metabolic Syndrome Diabetes	Congenital leptin deficiency Obesity Metabolic syndrome Diabetes	null	1	arm 1: Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).	[ 0 ]	1	[ 0 ]	intervention 1: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.	intervention 1: Recombinant methionyl human leptin	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	0	NCT00657605	1COMPLETED	2010-05-04	2001-06-01	University of Miami	7OTHER	false	false	false	null	0
[ 3 ]	5	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptom...	This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy scheduled two to four weeks apart are safe, and whether combining a fully therapeutic dose of MDMA with psychotherapy, compared with a low ("active placebo") dose of MDMA, will reduce PTSD sy...	Posttraumatic Stress Disorder	PTSD MDMA therapy Posttraumatic stress disorder Israel	null	2	arm 1: Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long therapy sessions. arm 2: Participants will receive an initial dose of 25 mg midomafetamine HCl followed 2.5 hours later by a suppl...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Participants will receive an initial dose of 125 mg midomafetamine HCl orally followed 2.5 hours later by 62.5 mg midomafetamine HCl orally during the course of a day-long therapy session. intervention 2: Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours lat...	intervention 1: Full Dose Midomafetamine HCl intervention 2: Low Dose Midomafetamine HCl	1	Be’er Ya‘aqov \| N/A \| Israel \| 34.83749 \| 31.93864	5	NCT00402298	6TERMINATED	2010-05-05	2007-05-27	Lykos Therapeutics	4INDUSTRY	false	false	true	null	0
[ 4 ]	421	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.	null	Chemotherapy-induced Nausea and Vomiting (CINV)	CINV	null	2	arm 1: None arm 2: None	[ 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg intervention 2: Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg intervention 3: Day 1: Oral dexamethasone 10.5 mg prior to...	intervention 1: aprepitant intervention 2: Comparator: Placebo to aprepitant intervention 3: dexamethasone intervention 4: granisetron intervention 5: dexamethasone	0	null	415	NCT00952341	1COMPLETED	2010-05-05	2009-08-25	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	2,792	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.	Patients who completed 178-CL-046 (NCT00689104) or 178-CL-047 (NCT00662909) or new patients could be enrolled in this study if eligible.	Urinary Bladder, Overactive	Frequency Overactive Bladder Urgency Urinary urge incontinence Urinary incontinence Micturition	null	3	arm 1: Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months. arm 2: Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months. arm 3: Participants received toltero...	[ 0, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tablets intervention 2: Extended release capsules intervention 3: Matching mirabegron placebo tablets. intervention 4: Matching tolterodine placebo capsules.	intervention 1: Mirabegron intervention 2: Tolterodine intervention 3: Placebo to Mirabegron intervention 4: Placebo to Tolterodine	308	Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Phoenix \| Arizona \| United S...	2,444	NCT00688688	1COMPLETED	2010-05-06	2008-04-25	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	1	NA	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	false	Catastrophic Antiphospholipid Antibody Syndrome (CAPS) is a rare condition in which life-threatening blood clots form in multiple organs simultaneously and can lead to multi-organ system failure and death. The causes of CAPS are not entirely understood, but CAPS episodes are often triggered by stressful events such as ...	null	Antiphospholipid Antibody Syndrome End Stage Renal Disease	CAPS Kidney transplant Renal transplant Catastrophic Antiphospholipid Antibody Syndrome	null	1	arm 1: Patients will receive eculizumab in conjunction with systemic anticoagulation before and after kidney transplant operation	[ 0 ]	1	[ 0 ]	intervention 1: Eculizumab will be administered by intravenous infusion. Eculizumab will be administered at a dose of 1200mg by intravenous (IV) infusion on the day of or on the day prior to kidney transplantation, and at a dose of 900mg IV on post-operative day 1. Subsequently, the post-operative dosing regimen would ...	intervention 1: Eculizumab	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	1	NCT01029587	1COMPLETED	2010-05-06	2009-11-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 3 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether TAC-101 as a second line therapy for participants who received Sorafenib as first line therapy is effective in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 following treatment with Sorafeni...	Advanced metastatic hepatocellular carcinoma (HCC) is not treatable by surgical approaches or locoregional therapies such as hepatic artery hemoembolization or radiofrequency ablation (RFA) which are effective in controlling localized tumors. Currently marketed systemic chemotherapy agents, with the exception of sorafe...	Hepatocellular Carcinoma		null	2	arm 1: Participants with advanced hepatocellular carcinoma who had previously received Sorafenib (as first line therapy) were administered a dose of 20 milligram per day (mg/day) of TAC-101 (as second line treatment) oral tablets within 1 hour post morning meals on Days 1 to 14 followed by a recovery period on Days 15 ...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Participants were randomized to TAC 101 received TAC 101 20 mg (administered as 2 10 mg formulated tablets) PO daily with approximately 240 mL (8 oz) of water under fed conditions (no later than 1 hour after a meal) for 14 days followed by a 7 day recovery period. This cycle was repeated every 21 days. ...	intervention 1: TAC-101 intervention 2: Placebo	1	Pavia \| N/A \| Italy \| 9.15917 \| 45.19205	52	NCT00687596	6TERMINATED	2010-05-10	2008-08-01	Taiho Oncology, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,468	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	null	This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.	null	Prostate Cancer	Prostate Cancer Bone Loss with Prostate Cancer Treatment of bone loss in patients undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer (PC).	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30 intervention 2: 60 mg (1.0mL) administered subcutaneously at Day 1, Months 6, 12, 18, 24, 30	intervention 1: AMG 162 intervention 2: Placebo	0	null	1,456	NCT00089674	1COMPLETED	2010-05-11	2004-08-01	Amgen	4INDUSTRY	false	false	false	null	0

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