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
[ 0 ]	38	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast cancer. The combination, of these three drugs, has been used for approximately 30 years in the treatment of breast cancer, and has been shown to be safe and effective. It is usually given every 3 weeks. Doctors believe, based on othe...	null	Breast Cancer	cyclophosphamide methotrexate fluorouracil PEG-filgrastim	null	1	arm 1: This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.	[ 0 ]	1	[ 0 ]	intervention 1: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.	intervention 1: cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim	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	38	NCT00615901	1COMPLETED	2010-06-01	2008-01-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 0 ]	969	NA	SINGLE_GROUP	2DIAGNOSTIC	1SINGLE	true	1FEMALE	false	We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.	The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (\~90%) for the detection of b...	Breast Cancer	Dense breast tissue Breast Cancer Screening Molecular Breast Imaging Breast Cancer Breast	null	1	arm 1: Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.	[ 0 ]	3	[ 1, 1, 0 ]	intervention 1: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors. intervention 2: Mammogr...	intervention 1: Molecular Breast Imaging intervention 2: Conventional Mammography intervention 3: Technetium (99mTc) sestamibi	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	969	NCT00620373	1COMPLETED	2010-06-01	2005-08-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	7	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Primary Objective: -To identify the optimal dose of a seven-day course of twice-daily teriparatide as compared to standard therapy for hypocalcemia in patients after total thyroidectomy and/or extensive neck dissections (pharyngectomy, laryngectomy,unilateral, bilateral / central neck, mediastinal lymph node neck diss...	Teriparatide is designed to act like a natural human hormone called parathyroid hormone, which can increase the blood levels of calcium. Calcium plus calcitriol is considered the standard treatment for low calcium in the blood. After scheduled surgery, the level of calcium in the blood will be monitored according to t...	Hypocalcemia	Hypocalcemia Teriparatide Forteo Calcium Calcitriol Rocaltrol	null	4	arm 1: 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours arm 2: Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours arm 3: Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours arm 4: Teriparatid...	[ 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Subcutaneous Injection Every 12 Hours for 7 Days intervention 2: 1000 milligrams by mouth (PO) Every 12 Hours intervention 3: 0.25 micrograms PO Every 12 Hours	intervention 1: Teriparatide (Forteo) intervention 2: Calcium intervention 3: Calcitriol	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	0	NCT00623974	6TERMINATED	2010-06-01	2008-05-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 5 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.	It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.	HIV Infections	Raltegravir Lopinavir	null	2	arm 1: Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) arm 2: Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 1, 400mg tablet twice a day, with Truvada 1 tablet once a day intervention 2: 2 tablets twice a day, with Truvada 1 tablet once a day intervention 3: 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)	intervention 1: Raltegravir intervention 2: Lopinavir/Ritonavir intervention 3: Truvada	1	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	6	NCT00632970	6TERMINATED	2010-06-01	2008-02-01	George Washington University	7OTHER	false	false	false	null	0
[ 2 ]	13	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.	null	Locally Advanced or Metastatic Breast Cancer		null	4	arm 1: Dose Level 1 arm 2: Dose Level 2 arm 3: Dose Level 3 arm 4: Triplet Combination	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hou...	intervention 1: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg intervention 2: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg intervention 3: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg intervention 4: Ixabepilone + Lapatinib + Capecitabine	3	New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Brisbane \| Queensland \| Australia \| 153.02809 \| -27.46794 Modena \| N/A \| Italy \| 10.92539 \| 44.64783	10	NCT00634088	6TERMINATED	2010-06-01	2008-06-01	R-Pharm	4INDUSTRY	false	false	false	null	0
[ 4 ]	84	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).	Study Design: A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a 1:1 ratio to receive 2 injections of either leuprolide acetate 11.25 mg or 30 mg depot formulation, each injection administered 3 mo apart (6 mo of treatment): This study includes a 4-week Screening Period, two 3-m...	Puberty, Precocious	CPP central precocious puberty pediatrics suppression of luteinizing hormone Lupron leuprolide acetate depot formulation GnRHa GnRH agonist GnRH analog luteinizing hormone	null	2	arm 1: There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B. arm 2: There are 2 arms that received leuprolide acetate 30 mg. Sub...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart. intervention 2: Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.	intervention 1: Leuprolide acetate 11.25 mg intervention 2: Leuprolide acetate 30 mg	25	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Stanf...	84	NCT00635817	1COMPLETED	2010-06-01	2008-06-01	Abbott	4INDUSTRY	false	false	false	null	0
[ 3 ]	142	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemc...	null	Pancreatic Neoplasms	pancreatic cancer metastatic chemotherapy naive	null	2	arm 1: imexon + gemcitabine arm 2: Placebo in combination with gemcitabine	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV intervention 2: imexon placebo IV + 1000 mg/m\^2 gemcitabine IV	intervention 1: imexon in combination with gemcitabine intervention 2: imexon placebo + gemcitabine	48	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Orlando \| Florida \| United States \|...	135	NCT00637247	1COMPLETED	2010-06-01	2008-04-01	AmpliMed Corporation	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to investigate the efficacy of allopurinol as an augmentation agent for treatment resistant mania and mixed mania.	Bipolar disorder is a severe mental disorder with episodes of mania and depression. Current medications for mania can have significant side effects, high costs and the need for blood monitoring. The purpose of this research study is to study the effectiveness of allopurinol, in combination with lithium or valproic acid...	Bipolar Disorder Mixed Mania Treatment-Resistant Mania	Bipolar Disorder Mania Mixed mania Allopurinol Treatment-Resistant mania	null	2	arm 1: Subjects will be randomized to allopurinol at a fixed dose of 300 mg/day for the first week and then 600mg/day while continuing their current medications during the 7-week study. A battery of assessments will be administered at baseline and weeks 1, 2, 4, 6 after baseline. At each assessment, subjects will also ...	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 300-600 mg/day over a 6 week period intervention 2: Inactive substance	intervention 1: Allopurinol intervention 2: Placebo	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	27	NCT00643123	1COMPLETED	2010-06-01	2007-09-01	Cedars-Sinai Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	97	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data	A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide m...	Partial Epilepsies Partial Onset Seizures	Epilepsy seizures antiepileptic Lacosamide Vimpat safety adjunctive	null	1	arm 1: Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)	[ 0 ]	1	[ 0 ]	intervention 1: Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).	intervention 1: lacosamide	7	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Dallas \| Texas \| ...	97	NCT00655486	1COMPLETED	2010-06-01	2008-04-01	UCB BIOSCIENCES, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	232	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid ...	The purpose of this study is to compare different methods of giving combination drug therapy for treating Helicobacter pylori infection of the stomach. The entire study will last less than 2 years. Each subject will be participating in the study for approximately 60 days. A total of 360 subjects will be asked to parti...	Helicobacter Infection	peptic ulcer disease gastric cancer therapeutics	null	2	arm 1: esomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days arm 2: esomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10 intervention 2: esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, cl...	intervention 1: 10-day sequential treatment intervention 2: 10-day concomitant therapy	2	Kaohsiung \| Taiwan \| Taiwan \| N/A \| N/A Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626	232	NCT00656968	1COMPLETED	2010-06-01	2007-05-01	Kaohsiung Veterans General Hospital.	7OTHER	false	false	false	null	0
[ 5 ]	150	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	0ALL	true	Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after surgery. Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have r...	We plan to enroll women and men undergoing outpatient plastic surgical procedures under general anesthesia. Patients who are scheduled for outpatient plastic surgery will be contacted by one of the investigators, who would be involved in the care of the patient, as soon as they come to the hospital on the day of surger...	Postoperative Nausea and Vomiting	Postoperation, nausea, vomiting, anesthesia, plastic surgery	null	2	arm 1: Pre-op Aprepitant plus Ondansetron for PONV prophylaxis in patients undergoing outpatient plastic surgery arm 2: Pre-op Placebo plus Ondansetron for PONV prophylaxis in patients undergoing outpatient plastic surgery	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Aprepitant plus Ondansetron intervention 2: Ondansetron plus placebo	intervention 1: Aprepitant plus Ondansetron intervention 2: Ondansetron plus placebo	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	150	NCT00659945	1COMPLETED	2010-06-01	2008-06-01	University of Pittsburgh	7OTHER	false	false	false	null	0
[ 3 ]	103	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the role of sorafenib i...	null	Adenocarcinoma	advanced metastatic biliary tract	null	2	arm 1: Gemcitabine + Sorafenib arm 2: Gemcitabine + Placebo	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15. intervention 2: Placebo intervention 3: Sorafenib 400 mg bid orally continuously	intervention 1: Gemcitabine intervention 2: Placebo intervention 3: Sorafenib	11	Mainz \| Rhineland-Palatinate \| Germany \| 8.2791 \| 49.98419 D-07740 Jena \| N/A \| Germany \| N/A \| N/A D-20248 Hamburg \| N/A \| Germany \| N/A \| N/A D-36043 Fulda \| N/A \| Germany \| N/A \| N/A D-60590 Frankfurt \| N/A \| Germany \| N/A \| N/A D-66421 Homburg/Saar \| N/A \| Germany \| N/A \| N/A D-81377 München \| N/A \| Germany \| N/A \|...	97	NCT00661830	1COMPLETED	2010-06-01	2008-05-01	PD Dr Markus Möhler	7OTHER	false	false	false	null	0
