Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_count_Accidental overdose int64	METADATA_count_Intentional overdose int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 0 ]	9	NA	SINGLE_GROUP	null	0NONE	false	0ALL	false	Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion. We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets. healthy volunteers, with no kno...	null	Aspirin Blood Level Proton Pump Inhiditor Treatment	pharmacokinetics aspirin proton pump inhiditor	null	0	null	null	1	[ 0 ]	intervention 1: aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.	intervention 1: aspirin and omeprazole	1	Ẕerifin \| N/A \| Israel \| 34.84852 \| 31.95731	9	0	0	0	NCT01061034	1COMPLETED	2007-06-01	2007-03-01	Assaf-Harofeh Medical Center	2OTHER_GOV	false	false	false	null	0	0	0	0
[ 2 ]	84	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	false	The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fasted state.	Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.	Healthy Volunteers	Healthy subjects Opioid	null	2	arm 1: Reformulated OXY 10 mg x 1 dose arm 2: Original OxyContin® (OXY)10 mg x 1 dose	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Reformulated OXY 10-mg tablet x 1 dose taken without food intervention 2: Original OxyContin® (OXY) 10-mg tablet x 1 dose taken without food	intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	167	0	0	0	NCT01100086	1COMPLETED	2007-06-01	2007-01-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	16	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).	null	Leukemia	Acute myelogenous leukemia myelodysplastic Syndrome cancer	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Intravenous injection; total dose-per-cycle was 135 mg/m\^2 of decitabine.	intervention 1: Decitabine (Dacogen)	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	16	0	0	0	NCT01378416	1COMPLETED	2007-06-01	2005-04-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	104	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily...	The occurrence of a new manic/depressive episode was considered a treatment failure, and the patient was discontinued from the study. At the end of Part II, 6 months after last patient enrolled and after no longer than approximately 15 months, if patients were still in remission and the investigational product was well...	Bipolar I Disorder	bipolar I disorder Eslicarbazepine acetate BIA 2-093	null	4	arm 1: BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening. arm 2: BIA 2-093 900 mg once daily (Part II fo...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: BIA 2-093 1800 mg taken orally in the evening, for 2 weeks intervention 2: BIA 2-093 900 mg taken orally in the evening, for 2 weeks intervention 3: BIA 2-093 300 mg taken orally in the evening, for 2 weeks. intervention 4: In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orall...	intervention 1: BIA 2-093 1800 mg once daily [Group 1 (Part II)] intervention 2: BIA 2-093 900 mg once daily [Group 2 (Part II)] intervention 3: BIA 2-093 300 mg once daily [Group 3 (Part II)] intervention 4: BIA 2-093 900 mg (Part I)	0	null	87	0	0	0	NCT01825837	1COMPLETED	2007-06-01	2006-03-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	67	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy adult men and women	The purpose of this randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched change from baseline using individually corrected QT (QTcI) i...	Epilepsy		null	4	arm 1: A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days arm 2: A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days arm 3: A...	[ 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: BIA 2-093 intervention 2: Moxifloxacin intervention 3: Placebo	1	Miramar \| Florida \| United States \| -80.23227 \| 25.98731	67	0	0	0	NCT02283788	1COMPLETED	2007-06-01	2007-03-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	60	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	true	0ALL	false	Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design	Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design to evaluate and compare the relative bioavailability and therefore the bioequivalence of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations (CTF versus TBM) after a single oral dose ad...	Epilepsy		null	6	arm 1: One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) arm 2: One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 4...	[ 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: BIA 2-093	0	null	119	0	0	0	NCT02283840	1COMPLETED	2007-06-01	2007-05-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	551	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration ...	null	Painful Diabetic Neuropathy	Painful Diabetic Neuropathy Lacosamide	null	3	arm 1: Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. arm 2: Subjects receive 200 mg/day LCM for the...	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: * Pharmaceutical form: Immediate release film-coated tablets * Concentration: 50mg/ 100mg * Route of administration: Oral use intervention 2: * Pharmaceutical form: Immediate release film-coated tablets * Route of administration: Oral use	intervention 1: SPM 929 intervention 2: Placebo	1	Monheim \| N/A \| Germany \| 10.85834 \| 48.84389	549	0	0	0	NCT00350103	1COMPLETED	2007-06-29	2006-06-30	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	60	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	false	0ALL	true	To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.	The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicin...	Hyperuricemia		null	3	arm 1: Drug : Wu Ling San Extract Granules "Sun-Ten" arm 2: Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN" arm 3: Drug : 1/10 Wu Ling San	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks. intervention 2: assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks. intervention 3: 1/10 Wu ...	intervention 1: Wu Ling San intervention 2: Yin-Chen Wu Ling San intervention 3: Placebo	0	null	60	0	0	0	NCT04144088	1COMPLETED	2007-06-30	2006-06-01	Chung Shan Medical University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	358	RANDOMIZED	PARALLEL	9OTHER	0NONE	false	0ALL	true	The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid l...	Comparison/Control Interventions offered the physician three options: * Best supportive care (BSC) alone, * Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or * Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (dau...	Myelodysplastic Syndromes		null	2	arm 1: Study Drug plus best supportive care. Treatment with erythropoietin was not permitted arm 2: Physician choice of low dose cytarabine (plus best supportive care), standard chemotherapy (plus best supportive care) or best supportive care (only). Treatment with erythropoietin was not permitted	[ 0, 1 ]	2	[ 0, 10 ]	intervention 1: Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m\^2/day for 7 days. The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results. Number of cycles: Azacitidine treatment was to be continued until the end of the stud...	intervention 1: Azacitidine intervention 2: Physician Choice	108	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Portland \| Oregon \| Unite...	340	1	0.002941	1	NCT00071799	1COMPLETED	2007-07-01	2003-11-01	Celgene	4INDUSTRY	false	false	false	null	0	0	1	0.000519
[ 4 ]	13,619	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compare...	null	Coronary Arteriosclerosis Acute Coronary Syndromes		null	2	arm 1: Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily arm 2: Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched ...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Administered orally intervention 2: Administered orally	intervention 1: Prasugrel intervention 2: Clopidogrel	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	13,457	2	0.000149	0	NCT00097591	1COMPLETED	2007-07-01	2004-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	1	1	0	0.000041
[ 4 ]	238	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).	null	Bipolar Disorder		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. intervention 2: Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.	intervention 1: Ziprasidone oral capsules intervention 2: placebo oral capsules	50	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Orange \| California \| United States \| -117.85311 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 Fort Lauderd...	237	11	0.046414	1	NCT00257166	1COMPLETED	2007-07-01	2006-01-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	11	0.026111
[ 4 ]	421	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.	null	Asthma		null	2	arm 1: montelukast arm 2: placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment. intervention 2: Placebo. Up to 3 weeks of treatment	intervention 1: montelukast sodium intervention 2: Comparator: Placebo	0	null	420	1	0.002381	1	NCT00289874	1COMPLETED	2007-07-01	2006-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	1	0.00042
