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 ]	15	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objectives * Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy * Detailed characterization of peripheral neuropathy in patients who receive ixabepilone Secondary Objectives * Clinical benefit rate * Time to progression ( TTP) * Toxicity * Exploratory s...	Eligible patient population: * Stage 4 breast cancer * Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia) * No limit on prior number of therapies to treat cancer * Adequate organ function * Life expectancy greater than 3 months Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours Evaluation on...	Metastatic Breast Cancer	breast	null	2	arm 1: Participants are treated with Ixabepilone. arm 2: None	[ 0, 4 ]	1	[ 0 ]	intervention 1: ixabepilone 40 mg/m2 Q3w over 3 hours	intervention 1: ixabepilone	1	New York \| New York \| United States \| -74.00597 \| 40.71427	0	NCT00627978	1COMPLETED	2011-01-01	2007-11-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0
[ 0 ]	11	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.	This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients. Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation. Consented, enrolled subjects assigned to the tr...	Glaucoma	Glaucoma,Ahmed Valve	null	2	arm 1: Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery arm 2: Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab	[ 1, 4 ]	1	[ 0 ]	intervention 1: intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections	intervention 1: Ranibizumab	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	11	NCT00644280	6TERMINATED	2011-01-01	2008-04-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 5 ]	172	NON_RANDOMIZED	SINGLE_GROUP	null	0NONE	false	1FEMALE	false	According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, ...	null	Chronic Angina		null	0	null	null	1	[ 0 ]	intervention 1: Oral dosage form.	intervention 1: Ranolazine	29	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Escondido \| California \| United States \| -117.08642 \| 33.11921 Los Angeles ...	171	NCT00644332	1COMPLETED	2011-01-01	2007-11-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0
[ 3 ]	288	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.	Safety issues are addressed in the Adverse Events section.	Cystic Fibrosis	Ciprofloxacin cystic fibrosis sweat test pulmonary function test	null	4	arm 1: 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days arm 2: 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days arm 3: Inhalation of placebo powder formul...	[ 0, 0, 2, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days intervention 2: 50 mg matching placebo powder formulation twice a day for 28 days intervention 3: 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation po...	intervention 1: Ciprofloxacin (Cipro Inhale, BAYQ3939) intervention 2: Placebo intervention 3: Ciprofloxacin (Cipro Inhale, BAYQ3939) intervention 4: Placebo	86	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \|...	286	NCT00645788	1COMPLETED	2011-01-01	2008-05-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 4 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain. The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone ("therapeutic block"). There control group will undergo EUS...	There are few effective options for the treatment of abdominal pain in chronic pancreatitis. For the past 20 years, percutaneous injection of anesthetic agents into the celiac plexus (celiac plexus blockade or CPB) has been performed by pain anesthesiologists to diagnose the origin of pancreatic pain (visceral vs. non-...	Chronic Pancreatitis		null	2	arm 1: EUS guided celiac block with bupivicaine and triamcinolone. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered. arm 2: EUS guided celiac block with bupivicaine only. Patient will undergo endoscopic ult...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Injection of bupivacaine and triamcinolone intervention 2: Injection of bupivacaine	intervention 1: Triamcinolone intervention 2: Bupivicaine alone	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	40	NCT00658736	1COMPLETED	2011-01-01	2008-03-01	The Cleveland Clinic	7OTHER	false	false	false	null	0
[ 0 ]	10	RANDOMIZED	CROSSOVER	9OTHER	3TRIPLE	false	0ALL	false	Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment. Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes. It is similar to other long acting insulins (Neutral Protein Hagedorn \[NPH...	Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties. In limited studies, it has been shown to result in less weight gain in type 1 and type 2 diabetics compared with other long acting insulin formations. A possible mechanism for its weight neutrality is the fatty acid chain t...	Diabetes Mellitus	diabetes insulin dependent diabetes diabetes mellitus detemir levemir glargine lantus insulin appetite satiety centrally acting mediators of satiety three factor eating questionnaire PYY ghrelin leptin	null	2	arm 1: Insulin Detemir arm 2: Insulin Glargine	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks. intervention 2: Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study ...	intervention 1: Insulin Detemir intervention 2: Insulin Glargine	1	Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449	20	NCT00659165	1COMPLETED	2011-01-01	2008-04-01	University of New Mexico	7OTHER	false	false	false	null	0
[ 3 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well saracatinib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth	PRIMARY OBJECTIVES: I. To determine whether the Src kinase inhibitor, AZD0530 (saracatinib), has single agent clinical activity in patients with advanced melanoma. II. To determine whether this drug will increase progression-free survival of these patients from 3 months to 4.5 months. SECONDARY OBJECTIVES: I. To de...	Recurrent Melanoma Stage IIA Melanoma Stage IIB Melanoma Stage IIC Melanoma Stage IV Melanoma		null	1	arm 1: Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: saracatinib	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	23	NCT00669019	1COMPLETED	2011-01-01	2006-07-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 4 ]	1,240	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin	null	Type 2 Diabetes	Dapagliflozin efficacy safety add on to insulin Oral AntiDiabetic Type 2 diabetes	null	4	arm 1: 2.5mg arm 2: 5mg arm 3: 10mg arm 4: None	[ 0, 0, 0, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 2: Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 3: Tablet oral ...	intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Dapagliflozin intervention 4: Placebo intervention 5: Dapagliflozin intervention 6: Dapagliflozin	92	Fresno \| California \| United States \| -119.77237 \| 36.74773 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Indianapolis \| Indian...	807	NCT00673231	1COMPLETED	2011-01-01	2008-04-01	AstraZeneca	4INDUSTRY	false	false	false	null	-0
[ 4 ]	820	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.	null	Type 2 Diabetes Mellitus	Amylin Lilly exenatide once weekly Byetta Januvia sitagliptin thiazolidinedione	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: subcutaneous injection, 2mg, once weekly plus placebo oral once daily intervention 2: oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection intervention 3: oral, 100 mg, daily plus placebo once weekly subcutaneous injection intervention 4: oral, 30-45mg, daily plus placebo once weekly...	intervention 1: exenatide once weekly intervention 2: metformin intervention 3: sitagliptin intervention 4: pioglitazone	106	Buena Park \| California \| United States \| -117.99812 \| 33.86751 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Valencia \| California \| United States \| -118.60953 \| 34.44361 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Meridian \| I...	820	NCT00676338	1COMPLETED	2011-01-01	2008-11-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	30	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	true	0ALL	true	This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medicat...	Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased Cerebrospinal fluid CSF) prostaglandin E2 (PGE2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac. Areas of mechanical hype...	Healthy	healthy volunteers analgesia pain Healthy subjects	null	2	arm 1: In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg Each subject will receive the topical capsaicin model for hyperalgesia and allodynia assessment. arm 2: In the presence of remifentanil the subject will receive a single intrathecal injection of place...	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: single intrathecal injection of ketorolac 2 mg intervention 2: subject will receive a placebo (preservative free normal saline) spinal injection intervention 3: All subjects will receive a remifentanil infusion intervention 4: Topical capsaicin pain model utilized for each subject	intervention 1: ketorolac intervention 2: placebo intervention 3: remifentanil intervention 4: Capsaicin	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	30	NCT00693160	6TERMINATED	2011-01-01	2007-12-01	Wake Forest University	7OTHER	false	false	false	null	0
[ 2, 3 ]	17	NA	SINGLE_GROUP	null	0NONE	false	0ALL	false	This study will test whether donepezil (Aricept(Registered Trademark)), a drug that is approved by the Food and Drug Administration to treat Alzheimer's disease, can increase rapid eye movement (REM) sleep in children with autism and autism spectrum disorder (ASD). Some children with autism and ASD spend very little ti...	Autism spectrum disorders are defined by aberrant development of communication and socialization in the presence of restrictive and/or repetitive behaviors. Recent epidemiologic studies have documented an increase in the number of children identified with autism spectrum disorder over the past decade and according to s...	Autism Cognition Disorder	Autism Cognitive Disorder Sleep Autism Spectrum Disorder ASD	null	1	arm 1: Single group study of Donepezil	[ 0 ]	2	[ 0, 5 ]	intervention 1: None intervention 2: None	intervention 1: Donepezil hydrochloride intervention 2: Increase REM sleep percentage	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	7	NCT00695136	1COMPLETED	2011-01-01	2008-06-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0
[ 5 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong effects against the HIV virus. Isentress has been...	RATIONALE: Virologic failure and adverse effects associated with current highly active antiretroviral therapy (HAART) warrant continuing search for novel combination therapeutic options. Raltegravir's (RAL) was recently shown to be a potent antiretroviral (ARV) agent with a favorable safety profile. If future reports c...	HIV Infections	HAART lopinavir/ritonavir raltegravir HIV/AIDS patients on HAART Treatment Experienced	null	2	arm 1: Kaletra + Isentress arm 2: Pre-study Antiretroviral regimen	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Kaletra 400/100 mg + Isentress 400 mg BID intervention 2: Standard doses of pre-study antiretroviral regimen	intervention 1: Kaletra + Isentress intervention 2: Pre-study antiretroviral regimen	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	58	NCT00700115	1COMPLETED	2011-01-01	2008-06-01	Emory University	7OTHER	false	false	false	null	0
