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_Incorrect dose administered int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 2 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline pharmacokinetics in healthy subjects.	Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more	Parkinson Disease	Parkinson Disease BIA 9-1067	null	3	arm 1: Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg arm 2: Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg arm 3: Period 1:...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1 mg rasagiline (single-dose) intervention 2: 50 mg BIA 9-1067 (single-dose)	intervention 1: rasagiline intervention 2: BIA 9-1067	1	Rennes \| N/A \| France \| -1.67429 \| 48.11198	96	0	0	0	NCT01532128	1COMPLETED	2010-07-01	2009-11-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0
[ 0 ]	15	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects between the treatment for xerostomia with cevimeline and with pilocarpine.	Pilocarpine is a cholinergic agonist with predominant muscarinic action.As such, it acts at muscarinic-cholinergic receptors found throughout the body and promotes fluid secretion. Due to this, one of the main side-effects of pilocarpine is an increased amount of sweating. Thus, not only are the salivary glands stimula...	Dry Mouth	dry mouth	null	2	arm 1: Cevimeline vs Pilocarpine arm 2: Pilocarpine vs. Cevimeline	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Cevimlenine Vs Pilocarpine, cross over design. Two sequences were evaluated "cevimeline first, then pilocarpine" and "pilocarpine first, then cevimeline". Each sequence was evaluated for 4 weeks with one week "washout" period in between both sequences. 15 patients were randomly assigned to a specific se...	intervention 1: Cevimeline intervention 2: Pilocarpine	1	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869	24	0	0	0	NCT01690052	1COMPLETED	2010-07-01	2009-01-01	University of Kentucky	7OTHER	false	false	false	null	0	0	0
[ 5 ]	180	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique.	Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate...	Disorder of Knee Anesthesia	Knee Arthroscopy Levobupivacaine Spinal Anesthesia Motor Block	null	3	arm 1: Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. arm 2: Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. arm 3: Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27...	[ 0, 0, 1 ]	1	[ 0 ]	intervention 1: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.	intervention 1: Hyperbaric Levobupivacaine 0.75%	1	Santiago de Cali \| Valle del Cauca Department \| Colombia \| -76.5199 \| 3.43054	180	0	0	0	NCT01881087	1COMPLETED	2010-07-01	2006-06-01	Fundacion Clinica Valle del Lili	7OTHER	false	false	false	null	0	0	0
[ 5 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.	null	Rheumatoid Arthritis		null	1	arm 1: Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).	[ 0 ]	1	[ 0 ]	intervention 1: 8 mg/kg by intravenous infusion every 4 weeks	intervention 1: tocilizumab [RoActemra/Actemra]	6	Almaty \| N/A \| Kazakhstan \| 76.9115 \| 43.25249 Astana \| N/A \| Kazakhstan \| 71.44598 \| 51.1801 Astana \| N/A \| Kazakhstan \| 71.44598 \| 51.1801 Shymkent \| N/A \| Kazakhstan \| 69.60042 \| 42.30988 Shymkent \| N/A \| Kazakhstan \| 69.60042 \| 42.30988 Ust-Kamenogorsk \| N/A \| Kazakhstan \| 82.60586 \| 49.97143	23	0	0	0	NCT02010216	1COMPLETED	2010-07-01	2010-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0
[ 2 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.	A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa ...	Parkinson's Disease (PD)	Parkinson's disease (PD) BIA 9-1067 Opicapone	null	4	arm 1: 1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 2: 3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on...	[ 0, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: OPC, Opicapone intervention 2: OPC, Opicapone intervention 3: immediate (standard) release levodopa/carbidopa 100/25 intervention 4: PLC, Placebo intervention 5: immediate (standard) release levodopa/benserazide	intervention 1: BIA 9-1067 5 mg intervention 2: BIA 9-1067 25 mg intervention 3: levodopa/carbidopa 100/25 intervention 4: Placebo intervention 5: levodopa/benserazide 100/25 mg	1	Rennes \| N/A \| France \| -1.67429 \| 48.11198	74	0	0	0	NCT02169414	1COMPLETED	2010-07-01	2010-02-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	285	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD	This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.	