[ 5 ]	540	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking. PURPOSE: This clinical trial is studying ...	OBJECTIVES: Primary * To evaluate the efficacy of bupropion hydrochloride and health education counseling vs placebo and health education counseling for smoking cessation among African Americans who are light smokers. Secondary * To characterize CYP2A6 activity in African Americans who are light smokers by evaluati...	Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder	bladder cancer cervical cancer esophageal cancer gastric cancer renal cell carcinoma adult primary liver cancer non-small cell lung cancer small cell lung cancer pancreatic cancer hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavit...	null	2	arm 1: Subjects undergo smoking cessation intervention and take bupropion. arm 2: Subjects receive counseling intervention and take placebo.	[ 0, 2 ]	7	[ 5, 0, 6, 6, 10, 10, 3 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None	intervention 1: smoking cessation intervention intervention 2: bupropion hydrochloride intervention 3: gene expression analysis intervention 4: polymerase chain reaction intervention 5: counseling intervention intervention 6: educational intervention intervention 7: psychosocial assessment and care	2	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973	540	NCT00666978	1COMPLETED	2010-06-01	2007-12-01	Lisa Sanderson Cox, PhD	7OTHER	false	false	false	null	0
[ 0 ]	242	RANDOMIZED	CROSSOVER	null	2DOUBLE	true	0ALL	false	Proposed twin study will test to what degree inter-individual differences in pain sensitivity and amount of pain relief in response to opioid therapy are inherited or alternatively, are due to environmental factors. This knowledge is important to guide future studies trying to explain such inter-individual differences....	The principal hypothesis to be evaluated is that the degree of analgesia provided by opioids in humans displays substantial familial aggregation, and is, in fact, heritable. These studies will use a classical twin paradigm to determine the role of genetics and the environment in influencing analgesia and a range of oth...	Pain		null	2	arm 1: Subjects will receive an intravenous infusion of normal saline. arm 2: Subjects will receive an intravenous infusion of alfentanil.	[ 2, 0 ]	2	[ 0, 10 ]	intervention 1: Target controlled intravenous infusion of alfentanil at a plasma concentration of 100ng/ml intervention 2: Intravenous infusion of normal saline	intervention 1: Alfentanil intervention 2: Saline placebo infusion	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	228	NCT00672438	1COMPLETED	2010-06-01	2008-05-01	Martin Angst	7OTHER	false	false	false	null	0
[ 3 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.	N-Acetyl Cysteine (NAC) is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called free radicals. It is possible...	Autistic Disorder	N-Acetyl Cysteine	null	1	arm 1: Dosage of orally administered N-Acetyl Cysteine is as follows: Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day	[ 0 ]	1	[ 0 ]	intervention 1: Dosage of orally administered N-Acetyl Cysteine is as follows: Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day	intervention 1: N-Acetyl Cysteine	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	24	NCT00676195	1COMPLETED	2010-06-01	2008-06-01	Stanford University	7OTHER	false	false	false	null	0
[ 4 ]	510	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.	Each patient will receive one of the following regimens in the morning after breakfast: 1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or 2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or 3. two placebo Asacol® over encapsulated tablets pl...	Ulcerative Colitis	Ulcerative colitis	null	4	arm 1: One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. arm 2: One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets dai...	[ 0, 0, 2, 1 ]	5	[ 3, 0, 0, 0, 0 ]	intervention 1: Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores intervention 2: 6 mg/day, 6 mg tablets intervention 3: 9 mg/day, 9 mg tablets intervention 4: Placebo intervention 5: 2400 mg/day, 400 mg tablets	intervention 1: Blood sampling, endoscopy intervention 2: budesonide-MMX® 6 mg intervention 3: budesonide-MMX® 9 mg intervention 4: Placebo intervention 5: Asacol® 400 mg	105	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Sylacauga \| Alabama \| United States \| -86.25164 \| 33.17317 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Encinitas \| California \| Unit...	509	NCT00679432	1COMPLETED	2010-06-01	2008-06-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	972	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied	null	Type 2 Diabetes		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tablets, Oral, 5.0 mg, once daily, up to 48 weeks intervention 2: Tablets, Oral, 10.0 mg, once daily, up to 48 weeks intervention 3: Tablets, Oral, 0 mg, once daily, up to 48 weeks intervention 4: Tablets, ≥ 30 mg, Once daily, up to 48 weeks	intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo matching Dapagliflozin intervention 4: Thiazolidinedione (Pioglitazone)	89	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Ozark \| Alabama \| United States \| -85.64049 \| 31.45906 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Little Rock \| Arkansas \| United State...	420	NCT00683878	1COMPLETED	2010-06-01	2008-07-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	392	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general popula...	Patients who continue smoking after ACS have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an acute coronary syndrome (ACS), but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general popul...	Acute Coronary Syndrome Myocardial Infarction Smoking	Acute coronary syndrome Myocardial infarction Smoking cessation Zyban Secondary intervention post-ACS	null	2	arm 1: Half of patients will receive placebo for 9 weeks. arm 2: Half of patients will receive bupropion for 9 weeks.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks intervention 2: Placebo	intervention 1: Bupropion HCl ER intervention 2: Placebo	38	Pueblo \| Colorado \| United States \| -104.60914 \| 38.25445 Lewiston \| Maine \| United States \| -70.21478 \| 44.10035 Bay City \| Michigan \| United States \| -83.88886 \| 43.59447 Cooperstown \| New York \| United States \| -74.92426 \| 42.70048 Johnson City \| New York \| United States \| -75.95881 \| 42.11563 Stony Brook \| New York...	392	NCT00689611	1COMPLETED	2010-06-01	2005-12-01	Mark Eisenberg	7OTHER	false	false	false	null	0
[ 4 ]	665	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The exten...	null	Diabetes Diabetes Mellitus, Type 2		null	5	arm 1: Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). ar...	[ 0, 0, 1, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1.2 mg once daily, subcutaneous (under the skin) injection intervention 2: Tablets, 100 mg daily intervention 3: Tablets, minimum 1500 mg daily intervention 4: 1.8 mg once daily, subcutaneous (under the skin) injection	intervention 1: liraglutide intervention 2: sitagliptin intervention 3: metformin intervention 4: liraglutide	166	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Escondido \| California \| United States \| -117.08642 \| 33.11921 Fresno \| California \| United States \| -119.77237 \| 36.74773 Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Nort...	658	NCT00700817	1COMPLETED	2010-06-01	2008-06-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 4 ]	49	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extens...	null	Pulmonary Arterial Hypertension	pulmonary arterial hypertension inhaled treatment inhalation solution iloprost Ventavis	null	2	arm 1: iloprost power 15 arm 2: iloprost power 15	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of st...	intervention 1: iloprost intervention 2: iloprost	34	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Torrance \| California \| United States \| -118.34063 \| 33.83585 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Atlanta \| Georgi...	81	NCT00709098	1COMPLETED	2010-06-01	2008-09-01	Actelion	4INDUSTRY	false	false	false	null	0
[ 3 ]	46	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	false	1FEMALE	false	The purpose of this study was to assess the effect of naltrexone SR/bupropion SR (NB) on brain function in response to food cues using functional magnetic resonance imaging in overweight or obese subjects.	null	Obesity	obesity overweight magnetic resonance imaging naltrexone bupropion	null	2	arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day arm 2: Placebo tablets	[ 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: None intervention 2: None intervention 3: fMRI to assess the effects of the drug/placebo on areas of the brain	intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day intervention 2: Placebo intervention 3: fMRI scan	1	Upton \| New York \| United States \| -72.88677 \| 40.86954	45	NCT00711477	1COMPLETED	2010-06-01	2008-09-01	Orexigen Therapeutics, Inc	4INDUSTRY	false	false	false	null	0
[ 0 ]	46	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	2DOUBLE	false	0ALL	true	Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to tr...	null	Temporomandibular Joint Dysfunction Syndrome Burning Mouth Syndrome	BMS TMD	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 2, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only). intervention 2: Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone...	intervention 1: nalbuphine plus naloxone intervention 2: nalbuphine plus placebo intervention 3: nalbuphine plus naloxone intervention 4: nalbuphine plus placebo	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	0	NCT00716807	6TERMINATED	2010-06-01	2008-01-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 3, 4 ]	150	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%...	In this study, after consenting, subject is screened for study eligibility. If they pass the study screen, they are randomized to study drug (800 mg/day of SAMe, 1600 mg/day of SAMe or placebo-look-alike). Subjects will stay on their assigned dose for 8 weeks with weekly (visits 3-6) or biweekly (visits 7-8) clinic vis...	Tobacco Dependence	tobacco use cigarettes smokers	null	3	arm 1: Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM arm 2: Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM arm 3: Each subject randomized to this arm will take 2 placebo pills in the AM a...	[ 1, 1, 2 ]	3	[ 0, 0, 10 ]	intervention 1: 800 mg dose per day for 8 weeks intervention 2: 1600 mg per day for 8 weeks intervention 3: 4 pills (2 in the AM and 2 in the PM) of placebos for 8 weeks	intervention 1: S-Adenosyl-L-Methionine intervention 2: S-Adenosyl-L-Methionine intervention 3: placebo	2	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 La Crosse \| Wisconsin \| United States \| -91.23958 \| 43.80136	120	NCT00722124	1COMPLETED	2010-06-01	2008-09-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 4 ]	303	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperacti...	null	Attention Deficit Hyperactivity Disorder	CLONICEL Attention Deficit Hyperactivity Disorder clonidine HCl sustained release	null	1	arm 1: CLONICEL (Clonidine HCl sustained release)	[ 0 ]	1	[ 0 ]	intervention 1: 0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4	intervention 1: CLONICEL (Clonidine HCl sustained release)	27	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 El Centro \| California \| United States \| -115.56305 \| 32.792 Irvine \| California \| United States \| -117.82311 \| 33.66946 San Diego \| California \| United States \| -117.16472 \| 32.71571 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Gainesville \| F...	301	NCT00723190	1COMPLETED	2010-06-01	2008-01-01	Shionogi	4INDUSTRY	false	false	false	null	0