[ 4 ]	49	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.	Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response r...	Bipolar Disorder	Depression	null	2	arm 1: None arm 2: None	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent /L (mEq/L). intervention 2: Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I v...	intervention 1: Lithium intervention 2: Lamotrigine intervention 3: Divalproex intervention 4: Placebo	0	null	49	0	0	0	NCT00063362	6TERMINATED	2007-07-01	2002-02-01	University Hospitals Cleveland Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	1,077	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects	null	Skin/Soft Tissue Infections Methicillin Resistant Staphylococcus Aureus (MRSA)		null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: linezolid intervention 2: vancomycin	126	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 San Pe...	1,052	0	0	0	NCT00087490	1COMPLETED	2007-07-01	2004-10-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	32	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have...	null	Lung Neoplasms Carcinoma, Non-small Cell Lung		null	1	arm 1: AG-013736 is a vascular endothelial growth factor \[VEGF\] inhibitor	[ 0 ]	1	[ 0 ]	intervention 1: Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.	intervention 1: axitinib	11	Irvine \| California \| United States \| -117.82311 \| 33.66946 Orange \| California \| United States \| -117.85311 \| 33.78779 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Park Ridge \| Illinois \| United States \| -87.84062 \| 42.01114 Coon Rapids \| Minnesota \| United States \| -93.28773 \| 45.11997 Fridley \| Minnesot...	32	0	0	0	NCT00094094	1COMPLETED	2007-07-01	2005-02-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	761	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.	null	Bacterial Pneumonia	Nosocomial pneumonia MRSA	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Telavancin 10 mg/kg/day IV for up to 21 days. intervention 2: Vancomycin 1 Gm IV q 12 hrs for up to 21 days	intervention 1: Telavancin intervention 2: Vancomycin	1	Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148	746	0	0	0	NCT00107952	1COMPLETED	2007-07-01	2005-02-01	Cumberland Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	357	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A second...	null	Chronic Hepatitis C	PEG-Intron Ribavirin Protease Inhibitor	null	9	arm 1: A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks. arm 2: A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 ...	[ 1, 1, 0, 0, 0, 0, 0, 0, 0 ]	3	[ 0, 2, 0 ]	intervention 1: 100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID intervention 2: 1.5 mcg/kg weekly subcutaneously intervention 3: 200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \[weight-based dosing {WBD}\])	intervention 1: Boceprevir (BOC) intervention 2: PegIntron (PEG) intervention 3: Ribavirin (RBV)	0	null	500	0	0	0	NCT00160251	1COMPLETED	2007-07-01	2005-09-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	240	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	null	1FEMALE	null	To determine the effect and safety of menatetrenone on treatment of postmenopausal osteoporosis comparing with alfacalcidol.	null	Postmenopausal Osteoporosis	Postmenopausal osteoporosis	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 15 mg three times a day orally for 12 months intervention 2: 0.25 μg twice a day orally for 12 months	intervention 1: menatetranone intervention 2: alfacalcidol	5	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222	235	0	0	0	NCT00165698	1COMPLETED	2007-07-01	2005-05-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	192	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor	null	Obstetric Labor, Premature		null	2	arm 1: Preterm labor treatment with Magnesium Sulfate. arm 2: Preterm labor treatment with Nifedipine.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician. intervention 2: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minu...	intervention 1: Magnesium Sulfate intervention 2: Nifedipine	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	192	0	0	0	NCT00185900	1COMPLETED	2007-07-01	1999-04-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	84	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	false	Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.	This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects complete daily assessments of cold symptoms, nasal clearan...	Upper Respiratory Infection	Cold Upper Respiratory Infection	null	2	arm 1: Treated for 4 months with montelukast 4 mg per day arm 2: Treated for 4 months with placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Montelukast intervention 2: Placebo	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	84	0	0	0	NCT00189475	1COMPLETED	2007-07-01	2003-10-01	Deborah Gentile	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	309	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.	This is a multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical study), parallel-gro...	Asthma	Asthma Severe Persistent Asthma Subcutaneous injections Immunology disorder Breathlesness	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms intervention 2: Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through ...	intervention 1: CNTO148 intervention 2: Placebo	57	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 Stockton \| California \| United States \| -121.29078 \| 37.9577 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 New Haven \| ...	309	0	0	0	NCT00207740	1COMPLETED	2007-07-01	2004-08-01	Centocor, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	63	RANDOMIZED	SINGLE_GROUP	1PREVENTION	2DOUBLE	false	0ALL	false	The aim of this project is to determine if a single dose of oral dexamethasone at the time of discharge from the emergency department (ED) \[after successful treatment\] prevents rebound headache. Hypothesis: That single dose oral dexamethasone 8mg reduces the proportion of patients who suffer rebound headache after t...	Migraine headache can be a debilitating condition. A small but significant proportion of sufferers seek treatment in emergency departments \[ED\], accounting for 2-5% of ED visits.Available data suggests that up to 66% of these patients may experience rebound headache after discharge that affects their ability to funct...	Migraine	Migraine Headache Rebound headache	null	2	arm 1: This group received intravenous phenothiazine treatment for migraine (dosing at physician discretion) plus placebo. Patients and clinicians were blinded. arm 2: This group received intravenous phenothiazine migraine treatment (dosage at physician discretion) plus oral dexamethasone 8mg at time of emergency depar...	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Single dose oral dexamethasone 8mg at time of ED discharge intervention 2: Single dose oral placebo at ED discharge	intervention 1: Dexamethasone intervention 2: placebo	1	Melbourne \| Victoria \| Australia \| 144.96332 \| -37.814	63	0	0	0	NCT00216736	1COMPLETED	2007-07-01	2005-04-01	The Joseph Epstein Centre for Emergency Medicine Research	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	329	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), in adults with type 2 diabetes.	There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, ...	Diabetes Mellitus	Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes; Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.	intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Placebo	67	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Artesia \| California \| United States \| -118.08312 \| 33.86585 Fresno \| California \| Uni...	329	0	0	0	NCT00286455	1COMPLETED	2007-07-01	2006-02-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	false	This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own c...	Specific Aims: This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will ac...	Schizophrenia	Schizophrenia Diabetes Obesity Olanzapine Insulin Resistance	null	2	arm 1: aripiprazole 15mg/day arm 2: matched placebo for aripiprazole 15mg/day	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Aripiprazole intervention 2: placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	15	0	0	0	NCT00351936	1COMPLETED	2007-07-01	2005-12-01	North Suffolk Mental Health Association	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Primary Objective: 1\. To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedation/drowsiness in patients with stable cancer pain Secondary Objectives: 1. To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo 2. To assess the ...	Donepezil is currently used in the treatment of certain types of mental disorders, including Alzheimer's disease. Recent research studies have shown that donepezil helps to improve drowsiness in cancer patients receiving opioid medication. Before treatment starts, you will be asked to answer some questions regarding y...	Advanced Cancer	Advanced Cancer Cancer Pain Donepezil Sedation Placebo	null	2	arm 1: Oral Donepezil 5 mg daily x 7 days arm 2: Placebo tablet daily x 7 days	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 5 mg once a day by mouth for 7 day cycle. After evaluation on Day 8, all participants will be offered donepezil every day for 7 days. intervention 2: Placebo tablet once a day by mouth for one 7 day cycle. After evaluation on day 8, all participants offered donepezil every day for 7 days.	intervention 1: Donepezil intervention 2: Placebo	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	20	0	0	0	NCT00352664	6TERMINATED	2007-07-01	2003-11-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3, 4 ]	107	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis	null	Conjunctivitis, Allergic		null	3	arm 1: Bepotastine Besilate Ophthalmic Solution 1.5% arm 2: sterile ophthalmic solution arm 3: sterile ophthalmic solution 1.0%	[ 0, 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution intervention 3: sterile ophthalmic solution	intervention 1: Bepreve intervention 2: Placebo intervention 3: Bepotastine Besilate	1	Irvine \| California \| United States \| -117.82311 \| 33.66946	107	0	0	0	NCT00424398	1COMPLETED	2007-07-01	2007-02-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	429	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.	