Pulmonary Disease, Chronic Obstructive	Chronic Bronchitis Anticholinergic Emphysema Long-acting muscarinic antagonist COPD	null	4	arm 1: 125mcg once-daily via novel dry powder inhaler arm 2: 250mcg once-daily via novel dry powder inhaler arm 3: 500mcg once-daily via novel dry powder inhaler arm 4: once-daily via novel dry powder inhaler	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 125mcg once-daily intervention 2: 250mcg once-daily intervention 3: 500mcg once-daily intervention 4: once-daily	intervention 1: GSK573719 125mcg intervention 2: GSK573719 250mcg intervention 3: GSK573719 500mcg intervention 4: Placebo	20	Madisonville \| Kentucky \| United States \| -87.49889 \| 37.3281 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Union \| South Carolina \| United States \| -81.62371 \| 34.71541 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tallinn \| N/A \| ...	285	0	0	0	NCT01030965	1COMPLETED	2010-07-04	2009-12-15	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0
[ 2 ]	15	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of the study is to evaluate the safety of PF-04447943 when given in combination with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the absorption and distribution of both PF-04447943 and donepezil.	null	Alzheimer's Disease	phase 1 Alzheimer's disease donepezil	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 25 mg of PF-04447943 orally every 12 hours for 7 days intervention 2: 25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days	intervention 1: PF-04447943 intervention 2: Placebo	3	Glendale \| California \| United States \| -118.25508 \| 34.14251 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Hallandale \| Florida \| United States \| -80.14838 \| 25.9812	15	0	0	0	NCT00988598	1COMPLETED	2010-07-05	2009-10-26	Pfizer	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	25	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary objective of the study is to assess the anti-tumor activity of REVLIMID® (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and response duration.	Thalidomide has found new uses as a tumor anti-angiogenesis agent that is capable of diminishing the proliferation of angiogenesis-dependent solid malignancies. Distantly metastatic, unresectable medullary thyroid carcinomas, as well as de-differentiated papillary and follicular thyroid carcinomas, which no longer conc...	Thyroid Neoplasms	Lenalidomide Clinical Trials phase II Carcinomas, thyroid Radioiodine-Unresponsive Papillary Follicular	Prot_SAP_000.pdf: PROTOCOL AND STATISTICAL ANALYSIS PLAN Study Title: REVLIMID (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinoma Institution/Site: University of Kentucky Document (Approval/Update) Date: 09-21-2008 NCT Number: NCT00287287 IRB Number 05-701-F...	1	arm 1: Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.	[ 0 ]	1	[ 0 ]	intervention 1: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day	intervention 1: Lenalidomide	1	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869	25	0	0	0	NCT00287287	1COMPLETED	2010-07-06	2006-02-01	Kenneth Ain	7OTHER	true	true	false	https://cdn.clinicaltrials.gov/large-docs/87/NCT00287287/Prot_SAP_000.pdf	0	0	0
[ 4 ]	208	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial d...	null	Chronic Pain Low Back Pain	low back pain pain assessment tapentadol centrally acting analgesic	null	1	arm 1: Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (IR) tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.	[ 0 ]	3	[ 0, 10, 0 ]	intervention 1: Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusted with 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed ...	intervention 1: Tapentadol PR intervention 2: Observation period intervention 3: Tapentadol PR	46	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Karlovac \| N/A \| Croatia \| 15.55 \| 45.49167 Opatija \| N/A \| Croatia \| 14.30782 \| 45.33658 Sisak \| N/...	176	0	0	0	NCT00983385	1COMPLETED	2010-07-06	2009-09-30	Grünenthal GmbH	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	128	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of GW856553 or placebo for six weeks. Safety, tolera...	null	Depressive Disorder, Major	Lack of interest and energy Psychomotor retardation Cytokines Major Depressive disorder	null	2	arm 1: GW856553 7.5 mg BID arm 2: Matching Placebo BID	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553 intervention 2: Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.	