[ 3 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects intolerant to statins.	In humans, apoB is the principal apolipoprotein of the atherogenic lipoproteins, comprising very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL) and low density lipoprotein (LDL). ApoB messenger ribonucleic acid (mRNA) is abundantly present in the liver. Within the endoplasmatic reticulum, apoB r...	Metabolic Diseases Hyperlipidemias Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders	statin intolerant hypercholesterolemia	null	2	arm 1: 1 mL placebo saline, weekly subcutaneous injections for 26 weeks arm 2: 200 mg (1 mL), weekly subcutaneous injections for 26 weeks	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: mipomersen intervention 2: placebo	1	Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403	33	NCT00707746	1COMPLETED	2011-01-01	2008-10-01	Kastle Therapeutics, LLC	4INDUSTRY	false	false	false	null	0
[ 2 ]	22	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.	null	Pancreatic Neoplasm	pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40	null	1	arm 1: None	[ 0 ]	2	[ 2, 0 ]	intervention 1: CP-870,893 intravenous administration \[IV\] on day 3 of 4-week cycles intervention 2: gemcitabine 1000 mg/m\^2 intravenous administration \[IV\] q week \[wk\]x3 of 4-week cycles	intervention 1: monoclonal antibody intervention 2: chemotherapy	2	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	22	NCT00711191	1COMPLETED	2011-01-01	2008-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Objective: Diabetic macular edema (DME) is a frequent manifestation of diabetic retinopathy, a leading cause of blindness in the United States. The only proven treatment for DME is laser photocoagulation. Sirolimus has been shown to inhibit the production, signaling and activity of many growth factors relevant to the d...	null	Diabetic Retinopathy	Diabetic Macular Edema Diabetic Retinopathy Rapamycin Sirolimus Diabetes	null	1	arm 1: The study eye was treated with sirolimus.	[ 0 ]	1	[ 0 ]	intervention 1: 20 μL (440 μg) of sirolimus were injected at baseline, Month 2, and every 2 months thereafter if re-treatment criteria were satisfied.	intervention 1: Sirolimus	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	5	NCT00711490	1COMPLETED	2011-01-01	2008-07-01	National Eye Institute (NEI)	0NIH	false	false	false	null	0
[ 4 ]	859	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when ad...	Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patient.	Diabetes Mellitus, Type 2	hyperglycemia, GLP-1	null	2	arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end ...	[ 0, 2 ]	5	[ 0, 0, 1, 0, 0 ]	intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Sulfonylurea to be continued at maximum effective dose according ...	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Sulfonylurea intervention 5: Metformin	16	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Netanya \| N/A \| Israel \| 34.85992 \| ...	859	NCT00713830	1COMPLETED	2011-01-01	2008-07-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 5 ]	228	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir	null	Hepatitis B, Chronic		null	2	arm 1: None arm 2: Control	[ 0, 5 ]	2	[ 0, 0 ]	intervention 1: Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks intervention 2: Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks	intervention 1: Entecavir intervention 2: Adefovir/Entecavir	8	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Guiyang \| Guizhou \| China \| 106.71667 \| 26.58333 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Nanchang \| Jiangxi \| China \| 115.85306 \| 28.68396 Changchun \| Jilin \| China \| 125.32278 \| 43.88 Shenyang \| Liaoning \| China \| 123.43278 \| 41.79222 Shanghai \| Sha...	166	NCT00718887	1COMPLETED	2011-01-01	2008-07-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0
[ 0 ]	53	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time o...	null	Kidney Stone	Kidney stone Ureterolithiasis Tamsulosin Flowmax Emergency Department	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 0.4 mg once a day until stone passage total = 9 tablets intervention 2: cornstarch	intervention 1: Flowmax intervention 2: placebo	1	York \| Pennsylvania \| United States \| -76.72774 \| 39.9626	53	NCT00762424	1COMPLETED	2011-01-01	2007-06-01	WellSpan Health	7OTHER	false	false	false	null	0
[ 4 ]	484	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic ...	Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patients.	Diabetes Mellitus, Type 2	hyperglycemia, GLP-1	null	4	arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to the end of treatment. arm 3: 2-step initiation regim...	[ 0, 0, 2, 2 ]	4	[ 0, 0, 1, 0 ]	intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Metformin to be continued at stable dose (at least 1.5 gram per d...	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Metformin	15	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Bogotá \| N/A \| Colombia \| -74.08175 \| 4.60971 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Milan \| N/A \| Italy \| 12...	964	NCT00763451	1COMPLETED	2011-01-01	2008-09-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 2 ]	10	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in combination with paclitaxel.	null	Advanced Malignant Solid Tumors	HKI-272 Paclitaxel Combination Solid Tumor	null	2	arm 1: Neratinib 160 mg + Paclitaxel 80 mg/m\^2 arm 2: Neratinib 240 mg + Paclitaxel 80 mg/m\^2	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Administered orally, continuous, once daily. intervention 2: Administered IV, on days 1, 8, 15 of 28 day cycle.	intervention 1: Neratinib intervention 2: Paclitaxel	2	Shizuoka \| N/A \| Japan \| 138.38333 \| 34.98333 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	10	NCT00768469	1COMPLETED	2011-01-01	2008-10-01	Puma Biotechnology, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	10	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techni...	The most common type of primary late-onset dystonia is cervical dystonia. Botulinum toxin A (BTX-A) injections are a safe and effective treatment for cervical dystonia in a majority of patients, however, a significant minority of patients (between 15 and 25%) have a suboptimal response to Botulinum toxin therapy. It is...	Cervical Dystonia	dystonia cervical dystonia Botox idiopathic primary cervical dystonia	null	2	arm 1: All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm...	[ 1, 0 ]	1	[ 0 ]	intervention 1: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.	intervention 1: Botulinum toxin A	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	19	NCT00773253	1COMPLETED	2011-01-01	2008-04-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 5 ]	15	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function better than regimens that do not contain protease inhibitors. This is a study that will determine the difference in immune enhancement c...	DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to efavirenz (EFV), in combination with daily emtricitabine (FTC)/tenofovir (TDF) as initial therapy for HIV-1 infection in HIV-infected treatment naïv...	Acquired Immune Deficiency Syndrome	AIDS, HIV	null	2	arm 1: Subjects randomized to Arm A initiated Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD arm 2: Subjects randomized to Arm B initiated Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Lopinavir 400 mg/ritonavir 100 mg fixed dose combination BID + emtricitabine 200 mg/tenofovir 300 mg fixed dose combination QD intervention 2: Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg fixed dose combination QD	intervention 1: Lopinavir 400 mg/ritonavir 100 mg intervention 2: Efavirenz	4	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	13	NCT00775606	6TERMINATED	2011-01-01	2008-10-01	Rush University Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	289	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from realit...	This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia. The study consists of following parts: Screening (that is, 14 days befor...	Schizophrenia	Schizophrenia Paliperidone Extended-release Paliperidone R076477	null	1	arm 1: Paliperidone Extended-Release (ER) oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.	[ 0 ]	1	[ 0 ]	intervention 1: Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.	intervention 1: Paliperidone	11	Busan \| N/A \| South Korea \| 129.03004 \| 35.10168 Changnyeong \| N/A \| South Korea \| 128.49506 \| 35.54145 Chungcheongbuk-Do \| N/A \| South Korea \| N/A \| N/A Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Daejeon \| N/A \| South Korea \| 127.38493 \| 36.34913 Hwasun Gun \| N/A \| South Korea \| N/A \| N/A Iksan \| N/A \| South Kor...	289	NCT00784238	1COMPLETED	2011-01-01	2008-04-01	Janssen Korea, Ltd., Korea	4INDUSTRY	false	false	false	null	0
[ 5 ]	109	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	3TRIPLE	true	0ALL	false	This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocain...	null	Pain	pain propofol lidocaine sedation pediatric	null	3	arm 1: Saline arm 2: Lidocaine 0.25 mg/kg arm 3: Lidocaine 0.5 mg/kg	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol in...	intervention 1: normal saline intervention 2: lidocaine intervention 3: lidocaine	1	Akron \| Ohio \| United States \| -81.51901 \| 41.08144	109	NCT00786916	1COMPLETED	2011-01-01	2008-02-01	Akron Children's Hospital	7OTHER	false	false	false	null	0
[ 4 ]	127	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).	This is a randomized, double-blind study that consists of two parts. In Part 1, the study will consist of 3 phases: a 14-day screening phase, a double-blind treatment phase of 12 weeks comparing two doses of study drug (0.5 mg/kg or 1.0 mg/kg groups based on patient's body weight), and an end-of-study or early withdraw...	Gastroesophageal Reflux Disease (GERD)	Gastroesophageal Reflux Disease (GERD) Erosive Gastroesophageal Reflux Disease Ulcerative Gastroesophageal Reflux Disease Endoscopy Pediatrics Rabeprazole	null	2	arm 1: rabeprazole 0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks arm 2: rabeprazole 1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks intervention 2: 1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks	intervention 1: rabeprazole intervention 2: rabeprazole	0	null	191	NCT00787891	1COMPLETED	2011-01-01	2009-01-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	12	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	true	People over 65 years of ag break down (metabolize) drugs differently than younger adults. It is not known why this happens or how elderly people absorb or break down these drug differently. These difference may show that elderly individuals need lower doses of medications to avoid possible toxicity. We are interested i...	If you agree to be in this study you will be admitted in to the General Clinical Research Center (GCRC) for approximately 24 hours on two different days (Part 1 and Part2). We will need you take a portion of your lamotrigine medication in a special form through a needle in your arm (intravenously). The special form of ...	Epilepsy Seizures Bipolar Disorder Bipolar Depression	lamotrigine epilepsy metabolism bipolar disorder bipolar depression glucuronidation	null	1	arm 1: Extended Release Lamotrigine	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Extended Release Lamotrigine	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	12	NCT00789113	1COMPLETED	2011-01-01	2008-11-01	University of Minnesota	7OTHER	false	false	false	null	0