[ 4 ]	65	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if the early treatment with a blood pressure medication (an ACE Inhibitor) can prevent or delay the development of kidney disease (microalbuminuria) in patients with Type 1 diabetes who have normal blood pressure and urine albumin levels.	Only a fraction of persons with Type 1 diabetes (less than 40%) develop diabetic kidney disease (nephropathy). When the urinary albumin (a protein normally excreted in small amounts) is within the normal range, the prevalence of high blood pressure (hypertension) based on office blood pressure readings is very low. Man...	Type 1 Diabetes	Urine albumin excretion rates Nighttime and daytime blood pressure Endothelial Dysfunction	null	3	arm 1: Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo. arm 2: Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo. arm 3: Subjects with nighttime blood pressure that does not...	[ 2, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: ACE inhibitor known as Ramipril Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the "Non-Dippers" groups II and III will be randomized to receive either drug or placebo....	intervention 1: Ramipril intervention 2: Placebo intervention 3: Placebo	6	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 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 Maywood \| Illinois \| United...	0	NCT00729365	6TERMINATED	2010-06-01	2008-07-01	Northwestern University	7OTHER	false	false	false	null	0
[ 2 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of st...	null	Invasive Fungal Infections		null	1	arm 1: Treatment	[ 0 ]	1	[ 0 ]	intervention 1: Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.	intervention 1: Anidulafungin	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	15	NCT00734500	1COMPLETED	2010-06-01	2008-01-01	Michael Cohen-Wolkowiez	7OTHER	false	false	false	null	0
[ 4 ]	301	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.	null	Uterine Myomas	Uterine Myomas	null	3	arm 1: Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection) arm 2: Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection) arm 3: PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)	[ 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: tablets intervention 2: solution for injection	intervention 1: PGL4001 intervention 2: leuprorelin	46	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Neunkirchen \| N/A \| Austria \| 16.08107 \| 47.72096 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Yv...	301	NCT00740831	1COMPLETED	2010-06-01	2008-08-01	PregLem SA	4INDUSTRY	false	false	false	null	0
[ 4 ]	41	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).	null	Constipation-Predominant Irritable Bowel Syndrome	Mosapride Irritable Bowel Syndrome Constipation	null	2	arm 1: Mosapride arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks. intervention 2: One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.	intervention 1: Mosapride Citrate intervention 2: Placebo	1	Beirut \| N/A \| Lebanon \| 35.50157 \| 33.89332	41	NCT00742872	6TERMINATED	2010-06-01	2008-09-01	American University of Beirut Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	8	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To evaluate the tumor responses to SNDX-275 (entinostat) in combination with continued erlotinib in participants with non-small Cell Lung Carcinoma (NSCLC) who are progressing on erlotinib.	null	Non Small Cell Lung Cancer	lung cancer non small cell lung cancer	null	2	arm 1: Participants self-administered entinostat in combination with continued erlotinib self-administration. "Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months. arm 2: Participants self-admin...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Entinostat (10 milligrams \[mg\] fixed dose orally \[PO\] every 2 weeks \[Q2W\]) on Days 1 and 15 of a 28-day cycle for up to 6 cycles intervention 2: Erlotinib (150 mg PO QD) for up to six (6) 28-day cycles	intervention 1: Entinostat intervention 2: Erlotinib	5	San Diego \| California \| United States \| -117.16472 \| 32.71571 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	8	NCT00750698	6TERMINATED	2010-06-01	2008-08-01	Syndax Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	19	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.	NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for th...	Sialorrhea Secondary to Parkinson's Disease	sialorrhea drooling excessive salivation parkinson's disease	null	4	arm 1: subject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide arm 2: subject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide arm 3: subje...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 0.3 mg tropicamide in intra-oral thin film intervention 2: 1 mg tropicamide in intra-oral thin film intervention 3: 3 mg tropicamide in intra-oral thin film intervention 4: 0 mg tropicamide (placebo) in intra-oral thin film	intervention 1: 0.3 mg tropicamide intervention 2: 1 mg tropicamide intervention 3: 3 mg tropicamide intervention 4: 0 mg tropicamide	1	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315	19	NCT00761137	1COMPLETED	2010-06-01	2008-03-01	NeuroHealing Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	190	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this is study to evaluate improvement of sleep disorder caused by cancer pain after the administration of Hydromorphone Oral Osmotic System (OROS) in Korean participants with cancer.	This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) dose-ascending study to evaluate the clinical usefulness of hydromorphone OROS in improvement of sleep disturbance caused by cancer pain.To...	Cancer Pain	Cancer pain Hydromorphone OROS Jurnista	null	1	arm 1: Participants will receive hydromorphone OROS (8 milligram \[mg\] up to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphon...	[ 0 ]	1	[ 0 ]	intervention 1: Participants will receive hydromorphone OROS (8 milligram \[mg\] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydrom...	intervention 1: Hydromorphone	0	null	120	NCT00766831	1COMPLETED	2010-06-01	2008-10-01	Janssen Korea, Ltd., Korea	4INDUSTRY	false	false	false	null	0
[ 3 ]	813	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insul...	This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to e...	Diabetes Mellitus, Type 2		null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 0, 2 ]	4	[ 0, 0, 2, 0 ]	intervention 1: MK-0941 tablets three times daily intervention 2: Matching placebo to MK-0941 three times daily intervention 3: Lantus injection once daily intervention 4: Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participan...	intervention 1: MK-0941 intervention 2: Comparator: Placebo intervention 3: Lantus intervention 4: Metformin	0	null	813	NCT00767000	6TERMINATED	2010-06-01	2008-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	141	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.	null	Allergic Conjunctivitis		null	4	arm 1: Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 2: Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 3: Naphazoline ophthalmic solution admi...	[ 0, 2, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. intervention 2: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. intervention 3: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. intervention 4...	intervention 1: Ketotifen/naphazoline intervention 2: Naphazoline intervention 3: Ketotifen intervention 4: Vehicle	1	North Andover \| Massachusetts \| United States \| -71.13506 \| 42.6987	141	NCT00770133	1COMPLETED	2010-06-01	2010-02-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0
[ 5 ]	36	RANDOMIZED	CROSSOVER	1PREVENTION	4QUADRUPLE	false	0ALL	false	SPECIFIC AIMS 1. To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes. 2. To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment. 3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).	The primary purpose of this study is to determine whether treatment with pioglitazone can reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes. Recent research has found that elevated serum ADMA is associated with increased cardiovascular events and mortality, particularly in people...	Diabetes	Cardiovascular risk biological markers	null	2	arm 1: 18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study. arm 2: 18 (other half of participants) volunteers that are Diabetic ad...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo. intervention 2: Subjects will take the placebo for the fi...	intervention 1: Pioglitazone then Placebo intervention 2: Placebo then Pioglitazone	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	36	NCT00770367	1COMPLETED	2010-06-01	2008-10-01	Medical University of South Carolina	7OTHER	false	false	false	null	0
[ 3 ]	22	RANDOMIZED	FACTORIAL	1PREVENTION	3TRIPLE	false	0ALL	false	The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.	Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment...	HIV Infection	HIV Cardiovascular Disease Endothelial Dysfunction	null	4	arm 1: Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily arm 2: Start antiretroviral therapy (ART) immediately and initiate placebo pill daily arm 3: Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily arm 4: Defer antiretroviral therapy (ART) ...	[ 1, 2, 1, 2 ]	2	[ 0, 0 ]	intervention 1: Patients randomized to Aspirin 325mg po daily versus placebo pill daily intervention 2: Patients randomized to start ART immediately or defer use for 1 month	intervention 1: Aspirin 325mg intervention 2: Antiretroviral therapy (ART)	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	22	NCT00783614	6TERMINATED	2010-06-01	2008-10-01	Hennepin Healthcare Research Institute	7OTHER	false	false	false	null	0