intervention 1: GW856553 intervention 2: Placebo	21	Hoffman Estates \| Illinois \| United States \| -88.0798 \| 42.04281 Park Ridge \| Illinois \| United States \| -87.84062 \| 42.01114 New York \| New York \| United States \| -74.00597 \| 40.71427 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Pazardzhik \| N/A \| Bulgaria \| 24.33333 \| 42.2 Plovdiv \| N/A \| Bulgaria \| 24.75 \|...	128	0	0	0	NCT00976560	1COMPLETED	2010-07-07	2009-09-25	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	1FEMALE	false	This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.	null	Scar Prevention	Scarring	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Intradermal injections of EXC 001 and placebo given on various schedules. intervention 2: Intradermal injections of EXC 001 and placebo given on various schedules.	intervention 1: EXC 001 intervention 2: Placebo	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	59	0	0	0	NCT01038297	1COMPLETED	2010-07-07	2009-12-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	141	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.	null	Alcoholism		null	2	arm 1: Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. arm 2: Participants received matching placebo tablets by mouth twice daily for 12 weeks.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: tablets intervention 2: tablets	intervention 1: SCH 900435 intervention 2: Placebo	0	null	141	0	0	0	NCT00764660	6TERMINATED	2010-07-08	2009-02-13	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	123	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with com...	null	Attention-Deficit/Hyperactivity Disorder	ADHD	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks. intervention 2: 1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.	intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo	55	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 El Centro \| California \| United States \| -115.56305 \| 32.792 Rolling Hills Estates \| California \| United States \| -118.35813 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 Wildomar \| California \| United States \| -117.28004 \| 33.598...	116	0	0	0	NCT00877487	1COMPLETED	2010-07-08	2009-04-30	Shire	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	537	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.	This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide). All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin r...	Hypertension	nebivolol BYSTOLIC ™ hydrochlorothiazide lisinopril Prinivil (TM) Zestril (TM) losartan Cozaar (TM) Impaired Fasting Glucose Impaired Glucose Tolerance hypertension	null	3	arm 1: Nebivolol with concomitant losartan or lisinopril arm 2: HCTZ with concomitant losartan or lisinopril arm 3: Placebo with concomitant losartan or lisinopril	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration. intervention 2: Encapsulated Hydrochlorothiazide 12.5 mg ...	intervention 1: Nebivolol with concomitant losartan or lisinopril intervention 2: HCTZ with concomitant losartan or lisinopril intervention 3: Placebo with concomitant losartan or lisinopril	88	Athens \| Alabama \| United States \| -86.97219 \| 34.80243 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United ...	537	0	0	0	NCT00673790	1COMPLETED	2010-07-09	2008-05-15	Forest Laboratories	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	118	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	true	This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM) administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG) levels compared to placebo (PLA). The prim...	This was a 4-period/5-treatment crossover study. Each period was 4 weeks. The 5 treatments consisted of MK-3577 10 mg once daily (QD) in the AM, MK-3577 6 mg QD in the evening (PM), MK-3577 25 mg twice daily (BID), metformin 1000 mg BID, and placebo to MK-3577/placebo to metformin. Participants were to be randomized to...	Type 2 Diabetes Mellitus		null	14	arm 1: Participants were to receive oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants ...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: MK-3577 oral tablets totaling 6 mg in the evening (PM), 10 mg in the morning (AM), or 25 mg twice daily (BID) depending upon randomization, administered during a 4 week treatment period. intervention 2: Dose-matched placebo tablets to MK-3577 administered during a 4 week treatment period intervention 3:...	intervention 1: MK-3577 intervention 2: Placebo to MK-3577 intervention 3: Metformin intervention 4: Placebo to Metformin	0	null	426	0	0	0	NCT00868790	6TERMINATED	2010-07-13	2009-03-24	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0