[ 0 ]	129	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	true	1FEMALE	true	We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare ...	The levonorgestrel intrauterine system (LNG-IUC) is one of the most effective, reversible methods of contraception currently available in the United States. User satisfaction is overall high , however the most often cited reason for discontinuation is irregular bleeding . The LNG-IUC has mainly progesteronic effects on...	Contraception Bleeding	contraception progestin contraception intrauterine contraception unscheduled bleeding placebo	null	3	arm 1: participants will be randomized to transdermal estradiol arm 2: participants will be randomized to oral naproxen arm 3: participants will be randomized to oral placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks. intervention 2: naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks intervention 3: oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of...	intervention 1: transdermal estradiol intervention 2: naproxen intervention 3: oral placebo	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	129	NCT00789802	1COMPLETED	2011-01-01	2008-11-01	Washington University School of Medicine	7OTHER	false	false	false	null	0
[ 3, 4 ]	316	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also b...	null	Rheumatoid Arthritis	Rheumatoid Arthritis Certolizumab Pegol Cimzia	null	4	arm 1: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks arm 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks arm 3: 400mg CDP870 given every 2 weeks arm 4: Placebo given every 2 weeks	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 400mg CDP870 given every 2 weeks until Week22 (SC) intervention 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC) intervention 3: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC) interve...	intervention 1: CDP870 400mg intervention 2: CDP870 200mg intervention 3: CDP870 100mg intervention 4: Placebo of CDP870	8	Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushuh Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/...	316	NCT00791999	1COMPLETED	2011-01-01	2008-11-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	3	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.	null	Pulmonary Arterial Hypertension Pulmonary Hypertension	endothelin receptor antagonist (ETRA) sitaxsentan	null	2	arm 1: Monotherapy arm arm 2: Combination treatment	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Sitaxsentan = 100 mg tablet administered orally, once daily intervention 2: Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day	intervention 1: Sitaxsentan intervention 2: Sitaxsentan and Sildenafil	3	Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466	3	NCT00796510	6TERMINATED	2011-01-01	2010-07-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	133	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	to determine safety, efficacy and tolerability of BI 1356 versus placebo	null	Diabetes Mellitus, Type 2		null	2	arm 1: patient to receive a tablet containing BI 1356 once daily arm 2: patient to receive a tablet identical to BI 1356 once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: BI 1356 dosed once daily intervention 2: placebo matching BI 1356 taken once daily	intervention 1: BI 1356 intervention 2: placebo	53	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Riverside \| California \| United States \| -117.39616 \| 33.95335 Whittier \| California \| United States \| -118.03284 \| 33.97918 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 West Palm...	133	NCT00800683	1COMPLETED	2011-01-01	2008-12-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,023	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.	Seizures are a common medical problem. Although they can be frightening to watch, most seizures are brief and stop by themselves. Seizures that don't stop in seconds or minutes are a dangerous life-threatening medical emergency. Paramedics often have medications that can stop seizures, but the best way to give the medi...	Status Epilepticus	Status Epilepticus Emergency Medical Services Anticonvulsants Drug Administration Routes Seizures	null	2	arm 1: This group gets active treatment with an anticonvulsant by the intramuscular route of administration. arm 2: This group gets active treatment with an anticonvulsant by the intravenous route of administration.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush. intervention 2: IV administration of lorazepam 2 mg for subjects under estimated wei...	intervention 1: Intramuscular route of active treatment intervention 2: Intravenous route of active treatment	17	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baltimore \| Maryla...	1,023	NCT00809146	1COMPLETED	2011-01-01	2009-06-01	Robert Silbergleit	7OTHER	false	false	false	null	0
[ 0 ]	76	RANDOMIZED	SINGLE_GROUP	0TREATMENT	4QUADRUPLE	true	0ALL	false	Varenicline (Chantix™, Pfizer) is a novel selective nicotinic receptor partial agonist with specificity for the α4β2 nicotine acetylcholine receptor that has demonstrated remarkable efficacy for increasing long-term tobacco abstinence rates in cigarette smokers. The novel mechanism of action of varenicline potentially ...	In the United States, approximately 7.7 million individuals older than 12 years of age report current (past month) use of smokeless tobacco (ST). ST use has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular disease. To date, no pharmacotherapies have been shown to increase lo...	Nicotine Dependence		null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 12 weeks of varenicline 1 mg by mouth twice per day intervention 2: 12 weeks of placebo (double blinded) by mouth twice per day	intervention 1: varenicline intervention 2: placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	76	NCT00813917	1COMPLETED	2011-01-01	2009-02-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 4 ]	154	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients	null	Dry Eye Syndromes		null	1	arm 1: Instillation, 4times/day	[ 0 ]	1	[ 0 ]	intervention 1: Instillation,4times/day,for 52weeks	intervention 1: OPC-12759 Ophthalmic suspension	5	Kansai Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/A Tokai Region \| N/A \| Japan \| N/A \| N/A	154	NCT00818324	1COMPLETED	2011-01-01	2009-01-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	-0
[ 3 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	This phase II trial is studying the side effects of gemcitabine and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them fr...	PRIMARY OBJECTIVES: I. To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed higher priority treatment protocols. II. To determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multice...	Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Recurrent Uterine Corpus Carcinoma		null	1	arm 1: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	1	[ 0 ]	intervention 1: Given IV	intervention 1: Gemcitabine Hydrochloride	20	Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Decatur \| Illinois \| United States \| -88.9548 \| 39.84031 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Indianapolis \| Indiana ...	23	NCT00820898	1COMPLETED	2011-01-01	2009-02-01	Gynecologic Oncology Group	5NETWORK	false	false	false	null	0
[ 0 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to see if giving chemo-therapy for colon cancer before surgery can shrink the cancer and lead to a higher rate of cure than operating first and then giving chemotherapy. Standard treatment for colon cancer is to first operate, and then, if the tumor is advanced, give chemotherapy for about ...	null	Colon Cancer	BEVACIZUMAB (AVASTIN) FLUOROURACIL LEUCOVORIN OXALIPLATIN Chemotherapy	null	1	arm 1: FOLFOX and bevacizumab will be given to colon cancer patients for 4 cycles over 8 weeks; an additional 2 cycles of FOLFOX without bevacizumab will be given for a total of 12 weeks of pre-operative chemotherapy.Restaging will be performed within 3 weeks of the 6th chemotherapy cycle. Colon surgery will be perform...	[ 0 ]	1	[ 0 ]	intervention 1: The patient will receive six treatments, two weeks apart. On each treatment day you will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments you will also get Bevacizumab (Avastin). These drugs are given through a Mediport. They will be given in an outpatient chemotherapy unit. Each tx will t...	intervention 1: FOLFOX and bevacizumab	5	Basking Ridge \| New Jersey \| United States \| -74.54932 \| 40.70621 Commack \| New York \| United States \| -73.29289 \| 40.84288 New York \| New York \| United States \| -74.00597 \| 40.71427 Rockville Centre \| New York \| United States \| -73.64124 \| 40.65871 Sleepy Hollow \| New York \| United States \| -73.85847 \| 41.08565	2	NCT00826800	6TERMINATED	2011-01-01	2009-02-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 2 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied	null	Non Small Cell Lung Cancer	Lung Cancer (NSCLC)	null	1	arm 1: None	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months intervention 2: Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months intervention 3: Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months intervention 4: Expansion: Sol...	intervention 1: Ixabepilone intervention 2: Cisplatin intervention 3: Ixabepilone intervention 4: Cisplatin	7	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Lucca \| N/A \| Italy \| 10.50447 \| 43.84369 Meldola (Fc) \| N/A \| Italy \| 12.0626 \| 44.12775 Rimini \| N/A \| Italy \| 1...	29	NCT00832117	1COMPLETED	2011-01-01	2009-05-01	R-Pharm	4INDUSTRY	false	false	false	null	0
[ 5 ]	55	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	true	0ALL	false	Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subject...	null	Migraine	Migraine Migraine prevention Prodrome Premonitory phase Preemptive therapy	null	2	arm 1: Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily. arm 2: Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks intervention 2: frovatriptan 5mg tab during premonitory phase of migraine	intervention 1: topiramate intervention 2: frovatriptan	2	Oviedo \| Florida \| United States \| -81.20812 \| 28.67 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533	55	NCT00846495	1COMPLETED	2011-01-01	2009-08-01	Clinvest	3INDIV	false	false	false	null	0