[ 3 ]	273	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.	null	Diabetic Neuropathy, Painful		null	5	arm 1: LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks arm 2: Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6 LY545694 placebo BID po for 5 weeks arm 3: L...	[ 2, 1, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: LY545694 placebo BID po for 5 weeks Pregabalin placebo capsules TID po for 6 weeks intervention 2: Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6 LY545694 placebo BID po for 5 weeks intervention 3: LY545694 21 mg BID po for 1 we...	intervention 1: Placebo intervention 2: Pregabalin intervention 3: LY545694 21 mg intervention 4: LY545694 49 mg intervention 5: LY545694 105 mg	13	Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Tustin \| California \| United States \| -117.82617 \| 33.74585 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 St Louis \| Missouri ...	546	NCT00785577	1COMPLETED	2010-06-01	2008-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This phase II trial studies how well giving sunitinib malate together with capecitabine works in treating patients with unresectable or metastatic liver cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used ...	PRIMARY OBJECTIVES: I. To determine the progression-free survival of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with sunitinib and capecitabine. SECONDARY OBJECTIVES: I. To determine the overall survival, response rate by Response Evaluation Criteria in Solid Tumors (RESIST) crit...	Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer		null	1	arm 1: Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Given PO intervention 2: Given PO	intervention 1: sunitinib malate intervention 2: capecitabine	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	7	NCT00787787	6TERMINATED	2010-06-01	2008-09-01	University of Washington	7OTHER	false	false	false	null	0
[ 5 ]	1,798	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	1FEMALE	true	This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum...	Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.	Uterine Atony Postpartum Hemorrhage	Uterine atony Postpartum hemorrhage clinical trial Prophylactic oxytocin	null	3	arm 1: 1 dose only for prophylaxis given over 1 hour arm 2: One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010. arm 3: 1 dose only given over 1 hour	[ 1, 0, 0 ]	1	[ 0 ]	intervention 1: See arms	intervention 1: Oxytocin	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	1,798	NCT00790062	1COMPLETED	2010-06-01	2008-11-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0
[ 3 ]	8	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.	The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However,...	Diabetes Mellitus, Type 1	Insulin pump therapy Type 1 diabetic Chronic pancreatitis Pancreatic resection Pancreatic polypeptide	null	2	arm 1: Saline arm 2: Pancreatic Polypeptide	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 2pmol/kg-1/min-1 placebo infused continuously over 72 hours. intervention 2: 2pmol/kg-1/min-1 PP infused continuously over 72 hours.	intervention 1: Placebo intervention 2: Pancreatic Polypeptide (PP)	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	0	NCT00791076	6TERMINATED	2010-06-01	2007-10-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 3 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monito...	This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.	Advanced Breast Cancer	Bosutinib Exemestane postmenopausal breast cancer	null	2	arm 1: combination of bosutinib and exemestane arm 2: exemestane	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs intervention 2: 25 mg tablet once daily intervention 3: 25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease...	intervention 1: Bosutinib intervention 2: exemestane intervention 3: Exemestane	28	Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 Joliet \| Illinois \| United States \| -88.0834 \| 41.52519 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 New Brunswick \| New Je...	42	NCT00793546	6TERMINATED	2010-06-01	2009-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 0 ]	3	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. The purpose of this study is to measure the reduction of the movements...	Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or ...	Parkinson's Disease	Parkinsons disease dyskinesia amantadine efficacy	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Amantadine, 300 mg, capsule, three times a day, two weeks intervention 2: Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week intervention 3: sugar pill, capsule, three times a day, 2 weeks	intervention 1: Amantadine 300 mg intervention 2: Topiramate intervention 3: Sugar Pill	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	9	NCT00794313	6TERMINATED	2010-06-01	2009-09-01	Oregon Health and Science University	7OTHER	false	false	false	null	0
[ 3 ]	620	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), pla...	null	Type 2 Diabetes Mellitus Hypertension		null	5	arm 1: One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B). arm 2: One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily ...	[ 0, 0, 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: MK-0736 intervention 2: Comparator: Placebo intervention 3: Comparator: HCTZ	0	null	620	NCT00806585	6TERMINATED	2010-06-01	2008-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is for women and men who have previously treated metastatic (has spread to other parts in the body), Her2- positive breast cancer. The purpose of this study is to find out what effects (good and bad) the FDA-approved drugs etoposide and trastuzumab have on this type of breast cancer and to determine if these...	null	HER-2 Positive Metastatic Breast Cancer	Her2 Positive Breast Cancer Metastatic	null	1	arm 1: Etoposide 100mg/m2 daily x 3 days Q3W and Trastuzumab 8mg/kg loading dose then 6mg/kg, then single agent until disease progression	[ 0 ]	2	[ 0, 0 ]	intervention 1: etoposide 100 mg/m2 daily for 3 days every three weeks for 6 cycles intervention 2: intravenous trastuzumab 8 mg/kg loading dose and then 6 mg/kg every three weeks and then single agent trastuzumab until progression of disease	intervention 1: Etoposide intervention 2: Trastuzumab	1	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	0	NCT00810017	6TERMINATED	2010-06-01	2009-02-01	Medstar Health Research Institute	7OTHER	false	false	false	null	0
[ 0 ]	301	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, bu...	Preterm labor is the most common complication of pregnancy and one of the most catastrophic occurring in 10-12% of all pregnancies and accounting for up to 80% of the neonatal morbidity1. In addition, the delivery of a very low birth weight baby often leads to a reduction in cognitive and academic skills as well an inc...	Preterm Labor	Preterm Labor in Pregnancy	null	3	arm 1: None arm 2: Participants randomized to this group will receive the medication nifedipine orally. arm 3: Participants randomized to this arm will receive the medication indomethacin per rectum and orally.	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion. intervention 2...	intervention 1: 1 Magnesium Sulfate intervention 2: Nifedipine intervention 3: Indomethacin	1	Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876	301	NCT00811057	1COMPLETED	2010-06-01	2004-06-01	University of Mississippi Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	611	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that...	null	Arthritis, Rheumatoid	Antirheumatic Agents Clinical Trial	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 2, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 5mg CP-690,550 BID PO for 6 months intervention 2: 10 mg CP-690,550 BID PO for 6 months intervention 3: Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit intervention 4: Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit	intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo	95	Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Tampa \| Florida \| United...	1,220	NCT00814307	1COMPLETED	2010-06-01	2009-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	true	This is a study involving treatment for alcohol dependence among males of European or Asian decent. The ultimate aim of this line of investigation is to further establish a genetic link between alcohol dependence and treatment by defining an endophenotype associated with treatment response. The study consists of two in...	Despite the well-established efficacy of naltrexone, there are significant variations in individual responses to naltrexone. A critical question remains: under what circumstances and for which patients will naltrexone be most beneficial? Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) ge...	Alcoholism		null	4	arm 1: Each alcohol session preceded by pretreatment with placebo oral tablet arm 2: The first alcohol session preceded by pretreatment with placebo oral tablet. The second alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose. arm 3: Each alcohol session preceded by pretreatment with placebo ...	[ 2, 1, 2, 1 ]	2	[ 0, 0 ]	intervention 1: Placebo pill intervention 2: 50 mg of naltrexone prior to challenge session	intervention 1: Placebo Oral Tablet intervention 2: Naltrexone	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	24	NCT00817089	1COMPLETED	2010-06-01	2007-12-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 5 ]	82	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss ...	null	Femoral Fractures	Tranexamic Acid Blood Loss Long Bone Fracture Surgery	null	2	arm 1: Tranexamic Acid plus standard of care arm 2: Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss.	[ 0, 5 ]	2	[ 0, 3 ]	intervention 1: Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques ...	intervention 1: Tranexamic Acid plus standard of care intervention 2: Standard of care	1	Coimbatore \| Tamil Nadu \| India \| 76.96612 \| 11.00555	81	NCT00824564	1COMPLETED	2010-06-01	2009-04-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 2 ]	16	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is designed to determine the highest dose of levodopa/carbidopa that can be tolerated without any serious side effects by children with Angelman syndrome. It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman...	Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. Animal studies have suggested that levodopa can reverse the excess phosphorylation of some enzymes involved in synaptic and neuronal functio...	Angelman Syndrome	Angelman syndrome Levodopa Carbidopa L-dopa	null	1	arm 1: Other Names: Sinemet L-dopa Dosages are based on levodopa. Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose. Levodopa/Carbidopa is a combined formulation that will be dispense...	[ 0 ]	1	[ 0 ]	intervention 1: Dosages are based on levodopa. Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose. Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It sho...	intervention 1: Levodopa/Carbidopa (4:1)	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	16	NCT00829439	1COMPLETED	2010-06-01	2009-01-01	Boston Children's Hospital	7OTHER	false	false	false	null	0