[ 0 ]	18	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	An increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. Omega-3 fatty acids may additionally represent a ...	See brief summary	Posttraumatic Stress Disorder	PTSD Cognition Fish Oil Omega-3 Fatty Acid	null	2	arm 1: Omega-3 Fatty Acid arm 2: Placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid) intervention 2: Matching Placebo	intervention 1: Omega-3 Fatty Acid intervention 2: Placebo	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	11	0	0	0	NCT00644423	1COMPLETED	2010-07-15	2008-09-22	Durham VA Medical Center	1FED	false	false	false	null	0	0	0
[ 4 ]	347	RANDOMIZED	PARALLEL	2DIAGNOSTIC	4QUADRUPLE	false	0ALL	false	Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease (CAD) undergoing SPECT MPI	All subjects will undergo rest and stress scans. Those subjects who qualify by demonstrating at least 1 reversible defect, will undergo a third scan. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent. Prior to the third scan, the subject will be administered blinded capsules o...	Coronary Artery Disease (CAD)	pharmacologic stress ischemia coronary artery disease (CAD)	null	3	arm 1: Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection arm 2: One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection arm 3: Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection	[ 2, 0, 0 ]	4	[ 0, 0, 4, 0 ]	intervention 1: IV intervention 2: oral intervention 3: IV intervention 4: oral	intervention 1: regadenoson intervention 2: overencapsulated caffeine intervention 3: technetium intervention 4: placebo	25	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 Roseville \| California \| United States \| -121.28801 \| 38.75212 Sacramento \|...	345	0	0	0	NCT00826280	1COMPLETED	2010-07-15	2009-03-24	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0	0	0
[ 2 ]	16	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired r...	Study Design: This study plans to enroll 16 participants in Part I (8 participants with severe renal impairment and a control group of 8 healthy participants) and 32 participants in Part II (8 participants with moderate renal impairment and a control group of 8 healthy participants; and 8 participants with mild renal ...	Insomnia		null	6	arm 1: Participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 2: Healthy participants matched to participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 3: Participa...	[ 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with \~240 mL of water after an 8 hour fast	intervention 1: Suvorexant	0	null	16	0	0	0	NCT01059851	1COMPLETED	2010-07-15	2010-05-24	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	741	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).	\- Rationale - Acute rhinosinusitis (ARS) is a condition caused by inflammation of the nose and the paranasal sinuses that generally lasts up to 4 weeks. Despite ARS being a self-limiting condition, untreated or inadequately treated sinus infection can lead to the development of complications. Uncomplicated ARS is a su...	Sinusitis, Acute	uncomplicated acute rhinosinusitis fluticasone furoate sinusitis	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Active Nasal Spray (AM) and Placebo Nasal Spray (PM) intervention 2: Active Nasal Spray (AM) and Active Nasal Spray (PM) intervention 3: Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)	intervention 1: FFNS 110 mcg QD intervention 2: FFNS 110 mcg BID intervention 3: Placebo Nasal Spray	87	Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Chilliwack \| British Columbia \| Canada \| -121.95257 \| 49.16638 Kelowna \| British Columbia \| Can...	737	0	0	0	NCT01018030	1COMPLETED	2010-07-16	2010-01-06	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	135	RANDOMIZED	PARALLEL	9OTHER	3TRIPLE	true	2MALE	false	This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.	null	Sleep Deprivation		null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Single oral dose of 20 mg intervention 2: Single oral dose of 50 mg intervention 3: Single oral dose of 70 mg intervention 4: Single oral dose of 250 mg intervention 5: Single oral dose	intervention 1: SPD489 20 mg intervention 2: SPD489 50 mg intervention 3: SPD489 70 mg intervention 4: Armodafinil intervention 5: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	135	0	0	0	NCT01096680	1COMPLETED	2010-07-18	2010-04-05	Shire	4INDUSTRY	false	false	false	null	0	0	0