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib	Sorafenib to be administered as 28-day cycles. Sorafenib dose escalation by cycle is: * Cycle 1: 400 mg BID * Cycle 2: 600 mg BID * Cycle 3+: 800 mg BID Within subject dose escalation and maximum dose is dependent on observed tolerability. Dose escalation only occurs after acceptable tolerability is demonstrated by...	Carcinoma, Renal Cell Kidney Disease Kidney Cancer		null	1	arm 1: * Cycle 1: 400 mg BID sorafenib * Cycle 2: 600 mg BID sorafenib * Cycle 3+: 800 mg BID sorafenib	[ 0 ]	1	[ 0 ]	intervention 1: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)	intervention 1: Sorafenib	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	9	NCT00854620	1COMPLETED	2011-01-01	2007-12-01	Stanford University	7OTHER	false	false	false	null	0
[ 3 ]	28	NA	SINGLE_GROUP	2DIAGNOSTIC	1SINGLE	true	0ALL	true	This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance c...	15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both \[18F\]-AV-45 and \[11C\]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic ...	Alzheimer's Disease	Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging	null	0	null	null	2	[ 0, 0 ]	intervention 1: 370 MBq (10 mCi), intravenous (IV) injection, single dose intervention 2: 555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB	intervention 1: florbetapir F 18 intervention 2: [11C]-PIB	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	28	NCT00855868	1COMPLETED	2011-01-01	2009-03-01	Avid Radiopharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	44	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	false	Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital aft...	null	Endometritis		null	2	arm 1: Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care. arm 2: No treatment group received only routine postpartum care.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay	intervention 1: Methergine	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	44	NCT00858832	1COMPLETED	2011-01-01	2008-12-01	University of South Florida	7OTHER	false	false	false	null	0
[ 3 ]	160	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	1FEMALE	true	The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.	The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in w...	Breast Cancer		null	2	arm 1: High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily). arm 2: Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).	[ 0, 2 ]	4	[ 7, 7, 7, 0 ]	intervention 1: High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks. intervention 2: Placebo comparator intervention 3: Standard Dose Vitamin D3 (600 IU of vitamin D3 daily) intervention 4: All subjects received letrozole as standard of care.	intervention 1: High Dose Vitamin D intervention 2: Placebo intervention 3: Standard Dose Vitamin D3 intervention 4: Letrozole 2.5mg	2	Westwood \| Kansas \| United States \| -94.6169 \| 39.04056 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224	160	NCT00867217	1COMPLETED	2011-01-01	2009-03-01	Qamar Khan	7OTHER	false	false	false	null	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This trial will include: * Study period up to 7 months. * Office visits monthly lasting approximately 1 hour. * Blood Draws. * Oral medication that is taken 2 times daily. * Photographs and biopsies if agreed.	null	Prurigo Nodularis	PN	null	1	arm 1: CC-10004 treament: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)	[ 0 ]	1	[ 0 ]	intervention 1: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)	intervention 1: CC-10004	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	5	NCT00869089	1COMPLETED	2011-01-01	2008-09-01	University Hospitals Cleveland Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.	null	Hepatitis C Infection	Antivirals	null	4	arm 1: Active Comparator arm 2: Active Comparator arm 3: Active Comparator arm 4: None	[ 0, 0, 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Tablets, oral, 3 mg, Daily, 48 weeks intervention 2: Tablets, oral, 10 mg, Daily, 48 weeks intervention 3: Tablets, oral, 60 mg, Daily, 48 weeks intervention 4: Tablet, oral, 0 mg, Daily 48 weeks intervention 5: Syringe, subcutaneous, 180 µg, Weekly, 48 weeks intervention 6: Tablet, oral, 1000 or 1200 m...	intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Daclatasvir intervention 4: Placebo intervention 5: Peginterferon alpha-2a intervention 6: ribavirin	14	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 The Bronx \| ...	48	NCT00874770	1COMPLETED	2011-01-01	2009-06-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0
[ 4 ]	175	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are: * To characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pedia...	An estimated 175 subjects will be enrolled at approximately 40 investigative sites. Subjects will be divided into two treatment groups to receive either high dose or low dose Dexmedetomidine (DEX). The loading and maintenance doses in both groups will be stratified according to the presence or absence of cardiopulmonar...	Sedation	Intubated and mechanically ventilated PICU subjects	null	2	arm 1: None arm 2: None	[ 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Study drug titrated up or down to maintain target UMSS range. intervention 2: Rescue medication for sedation according to UMSS scores intervention 3: Rescue medication for pain based on UMSS scores intervention 4: Rescue medication for pain based on UMSS scores.	intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Fentanyl intervention 4: Morphine	37	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Stanfo...	175	NCT00875550	1COMPLETED	2011-01-01	2010-01-01	Hospira, now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0
[ 2 ]	27	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.	null	Neoplasms Malignant		null	9	arm 1: Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle arm 2: Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle arm 3: Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle arm 4: Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle arm 5: Participants rec...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle intervention 2: MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle	intervention 1: MK-1496 intervention 2: MK-1496	0	null	27	NCT00880568	1COMPLETED	2011-01-01	2009-04-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	86	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery (BRB) - after titration of 4 weeks and mainte...	null	Multiple Sclerosis Cognitive Impairment	Multiple Sclerosis Cognition Rivastigmine Patch	null	2	arm 1: Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. arm 2: Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Transdermalapplication of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. All patches are round, beige in color. intervention 2: Transdermal application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. Matching the size, shape and col...	intervention 1: Rivastigmine transdermal patch intervention 2: Placebo	49	Aachen \| N/A \| Germany \| 6.08342 \| 50.77664 Aalen \| N/A \| Germany \| 10.0933 \| 48.83777 Abensberg \| N/A \| Germany \| 11.8498 \| 48.81684 Achim \| N/A \| Germany \| 9.0263 \| 53.01416 Alzenau in Unterfranken \| N/A \| Germany \| 9.06455 \| 50.0888 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Bad Mergentheim \| N/A \| Germany \|...	172	NCT00881205	6TERMINATED	2011-01-01	2009-04-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	749	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	1FEMALE	false	The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature ...	This was a randomized, open-label, assessor-blind, parallel groups, multicentre trial comparing the efficacy of highly purified menotrophin (MENOPUR; Ferring) and recombinant FSH (PUREGON/FOLLISTIM; MSD/Merck) in women undergoing controlled ovarian stimulation following a GnRH antagonist protocol. The use of oral cont...	Infertility		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allo...	intervention 1: Highly purified menotrophin intervention 2: Recombinant FSH	25	Anderlecht \| N/A \| Belgium \| 4.31454 \| 50.83619 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Copenha...	749	NCT00884221	1COMPLETED	2011-01-01	2009-07-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 0 ]	62	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its ability to reduce postoperative pain, the need for morphine-like pain medication, and the severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass surgery patients.	The occurrence of morbid obesity is at epidemic proportions in the United States. Laparoscopic gastric bypass is an effective means of safely facilitating patient weight loss and thereby drastically reducing the prevalence and severity of many future health complications \[1\]. However, managing morbidly obese surgical...	Obesity, Morbid Postoperative Pain Postoperative Nausea and Vomiting	Gastric Bypass Gabapentin Postoperative Nausea and Vomiting Analgesics, Opioids Sleep Apnea, Obstructive Respiratory Depression Oximetry	null	3	arm 1: Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses) arm 2: Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses) arm 3: Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)	[ 1, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2) interventio...	intervention 1: Gabapentin intervention 2: Placebo intervention 3: Gabapentin	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	62	NCT00886236	1COMPLETED	2011-01-01	2008-02-01	Medical University of South Carolina	7OTHER	false	false	false	null	0