[ 4 ]	589	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old	The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a \~25 week period.	Migraine Disorders	Migraine with or without aura Migraine efficacy Migraine Migraine headache Adolescent migraine TREXIMET Sumatriptan succinate Naproxen sodium Migraine, acute	null	4	arm 1: Sumatriptan succinate and naproxen sodium combination 10mg/60mg arm 2: Sumatriptan succinate and naproxen sodium combination 30mg/180mg arm 3: Sumatriptan succinate and naproxen sodium combination 85mg/500mg arm 4: Placebo to match	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Sumatriptan succinate and naproxen sodium intervention 2: Placebo to match	intervention 1: Sumatriptan and Naproxen Sodium intervention 2: Placebo	79	Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Conway \| Arkansas \| Un...	1,173	NCT00843024	1COMPLETED	2010-06-01	2008-12-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,351	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg...	The study is designed to evaluate the efficacy and safety of fondaparinux sodium 2.5 mg (1.5 mg in patients with a creatinine clearance between 30 and 50 mL/min) once daily versus Low-Molecular Weight Heparin (nadroparin 2850 anti-Xa IU, 0.3 mL, once daily), with respect to the occurrence of venous thromboembolism, dea...	Thrombosis, Venous	deep vein thrombosis immobilization nadroparin isolated lower-extremity injuries distal to the knee plaster cast non-surgical leg injury venous thromboembolism bleeding events fondaparinux	null	2	arm 1: After randomization (Day 1), subjects will receive subcutaneously once daily nadroparin 2850 anti-Xa IU (0.3 mL) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of treatment is 45 days. Patients will then be followed up to five weeks (± one week) af...	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: After randomization (Day 1), subjects will receive subcutaneously once daily fondaparinux 2.5 mg \[0.5mL\] (1.5 mg \[0.3mL\] in patients with creatinine clearance between 30 and 50 mL/min) for at least 21 Days, up to complete mobilization, corresponding to cast or brace removal. The maximal duration of ...	intervention 1: Fondaparinux sodium intervention 2: Nadroparin	122	Agen \| N/A \| France \| 0.62055 \| 44.20199 Angers \| N/A \| France \| -0.55202 \| 47.47156 Antony \| N/A \| France \| 2.29668 \| 48.75329 Argenteuil \| N/A \| France \| 2.24744 \| 48.94788 Beauvais \| N/A \| France \| 2.08333 \| 49.43333 Bobigny \| N/A \| France \| 2.45012 \| 48.90982 Brest \| N/A \| France \| -4.48628 \| 48.39029 Cergy-Pontois...	1,344	NCT00843492	1COMPLETED	2010-06-01	2008-12-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	250	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking	In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Interventi...	Cigarette Smoking	Smoking Smoking cessation Smokeless tobacco Snus	null	2	arm 1: Tobacco-based, smokefree product in pouch format for oral use, pouch size 1.0 or 0.5 g to be used ad libitum by participants arm 2: Non-tobacco, non-nicotine placebo product in pouch format for oral use, pouch size 1.0 g or 0.5 g, to be used ad libitum by the participants	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke \>15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sache...	intervention 1: Low-nitrosamine smokefree tobacco product for oral use intervention 2: Non-tobacco, non-nicotine placebo product	4	Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Austin \| Texas \| United States \| -97.74306 \| 30.26715	250	NCT00843622	1COMPLETED	2010-06-01	2009-02-01	Swedish Match AB	4INDUSTRY	false	false	false	null	0
[ 5 ]	108	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 ...	null	Diabetic Neuropathies Depressive Disorder, Major		null	4	arm 1: Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (\>30% pain reduction after week 6) arm 2: Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (\<30% pain reduction after week 6) arm 3: Patients that have diabet...	[ 5, 5, 5, 5 ]	12	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: given to (1) all patients week 2-6; (2) all responders of both arms week 7-12 intervention 2: given to (1) all patients week 2-6; (2) all responders of both arms week 7-12 intervention 3: given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks) interven...	intervention 1: Duloxetine 60 mg QD intervention 2: Duloxetine 60 mg QD intervention 3: Duloxetine 30 mg QD intervention 4: Duloxetine 30 mg QD intervention 5: Duloxetine 90 mg QD intervention 6: Duloxetine 90 mg QD intervention 7: Duloxetine 60 mg QD intervention 8: Duloxetine 60 mg QD intervention 9: Duloxetine 120 m...	25	Achim Bei Bremen \| N/A \| Germany \| N/A \| N/A Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Bad Mergentheim \| N/A \| Germany \| 9.77361 \| 49.4925 Baesweiler \| N/A \| Germany \| 6.18874 \| 50.90964 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 ...	108	NCT00844194	1COMPLETED	2010-06-01	2009-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,085	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe essential hypertension.	According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease and renal failure. As the population ages, the prevalence of hypertension w...	Essential Hypertension	Essential Hypertension Hypertensive Blood Pressure, High Vascular Disease Cardiovascular Disease Drug Therapy	null	3	arm 1: (dependant on blood pressure) arm 2: (dependant on blood pressure) arm 3: (dependant on blood pressure)	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks. If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidon...	intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Azilsartan medoxomil and chlorthalidone intervention 3: Olmesartan medoxomil-hydrochlorothiazide	80	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Haleyville \| Alabama \| United States \| -87.62141 \| 34.22649 Hueytown \| Alabama \| United States \| -86.99666 \| 33.45122 Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Tallassee \| Alabama \| United States \| -85.89329 \| 32.53597 Green Valley \| Arizona \| Un...	1,085	NCT00846365	1COMPLETED	2010-06-01	2009-03-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 3 ]	176	NON_RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	false	0ALL	true	The main purpose of this study is to get more information on using BMS747158 (the study drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET scan which can then be compared to other images such as SPECT. The safety and quality of images will be studied.	The primary objectives of this study are: * To acquire data for the development of one-day rest/stress cardiac PET perfusion imaging protocols for BMS747158 with comparable diagnostic image quality to a two-day rest/stress PET protocol * To assess the safety of multiple doses of BMS747158 The secondary objectives of ...	Ischemia	Myocardial Perfusion PET imaging SPECT imaging Coronary artery disease Subjects that are male and nonpregnant female patients presenting with reversible ischemia as characterized by a rest/stress SPECT imaging study using Technetium(99mTc)-labeled tracers	null	2	arm 1: Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period. arm 2: Patients to receive 2 IV bolus injections of BMS747158:1 at rest and 1 at stress For the Pharmacologic (Adenosine) Stress: * Doses at rest to ...	[ 0, 0 ]	1	[ 0 ]	intervention 1: dosages at rest and at stress were not to exceed a total of 14 mCi. Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period. Cohort 2: Patients to recieve IV bolus injections of BMS747158: For the Pharmacologic (Aden...	intervention 1: BMS747158	24	Fremont \| California \| United States \| -121.98857 \| 37.54827 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San D...	176	NCT00849108	1COMPLETED	2010-06-01	2009-01-01	Lantheus Medical Imaging	4INDUSTRY	false	false	false	null	0
[ 4 ]	612	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	false	This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).	null	Benign Prostatic Hyperplasia		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks intervention 2: PO, QD (30 min after meal) for 12 weeks intervention 3: PO, QD (30 min after meal) for 12 weeks	intervention 1: Tadalafil intervention 2: Placebo intervention 3: Tamsulosin	6	Hyōgo \| N/A \| Japan \| 144.43333 \| 43.36667 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896	612	NCT00861757	1COMPLETED	2010-06-01	2009-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	822	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensiv...	null	Hypertension	Hypertension ABPM systolic blood pressure diastolic blood pressure cardiovascular disease aliskiren telmisartan	null	2	arm 1: Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period. arm 2: Telmisarta...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks. intervention 2: Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks. intervention 3: Placebo to Aliskiren tablets taken orally dail...	intervention 1: Aliskiren intervention 2: Telmisartan intervention 3: Placebo to Aliskiren intervention 4: Placebo to Telmisartan	16	Sorocaba \| N/A \| Brazil \| -47.45806 \| -23.50167 Gatineau \| N/A \| Canada \| -75.70164 \| 45.47723 Guayaquil \| N/A \| Ecuador \| -79.88621 \| -2.19616 Erfurt \| N/A \| Germany \| 11.03283 \| 50.9787 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Mexico City \| N/A \| Mexico \| -99.1...	814	NCT00865020	1COMPLETED	2010-06-01	2009-03-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT) regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition, efficacy (i.e. anti-tumor effect) of the...	null	Carcinoma of the Head and Neck	Newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN)	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Patients receive Cetuximab at an initial dose of 400 mg/m\^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m\^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. Subjects wi...	intervention 1: Cetuximab	4	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Shizuoka \| N/A \| Japan \| 138.38333 \| 34.98333 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	22	NCT00865098	1COMPLETED	2010-06-01	2009-03-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0
[ 4 ]	311	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	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 basal insulin with or without sulfonylurea, over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide, when added to basal insulin,...	null	Diabetes Mellitus, Type 2	hyperglycemia GLP-1 sulfonylurea insulin	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 Week 24. 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 Week 24.	[ 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 if given, to be continued at a stable dose. interven...	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Sulfonylurea intervention 5: Basal Insulin	4	Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Makati City \| N/A \| Philippines \| 121.03269 \| 14.55027 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	311	NCT00866658	1COMPLETED	2010-06-01	2009-03-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 4 ]	119	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)	null	Fibromyalgia Sleep Disorders	Fibromyalgia sleep maintenance disturbance pregabalin	null	2	arm 1: flexible dosing Lyrica 300-450mg/day arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day intervention 2: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks	intervention 1: Pregabalin intervention 2: Placebo	50	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 San Diego \| California \| United States \| -117.16472 \| 32.71571 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 DeLand \| Florida...	223	NCT00883740	1COMPLETED	2010-06-01	2009-06-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	67	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.	A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory aggressive non-Hodgkin's Lymphoma. Primary • To assess the anti-tumour activity of Aplidin® given as a 1-hour weekly IV infusion, in patients with aggressive non-Ho...	Leukemia Lymphoma	Aplidin Aggressive Non Hodgkin Lymphoma Leukemia-Lymphoma, Adult T-Cell and B-cell	null	1	arm 1: Aplidin® given as a 1-hour weekly IV infusion	[ 0 ]	1	[ 0 ]	intervention 1: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.	intervention 1: Aplidin®	12	Lyon \| N/A \| France \| 4.84671 \| 45.74846 Paris \| N/A \| France \| 2.3488 \| 48.85341 Villejuif \| N/A \| France \| 2.35992 \| 48.7939 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Modena \| N/A \| Italy \| 10.92539 \| 44.64783 Surquillo \| Lima region \| Peru \| -77.01147 \| -12.11993 San Juan ...	64	NCT00884286	1COMPLETED	2010-06-01	2004-12-01	PharmaMar	4INDUSTRY	false	false	false	null	0