[ 4 ]	209	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocil...	null	Rheumatoid Arthritis		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 8mg/kg iv every 4 weeks for 24 weeks intervention 2: iv every 4 weeks for 24 weeks	intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Placebo	9	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Harbin \| N/A \| China \| 126.65 \| 45.75 Jinan \| N/A \| China \| 116.99722 \| 36.66833 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| ...	207	0	0	0	NCT00773461	1COMPLETED	2010-07-22	2008-10-31	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on da...	null	Rheumatoid Arthritis		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg/week	intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate	1	Genoa \| Liguria \| Italy \| 8.94439 \| 44.40478	10	0	0	0	NCT00502853	1COMPLETED	2010-07-23	2007-10-25	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0
[ 2, 3 ]	177	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS s...	This study consisted of 3 parts: Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2. Part 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus that of panitumumab alone. In Part 2, participants ...	Colon Cancer Colorectal Cancer Gastrointestinal Cancer Metastatic Colorectal Cancer Rectal Cancer	panitumumab vectibix AMG 102 AMG 479 colon cancer rectal cancer colorectal cancer metastatic colorectal cancer EGFR inhibitor IGF inhibitor c-MET inhibitor	Prot_SAP_000.pdf: Product: Panitumumab/AMG 102/AMG 479 Protocol Number: 20060447 Date: 22 April 2008 Page 1 of 174 CONFIDENTIAL A ® Title: A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorec...	6	arm 1: Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision. arm 2: Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive...	[ 0, 1, 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Panitumumab for intravenous infusion intervention 2: Ganitumab for intravenous infusion intervention 3: Rilotumumab for intravenous infusion intervention 4: Placebo intravenous infusion	intervention 1: Panitumumab intervention 2: Ganitumab intervention 3: Rilotumumab intervention 4: Placebo	0	null	177	0	0	0	NCT00788957	1COMPLETED	2010-07-23	2008-10-27	NantBioScience, Inc.	4INDUSTRY	true	true	false	https://cdn.clinicaltrials.gov/large-docs/57/NCT00788957/Prot_SAP_000.pdf	0	0	0
[ 3 ]	198	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study	A Multi-Centre, Multi-country, Randomized, Double-Blind (Subject, Investigator), Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma	Asthma	Asthma Asthma control questionnaire	null	2	arm 1: Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization arm 2: Subjects will receive three, once monthly intravenous administration of saline, according to randomization	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump intervention 2: Clear or colorless 0.9% sodium chloride saline solution will be infused over an...	intervention 1: INTRAVENOUS GSK679586 intervention 2: INTRAVENOUS PLACEBO intervention 3: FLUTICASONE PROPIONATE	35	Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Orangeburg \| South Carolina \| United States \| -80.85565 \| 33.49182 Boerne \| Texas \| United States \| -98.73197 \| 29.79466 Madison \| Wisconsin...	198	0	0	0	NCT00843193	1COMPLETED	2010-07-25	2008-12-09	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0
[ 4 ]	676	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	1FEMALE	true	Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries. The incidence of cervical cancer varies depending on the region of the world. Africa has some of the highest age-standardized incidence ...	null	Human Papillomavirus (HPV) Infection	Safety Immunogenicity Human Papillomavirus (HPV) vaccine	null	2	arm 1: Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. arm 2: Healthy female subjects who receive...	[ 1, 2 ]	2	[ 2, 0 ]	intervention 1: The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm. intervention 2: Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.	intervention 1: Cervarix intervention 2: Placebo Al(OH)3	2	Dakar \| N/A \| Senegal \| -17.44406 \| 14.6937 Mwanza \| N/A \| Tanzania \| 32.9 \| -2.51667	676	0	0	0	NCT00481767	1COMPLETED	2010-07-26	2007-10-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	227	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.	null	Huntington Disease	Huntington Disease	null	4	arm 1: Participants will receive a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule will be taken twice daily (BID) as 2 separate doses. arm 2: Participants will receive ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12...	