null	Seasonal Allergic Rhinitis		null	2	arm 1: 200 mcg daily arm 2: Two sprays in each nostril in the morning	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Two sprays (50 mcg/spray) in each nostril (200 mcg daily) in the morning intervention 2: Two sprays in each nostril in the morning	intervention 1: Mometasone furoate nasal spray intervention 2: Placebo	0	null	429	0	0	0	NCT00468312	1COMPLETED	2007-07-01	2007-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	310	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms ...	null	Seasonal Allergic Rhinitis		null	2	arm 1: MFNS 200 mcg total dose (2 sprays each nostril) arm 2: Placebo (2 sprays each nostril)	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg) intervention 2: Placebo: 2 sprays in each nostril	intervention 1: Mometasone Furoate Nasal Spray intervention 2: Placebo	0	null	310	0	0	0	NCT00491504	1COMPLETED	2007-07-01	2007-02-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	21	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.	Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligi...	Uveitis	uveitis Cystoid Macular Edema (CME) fluocinolone acetonide non-infectious uveitis affecting the posterior segment	null	1	arm 1: 0.59 mg Fluocinolone Acetonide implant	[ 0 ]	1	[ 0 ]	intervention 1: 0.59 mg Fluocinolone Acetonide implant	intervention 1: 0.59 mg Fluocinolone Acetonide implant	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	14	0	0	0	NCT00543296	1COMPLETED	2007-07-01	2004-03-01	Duke University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	83	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the dose...	null	Hypercholesterolemia		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks intervention 2: simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks	intervention 1: Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) intervention 2: Double Statin (simvastatin, atorvastatin, or pravastatin)	0	null	83	0	0	0	NCT00652327	1COMPLETED	2007-07-01	2005-12-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	19	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.	A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. ...	Pain Peripheral Neuropathy	Pain Peripheral Neuropathy	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v...	intervention 1: Sativex® intervention 2: Placebo	1	Solihull \| West Midlands \| United Kingdom \| -1.78094 \| 52.41426	19	0	0	0	NCT00713817	1COMPLETED	2007-07-01	2007-03-01	Jazz Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	88	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	false	To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.	Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.	Healthy Volunteers	Healthy subjects Opioid	null	2	arm 1: Reformulated OXY 40 mg x 1 dose arm 2: Original OxyContin® (OXY) 40 mg x 1 dose	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Reformulated OXY 40-mg tablet x 1 dose taken with food intervention 2: Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food	intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	164	0	0	0	NCT01100320	1COMPLETED	2007-07-01	2007-01-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	92	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	false	The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.	Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.	Healthy	Healthy subjects Opioid Healthy volunteers	null	2	arm 1: Reformulated OXY 40 mg x 1 dose arm 2: Original OxyContin® (OXY) 40 mg x 1 dose	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Reformulated OXY 40-mg tablet x 1 dose taken without food intervention 2: Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food	intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)	1	Evansville \| Indiana \| United States \| -87.55585 \| 37.97476	177	0	0	0	NCT01101165	1COMPLETED	2007-07-01	2007-02-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	48	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	1FEMALE	false	The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without Yasmin in...	null	Contraception		null	3	arm 1: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) arm 2: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospire...	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) intervention 2: single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as c...	intervention 1: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) intervention 2: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) intervention 3: L-5-MTHF Ca 0.451 mg (Metafolin)	1	Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073	130	0	0	0	NCT01253174	1COMPLETED	2007-07-01	2006-08-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	45	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)	null	Restless Legs Syndrome (RLS)		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Placebo	0	null	45	0	0	0	NCT01382901	1COMPLETED	2007-07-01	2006-03-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	26	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS	null	Restless Legs Syndrome		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: MIRAPEX® - low intervention 2: MIRAPEX® - medium intervention 3: MIRAPEX® - high	0	null	26	0	0	0	NCT02231918	1COMPLETED	2007-07-01	2006-05-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	18	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.	Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard...	Epilepsy		null	3	arm 1: Tablets 800 mg. Administration:Oral. arm 2: Tablets 800 mg. Administration:Oral. arm 3: Tablets 2 x 400 mg. Administration:Oral.	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: BIA 2-093	0	null	52	0	0	0	NCT02288312	1COMPLETED	2007-07-01	2007-05-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	84	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).	Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells,...	Short Bowel Syndrome	Short Bowel Syndrome Parenteral Nutrition SBS	null	3	arm 1: Placebo injectable subcutaneously daily into the thigh or abdomen arm 2: teduglutide 0.05 mg/kg/d arm 3: teduglutide 0.1 mg/kg/d	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: placebo injectable subcutaneously daily into thigh or abdomen intervention 2: Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen intervention 3: Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen	intervention 1: Placebo intervention 2: Teduglutide 0.05 mg/kg/d intervention 3: Teduglutide 0.1 mg/kg/d	32	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Omaha \| ...	83	0	0	0	NCT00081458	1COMPLETED	2007-07-06	2004-05-25	Shire	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	74	RANDOMIZED	SEQUENTIAL	0TREATMENT	2DOUBLE	true	0ALL	null	The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.	null	Osteopenia	Amgen First in Human Postmenopausal Phase 1	null	2	arm 1: Participants were randomized to receive a single dose of matching placebo administered by subcutaneous or intravenous injection. arm 2: Participants were randomized to receive a single dose of romosozumab administered by subcutaneous or intravenous injection. The starting dose was 0.1 mg/kg, with sequential esca...	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Administered subcutaneously or intravenously intervention 2: Administered subcutaneously or intravenously	intervention 1: Romosozumab intervention 2: Placebo	0	null	72	0	0	0	NCT01059435	1COMPLETED	2007-07-06	2006-12-13	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,668	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and ap...	null	Acne Vulgaris	Acne vulgaris Adapalene Benzoyl Peroxide	null	4	arm 1: Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. arm 2: Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. arm 3: Participants were treated with 2.5% of benzoyl pe...	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. intervention 2: 0.1% of adapalene gel topically daily in the evening for 12 Weeks. intervention 3: 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. interventi...	intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene Gel, 0.1% intervention 3: Benzoyl Peroxide Gel 2.5% intervention 4: Gel Vehicle	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	1,668	0	0	0	NCT00422240	1COMPLETED	2007-07-12	2006-06-27	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 5 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	null	false	0ALL	false	An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The ai...	null	Asthma	asthma exacerbation persistent bronchial hyperresponsiveness mild GINAII	null	2	arm 1: Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 month...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Seretide intervention 2: Flixotide	intervention 1: Seretide intervention 2: Flixotide	1	Luleå \| N/A \| Sweden \| 22.15465 \| 65.58415	100	0	0	0	NCT00455923	1COMPLETED	2007-07-31	2005-05-03	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with recurrent or refractory mixed gliomas. PURPOSE: This study is being p...	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults with recurrent or refractory mixed gliomas as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in adults with recurrent or r...	Mixed Gliomas	recurrent adult mixed glioma refractoy adult mixed glioma	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal). intervention 2: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).	