[ 4 ]	84	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.	null	Systemic Juvenile Idiopathic Arthritis	Flare arthritis IL-1beta antagonist systemic juvenile idiopathic arthritis Juvenile Rheumatoid Systemic juvenile idiopathic arthritis with active flare	null	2	arm 1: Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections. arm 2: Patients received a single dose matching placebo...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL. intervention 2: Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching cana...	intervention 1: Canakinumab intervention 2: Placebo	91	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Chicago \| Illinois \| United States \| -87.65005 \| 41.850...	84	NCT00886769	6TERMINATED	2011-01-01	2009-07-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	90	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if a special combination of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety of this...	The augmented hyper-CVAD chemotherapy is a combination of chemotherapy drugs including cyclophosphamide, vincristine, adriamycin, dexamethasone, and pegaspargase given together for one "course" of treatment. It is called "augmented" because additional drugs are being added to the hyper-CVAD combination, which is the st...	Acute Lymphoblastic Leukemia	Acute Lymphoblastic Leukemia ALL Leukemia Hyper-CVAD	null	1	arm 1: Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.	[ 0 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 300 mg/m\^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of intervention 2: 2 mg by vein (IV) weekly for 3: Days 1, 8, 15 intervention 3: 50 mg/m\^2 by vein (IV) over 24 hours intervention 4: 80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18 intervention 5: 10 mcg/kg/da...	intervention 1: Cyclophosphamide (CTX) intervention 2: Vincristine intervention 3: Doxorubicin intervention 4: Decadron intervention 5: G-CSF intervention 6: Methotrexate (MTX) intervention 7: Ara-C intervention 8: Pegaspargase	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	90	NCT00890656	1COMPLETED	2011-01-01	2003-06-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	157	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed t...	This is a phase IIb, randomised (study medication is assigned by chance), double-blind (neither the patient nor the study physician will know to which treatment group the patient is assigned) trial to assess the neuropsychiatric adverse event profile of etravirine (ETR) 400mg once daily versus efavirenz (EFV) 600mg onc...	HIV Infection HIV Acquired Immunodeficiency Syndrome	HIV Intelence etravirine ETR TMC125 Sustiva efavirenz EFV Non-nucleoside Reverse Transcriptase Inhibitor NNRTI treatment-naive	null	2	arm 1: etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks arm 2: efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks intervention 2: 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks	intervention 1: etravirine (ETR, TMC125) intervention 2: efavirenz (EFV)	33	Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Aarhus \| N/A \| Denmark \| 10.21076 \| 56.15674 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A...	157	NCT00903682	1COMPLETED	2011-01-01	2009-06-01	Janssen-Cilag International NV	4INDUSTRY	false	false	false	null	-0
[ 4 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24 weeks of treatment, followed by an extension up to Week 76. The primary objective of this study is to evaluate the safety of lixisenatid...	null	Diabetes Mellitus, Type 2	hyperglycemia GLP-1	null	2	arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. arm 2: 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to end of treatment.	[ 0, 0 ]	2	[ 0, 1 ]	intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: None	intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector	1	Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	69	NCT00905255	1COMPLETED	2011-01-01	2009-05-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 5 ]	350	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	1FEMALE	true	This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.	null	Labor Augmentation	Labor augmentation Oral misoprostol	null	2	arm 1: Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. arm 2: Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 75 micrograms orally every 4 hours for up to 2 doses. intervention 2: Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital	intervention 1: Misoprostol intervention 2: Oxytocin	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	350	NCT00906347	1COMPLETED	2011-01-01	2008-12-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	113	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	Smoking is the leading cause of preventable morbidity and mortality in the US. While approximately 70% of smokers attempt to quit each year, only 5-15% maintain abstinence for 12 months, even with effective pharmacological and psychological interventions. Novel therapies are needed for smoking cessation and relapse pre...	SPECIFIC AIMS 1. To evaluate, in current smokers, the efficacy of a single dose of study medication given an hour prior to smoking-related cue exposure (post-reactivation treatment) on psychophysiological response to smoking cues one week later. 2. To evaluate, during the smoking cessation process, the clinical effect...	Smoking Cessation	Smoking cessation propranolol memory reconsolidation blockade craving	null	2	arm 1: propranolol arm 2: sugar pill	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Visit 2 (first smoking-related memory reactivation session) the subject will be given 0.67 mg/kg (minimum 40 mg; maximum 80 mg) of short-acting propranolol (or placebo) rounded to the nearest 10 mg. Ninety minutes after this dose, if subject has tolerated the short-acting dose well, and if systolic bloo...	intervention 1: Propranolol intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	74	NCT00916721	1COMPLETED	2011-01-01	2008-04-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 4 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream applica...	A total of 20 patients with at least 5 non-hypertrophic actinic keratoses (AK) of the face were included in this open-label study. All AKs were mapped on a transparent template before the first PDT treatment. At Day 0, all patients received methylaminolevulinate (MAL) applied on the entire face (except the nose and per...	Actinic Keratosis	Actinic keratoses actinic keratosis methylamonolevulinate photodynamic therapy without occlusion short incubation	null	1	arm 1: Patients had 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and waited 90 minutes prior to photodynamic therapy (PDT) using red light.	[ 0 ]	2	[ 0, 1 ]	intervention 1: 2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4. intervention 2: Device set to 37 J/cm². Red light wavelength is approximately 630 nm.	intervention 1: Methylaminolevulinate (Metvix, Metvixia) intervention 2: Photodynamic Therapy (Aktilite)	1	Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	20	NCT00926952	1COMPLETED	2011-01-01	2009-07-01	Innovaderm Research Inc.	7OTHER	false	false	false	null	0
[ 3 ]	109	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	true	0ALL	false	To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndro...	null	Down Syndrome Amyloid Beta-protein	Amyloid beta-protein Down Syndrome	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 300 megabecquerels (MBq) as single IV injection of 2 to 10 mL	intervention 1: Florbetaben (BAY94-9172)	2	Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	109	NCT00928304	1COMPLETED	2011-01-01	2009-06-01	Life Molecular Imaging SA	4INDUSTRY	false	false	false	null	0
[ 3 ]	15	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.	This is a double-blind, placebo-controlled, bilateral, ascending dose study. In vitro, fluphenazine has been shown to suppress growth of proliferating T-lymphocytes. Fluphenazine would be expected to also suppress growth of proliferating T-lymphocytes in psoriatic plaques.	Psoriasis	Psoriasis T-lymphocytes Fluphenazine	null	2	arm 1: The sterile placebo: Bacteriostatic Sodium Chloride for Injection. arm 2: This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic l...	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Intralesional injection of Fluphenazine intervention 2: Intralesional injection of placebo	intervention 1: Fluphenazine intervention 2: Placebo	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622	15	NCT00929578	1COMPLETED	2011-01-01	2008-11-01	Tufts Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	38	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will evaluate the effectiveness of apremilast in AS as measured by improvement in patients' signs and symptoms of the disease and changes in imaging. Additionally the safety and tolerability of apremilast in AS will be assessed.	Presently, there are very few treatments available which affect the progression of the disease in the spine. The only proven treatment is the use of drugs inhibiting tumour necrosis factor alpha (TNF). However, there are limitations with this treatment in that it needs to be administered via an injection and is also ve...	Ankylosing Spondylitis	Ankylosing spondylitis Imaging	null	2	arm 1: placebo twice a day for 12 weeks, 4 weeks follow up arm 2: 30 mg twice a day for 12 weeks, 4 weeks follow up	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks intervention 2: twice a day	intervention 1: Apremilast intervention 2: Placebo (sugar pill)	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	38	NCT00944658	1COMPLETED	2011-01-01	2009-08-01	Imperial College London	7OTHER	false	false	false	null	0
[ 4 ]	1,152	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.	null	Dyslipidemia		null	3	arm 1: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks arm 2: One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. arm 3: One table...	[ 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks intervention 2: One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks. intervention 3: Two 1g tablets ERN (2g total) once daily f...	intervention 1: ER niacin (+) laropiprant (ERN/LRPT) intervention 2: ER niacin (+) laropiprant (ERN/LRPT) intervention 3: Extended-release niacin (ERN) intervention 4: Placebo to ERN/LRPT	0	null	1,148	NCT00961636	1COMPLETED	2011-01-01	2009-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	81	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administer...	Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study...	Breast Cancer	Cancer breast cancer neoplasm E7389 Eribulin	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Eribulin mesylate 1.4 mg/m\^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.	intervention 1: Eribulin Mesylate	5	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Kure \| Hiroshima \| Japan \| 132.56658 \| 34.23222 Kagoshima \| Kagoshima-ken \| Japan \| 130.55 \| 31.56667 Chūō \| Tokyo \| Japan \| 139.77544 \| 35.67004	81	NCT00965523	1COMPLETED	2011-01-01	2008-01-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	511	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	2MALE	false	The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)	null	Benign Prostatic Hyperplasia (BPH)		null	3	arm 1: Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks arm 2: Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks arm 3: Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks	[ 2, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tadalafil 5 mg po QD for 12 weeks intervention 2: Placebo tablet po QD for 12 weeks intervention 3: Tamsulosin 0.4 mg po QD for 12 weeks intervention 4: Placebo capsule po QD for 12 weeks	intervention 1: Tadalafil 5 mg intervention 2: Placebo tablet intervention 3: Tamsulosin intervention 4: Placebo capsule	44	Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Bentleigh East \| Victoria \| Australia \| 145.05301 \| -37.91928 Bunbury \| Western Australia \| Australia \| 115.64137 \| -33.32711 Nedlands \| Western Australia \| Australia \| 115.8073 \| -31.98184 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austr...	511	NCT00970632	1COMPLETED	2011-01-01	2009-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	136	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to ...	null	Pain Chronic Pain Low Back Pain Neuropathic Pain Nociceptive Pain	pain assessment tapentadol centrally acting analgesic	null	1	arm 1: Other Names: * Nucynta * Palexia	[ 0 ]	1	[ 0 ]	intervention 1: Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows: * if less than 100 mg morphine equivalent start with 50 mg tapentadol PR; * if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapen...	intervention 1: Tapentadol Prolonged Release	27	Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Charleroi \| N/A \| Belgium \| 4.44448 \| 50.41136 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Thionville \| N/A \| France \| 6.16044 \| 49.35994 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Albstad...	125	NCT00986258	6TERMINATED	2011-01-01	2009-10-30	Grünenthal GmbH	4INDUSTRY	false	false	false	null	0