[ 0 ]	205	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	1FEMALE	true	The purpose of this study is to test whether a medication reduces the number, severity and bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general anxiety disorder. An SSRI increases serotonin...	The MsFLASH-01 study, Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women is a randomized, double-blind, placebo-controlled, parallel arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes prior to drug treatment; 8 weeks of double-blind treat...	Hot Flashes Menopause Vasomotor Symptoms	Hot flashes Menopause Vasomotor symptoms	null	2	arm 1: Escitalopram is a selective serotonin reuptake inhibitor (SSRI) arm 2: Inactive pill	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: 10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose. intervention 2: Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.	intervention 1: Escitalopram intervention 2: Placebo	5	Oakland \| California \| United States \| -122.2708 \| 37.80437 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Chestnut Hill \| Massachusetts \| United States \| -71.16616 \| 42.33065 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	205	NCT00894543	1COMPLETED	2010-06-01	2009-07-01	Fred Hutchinson Cancer Center	7OTHER	false	false	false	null	0
[ 5 ]	30	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	true	2MALE	false	This study will examine the effects of two different antipsychotic medications on control of blood sugar in people who are at risk of diabetes but mentally healthy.	Antipsychotic medications are those that treat the most severe psychiatric symptoms, such as hallucinations, paranoid thoughts, and delusions. Research shows that some of these medications may put people at a higher risk of metabolic derangements, such as insulin resistance. Certain antipsychotics, like clozapine and o...	Diabetes	Insulin Resistance Antipsychotic Medications	null	2	arm 1: Participants will receive an injection of aripiprazole during the tracer-clamp study. arm 2: Participants will receive an injection of olanzapine during the tracer-clamp study.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Single intramuscular 10-mg dose intervention 2: Single intramuscular 9.75-mg dose	intervention 1: Olanzapine intervention 2: Aripiprazole	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	30	NCT00895921	1COMPLETED	2010-06-01	2008-11-01	Veterans Medical Research Foundation	7OTHER	false	false	false	null	0
[ 3 ]	27	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.	null	Advanced Cancer		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.	intervention 1: vorinostat	0	null	27	NCT00907738	1COMPLETED	2010-06-01	2005-08-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	457	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metfo...	null	Diabetes Diabetes Mellitus, Type 2		null	2	arm 1: Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day arm 2: Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued intervention 2: Treat-to-target (individually a...	intervention 1: insulin detemir intervention 2: insulin glargine	88	Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Searcy \| Arkansas \| United States \| -91.73625 \| 35.25064 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Concord \| California \| United States \| -122.03107 \| 37.97798 Escondido \| California \| United States \| -117.08642 \| 33.11921 Fresno \| Cali...	453	NCT00909480	1COMPLETED	2010-06-01	2009-05-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0
[ 0 ]	211	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.	The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms: 1. PCA with 1.0 mg morphine demand dosing every 6 minutes, 2. PCA with 1.5 mg demand dosing every 6 minutes and 3. a non-PCA comparison group. All patients will receive a loading dose of 0.1 mg/kg morphine. All p...	Pain	Pain Analgesia Analgesia, Patient-controlled Emergency Medicine	null	3	arm 1: 0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes arm 2: 0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes arm 3: 0.1 mg/kg morphine loading dose plus additional analgesia as needed	[ 0, 0, 1 ]	2	[ 1, 0 ]	intervention 1: Intravenous morphine delivered via Curlin painsmart PCA device intervention 2: Intravenous morphine	intervention 1: Patient-controlled analgesia intervention 2: morphine	1	The Bronx \| New York \| United States \| -73.86641 \| 40.84985	206	NCT00910208	1COMPLETED	2010-06-01	2009-04-01	Albert Einstein College of Medicine	7OTHER	false	false	false	null	0
[ 4 ]	254	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.	This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pha...	Pediculosis	Head Lice	null	2	arm 1: Malathion gel 0.5% 30 minute application arm 2: Nix applied to scalp for 10 minutes	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present. intervention 2: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.	intervention 1: Malathion gel 0.5% intervention 2: Permethrin 1% rinse	2	Bentonville \| Arkansas \| United States \| -94.20882 \| 36.37285 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423	254	NCT00927472	1COMPLETED	2010-06-01	2009-08-01	Sun Pharmaceutical Industries, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	160	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.	null	Diabetes Mellitus, Type 2	diabetes mellitus, type 2 nateglinide acarbose hyperglycemia dyslipidemias C-reactive protein	null	2	arm 1: Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. arm 2: Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Nateglinide 120 mg was supplied as tablets. intervention 2: Acarbose 50 mg was supplied as tablets.	intervention 1: Nateglinide 120 mg intervention 2: Acarbose 50 mg	6	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Guangzhou \| N/A \| China \| 113.25 \| 23.11667	160	NCT00928889	1COMPLETED	2010-06-01	2009-07-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	31	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	false	This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.	null	Glaucoma, Open-Angle Ocular Hypertension		null	2	arm 1: Active study drug + latanoprost vehicle arm 2: Active study drug + latanoprost	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Topical ocular solution, once-daily for 14 days intervention 2: Topical ocular solution, once-daily for 14 days intervention 3: Topical ocular solution, once-daily for 14 days intervention 4: Topical ocular solution, once-daily for 14 days	intervention 1: PF-04217329 intervention 2: latanoprost vehicle intervention 3: PF-04217329 intervention 4: latanoprost	8	Cypress \| California \| United States \| -118.03729 \| 33.81696 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Gardena \| California \| United States \| -118.30896 \| 33.88835 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los...	59	NCT00934089	1COMPLETED	2010-06-01	2010-01-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	3	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin resistance) will delay or prevent kidney transplant patients from getting diabetes.	New-onset diabetes after transplantation (NODAT) is a complication of solid organ transplantation. In the University of Nebraska Medical Center (UNMC) Kidney-Pancreas Transplant Clinic, the frequency of this complication exceeds 50% of kidney transplant recipients without diabetes prior to transplantation. NODAT is ass...	Type 2 Diabetes End Stage Renal Disease	Diabetes Kidney Transplant Sitagliptin	null	2	arm 1: sitagliptin 100 mg daily arm 2: placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis. intervention 2: Active drug dose will be 100 mg ...	intervention 1: Placebo intervention 2: Sitagliptin	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	3	NCT00936663	6TERMINATED	2010-06-01	2009-07-06	University of Nebraska	7OTHER	false	false	false	null	0
[ 3 ]	408	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747 versus placebo in relieving pain in participants with osteoarthritis of the knee.	null	Osteoarthritis of the Knee	delta opioid receptor agonist osteoarthritis pain	null	4	arm 1: One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days arm 2: One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days arm 3: One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsul...	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: ADL5859 intervention 2: ADL5747 intervention 3: Oxycodone CR intervention 4: Placebo	11	Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Stockbridge \| Georgia \| United States \| -84.23381 \| 33.54428 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Gurnee \| Illinois \| United States \| -87.90202 \| 42.3703 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Wilmington \| Nor...	408	NCT00979953	1COMPLETED	2010-06-01	2009-10-01	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	4INDUSTRY	false	false	false	null	0
[ 0 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less po...	null	Postoperative Pain		null	4	arm 1: General Anesthesia with Desflurane arm 2: General Anesthesia with Sevoflurane arm 3: General Anesthesia with Isoflurane arm 4: General Anesthesia with Propofol	[ 1, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane intervention 2: Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane intervention 3: Patient induced for general anest...	intervention 1: Desflurane intervention 2: Sevoflurane intervention 3: Isoflurane intervention 4: Propofol	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	74	NCT00983918	1COMPLETED	2010-06-01	2009-09-01	Baylor College of Medicine	7OTHER	false	false	false	null	0