[ 2, 0, 0, 0 ]	2	[ 0, 10 ]	intervention 1: ACR16 will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to ACR16 will be administered per schedule specified in the arm description.	intervention 1: ACR16 intervention 2: Placebo	28	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 San Diego \| California \| United States \| -117.16472 \| 32.71571 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana ...	227	0	0	0	NCT00724048	1COMPLETED	2010-07-26	2008-10-24	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	7	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.	null	Patients With Nasal Polyps	nasal polyps nasal steroid fluticasone furoate	null	2	arm 1: nasal steroid arm 2: nasal spray vehicle without drug	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: nasal steroid spray intervention 2: nasal steroid vehicle without drug	intervention 1: fluticasone furoate intervention 2: placebo	0	null	0	0	0	0	NCT01013701	6TERMINATED	2010-07-29	2009-11-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0
[ 3 ]	99	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline,...	null	Moderate to Severe Vasomotor Symptoms in Postmenopausal Women		null	4	arm 1: MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2) arm 2: 17β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2) arm 3: Matching placebo for MK-6913 75 mg capsule and matching placebo...	[ 0, 1, 2, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None	intervention 1: MK-6913 intervention 2: 17-β estradiol intervention 3: Placebo to MK-6913 intervention 4: Placebo to 17-β estradiol intervention 5: MK-6913 25 mg	0	null	99	0	0	0	NCT01015677	6TERMINATED	2010-07-30	2009-12-17	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0
[ 2 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	2MALE	false	The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.	null	Hyperparathyroidism, Secondary		null	2	arm 1: Participants received a single dose of placebo intravenous injection. arm 2: Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Administered as a single intravenous (IV) injection intervention 2: Administered as a single intravenous (IV) injection	intervention 1: Etelcalcetide intervention 2: Placebo	1	Melbourne \| Victoria \| Australia \| 144.96332 \| -37.814	56	0	0	0	NCT01134549	1COMPLETED	2010-07-31	2010-06-09	KAI Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	254	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.	null	Chronic Intractable Pain		null	4	arm 1: Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system arm 2: Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose arm 3: Intraspinal Gabapentin Medium delivered continuously for 22 days via an...	[ 2, 1, 1, 1 ]	1	[ 0 ]	intervention 1: Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may ...	intervention 1: Intraspinal Gabapentin	14	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Napa \| California \| United States \| -122.28553 \| 38.29714 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Edina \| Minnesota \| United States \| -93.34995 \| 44.88969 Rochester \| Minnesota \|...	170	1	0.005882	1	NCT00414466	6TERMINATED	2010-08-01	2006-12-01	MedtronicNeuro	4INDUSTRY	false	false	false	null	0	1	0.001039
[ 4 ]	470	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combina...	null	Diabetes Diabetes Mellitus, Type 1		null	2	arm 1: Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Treat-to-target, dose titration, s.c. (under the skin) injection intervention 2: Treat-to-target, dose titration, s.c. (under the skin) injection intervention 3: Treat-to-target, dose titration, s.c. (under the skin) injection	intervention 1: insulin detemir intervention 2: NPH insulin intervention 3: insulin aspart	98	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Mar del Plata \| N/A \| Argentina \| -57.5562 \| -38.00042 Pcia de Cordoba \| N/A \| Argentina \| N/A \| N/A...	310	2	0.006452	1	NCT00474045	1COMPLETED	2010-08-01	2007-05-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	2	0	0.001771
[ 3 ]	147	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarc...	null	Non-Small Cell Lung Cancer		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 100mg po daily intervention 2: 150mg po daily	intervention 1: Doxycline intervention 2: erlotinib [Tarceva]	24	Antibes \| N/A \| France \| 7.12487 \| 43.58127 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Brest \| N/A \| France \| -4.48628 \| 48.39029 Caen \| N/A \| France \| -0.35912 \| 49.18585 Chalon-sur-Saône \| N/A \| France \| 4.85372 \| 46.78112 Chartres \| N/A \| France \| 1.48925 \| 48.44685 Dra...	147	1	0.006803	1	NCT00531934	1COMPLETED	2010-08-01	2007-10-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	1	0.001202