intervention 1: Atengenal intervention 2: Astugenal	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	20	0	0	0	NCT00003473	1COMPLETED	2007-08-01	1996-03-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	48	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.	Objectives: 1. To determine the efficacy and response rates of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in the treatment of chronic lymphoid disorders that are refractory to conventional therapy, have relapsed, or have no established frontline therapy...	Chronic Lymphocytic Leukemia	Chronic Lymphocytic Leukemia CD-52 and CD-20 Positive Refractory Relapsed	null	1	arm 1: Campath 15 mg/day continuous intravenous (IV) infusion x 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks. intervention 2: 375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.	intervention 1: Campath-1H intervention 2: Rituximab	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	44	0	0	0	NCT00071396	1COMPLETED	2007-08-01	2002-10-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	89	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.	BACKGROUND: Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse. DESIGN NARRATIVE: Cavitary...	Tuberculosis AIDS-related Complex		null	3	arm 1: Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy arm 2: Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide arm 3: Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide	[ 2, 0, 0 ]	3	[ 0, 0, 10 ]	intervention 1: Participants will receive aerosol interferon-gamma. intervention 2: Patients will receive subcutaneous interferon-gamma intervention 3: None	intervention 1: Aerosol Interferon-Gamma intervention 2: Subcutaneous interferon-gamma intervention 3: Placebo	2	New York \| New York \| United States \| -74.00597 \| 40.71427 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584	89	0	0	0	NCT00201123	1COMPLETED	2007-08-01	2005-04-01	NYU Langone Health	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	1FEMALE	true	Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used...	Primary and secondary outcome measures presented under "results"	Labour Pain Satisfaction Adverse Effects	Remifentanil, parenteral opioids, obstetric analgesia, IVPCA	null	1	arm 1: Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time	[ 1 ]	1	[ 0 ]	intervention 1: Intravenous patient controlled analgesia (ivpca) during labour	intervention 1: Remifentanil	1	Kristiansand \| Vest-Agder \| Norway \| 7.9956 \| 58.14671	41	0	0	0	NCT00202722	1COMPLETED	2007-08-01	2004-01-01	Sorlandet Hospital HF	2OTHER_GOV	false	false	false	null	0	0	0	0
[ 3 ]	49	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The investigator wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind, placebo-controlled, parallel-group study.	The global burden of COPD - a common and debilitating chronic inflammatory disease that is characterised by the progressive development of airflow limitation (shortness of breath - SOB) and is poorly reversible with currently available drugs -is increasing. Cigarette smoking is strongly linked with the ongoing inflamma...	COPD	COPD	null	2	arm 1: Inhaled Theophylline placebo capsule, then placebo, then active Theophylline arm 2: Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline	[ 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 500 u intervention 2: None intervention 3: Theophylline placebo capcule	intervention 1: Fluticasone Propionate intervention 2: placebo intervention 3: Theophylline	1	Windsor \| Berks \| United Kingdom \| -0.6 \| 51.48333	30	0	0	0	NCT00241631	1COMPLETED	2007-08-01	2006-04-01	Imperial College London	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	493	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus	There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, ...	Diabetes Mellitus	Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks intervention 2: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks intervention 3: Alogliptin placebo...	intervention 1: Alogliptin and pioglitazone intervention 2: Alogliptin and pioglitazone intervention 3: Pioglitazone	77	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Artesia \| California \| United States \| -118.08312 \| 33.86585 Fresno \| California \| United States \| -119.77237 \| 36.74773 Mission Viejo \| Calif...	494	0	0	0	NCT00286494	1COMPLETED	2007-08-01	2006-02-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 4 ]	1,308	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	true	The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.	Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present,...	Cervical Ripening Labor, Induced	Cervical ripening Induction of labor Dinoprostone vaginal insert Cervidil Misoprostol vaginal insert Modified Bishop's Score PGE2 PGE1 Uterine Hyperstimulation Cesarean section	null	3	arm 1: Misoprostol vaginal insert 100 mcg over 24h arm 2: Misoprostol vaginal insert 50 mcg over 24h arm 3: Cervidil 10 mg over 24h	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Hydrogel polymer intravaginal insert with retrieval system. One insert is to remain in the posterior fornix of the vagina until removed for one of the following conditions: onset of active labor; maternal/fetal complication, e.g. non-reassuring fetal heart rate. Record if the insert falls out prior to m...	intervention 1: Misoprostol vaginal insert 100 mcg intervention 2: Misoprostol vaginal insert 50 mcg intervention 3: Dinoprostone vaginal insert (Cervidil)	52	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Long Beach \| California \| United...	1,307	0	0	0	NCT00308711	1COMPLETED	2007-08-01	2006-04-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	333	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an...	null	Diabetes Mellitus, Type 2		null	5	arm 1: Patients receive Linagliptin low dose tablets once daily arm 2: Patients receive Linagliptin medium dose tablets once daily arm 3: Patients receive Linagliptin high dose tablets once daily arm 4: Patients receive tablets identical to those containing Linagliptin low, medium and high dose arm 5: Patients receive ...	[ 0, 0, 0, 2, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Linagliptin medium dose tablet once daily intervention 2: Linagliptin high dose tablet once daily intervention 3: Linagliptin low dose tablet once daily intervention 4: Placebo tablets once daily intervention 5: Glimepiride tablets once daily	intervention 1: Linagliptin intervention 2: Linagliptin intervention 3: Linagliptin intervention 4: Placebo intervention 5: Glimepiride	48	Joué Les Tours \| N/A \| France \| N/A \| N/A Joué Les Tours \| N/A \| France \| N/A \| N/A Joué-lès-Tours \| N/A \| France \| 0.66513 \| 47.34907 Joué-lès-Tours \| N/A \| France \| 0.66513 \| 47.34907 Paris \| N/A \| France \| 2.3488 \| 48.85341 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Bosenheim \| N/A \| Germany \| 7.91382 \| 49.8...	333	0	0	0	NCT00309608	1COMPLETED	2007-08-01	2006-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	255	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).	This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).	Anemia	Anemia Chronic Kidney Disease Iron	null	2	arm 1: A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. arm 2: 325 mg/TID x 8 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 325 mg/TID x 8 weeks intervention 2: A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.	intervention 1: Ferrous Sulfate tablets intervention 2: Ferric Carboxymaltose (FCM)	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	250	0	0	0	NCT00317239	1COMPLETED	2007-08-01	2005-05-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	43	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.	null	Colitis, Ulcerative	OPC-6535 ulcerative colitis	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: OPC-6535(Tetomilast)	8	Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A Touhoku Region \| N/A \| Japan \| N/A \| N/...	43	0	0	0	NCT00317356	6TERMINATED	2007-08-01	2006-05-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patie...	null	Crohn Disease	OPC-6535 Crohn's disease	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: OPC-6535(Tetomilast)	8	Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A Touhoku Region \| N/A \| Japan \| N/A \| N/...	29	0	0	0	NCT00317369	6TERMINATED	2007-08-01	2006-05-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	302	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm wi...	null	Diabetes Mellitus, Type 2		null	5	arm 1: Placebo tablets matching BI 1356 arm 2: BI 1356 dose 1 once daily arm 3: BI 1356 dose 2 once daily arm 4: BI 1356 dose 3 once daily arm 5: Metformin	[ 2, 0, 0, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Placebo matching BI 1356 intervention 2: BI 1356 dose 3 once daily intervention 3: BI 1356 dose 2 once daily intervention 4: BI 1356 dose 1 once daily intervention 5: Metformin	intervention 1: Placebo intervention 2: BI 1356 dose 3 once daily intervention 3: BI 1356 dose 2 once daily intervention 4: BI 1356 dose 1 once daily intervention 5: Metformin	71	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jacksonville \|...	302	0	0	0	NCT00328172	1COMPLETED	2007-08-01	2006-05-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	190	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.	null	Type 2 Diabetes Mellitus (T2DM)		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets. intervention 2: Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metform...	