[ 2 ]	101	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).	This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In...	Multiple Myeloma	Multiple myeloma Hematopoietic stem cell transplant HSCT Melphalan Prednisolone Bortezomib JNJ-26866138	null	4	arm 1: JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. arm 2: JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 an...	[ 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. intervention 2: JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles intervention 3: Phase I: JNJ-26...	intervention 1: JNJ-26866138 0.7 mg/m2 intervention 2: JNJ-26866138 1.0 mg/m2 intervention 3: JNJ-26866138 1.3 mg/m2 intervention 4: Melphalan intervention 5: Prednisolone	28	Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Hitachi \| N/A \| Japan \| 140.65 \| 36.6 Isehara \| N/A \| Japan \| 139.31019 \| 35.39932 Kamogawa \| N/A \| Japan \| 140.1003 \| 35.0969 Kanazawa \| N/A \| Japan \| 136.61667 \| 36.6 Kawagoe \| N/A \| Japan \| 139.48528 \| 35.90861 Kobe \| N/A \| Japan \| 135....	105	NCT00985959	1COMPLETED	2010-06-01	2008-07-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0
[ 5 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	true	This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1...	null	Stable Plaque Psoriasis		null	2	arm 1: Patients will apply both Ultravate ointment and LacHydrin lotion twice daily arm 2: Patients will apply Ultravate ointment once daily, but will use LacHydrin lotion twice daily	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Topical corticosteroid intervention 2: Topical corticosteroid	intervention 1: Ultravate ointment twice daily + LacHydrin lotion twice daily intervention 2: Ultravate ointment once daily + LacHydrin lotion twice daily	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	40	NCT00990561	1COMPLETED	2010-06-01	2009-07-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 3 ]	343	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.	null	Obesity		null	7	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None	[ 2, 0, 1, 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Given daily, orally for 24 weeks intervention 2: given daily, orally for 24 weeks intervention 3: given daily, orally for 24 weeks (100 mg for 1 week followed by 200 mg for 23 weeks. Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper (1 week at 100 mg/day foll...	intervention 1: LY377604 intervention 2: Sibutramine intervention 3: Metoprolol intervention 4: Placebo sibutramine intervention 5: Placebo Metoprolol intervention 6: Placebo LY377604	21	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Concord \| California \| United States \| -122.03107 \| 37.97798 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Idaho Falls \| Idaho \|...	343	NCT00993421	6TERMINATED	2010-06-01	2009-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	203	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.	null	Type 2 Diabetes Mellitus	insulin resistance	null	2	arm 1: Teneligliptin 20 mg, orally, once daily arm 2: Teneligliptin placebo-matching tablets, orally, once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Teneligliptin 20 mg intervention 2: Placebo	1	Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667	203	NCT00998881	1COMPLETED	2010-06-01	2009-09-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0
[ 3 ]	35	RANDOMIZED	PARALLEL	null	3TRIPLE	false	0ALL	false	Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also ...	null	HIV Infections Heart Disease	Omega-3 Fatty Acids HIV Heart Disease Treatment experienced	null	2	arm 1: Lovaza 1 gram by mouth twice a day for 24 weeks. arm 2: Placebo capsule by mouth twice a day x 24 weeks.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Lovaza one gram twice a day for 24 weeks intervention 2: Placebo	intervention 1: Lovaza intervention 2: Placebo	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	35	NCT01001767	1COMPLETED	2010-06-01	2009-04-01	University Hospitals Cleveland Medical Center	7OTHER	false	false	false	null	0
[ 0 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes melli...	In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.	Obesity Vitamin D Deficiency Psychosis Schizophrenia Schizoaffective Disorder	Psychiatric illnesses Vitamin D deficiency Obesity	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 2000 international units by mouth daily for 8 weeks.	intervention 1: Ergocalciferols	1	Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259	12	NCT01004354	1COMPLETED	2010-06-01	2009-06-01	University of Massachusetts, Worcester	7OTHER	false	false	false	null	0
[ 5 ]	56	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12 reaction units (PRU...	null	Coronary Artery Disease	thienopyridine pharmacologic action prasugrel clopidogrel	null	2	arm 1: Prasugrel 10mg administered for 7 days followed by a Washout Period up to 12 days. arm 2: Clopidogrel 75mg administered for 7 days followed by a 12 day Washout Period up to 12 days.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Prasugrel 10mg tablet administered once daily for 7 days. After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout D...	intervention 1: Prasugrel intervention 2: Clopidogrel	4	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054	56	NCT01014624	1COMPLETED	2010-06-01	2010-02-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0
[ 3 ]	38	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to help answer the following research question(s): * To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks. * To evaluate the safety of LY2599506 in participants with diabetes. * To determine if LY2599506 has the ability to control blood su...	null	Diabetes Mellitus, Type 2		null	2	arm 1: Combinations of 50-milligram (mg) or 100-mg capsules of LY2599506 or matching placebo capsules (each dose contains at least 1 capsule of active drug). LY2599506 will be administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day. arm 2: Combinations of 2.5-mg capsules...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks intervention 2: Administered po, BID daily prior to morning and evening meals for 12 weeks intervention 3: Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks	intervention 1: LY2599506 intervention 2: Glyburide intervention 3: Placebo	16	Elizabeth Vale \| South Australia \| Australia \| 138.66819 \| -34.74857 East Ringwood \| Victoria \| Australia \| N/A \| N/A Heidelberg \| Victoria \| Australia \| 145.06667 \| -37.75 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Holešov \| N/A \| Czechia \| 17.57832 \| 49.33331 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Mainz \| N/A...	38	NCT01029795	6TERMINATED	2010-06-01	2010-02-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	22	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).	null	Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Chronic Obstructive Airway Disease COPD	Safety Pharmacokinetics Pharmacodynamics PF-03635659 COPD	null	3	arm 1: None arm 2: None arm 3: None	[ 2, 1, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: oral inhaled formulation, single dose intervention 2: oral inhaled formulation, single dose intervention 3: oral inhaled formulation, single dose, low dose intervention 4: oral inhaled formulation, single dose, mid dose intervention 5: oral inhaled formulation, single dose, high dose	intervention 1: placebo intervention 2: active comparator intervention 3: Low Dose PF-03635659 intervention 4: Mid Dose PF-03635659 intervention 5: High Dose PF-03635659	1	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437	109	NCT01033487	1COMPLETED	2010-06-01	2010-01-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	23	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples wil...	null	Kidney Transplantation		null	2	arm 1: Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month. arm 2: Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 1 g per day b.i.d. p.o. for at least 1 month intervention 2: 720 mg b.i.d. p.o. for at least 1 month intervention 3: 5 mg per day p.o.	intervention 1: MMF intervention 2: EC-MPS intervention 3: Prednisone	1	Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552	23	NCT01033864	1COMPLETED	2010-06-01	2009-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	183	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.	null	Atopic Dermatitis		null	7	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None	[ 0, 0, 0, 0, 0, 2, 1 ]	2	[ 0, 0 ]	intervention 1: comparison of different dosages of drug intervention 2: comparison	intervention 1: LEO 29102 intervention 2: Elidel®	3	Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438	364	NCT01037881	1COMPLETED	2010-06-01	2009-12-01	LEO Pharma	4INDUSTRY	false	false	false	null	0
[ 3 ]	24	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of this study is to evaluate the potential of desoximetasone 0.25% topical spray to suppress HPA axis function. The potential for adrenal suppression will be assessed following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate to severe plaque psoriasis. The secondary objec...	null	Psoriasis	Plaque psoriasis	null	2	arm 1: Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area. arm 2: Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Desoximetasone spray applied to affected areas twice daily for 28 days	intervention 1: Desoximetasone 0.25% spray	3	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706	24	NCT01043393	1COMPLETED	2010-06-01	2010-02-01	Sun Pharmaceutical Industries, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.	All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.	Inflammatory Reaction Due to Ocular Lens Prosthesis	ocular inflammation cataract surgery post cataract surgery inflammation	null	3	arm 1: 114ug arm 2: 513ug arm 3: 684ug	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Single intraocular injection	intervention 1: IBI-10090	1	Los Altos \| California \| United States \| -122.11413 \| 37.38522	6	NCT01048593	6TERMINATED	2010-06-01	2010-01-01	ICON Bioscience Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	72	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.	null	Asthma		null	5	arm 1: A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind. arm 2: A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers u...	[ 0, 0, 1, 1, 2 ]	3	[ 0, 0, 10 ]	intervention 1: Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg. intervention 2: ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg re...	intervention 1: Albuterol Spiromax® intervention 2: ProAir® HFA intervention 3: Placebo Inhaler	13	Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 Rolling Hills Est. \| California \| United States \| N/A \| N/A San Diego \| California \| United States \| -117.16472 \| 32.71571 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Margate \| Florida \| United States \| -80.20644 \| 26.24453 Mia...	343	NCT01058863	1COMPLETED	2010-06-01	2010-02-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	47	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety profile of orally administered tapentadol ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral neuropathy (DPN) over long-term exposure of up to 1 year.	This is a randomized, open-label, active-controlled, multicenter study evaluating the safety profile of orally administered tapentadol, using the extended release tamper-resistant formulation (TRF), at dosages of 100 to 250 mg twice daily in patients with moderate to severe pain due to chronic, painful DPN. The study c...	