[ 2 ]	63	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational...	This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of I...	Hepatitis C, Treatment Naïve, Genotype 1 Patients		null	2	arm 1: If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks arm 2: If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system. intervention 2: Subcutaneous injection once per week for four weeks	intervention 1: IMO-2125 intervention 2: Saline	1	Rennes \| N/A \| France \| -1.67429 \| 48.11198	63	NCT00990938	1COMPLETED	2011-01-01	2009-09-01	Idera Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	403	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.	null	Type 2 Diabetes	Type 2 Diabetes Metformin	null	5	arm 1: Tablet, once-daily for 24 weeks arm 2: Tablet, once-daily for 24 weeks arm 3: Tablet, once-daily for 24 weeks arm 4: Tablet, once-daily for 24 weeks (dose switch from 20 to 120 mg at week 12) arm 5: Tablet, once-daily for 24 weeks	[ 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Tablet intervention 2: Tablet	intervention 1: KRP-104 intervention 2: Placebo	45	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Valley Village \| California \| United States \| -118.3965 \| 34.16488 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Winston-Sale...	403	NCT00995345	1COMPLETED	2011-01-01	2009-10-01	ActivX Biosciences, Inc.	4INDUSTRY	false	false	false	null	0
[ 0 ]	16	NA	SINGLE_GROUP	1PREVENTION	0NONE	true	0ALL	false	The heart becoming "stiff" due to increased fibrous tissue or decreased elasticity of the heart tissue is one of the earliest changes caused by heart failure. These changes can be detected by simple non-invasive echocardiogram techniques. However, these techniques usually detect the increased "stiffness" of the heart o...	The heart becoming "stiff" due to increased fibrous tissue or decreased elasticity of the heart tissue is one of the earliest changes caused by heart failure. These changes can be detected by simple non-invasive echocardiogram techniques. However, these techniques usually detect the increased "stiffness" of the heart o...	Diastolic Dysfunction		null	1	arm 1: Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadeq...	[ 5 ]	2	[ 0, 0 ]	intervention 1: Dobutamine intravenous infusion would be undertaken starting at 10 micro-grams/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micro-grams/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. intervention 2: If at the end of the Dobutamin...	intervention 1: Dobutamine stress echo (DSE) intervention 2: Atropine bolus	1	Columbia \| Missouri \| United States \| -92.33407 \| 38.95171	16	NCT00998205	1COMPLETED	2011-01-01	2008-06-01	University of Missouri-Columbia	7OTHER	false	false	false	null	0
[ 5 ]	26	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.	null	Myelodysplastic Syndromes	MDS Myelodysplastic Syndromes	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days intervention 2: azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days	intervention 1: decitabine intervention 2: azacitidine	19	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Stanford \| California \| United States \| -122.16608 \| 37.42411 Stockton \| California \| United States \| -121.29078 \| 37.9577 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 St. Petersbu...	26	NCT01011283	6TERMINATED	2011-01-01	2009-11-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	173	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the pe...	null	Chronic Obstructive Pulmonary Disease	COPD indacaterol QAB149 inspiratory capacity	null	6	arm 1: In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium w...	[ 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI) intervention 2: Tiotropium 18µg o.d. delivered via a proprietary inhalation device. intervention 3: Placebo to indacaterol o.d. delivered via SDDPI	intervention 1: Indacaterol intervention 2: Tiotropium intervention 3: Placebo	21	Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Erfurt \| N/A \| Germany \| 11.03283 \| 50.9787 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Fulda \| N/A \| Germany \| 9.67518 \| 50.55162 Geesthacht \| N/A \| Germany \| 10.3779...	357	NCT01012765	1COMPLETED	2011-01-01	2009-11-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	198	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.	null	Asthma		null	6	arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: Very low dose inhaled orally once daily from the Respimat inhaler arm 3: Medium dose inhaled orally once daily from the Respimat inhaler arm 4: High dose inhaled orally once daily from the Respimat inhaler arm 5: 12mcg inhaled twice daily from t...	[ 0, 0, 0, 0, 1, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler intervention 2: Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat intervention 3: Determination of efficacy in ...	intervention 1: Placebo intervention 2: Olodaterol (BI 1744) high intervention 3: Olodaterol (BI 1744) medium intervention 4: Olodaterol (BI 1744) very low intervention 5: Formoterol 12 mcg intervention 6: Olodaterol (BI 1744) low	27	Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Schlüsslberg \| N/A \| Austria \| 13.87161 \| 48.21861 Thalheim bei Wels \| N/A \| Austria \| 14.03333 \| 48.15 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52...	752	NCT01013753	1COMPLETED	2011-01-01	2010-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.	null	Carcinoid Syndrome		null	1	arm 1: This dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first coho...	[ 0 ]	1	[ 0 ]	intervention 1: BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients...	intervention 1: BIM 23A760	54	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Hel...	8	NCT01018953	6TERMINATED	2011-01-01	2010-02-01	Ipsen	4INDUSTRY	false	false	false	null	0
[ 3 ]	14	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.	null	Sensitivity in Esophagus	GERD patient esophagus pain	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 95 mg, oral solution, single dose intervention 2: Placebo, oral solution, single dose	intervention 1: AZD1386 intervention 2: Placebo to AZD1386	2	Århus C \| N/A \| Denmark \| N/A \| N/A Gothenburg \| Västra Götaland County \| Sweden \| 11.96679 \| 57.70716	27	NCT01019928	1COMPLETED	2011-01-01	2009-11-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	289	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.	Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea. Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin. The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will ...	Diabetes Mellitus, Type 2		null	3	arm 1: Participants took both LY2605541 and their pre-study insulin for first several days arm 2: Participants took only LY2605541 with first dose doubled arm 3: None	[ 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks intervention 2: subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks	intervention 1: LY2605541 intervention 2: insulin glargine	25	Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Coffs Harbour \| New South Wales \| Australia \| 153.11351 \| -30.29626 Keswick \| South Australia \| Australia \| 138.57459 \| -34.94178 Ringwood East...	289	NCT01027871	1COMPLETED	2011-01-01	2010-01-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable behaviors in autism spectrum disorders. All participants will receive active study medication. Participants will also receive diagnostic and cognitive evaluations at no cost. Participants will be required to undergo two fMRI (f...	null	Autism Spectrum Disorder	autism asperger's repetitive restricted compulsions	null	1	arm 1: This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily	intervention 1: Aripiprazole	2	Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	13	NCT01028820	1COMPLETED	2011-01-01	2009-08-01	University of North Carolina, Chapel Hill	7OTHER	false	false	false	null	0
[ 3 ]	51	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.	null	Colorectal Cancer	Colorectal cancer Revlimid Lenalidomide Cetuximab Erbitux KRAS	null	2	arm 1: Combination therapy of lenalidomide plus cetuximab arm 2: Single agent therapy of lenalidomide	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Intravenous infusions of cetuximab (400 mg/m\^2 Cycle 1 Day 1, thereafter 250 mg/m\^2), administered on days 1, 8, 15 and 22 of each 28 day cycle. intervention 2: Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle	intervention 1: cetuximab intervention 2: lenalidomide	17	Bedford Park \| South Australia \| Australia \| 138.56815 \| -35.02204 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Charleroi \| N/A \| Belgium \| 4.44448 \| 50.41136 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749...	50	NCT01032291	6TERMINATED	2011-01-01	2009-12-01	Celgene Corporation	4INDUSTRY	false	false	false	null	0
[ 3 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation.	Study period Estimated date of first patient enrolled: January 2010 Study design This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with fun...	Functional Constipation	functional constipation bile acid	Prot_SAP_ICF_000.pdf: Effects of A3309, an Ileal Bile Acid Transport Inhibitor, on Gastrointestinal and Colonic Motor Functions in Female Patients with Functional Constipation NCT# 01038687 June 7, 2010 Albireo 1(89) 07 June 2010 Clinical Study Protocol Investigational Product A3309 ...	3	arm 1: Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days. arm 2: Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days. arm 3: Patients randomized to this arm received one oral tablet daily of a m...	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: A3390, a bile acid transport inhibitor was provided in either 15 mg or 20 mg oral tablets intervention 2: placebo	intervention 1: A3309 intervention 2: placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	36	NCT01038687	1COMPLETED	2011-01-01	2010-01-01	Michael Camilleri, MD	7OTHER	true	true	true	https://cdn.clinicaltrials.gov/large-docs/87/NCT01038687/Prot_SAP_ICF_000.pdf	0