intervention 1: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day intervention 2: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day	0	null	190	0	0	0	NCT00337610	1COMPLETED	2007-08-01	2006-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	178	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.	This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.	Hypercholesterolemia Dyslipidemia Coronary Heart Disease	hypercholesterolemia dyslipidemia CHD pitavastatin simvastatin 2 or more risk factors for coronary heart disease combined dyslipidemia	null	2	arm 1: Pitavastatin 4 mg once daily arm 2: Simvastatin 40 mg or 80 mg once daily	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: pitavastatin intervention 2: simvastatin	28	Copenhagen Nv \| N/A \| Denmark \| N/A \| N/A Frederiksberg \| N/A \| Denmark \| 12.53463 \| 55.67938 Hellerup \| N/A \| Denmark \| 12.57093 \| 55.73204 Vejle \| N/A \| Denmark \| 9.5357 \| 55.70927 Breda \| N/A \| Netherlands \| 4.77596 \| 51.58656 Eindhoven \| N/A \| Netherlands \| 5.47778 \| 51.44083 Groningen \| N/A \| Netherlands \| 6.56667...	178	0	0	0	NCT00344175	1COMPLETED	2007-08-01	2006-06-01	Kowa Research Europe	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee re...	Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.	Postoperative Pain	Postoperative pain opioid transdermal TKA (total knee arthroplasty)	null	4	arm 1: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear arm 3: Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear arm 4: Placebo patches were similar to BTDS 10 and 20.	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. intervention 3: Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear. intervention 4: Placebo to match BTDS tran...	intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch intervention 4: Placebo BTDS	5	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 San Clemente \| California \| United States \| -117.61199 \| 33.42697 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Sewickley \| Pennsylvania \| United States \| -80.1845 \| 40.53646	10	0	0	0	NCT00403234	6TERMINATED	2007-08-01	2006-11-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	91	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.	null	Asthma		null	3	arm 1: Montelukast 7 mg IV administration arm 2: Montelukast 14 mg IV administration arm 3: Aminophylline 250 mg IV drip administration	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes intervention 2: Montelukast 14 mg single injection (IV bolus administration) over 5 minutes intervention 3: Aminophylline 250 mg IV drip infusion over 60 minutes	intervention 1: montelukast sodium intervention 2: montelukast sodium intervention 3: aminophylline hydrate	0	null	91	0	0	0	NCT00442338	1COMPLETED	2007-08-01	2007-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	23	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Eligible male and female subjects with renal impairment (aged 18-78 years) and healthy control subjects (aged 35 to 78 years) will be enrolled in the study. Subjects with renal impairment will be enrolled and entered into three groups based on their renal function: Mild Impairment, Moderate Impairment, and Severe Impai...	This is a phase I, open label, multi-center study in which up to eighteen subjects with renal impairment and six healthy control subjects with normal renal function will receive a single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. Eligible male and female subjects with renal impairment ...	Renal Impairment	AMD3100	null	4	arm 1: Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) who serve as the study control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. arm 2: Participants have mild renal impairment (creatinine clearance (CLcr) = 51 to 80 mL/mi...	[ 1, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Single dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection	intervention 1: plerixafor	3	Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Saint Paul \| Minnesota \| United States \| -93.09327 \| 44.94441 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	23	0	0	0	NCT00445302	1COMPLETED	2007-08-01	2006-01-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	21	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	false	Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential constituent of the process of energy production on the cellular level. It can protect mitochondria from oxidative damage and boost their impaired function. It is thought that this mechanism will slow decline in heart function ...	null	Duchenne Muscular Dystrophy (DMD)	Duchenne Muscular Dystrophy DMD Duchenne	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: idebenone 450 mg/day (150 mg three times a day) intervention 2: None	intervention 1: idebenone intervention 2: placebo	1	Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959	21	0	0	0	NCT00654784	1COMPLETED	2007-08-01	2005-10-01	Santhera Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	120	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment \>90% of the patients would achieve and maintain castrate levels of serum testosterone.	Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.	Prostatic Neoplasm	triptorelin, 6-month formulation, advanced prostate cancer	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks	intervention 1: triptorelin embonate (INN)	1	Lyttelton Manor \| Centurion \| South Africa \| N/A \| N/A	120	0	0	0	NCT00751790	1COMPLETED	2007-08-01	2006-07-01	Debiopharm International SA	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	18	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules.	Prior studies have shown that intact quinine sulfate capsules can be taken without regard for food. This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648mg(2 x 324 mg capsules) when opened and mixed with 120 ml of chocolate puddi...	Healthy	Healthy Bioequivalence Pharmacokinetics	null	2	arm 1: Single dose intact capsules 2 x 324 mg arm 2: Single dose contents of two capsules (2 x 324 mg) opened and mixed in 120 mL of chocolate pudding	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 2 x 324 mg capsules (648 mg) intervention 2: 2 x 324 mg capsules (648 mg)	intervention 1: quinine sulfate intervention 2: quinine sulfate	1	Saint Laurent, Montreal \| Quebec \| Canada \| N/A \| N/A	36	0	0	0	NCT00806078	1COMPLETED	2007-08-01	2007-07-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	220	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	This study will evaluate: 1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B. 2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination...	null	Dyslipidemia		null	2	arm 1: Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. arm 2: Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin ...	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods. intervention 2: Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods. intervention 3: Single dose simvastatin (Zocor™) 20 mg in one of two treatment p...	intervention 1: MK0524B (ER niacin (+) laropiprant (+) simvastatin) intervention 2: MK0524A (ER niacin + laropiprant) intervention 3: Simvastatin	0	null	440	0	0	0	NCT00943124	1COMPLETED	2007-08-01	2007-07-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	81	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.	null	Hepatitis C, Chronic		null	2	arm 1: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. arm 2: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.	intervention 1: Peginterferon alfa-2a	22	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Porto Alegre \| N/A \| Brazil \| -51.23019 \| -30.03283 Sao Jose Rio Preto \| N/A \| Brazil \| N/A \| N/A São Luís \| N/A \| Brazil \| -44.30278 \| -2.52972 São Paulo \| N/A \| Brazil \| -46.63611 \| -23...	81	0	0	0	NCT02806505	1COMPLETED	2007-08-01	2004-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	288	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.	Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life. Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve pat...	Scalp Psoriasis	maintenance scalp psoriasis Galderma	null	3	arm 1: In initial open-label phase, participants were applied Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams \[50 Milliliter\]). arm 2: In maintenance double-blind phase, participants pr...	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks. intervention 2: Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months. intervention 3: Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.	intervention 1: Clobex® Shampoo intervention 2: Clobex® Vehicle Shampoo intervention 3: Clobex® Shampoo	1	Québec \| N/A \| Canada \| -71.21454 \| 46.81228	505	0	0	0	NCT00400725	1COMPLETED	2007-08-20	2006-09-29	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	26	RANDOMIZED	CROSSOVER	1PREVENTION	2DOUBLE	false	0ALL	true	The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.	Subjects were given diary cards and instructed to document all HAE attacks on a daily basis. Subjects evaluated their symptoms over the previous 24 hours, noting the severity and duration of swelling at each of 5 locations (abdominal, genitourinary, facial, respiratory \[including laryngeal\], and/or extremity). The s...	Hereditary Angioedema	Hereditary angioedema HAE C1 esterase inhibitor (human) C1INH-nf	null	2	arm 1: 1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks. arm 2: Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 wee...	