Diabetic Neuropathy, Painful Diabetic Polyneuropathy	Diabetic neuropathy Painful Polyneuropathy Peripheral neuropathy	null	2	arm 1: Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks arm 2: Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 100, 150, 200, 250 mg twice daily for 52 weeks intervention 2: 20, 30, 40, 50 mg twice daily for 52 weeks	intervention 1: Tapentadol extended release (ER) intervention 2: Oxycodone controlled release (CR)	23	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Fruitland Park \| Florida \| United States \| -81.90647 \| 28.86138 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Oviedo \| Florida \| United States \| -81.20812 \| 28.67 Tampa \| Florida \| United S...	47	NCT01063868	6TERMINATED	2010-06-01	2010-01-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 4 ]	318	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.	null	Chronic Obstructive Pulmonary Disease	COPD Indacaterol	null	2	arm 1: Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use thr...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Once daily via single-dose dry powder inhaler (SDDPI) intervention 2: Once daily via SDDPI	intervention 1: Indacaterol intervention 2: Placebo to indacaterol	54	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Los Angeles \| California \|...	318	NCT01068600	1COMPLETED	2010-06-01	2010-01-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 5 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	true	The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.	This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than...	Obesity Nutrition Disorders Overweight	Micafungin Body Weight Anti-Infective Agents Signs and Symptoms Mycoses Therapeutic Uses Antifungal Agents Overnutrition Pharmacologic Actions	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 100 mg IV infusion over 1 hour intervention 2: 300 mg IV infusion over 1 hour	intervention 1: Micafungin intervention 2: Micafungin	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	0	NCT01090141	1COMPLETED	2010-06-01	2009-11-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0
[ 2 ]	28	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	2MALE	false	This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC...	null	Type 2 Diabetes	Type 2 Diabetes	null	4	arm 1: Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 500 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg si...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours. intervention 2: Single dose administration of the final marketing image (FMI) sitagliptin/metfor...	intervention 1: Co-administration of 50 mg sitagliptin and 500 mg metformin intervention 2: sitagliptin/metformin 50 mg/500 mg tablet intervention 3: Co-administration of 50 mg sitagliptin and 850 mg metformin intervention 4: sitagliptin/metformin 50 mg/850 mg tablet	0	null	112	NCT01093794	1COMPLETED	2010-06-01	2010-04-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 0 ]	130	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.	Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD (Department of Defense) beneficiaries. Prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular sta...	Postoperative Pain	photorefractive keratectomy excimer laser PRK pain, postoperative pregabalin	null	2	arm 1: Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days arm 2: Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively. intervention 2: 1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.	intervention 1: pregabalin intervention 2: Placebo	1	Lackland Air Force Base \| Texas \| United States \| -98.61797 \| 29.38663	129	NCT01097577	1COMPLETED	2010-06-01	2010-03-01	59th Medical Wing	1FED	false	false	false	null	0
[ 2 ]	28	RANDOMIZED	CROSSOVER	null	0NONE	true	2MALE	null	Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.	null	Healthy		null	2	arm 1: V4: PPX ER 1.5mg x 1 fed, V5: PPX ER 0.375mg x 4 fed, V6:: PPX ER 1.5mg x 1 fasted, V5: PPX ER 0.375mg x 4 fasted arm 2: V4: PPX ER 0.375mg x 4 fed, V5: PPX ER 1.5mg x 1 fed, V6:: PPX ER 0.375mg x 4 fasted, V5: PPX ER 1.5mg x 1 fasted	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: PPX ER 0.375mg - 1.5mg for 32 days totally intervention 2: PPX ER 0.375mg - 1.5mg for 32 days totally	intervention 1: PPX ER intervention 2: PPX ER	1	Sumida-ku, Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	83	NCT01119443	1COMPLETED	2010-06-01	2010-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2 ]	16	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.	The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese...	Healthy	bioavailability	null	2	arm 1: One Colcrys® (colchicine USP) 0.6 mg intact tablet taken by mouth arm 2: One Colcrys® 0.6 mg tablet crushed and dissolved in apple juice	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: One Colcrys® 0.6 mg intact tablet taken by mouth intervention 2: One Colcrys® 0.6 mg tablet dissolved in apple juice	intervention 1: colchicine 0.6 mg tablet intervention 2: colchicine 0.6 mg tablet	1	Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497	31	NCT01123395	1COMPLETED	2010-06-01	2010-05-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0
[ 2 ]	16	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. A secondary objective is ...	The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smok...	Healthy	bioavailability	null	2	arm 1: One Colcrys® 0.6 mg intact tablet taken by mouth arm 2: One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: One Colcrys® 0.6 mg intact tablet taken by mouth intervention 2: One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce	intervention 1: Colchicine 0.6 mg tablet intervention 2: Colchicine 0.6 mg tablet	1	Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497	29	NCT01130051	1COMPLETED	2010-06-01	2010-05-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly, Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from mutation of a unique gene, named MYH9, and they have been recognized as different clinical presentations of a single illness that was ...	null	Blood Platelet Disorders	inherited thrombocytopenia MYH9 mutations eltrombopag	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 will continue eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 will receive eltrombopag 75 mg/daily for additional 21 ...	intervention 1: eltrombopag	3	Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Perugia \| N/A \| Italy \| 12.38878 \| 43.1122	12	NCT01133860	1COMPLETED	2010-06-01	2009-01-01	Fondazione IRCCS Policlinico San Matteo di Pavia	7OTHER	false	false	false	null	0
[ 2 ]	18	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.	null	Healthy Volunteers	biological availability bioavailability amlodipine orally disintegrating tablet ODT tablets	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg tablet, single dose, with water intervention 2: 10 mg orally disintegrating tablet (ODT), single dose, with water intervention 3: 10 mg orally disintegrating tablet (ODT), single dose, without water	intervention 1: Amlodipine - reference intervention 2: Amlodipine ODT - test intervention 3: Amlodipine ODT - test	1	Hydrabad \| Andhra Pradesh \| India \| N/A \| N/A	54	NCT01138826	1COMPLETED	2010-06-01	2010-05-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.	null	Skin Manifestations		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Apply topically on one side of the face once daily for three weeks intervention 2: Apply topically on the opposite side of the face twice daily for three weeks	intervention 1: metronidazole 1% gel intervention 2: azelaic acid 15% gel	1	Carrollton \| Texas \| United States \| -96.89028 \| 32.95373	160	NCT01139008	1COMPLETED	2010-06-01	2010-06-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 5 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.	null	Skin Manifestations		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Apply topically once daily on one side of the face for three weeks intervention 2: Apply topically twice daily on the opposite side of the face for three weeks	intervention 1: metronidazole 1% gel intervention 2: azelaic acid 15% gel	1	Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388	154	NCT01139047	1COMPLETED	2010-06-01	2010-06-01	Galderma R&D	4INDUSTRY	false	false	false	null	-0
[ 2, 3 ]	24	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), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.	This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C). ...	Asthma	Asthma Pharmacokinetics Epinephrine Bronchodilator metered dose inhaler	null	3	arm 1: Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. arm 2: T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation arm 3: HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Single dose 220 mcg/inhalation, 10 inhalations intervention 2: HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations intervention 3: HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations	intervention 1: epinephrine inhalation aerosol intervention 2: epinephrine inhalation aerosol intervention 3: epinephrine inhalation aerosol	1	Cypress \| California \| United States \| -118.03729 \| 33.81696	69	NCT01143051	1COMPLETED	2010-06-01	2010-01-01	Amphastar Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	106	NA	SINGLE_GROUP	6HEALTH_SERVICES_RESEARCH	0NONE	false	0ALL	false	The purpose of this study is to determine the amount of propofol required to achieve 50% of patients obtaining a perfect ("excellent") intubation score of 5 on the Steyn modification of the Helbo-Hansen Intubation Score, when placing a tracheal tube in children 1-6 years and 6-12 years (division of age groups at 6th bi...	The practice of tracheal intubation of children without neuromuscular blockade (TIWNB) is widespread in pediatric anesthesia practices. There are several different methods reported for TIWNB, most of which involve administration of an inhaled anesthetic in combination with an intravenous adjunctive medication. The tech...	Anesthesia Intubation Complication	intubation of children without neuromuscular blockade	null	1	arm 1: For each of the 6 groups, propofol 2 mg/kg will be administered to first subject. The propofol dose will move separately for each of the 6 groups, and be increased by 0.3 mg/kg for the next subject if intubation score is "not excellent" and decreased by 0.3 mg/kg if intubation score is "excellent". This dosing s...	[ 0 ]	1	[ 0 ]	intervention 1: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range	intervention 1: propofol	1	Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931	106	NCT01150838	1COMPLETED	2010-06-01	2008-07-01	University of Virginia	7OTHER	false	false	false	null	0
[ 2 ]	14	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.	null	Healthy Volunteers	biological availability bioavailability amlodipine orally disintegrating tablet ODT tablets	null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Amlodipine capsule, 10 mg, single dose, with water intervention 2: Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water	intervention 1: Amlodipine - reference intervention 2: Amlodipine ODT - test	1	Hydrabad \| Andhra Pradesh \| India \| N/A \| N/A	28	NCT01177293	1COMPLETED	2010-06-01	2010-03-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0

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