[ 4 ]	111	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.	null	Sexual Dysfunctions, Psychological Depression		null	3	arm 1: Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs arm 2: Patient to receive 2 flibanserin tablets of 50 mg qhs arm 3: Patient to receive 2 placebo tablets of 50 mg qhs	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 50 to 100mg qhs intervention 2: 100mg qhs intervention 3: 50 mg placebo	intervention 1: flibanserin 50 mg to 100 mg qhs intervention 2: flibanserin 100 mg qhs intervention 3: placebo 2 tablets qhs	42	Costa Mesa \| California \| United States \| -117.91867 \| 33.64113 Fresno \| California \| United States \| -119.77237 \| 36.74773 National City \| California \| United States \| -117.0992 \| 32.67811 Riverside \| California \| United States \| -117.39616 \| 33.95335 Sherman Oaks \| California \| United States \| -118.44925 \| 34.15112 W...	111	NCT01040208	6TERMINATED	2011-01-01	2010-01-01	Sprout Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 4 ]	108	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: olodaterol placebo and/or Tiotropium placebo inhaled once daily arm 2: Low dose inhaled orally once daily from Respimat inhaler arm 3: High dose inhaled orally once daily from Respimat inhaler arm 4: 18mcg inhaled once daily from Handihaler	[ 2, 0, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Low dose inhaled orally once daily from Respimat inhaler intervention 2: Placebo (olodaterol low and high dose)delivered by Respimat intervention 3: Placebo (Tiotropium 18 mcg) delivered by HandiHaler intervention 4: High dose inhaled orally once daily from Respimat inhaler intervention 5: 18mcg inhaled...	intervention 1: Olodaterol (BI1744) Low intervention 2: Placebo (for olodaterol BI1744) intervention 3: Placebo (for Tiotropium) intervention 4: Olodaterol (BI1744) High intervention 5: Tiotropium 18 mcg	15	Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Hasselt \| N/A \| Belgium \| 5.33781 \| 50.93106 Hvidovre \| N/A \| Denmark \| 12.47708 \| 55.64297 Kolding \| N/A \| Denmark \| 9.47216 \| 55.4904 Odense C \| N/A \| Denmark \| 10.39538 \| 55.40841 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Hamburg \| N/...	405	NCT01040689	1COMPLETED	2011-01-01	2010-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	122	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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: Low dose inhaled orally once daily from Respimat inhaler arm 2: High dose inhaled orally once daily from Respimat inhaler arm 3: 18 mcg inhaled once daily from HandiHaler arm 4: Olodaterol placebo and/or Tiotropium placebo inhaled once daily	[ 0, 0, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Low dose inhaled orally once daily from Respimat inhaler intervention 2: High dose inhaled orally once daily from Respimat inhaler intervention 3: 18 mcg inhaled once daily from HandiHaler intervention 4: Placebo (olodaterol low and high dose) delivered by Respimat intervention 5: Placebo (Tiotropium 18...	intervention 1: Olodaterol (BI1744) Low intervention 2: Olodaterol (BI1744) High intervention 3: Tiotropium 18 mcg intervention 4: Placebo (for Olodaterol (BI1744)l) intervention 5: Placebo (for Tiotropium)	12	Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Breda \| N/A \| N...	450	NCT01040728	1COMPLETED	2011-01-01	2010-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	-0
[ 5 ]	506	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.	null	Essential Hypertension	Moderate systolic hypertension - adults - aliskiren -ramipril	null	4	arm 1: In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in. In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to...	[ 1, 0, 2, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 150 mg Aliskiren as film-coated tablet intervention 2: Ramipril 5 mg was given in capsule form. intervention 3: The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm. intervention 4: The placebo cap...	intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Matching placebo to Aliskiren intervention 4: Matching placebo to Ramipril	98	Aire Sur Adour \| N/A \| France \| N/A \| N/A Amboise \| N/A \| France \| 0.98266 \| 47.41249 Angers \| N/A \| France \| -0.55202 \| 47.47156 Anzin \| N/A \| France \| 3.50387 \| 50.37201 Bachant \| N/A \| France \| 3.86835 \| 50.2154 Bandol \| N/A \| France \| 5.74718 \| 43.14247 Bersée \| N/A \| France \| 3.14765 \| 50.47978 Bécon-les-Granits \|...	745	NCT01042392	1COMPLETED	2011-01-01	2009-11-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	138	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine	Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-wee...	Diabetes Mellitus, Type 1		null	2	arm 1: Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks. arm 2: Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods. intervention 2: Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.	intervention 1: LY2605541 intervention 2: Insulin glargine	13	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Baltimore \| Maryland \| Uni...	255	NCT01049412	1COMPLETED	2011-01-01	2010-01-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertensio...	The current literature addresses therapies for patients with resting PAH only, diagnosed by right heart catheterization. However, the World Health Organization (WHO) also recognizes and defines exercise induced pulmonary arterial hypertension (ex-PAH), which may precede the development of resting PAH. The natural progr...	Systemic Sclerosis Shortness of Breath Pulmonary Hypertension	Systemic Sclerosis connective tissue disease Shortness of breath Pulmonary Hypertension	null	1	arm 1: ambrisentan dosed at either 5mg or 10mg orally once per day	[ 0 ]	1	[ 0 ]	intervention 1: Ambrisentan 5mg or 10mg once daily	intervention 1: Ambrisentan	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	12	NCT01051960	1COMPLETED	2011-01-01	2009-03-01	University of California, Los Angeles	7OTHER	false	false	false	null	0
[ 3 ]	553	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).	null	Painful Diabetic Neuropathy	Analgesia Diabetic Neuropathy Neuropathic pain Painful Chronic pain	null	2	arm 1: Participants randomly assigned to receive GRT3983Y. arm 2: Participants randomly assigned to placebo.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment. intervention 2: Overencapsulated tablets of placebo, 16 weeks treatment.	intervention 1: GRT3938Y intervention 2: Placebo	61	Fairhope \| Alabama \| United States \| -87.90333 \| 30.52297 Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Escondido \| California \| United States \| -117.08642 \| 33.11921 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Long Beach \| Californ...	50	NCT01056315	6TERMINATED	2011-01-01	2009-11-01	Grünenthal GmbH	4INDUSTRY	false	false	false	null	0
[ 5 ]	433	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.	null	Hypertension	Nebivolol Bystolic TM Hypertension Stage 2 Hypertension	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 5 mg, titrated to 20 mg, once daily oral administration intervention 2: 5 mg or 20 mg once daily, oral administration	intervention 1: Nebivolol intervention 2: Placebo	36	Foley \| Alabama \| United States \| -87.6836 \| 30.40659 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Chino \| California \| United States \| -117.68894 \| 34.01223 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Temecula \| Califor...	432	NCT01057251	1COMPLETED	2011-01-01	2010-03-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 4 ]	748	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.	null	Sexual Dysfunctions, Psychological		null	2	arm 1: Flibanserin 100 mg administered at bedtime arm 2: This is the matched placebo which will be administered two tablets daily at bedtime.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Flibanserin 100mg administered at bedtime for 24 weeks intervention 2: This is the matched placebo which will be administered two tablets daily at bedtime.	intervention 1: Flibanserin intervention 2: Placebo	100	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tuscon \| Arizona \| United States \| N/A \| N/A Tuscon \| Arizona \| United States \| N/A \| N/A Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 ...	745	NCT01057901	6TERMINATED	2011-01-01	2010-01-01	Sprout Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	1	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction	Adverse event data will be covered in Adverse events section.	Hypertension, Pulmonary Ventricular Dysfunction, Left	Pulmonary Hypertension Left ventricular dysfunction	null	2	arm 1: Participants received a single oral dose of 1 mg riociguat. arm 2: Participants received a single oral dose of 1 mg placebo.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1 mg single oral dose intervention 2: Single oral dose	intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	1	NCT01065051	6TERMINATED	2011-01-01	2010-11-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 5 ]	107	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.	* Two weeks Duloxetine 60 mg Open-Label Period * Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine) * One week Double-Blind Down-Taper Period	Fibromyalgia	Milnacipran Duloxetine Switch Forest Research Institute	null	2	arm 1: Placebo tablets, twice a day, oral administration arm 2: Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: * Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper. * Placebo tablets, twice daily for 1 week during double-blind down-tape...	intervention 1: Placebo intervention 2: Milnacipran	26	Sacramento \| California \| United States \| -121.4944 \| 38.58157 Cromwell \| Connecticut \| United States \| -72.64537 \| 41.5951 Danbury \| Connecticut \| United States \| -73.45401 \| 41.39482 Delray Beach \| Florida \| United States \| -80.07282 \| 26.46146 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Orlando \| Florida \|...	106	NCT01077375	1COMPLETED	2011-01-01	2010-02-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 3 ]	80	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy. Primary Objectives: Evaluate the therapeutic efficacy, including the c...	Fludarabine is a chemotherapy drug that is approved for the treatment of CLL. Cyclophosphamide is also a chemotherapy drug that is commonly used in the treatment of CLL. Rituximab and alemtuzumab are special proteins that specifically target and attach to proteins on leukemia cells. These targeted proteins may also be ...	Chronic Lymphocytic Leukemia	Chronic lymphocytic leukemia Refractory CLL CFAR Alemtuzumab Campath-1H Campath Cyclophosphamide Cytoxan Neosar Fludarabine Fludara Fludarabine Phosphate Rituximab Rituxan CLL	null	1	arm 1: CFAR: Cyclophosphamide 250 mg/m\^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m\^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m\^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1):...	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 25 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles. intervention 2: 250 mg/m\^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles. intervention 3: 30 mg IV on Days 1, 3 and 5 over 2-4 hours; repeated every four weeks for a total of 6 plan...	intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Alemtuzumab intervention 4: Rituximab	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	80	NCT01082939	1COMPLETED	2011-01-01	2002-12-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this wi...	The key role of vitamin D (vit D) in maintaining optimal bone health has long been recognized, but its role in modulating the innate immune response and inflammatory reaction has only recently come under active investigation. As such, vit D is an increasingly frequently chosen and prescribed high dose dietary supplemen...	HIV Infections AIDS	Human Immunodeficiency Virus Acquired Immune Deficiency Syndrome Vitamin D HIV Complementary therapies	null	2	arm 1: Subjects in this arm take a daily dose of 4000IU of Vitamin D3 arm 2: Subjects in this arm of the study take a daily dose of 7000IU of Vitamin D3	[ 1, 1 ]	1	[ 0 ]	intervention 1: To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.	intervention 1: Cholecalciferol (Vit D3)	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	44	NCT01092338	1COMPLETED	2011-01-01	2010-01-01	Children's Hospital of Philadelphia	7OTHER	false	false	false	null	0