[ 0, 0 ]	2	[ 2, 0 ]	intervention 1: None intervention 2: None	intervention 1: C1 esterase inhibitor [human] (C1INH-nf) intervention 2: Placebo (saline)	16	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 San Diego \| California \| United States \| -117.16472 \| 32.71571 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Suwanee \| Georgia \| United States \| -84.0713 \| 34.05149 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Evansville \| Ind...	48	0	0	0	NCT01005888	1COMPLETED	2007-08-22	2005-03-14	Shire	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	336	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.	Integrated Biomarker and Imaging Study -2 (IBIS-2): An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associate...	Atherosclerosis	Coronary artery disease Lipoprotein-associated Phospholipase A2 palpography hs-CRP endothelial function intravascular ultrasound	null	4	arm 1: Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks arm 2: Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks arm 3: Enrolled su...	[ 0, 2, 0, 2 ]	2	[ 0, 0 ]	intervention 1: SB-480848 is available as enteric-coated, free-base micronized tablet intervention 2: Placebo is available as enteric-coated, free-base micronized tablet	intervention 1: SB-480848 intervention 2: SB-480848 matching placebo	26	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Aarhus N \| N/A \| Denmark \| 10.17317 \| 56.20367 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Brest \| ...	323	0	0	0	NCT00268996	1COMPLETED	2007-08-28	2005-11-10	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	399	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.	null	Lung Cancer, Non-Small Cell Non-Small-Cell Lung Cancer	HYCAMTIN TAXOTERE non-small cell lung cancer NSCLC docetaxel topotecan Stage IIIB/IV Advanced	null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Topotecan/Docetaxel combination intervention 2: Docetaxel	85	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Fresno \| California \| United States \| -119.77237 \| 36.74773 Los Angeles \| California \|...	395	0	0	0	NCT00065182	1COMPLETED	2007-08-30	2003-08-14	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	2,333	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Pat...	null	Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis		null	1	arm 1: None	[ 0 ]	2	[ 2, 0 ]	intervention 1: PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks intervention 2: REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks	intervention 1: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 2: REBETOL (ribavirin; SCH 18908)	0	null	2,312	3	0.001298	1	NCT00039871	1COMPLETED	2007-09-01	2002-05-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	1	2	0.000441
[ 5 ]	569	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target samp...	null	Hepatitis C, Chronic		null	2	arm 1: Participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning an...	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1000-1200mg po daily for 48 weeks intervention 2: 180 micrograms sc/week for 48 weeks intervention 3: 1000-1200mg po daily for 48 weeks intervention 4: 180 micrograms sc/week for 48 weeks	intervention 1: Ribavirin intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: Peginterferon alfa-2a	60	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Fresno \| California \| United States \| -119.77237 \| 36.74773 Lancaster \| C...	568	2	0.003521	1	NCT00107653	1COMPLETED	2007-09-01	2004-10-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	2	0.000966
[ 4 ]	331	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.	The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.	Postoperative Pain Hysterectomy	Pain Gynecologic IV Acetaminophen Postoperative Analgesic	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Intravenous acetaminophen 1 g/100 mL intervention 2: IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)	intervention 1: IV Acetaminophen intervention 2: IV Placebo 100 mL solution	27	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Sheffield \| Alabama \| United States \| -87.69864 \| 34.76509 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Arcadia \| California \| Unit...	331	6	0.018127	1	NCT00399568	1COMPLETED	2007-09-01	2006-11-01	Mallinckrodt	4INDUSTRY	false	false	false	null	6	0	0	0.008334
[ 3 ]	40	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineo...	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with a brain stem glioma. OVERV...	Brain Stem Gliomas	recurrent adult brain stem glioma untreated adult brain stem glioma untreated childhood brain stem glioma recurrent childhood brain stem glioma	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.	[ 0 ]	1	[ 0 ]	intervention 1: Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	40	0	0	0	NCT00003459	1COMPLETED	2007-09-01	1996-03-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for adult recurrent/progressive oligodendrogliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors. PURPOSE: This study is being performed to determine the effe...	OVERVIEW: This is a single arm, open-label study in which adults with recurrent/progressive oligodendrogliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of diseas...	Oligodendroglioma, Adult	Recurrent/progressive adult oligodendroglioma Recurrent/progressive adult anaplastic oligodendroglioma	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	[ 0 ]	1	[ 0 ]	intervention 1: Adults with a recurrent/progressive Oligodendroglioma will receive Antineoplaston therapy (Atengenal + Astugenal).	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	13	0	0	0	NCT00003472	6TERMINATED	2007-09-01	1996-05-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	600	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomize...	BACKGROUND: Allogeneic blood and marrow transplant patients are highly susceptible to invasive fungal infection prior to engraftment, due to neutropenia and mucosal injury. After engraftment, an impairment of cell mediated immunity from graft-versus-host disease (GVHD) and the use of aggressive immunosuppressive thera...	Lymphoma Infection Leukemia	Myelodysplastic and Myeloproliferative Diseases	Prot_SAP_ICF_000.pdf: BMT CTN 0101 A Randomized Double-blind Trial of Fluconazole vs. Voriconazole for the Prevention of Invasive Fungal Infection in Allogeneic Blood and Marrow Transplant Patients NCT00075803 A Randomized Double-blind Trial of Fluconazole vs. Voriconazole for the Prevention of Invasive F...	2	arm 1: The dose of fluconazole is 400 mg by mouth or intravenous drip. arm 2: The dose of oral voriconazole is 200 mg twice daily. When voriconazole must be given intravenously, it will be given at a dose of 200 mg every 12 hours for the duration of intravenous therapy.	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Fluconazole will be administered orally once daily. Fluconazole capsules should be taken at least one hour before or one hour after a meal. If oral drug is not possible, it will be given intravenously once daily in a total volume of 200 mL in patients \> 12 years. For adults, each 200 mL infusion will b...	intervention 1: Fluconazole intervention 2: Voriconazole	33	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Stanford \| California \| United States \| -122.16608 \| 37.42411 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Gainesville \| Florida \| United States \| -82.32483 \| 29.6516...	600	0	0	0	NCT00075803	1COMPLETED	2007-09-01	2003-11-01	Medical College of Wisconsin	7OTHER	true	true	true	https://cdn.clinicaltrials.gov/large-docs/03/NCT00075803/Prot_SAP_ICF_000.pdf	0	0	0	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.	Bevacizumab is a new research drug that may help to stop or slow the growth of blood vessels in your tumor. These blood vessels are needed by the tumor to grow. Rituxan is a commercially available drug that is commonly used to treat relapsed and refractory lymphoma. Before treatment starts, you will be asked questions...	Lymphoma	Non-Hodgkin's Lymphoma B-Cell Lymphoma Lymphoma Avastin Bevacizumab Rituximab Rituxan	null	1	arm 1: Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m\^2 intravenously weekly for 8 doses.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 10 mg/kg given intravenously every 2 weeks for 4 doses. intervention 2: 375 mg/m\^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.	intervention 1: Avastin intervention 2: Rituximab	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	13	0	0	0	NCT00081861	1COMPLETED	2007-09-01	2004-03-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	131	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.	null	Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Omnitarg Cancer Platinum-Resistant	null	2	arm 1: Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). arm 2: Participants received pertuz...	[ 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Placebo was provided as a single-use formulation for infusion. intervention 2: Gemcitabine was provided as a solution for infusion. intervention 3: Pertuzumab was provided as a single-use formulation for infusion.	intervention 1: Placebo intervention 2: Gemcitabine intervention 3: Pertuzumab	41	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Muscle Shoals \| Alabama \| United States \| -87.66753 \| 34.74481 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Greenbrae \| Califor...	130	0	0	0	NCT00096993	1COMPLETED	2007-09-01	2005-01-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	552	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.	null	End Stage Renal Disease	Secondary HyperParaThyroidism (SHPT) Dialysis, End Stage Renal Disease (ESRD) KDOQI, Cinacalcet Clinical Trial, Amgen	null	2	arm 1: Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. arm 2: Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible dail...	[ 4, 5 ]	2	[ 0, 10 ]	intervention 1: Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. intervention 2: Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve ...	intervention 1: cinacalcet intervention 2: Standard of care	0	null	547	0	0	0	NCT00110890	1COMPLETED	2007-09-01	2004-05-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	149	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or ...	null	Anesthesia		null	2	arm 1: Rocuronium bolus maintenance arm 2: Rocuronium continuous infusion maintenance	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation intervention 2: Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation	intervention 1: Rocuronium bolus maintenance intervention 2: rocuronium continuous infusion maintenance	0	null	137	0	0	0	NCT00124735	1COMPLETED	2007-09-01	2004-10-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe ...	null	Pompe Disease (Late-onset) Glycogen Storage Disease Type II (GSD-II) Acid Maltase Deficiency Disease Glycogenosis 2	Glycogen Storage Disease Type II GSD-II Pompe Disease	null	2	arm 1: Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks. arm 2: Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.	[ 1, 2 ]	2	[ 2, 0 ]	intervention 1: IV infusion of 20mg/kg; qow for 78 weeks. intervention 2: Placebo Comparator; qow for 78 weeks.	intervention 1: alglucosidase alfa intervention 2: Placebo	8	Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 4...	180	0	0	0	NCT00158600	1COMPLETED	2007-09-01	2005-09-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same ...	The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same ...	Major Depressive Disorder Nicotine Dependence		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: bupropion and smoking cessation behavioral intervention	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	20	0	0	0	NCT00186446	1COMPLETED	2007-09-01	2004-06-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	298	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.	null	Breast Cancer		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: E7389 1.4 mg/m\^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.	intervention 1: E7389	65	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 La Verne \| California \| United States \| -117.76784 \| 34.10084 Denver \| Colora...	291	0	0	0	NCT00246090	1COMPLETED	2007-09-01	2005-10-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	146	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.	This study is a randomized (the study drug is assigned by chance), double-blind (neither physician nor the patient knows the treatment that the patient receives), parallel-group (each group of patients will be treated at the same time), multicenter study to evaluate the effectiveness and safety of CNTO 1275 compared to...	Psoriatic Arthritis	Psoriatic arthritis CNTO 1275 Ustekinumab Interleukin-23, IL-12, IL-23 Monoclonal antibodies	null	2	arm 1: Group 1: Patients will receive CNTO 1275 63 mg at Weeks 0, 1, 2, and 3. At Weeks 12 and 16, patients will receive placebo to maintain the blind. arm 2: Group 2: Patients will receive placebo at Weeks 0, 1, 2, and 3. At Weeks 12 and 16, patients will receive CNTO 1275 63 mg.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16. intervention 2: The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CN...	intervention 1: CNTO 1275 63 mg intervention 2: Placebo	25	Macon \| Georgia \| United States \| -83.6324 \| 32.84069 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Normal \| Illinois \| United States \| -88.99063 \| 40.5142 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Covington \| Louisiana \| United States \| -90.10042 \| 30.47549 Boston \| Massachusetts \| United St...	277	0	0	0	NCT00267956	1COMPLETED	2007-09-01	2005-12-01	Centocor, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	145	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).	The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004. In this study patients that c...	Anemia	Anemia CKD Chronic Kidney Disease Iron Maintenance Dose	null	1	arm 1: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit	[ 0 ]	1	[ 0 ]	intervention 1: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit	intervention 1: Ferric Carboxymaltose (FCM)	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	127	0	0	0	NCT00317226	1COMPLETED	2007-09-01	2005-06-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	622	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.	The study will include a screening period up to 4 weeks and a 12- week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will unde...	Menopause	vaginal atrophy vaginal dryness vaginal itching vaginal pain	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 2, 2 ]	4	[ 0, 0, 10, 10 ]	intervention 1: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 2: 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 3: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 4: 2 g...	intervention 1: DR-2041a intervention 2: DR-2041b intervention 3: Placebo intervention 4: Placebo	97	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United St...	622	0	0	0	NCT00361569	1COMPLETED	2007-09-01	2006-08-01	Duramed Research	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	638	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	null	0ALL	null	The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.	null	Depressive Disorder, Major	MDD Major Depressive Disorder Depression	null	4	arm 1: None arm 2: None arm 3: None arm 4: Active control to assess assay sensitivity	[ 0, 0, 2, 5 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 50 mg tablet, once daily dosing for 8 weeks intervention 2: 100 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets and capsules, once daily dosing for 8 weeks intervention 4: 60 mg capsule, once daily dosing for 8 weeks	intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 2: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 3: Placebo intervention 4: Duloxetine 60 mg/day	22	Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Burbank \| California \| United States \| -118.30897 \| 34.18084 Encino \| California \| United States \| -118.50119 \| 34.15917 Los Alamitos \| California \| United States \| -118.07256 \| 33.80307 Newport Beach \| California \| United States \| -117.92895 \| 33.61891...	616	0	0	0	NCT00384033	1COMPLETED	2007-09-01	2006-09-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 3 ]	177	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.	null	Overweight Obesity	overweight obesity pramlintide leptin Amylin	null	4	arm 1: Placebo-pramlintide 600 microliters (µL) twice a day (BID) and metreleptin (recombinant-methionyl human leptin) 5 milligram (mg) BID, 20 weeks arm 2: Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and placebo-met...	[ 0, 0, 0, 5 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: subcutaneous injection, twice a day, 360mcg intervention 2: subcutaneous injection, twice a day, 5mg intervention 3: twice a day intervention 4: twice a day intervention 5: subcutaneous injection twice a day, 180 mcg	intervention 1: pramlintide acetate 360 mcg intervention 2: metreleptin intervention 3: placebo-pramlintide 600 uL intervention 4: placebo-metreleptin 1 mL intervention 5: Pramlintide acetate 180 mcg	12	DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Detroit \| Michigan ...	177	0	0	0	NCT00392925	1COMPLETED	2007-09-01	2006-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	278	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.	null	Allergy	Sublingual immunotherapy Grass pollen tablet Allergic rhinoconjunctivitis	null	2	arm 1: 300 IR grass pollen allergen extract tablet arm 2: Placebo tablet	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 2: One sublingual tablet daily during 4 months before pollen season and during pollen season	intervention 1: 300 IR grass pollen allergen extract tablet intervention 2: Placebo tablet	1	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437	278	0	0	0	NCT00409409	1COMPLETED	2007-09-01	2006-12-01	Stallergenes Greer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	344	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will...	Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study. A series of Phas...	Influenza	influenza flu	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). intervention 2: Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). inte...	intervention 1: Peramivir 150 mg intervention 2: Peramivir 300 mg intervention 3: Placebo	69	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Carmichael \| California \| United States \| -121.32828 \| 38.61713 El Centro \| Calif...	684	0	0	0	NCT00419263	1COMPLETED	2007-09-01	2007-01-01	BioCryst Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	1	RANDOMIZED	CROSSOVER	0TREATMENT	null	false	0ALL	false	SB-705498 has demonstrated efficacy in several preclinical and human experimental pain models. This study will investigate the efficacy of SB-705498 in patients with rectal pain. This will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with faecal urgency (Group 1), and 21 patients with IBS...	null	Irritable Colon	TRPV1 antagonist Fecal Urgency rectal pain IBS	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: SB-705498	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	2	0	0	0	NCT00461682	6TERMINATED	2007-09-01	2007-01-26	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	false	The objectives of this study are: * to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration; * and to establish the pharmacokinetic comparability of subcutaneous administration of ceftr...	