[ 4 ]	59	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy	null	Uveitis	uveitis	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 300mg every 4 weeks intervention 2: 300mg every 2 weeks intervention 3: Placebo to AIN457	intervention 1: AIN457 intervention 2: AIN457 intervention 3: Placebo AIN457	25	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Alexandria \| N/A \| Egypt \| 29.91582 \| 31.20176 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Athens \| GR \| Greece \| 23.72784 \| 37.98376 Ioannina \| GR \| Greece \| 20.85189 \| 39.66486 Larissa \| GR \| Greece \| 22.41761...	117	NCT01093846	6TERMINATED	2011-01-01	2010-03-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 4 ]	596	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511...	null	Sexual Dysfunctions, Psychological		null	1	arm 1: flibanserin 100mg po qd	[ 0 ]	1	[ 0 ]	intervention 1: all patients will receive open-label flibanserin 100mg	intervention 1: flibanserin	95	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United ...	596	NCT01103362	6TERMINATED	2011-01-01	2010-04-01	Sprout Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 4 ]	540	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.	This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.	Pain		null	3	arm 1: 1000 mg Acetaminophen Caplet arm 2: 650 mg Acetaminophen Caplet arm 3: 0 mg Acetaminophen Caplet	[ 0, 1, 2 ]	2	[ 0, 0 ]	intervention 1: Acetaminophen Caplet - single dose intervention 2: 0 mg Caplet - single dose	intervention 1: Acetaminophen intervention 2: Placebo Control	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	540	NCT01115673	1COMPLETED	2011-01-01	2010-06-01	McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	78	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative dra...	null	Thyroid Carcinoma Thyroidectomy	Neck dissection	null	2	arm 1: usage of fibrin sealant after surgery arm 2: No usage of fibrin sealant	[ 1, 4 ]	2	[ 0, 3 ]	intervention 1: Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection intervention 2: surgical removal of bilateral thyroid glands	intervention 1: Usage of Fibrin sealant intervention 2: Thyroidectomy	1	Seoul \| Seoul \| South Korea \| 126.9784 \| 37.566	78	NCT01126060	1COMPLETED	2011-01-01	2010-02-01	Samsung Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	16	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to determine if an anti-inflammatory drug, called infliximab, will reduce inflammation in the synovial lining in patients with an early stage of osteoarthritis of the knee. It will also help determine if the study medication decreases the accumulation of synovial fluid and prevents cartilag...	This is an unbalanced randomized, double-blind pilot study of Infliximab (100 mg), placebo (100 mg) and Methylprednisolone acetate (80 mg). A total of 16 subjects will be randomized; 8 subjects will be randomized to receive infliximab, 4 subjects will be randomized to receive placebo and 4 additional subjects will be r...	Osteoarthritis of the Knee	Mild to moderate osteoarthritis of the knee	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: the study drug will be injected into the joint through a needle intervention 2: the placebo will be injected into the joint through a needle intervention 3: Methylprednisolone acetate will be injected into the joint through a needle	intervention 1: Infliximab intervention 2: Placebo intervention 3: Standard of Care: Methylprednisolone acetate	1	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417	16	NCT01144143	1COMPLETED	2011-01-01	2007-07-01	Herbert Lindsley, MD	7OTHER	false	false	false	null	0
[ 5 ]	61	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.	null	Wounds	Acute traumatic wounds	null	2	arm 1: None arm 2: None	[ 2, 1 ]	2	[ 0, 10 ]	intervention 1: Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound. Dosage Lavasept® 0.04% 50 ml 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes intervention 2: Method of Administration A sterile comp...	intervention 1: Lavasept 0.04% intervention 2: Ringer's Solution	1	Zurich \| Canton of Zurich \| Switzerland \| 8.55 \| 47.36667	61	NCT01153620	1COMPLETED	2011-01-01	2010-08-01	B. Braun Ltd. Centre of Excellence Infection Control	4INDUSTRY	false	false	false	null	0
[ 3 ]	38	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)	Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravi...	Vitrectomy		null	6	arm 1: Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection arm 2: Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection arm 3: Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection arm 4: Primar...	[ 0, 0, 0, 0, 0, 4 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 125µg ocriplasmin intravitreal injection intervention 2: 125µg ocriplasmin intravitreal injection intervention 3: 125µg ocriplasmin intravitreal injection intervention 4: 125µg ocriplasmin intravitreal injection intervention 5: 125µg ocriplasmin intravitreal injection	intervention 1: ocriplasmin intervention 2: ocriplasmin intervention 3: ocriplasmin intervention 4: ocriplasmin intervention 5: ocriplasmin	1	Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959	38	NCT01159665	1COMPLETED	2011-01-01	2010-07-01	ThromboGenics	4INDUSTRY	false	false	false	null	0
[ 3 ]	20	RANDOMIZED	PARALLEL	null	0NONE	false	0ALL	false	Open, prospective, randomized, single-centre study in patients with moderate to severe facial acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4 inflammatory lesions, will be selected in acne-affected areas in the face. One area should be identified on each cheek and one area ...	null	Acne Vulgaris	Moderate to severe Acne Vulgaris	null	2	arm 1: Three areas will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before application of the Visonac cream. One of the areas cleaned with saline wipe will also be occluded with a transparent dressi...	[ 5, 5 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None	intervention 1: Area cleaned with saline water and occluded with Tegaderm intervention 2: Area cleaned with saline water intervention 3: Area cleaned with Ethyl alcohol solution intervention 4: Visonac left on the skin for 24 hours in facial area one intervention 5: Visonac wiped off after one hour intervention 6: Viso...	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	20	NCT01160848	1COMPLETED	2011-01-01	2010-08-01	Photocure	4INDUSTRY	false	false	false	null	0
[ 2 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.	The planned study is designed to characterize the impact of heparin on the biologic activity of palifermin and assess the impact of the combination of palifermin and heparin on tolerability. Approximately forty-three (43) eligible healthy adult men and oophorectomized or postmenopausal women between 18-45 years of age ...	Oral Mucositis		null	3	arm 1: Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion arm 2: Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections arm 3: Treatment C: control group without any treatment administered.	[ 0, 0, 4 ]	2	[ 0, 0 ]	intervention 1: 40 µg/kg IV bolus injections for three consecutive days intervention 2: Heparin continuous IV infusion	intervention 1: Palifermin intervention 2: Heparin	1	Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064	44	NCT01163097	1COMPLETED	2011-01-01	2010-07-01	Swedish Orphan Biovitrum	4INDUSTRY	false	false	false	null	0
[ 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	This study examines topical treatment of under eye circles and swelling.	This study examines topical treatment of under eyes dark circles and under eye swelling.	Edema	Under eye dark circles Under eye puffiness	null	2	arm 1: Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. arm 2: Split face double blind	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Fexofenadine 1% intervention 2: Placebo	intervention 1: Fexofenadine intervention 2: Placebo	1	Paramus \| New Jersey \| United States \| -74.07542 \| 40.94454	30	NCT01172522	1COMPLETED	2011-01-01	2010-09-01	The Connecticut Sinus Center, PC	7OTHER	false	false	false	null	0
[ 3 ]	269	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosac...	null	Rosacea		null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 2, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: CD07805/47 Gel 0.5% QD intervention 2: Vehicle Gel QD intervention 3: CD07805/47 Gel 0.18% QD intervention 4: CD07805/47 Gel 0.18% BID intervention 5: Vehicle Gel BID	intervention 1: CD07805/47 Gel intervention 2: Vehicle Gel intervention 3: CD07805/47 Gel intervention 4: CD07805/47 Gel intervention 5: Vehicle Gel	20	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Newnan \| Georgia \| United States \| -84.79966 \| 33.38067 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 St Louis \| Misso...	269	NCT01174030	1COMPLETED	2011-01-01	2010-08-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 2 ]	26	NON_RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).	null	Anemia, Sickle Cell		null	1	arm 1: Participants received a single 10 milligram (mg) dose on Day 1 (single dose \[SD\]), followed by either 5 mg/day (for participants\<60 kilograms \[kg\]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose \[MD\]).	[ 0 ]	1	[ 0 ]	intervention 1: Oral, daily for 12 days	intervention 1: Prasugrel	1	London \| UK \| United Kingdom \| -0.12574 \| 51.50853	52	NCT01178099	1COMPLETED	2011-01-01	2010-07-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	23	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	true	0ALL	false	This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The cu...	E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant. In order to differentiate the inhaled epinephrine from the fluctuating background of endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine (epinephrine-d3) preparation wil...	Asthma Bronchospasm Wheezing Shortness of Breath	asthma bronchospasm wheezing shortness of breath	null	2	arm 1: Experimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a arm 2: Epinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation intervention 2: Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations	intervention 1: Epinephrine Inhalation Aerosol, HFA intervention 2: Epinephrine Inhalation Aerosol	1	Cypress \| California \| United States \| -118.03729 \| 33.81696	46	NCT01188577	1COMPLETED	2011-01-01	2010-08-01	Amphastar Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0

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