null	Healthy	ceftriaxone cephalosporins pharmacokinetics subcutaneous hyaluronoglucosaminidase hyaluronidase hyaluronan rHuPH20	null	6	arm 1: subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention arm 2: subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention arm ...	[ 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes) intervention 2: single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of c...	intervention 1: SC HYLENEX and Ceftriaxone intervention 2: SC Placebo and Ceftriaxone intervention 3: IV Ceftriaxone	0	null	89	0	0	0	NCT00493220	1COMPLETED	2007-09-01	2007-06-01	Baxter Healthcare Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	183	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.	null	Type 2 Diabetes	Type 2 Diabetes anion-exchange resin	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) intervention 2: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration	intervention 1: MCI-196 intervention 2: Placebo of MCI-196 Tablet	0	null	183	0	0	0	NCT00497198	1COMPLETED	2007-09-01	2005-10-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess the impact of delayed versus early initiation strategies for fixed dose combination zidovudi...	null	HIV Tuberculosis	HIV Tuberculosis Treatment Naive	null	2	arm 1: Initiation of fixed dose combination zidovudine/lamivudine/abacavir 2 weeks after commencing antituberculous therapy arm 2: Initiation of fixed dose combination zidovudine/lamivudine/abacavir 8 weeks after commencing antituberculous therapy	[ 0, 0 ]	1	[ 0 ]	intervention 1: All subjects will receive fixed dose combination zidovudine(300 mg) / lamivudine (150 mg) / abacavir (300 mg) by mouth twice daily. Medications will be provided as long as deemed beneficial by the site investigator and study subject for up to two years. Toxicity substitutions are allowed per protocol.	intervention 1: Fixed dose combination zidovudine/lamivudine/abacavir	1	Moshi \| N/A \| Tanzania \| 37.33333 \| -3.35	70	0	0	0	NCT00851630	1COMPLETED	2007-09-01	2004-06-01	Duke University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	145	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	null	0ALL	null	This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).	null	Mild Cognitive Impairment	Mild Cognitive Impairment	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. intervention 2: None	intervention 1: Aricept (donepezil hydrochloride) intervention 2: placebo	49	Alabaster \| Alabama \| United States \| -86.81638 \| 33.24428 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Fresno \| California \| Unit...	145	0	0	0	NCT00934375	1COMPLETED	2007-09-01	2006-02-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	40	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	false	The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following an...	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Bioequivalence Healthy	null	2	arm 1: Buprenorphine 8 mg Sublingual Tablets arm 2: Subutex® 8 mg Sublingual Tablets	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 8 mg Sublingual Tablets intervention 2: 8 mg Sublingual Tablets	intervention 1: Buprenorphine intervention 2: Buprenorphine	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	80	0	0	0	NCT01157169	1COMPLETED	2007-09-01	2007-08-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	false	This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).	null	Apathy Alzheimer's Disease	apathy Alzheimer's disease activities of daily living performance caregiver burden	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks intervention 2: 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks	intervention 1: Modafinil intervention 2: Placebo	1	Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	22	0	0	0	NCT01172145	1COMPLETED	2007-09-01	2005-07-01	Brown University	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	44	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	1FEMALE	false	The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body...	null	Contraception		null	3	arm 1: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) arm 2: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrah...	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Treatment group A: Single 1 film-coated tablet (Ethinylestradiol \[EE\] 0.02mg / Drospirenone \[DRSP\] 3mg) taken orally under fasting condition at intervals of at least one menstrual cycle. intervention 2: Treatment group B: Single 1 film-coated tablet (Ethinylestradiol \[EE\] 0.02mg / Drospirenone \[D...	intervention 1: EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) intervention 2: EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca) intervention 3: L-5-MTHF 0.451mg (Metafolin)	1	Groningen \| N/A \| Netherlands \| 6.56667 \| 53.21917	127	0	0	0	NCT01253187	1COMPLETED	2007-09-01	2006-10-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	20	NON_RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	1FEMALE	true	The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause tempora...	null	Hot Flashes	Lupron Premenopausal Hot flashes	null	2	arm 1: Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) arm 2: Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)	[ 0, 0 ]	1	[ 0 ]	intervention 1: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and...	intervention 1: Leuprolide acetate	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	20	0	0	0	NCT00455689	1COMPLETED	2007-09-02	2005-11-28	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	186	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonar...	null	Pulmonary Disease, Chronic Obstructive	Osteoporosis Bone Mineral Density Osteopenia Chronic Obstructive Pulmonary Disease COPD	null	2	arm 1: Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided...	[ 0, 0 ]	3	[ 0, 0, 1 ]	intervention 1: Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening. intervention 2: Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening. intervention 3: Each...	intervention 1: Salmeterol 50 mcg BID intervention 2: Fluticasone Propionate/Salmeterol 250/50 mcg BID intervention 3: DISKUS inhaler	37	Berkeley \| California \| United States \| -122.27275 \| 37.87159 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 San Diego \| California \| United States \| -117.16472 \| 32.71571 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631...	186	1	0.005376	1	NCT00355342	1COMPLETED	2007-09-06	2004-04-28	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	1	0.00095
[ 3 ]	21	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways ...	OBJECTIVES: * Determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk, refractory, or relapsed multiple myeloma. OUTLINE: Patients receive rituximab IV on days -10 and -7; once weekly for 4 weeks (after completion of high-dose cyclophosphamide); ...	Multiple Myeloma and Plasma Cell Neoplasm	stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma	null	1	arm 1: Rituximab 375 mg/m\^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m\^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m\^2 once each during months 3, 6, 9, and 12	[ 0 ]	2	[ 2, 0 ]	intervention 1: None intervention 2: None	intervention 1: rituximab intervention 2: cyclophosphamide	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	21	0	0	0	NCT00258206	1COMPLETED	2007-09-07	2004-12-01	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	35	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	Analysis of aldeyde biomarkers of exposure and host response The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by m...	Twenty subjects will be accrued in three groups based on smoking habit: 10-20, 20-30 and \>30 cigarettes/day. Eligibility criteria include male and female cigarette smokers ≥19 years of age, who are able to give informed consent, able to exhale into Eco Screen instrument for 15-20 minutes. All must be willing to make a...	Smoking Cessation	Smoking cessation Biomarkers Aldehydes Exhaled breath Harm Reduction Cigarette smoking cessation reduction	null	1	arm 1: open label NRT self comparator design	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: nicotine polacrilex intervention 2: nicotine transdermal system intervention 3: nicotine inhaler	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	35	0	0	0	NCT00482690	6TERMINATED	2007-09-09	2005-08-23	University of Nebraska	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	24	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by measuring selected markers in EBC believed related to the path...	Twenty subjects will be accrued in three groups based on smoking habit: 10-20, 20-30 and \>30 cigarettes/day. Eligibility criteria include male and female cigarette smokers ≥19 years of age, who are able to give informed consent, able to exhale into Eco Screen instrument for 15-20 minutes. All must be willing to make a...	Cigarette Smoking	smoking reduction inflammation harm reduction lipid biomarkers	null	1	arm 1: any form of nicotine replacement would be allowed at subject discretion	[ 0 ]	1	[ 0 ]	intervention 1: on label use of Nicotine replacement therapy (NRT)	intervention 1: nicotine polacrilex, transdermal system or inhaler	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	20	0	0	0	NCT00493831	6TERMINATED	2007-09-09	2005-08-23	University of Nebraska	7OTHER	false	false	false	null	0	0	0	0

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