[ 3 ]	36	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that examines effectivenes...	This is a Phase I/II study (a study that examines effectiveness and looks for side effects). The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstra...	Diabetes Mellitus, Insulin-Dependent		null	1	arm 1: All study participants	[ 0 ]	8	[ 3, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Participants will receive portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. Up to three transplants are possible depending on individual results. intervention 2: Administered ...	intervention 1: Islet Transplantation intervention 2: Sirolimus intervention 3: Tacrolimus intervention 4: Daclizumab intervention 5: Sulfamethoxazole intervention 6: Ganciclovir intervention 7: Trimethoprim intervention 8: Pentamidine	9	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Edmonton \| Alberta \|...	36	0	0	0	NCT00014911	1COMPLETED	2010-08-01	2001-04-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0	0	0
[ 3 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This study consisted of two parts: the pilot study and the main study. The purpose of the pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess for TNF-alpha gene expression from unstimulated saliva, plasma, and mucosal epithelial cells in patients who have chemotherapy-related stom...	This study consisted of two parts: the pilot study and the main study. The purpose of the pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess for TNF-alpha gene expression from unstimulated saliva, plasma, and mucosal epithelial cells in patients who have chemotherapy-related stom...	Stomatitis	Stomatitis Oropharyngeal pain TNF Etanercept Bone marrow transplantation Chemotherapy Cancer Oral cavity Oral mucous membranes Randomized controlled clinical trial Inflammation	null	3	arm 1: Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (...	[ 0, 2, 4 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Etanercept intervention 2: Placebo	2	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262	2	0	0	0	NCT00031551	6TERMINATED	2010-08-01	2002-03-01	National Institute of Nursing Research (NINR)	0NIH	false	false	false	null	0	0	0
[ 3 ]	51	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.	OBJECTIVES: I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone). II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to pro...	Anaplastic Large Cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma		null	1	arm 1: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.	[ 0 ]	1	[ 0 ]	intervention 1: Given IV	intervention 1: ixabepilone	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Houston \| Texas \| United States \| -95.36327 \| 29.76328	51	0	0	0	NCT00058019	1COMPLETED	2010-08-01	2003-02-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 4 ]	8	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	Focal segmental glomerulosclerosis (FSGS) and minimal change disease are kidney diseases that are associated with increased excretion of protein in the urine. Approximately half of FSGS patients will lose kidney function within 8 years of diagnosis and will require dialysis. The purpose of this study is to determine wh...	The major causes of primary nephritic syndrome in adults and children are idiopathic podocyte diseases, minimal change (MCD) and focal segmental glomerulosclerosis (FSGS). Our objective is to determine whether intermittent oral dexamethasone administered over 48 weeks can induce complete remission in these patients. Th...	Nephrosis Focal Lipoid Glomerulosclerosis	Steroids Osteoporosis Proteinuria Minimal Change Disease Focal Segmental Glomerulosclerosis FSGS MCD Kidney Disease	null	0	null	null	1	[ 0 ]	intervention 1: Stage I: Dexamethasone 25 mg/m2, 2 doses every 2 weeks over 48 weeks or dexamethasone 25 mg/m2, 4 doses every 4 weeks over 48 weeks. Stage II: 1.) Dexamethasone 50 mg/m2, 2 daily doses every 12 weeks, followed by 25 mg/m2, 2 daily doses every 2 weeks over 36 weeks, or 2.) Dexamethasone 50 mg/m2, 4 dail...	intervention 1: Oral dexamethasone	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	8	0	0	0	NCT00065611	1COMPLETED	2010-08-01	2003-07-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null	0	0	0
[ 3 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Rituximab is a man-made antibody used to treat certain types of cancer. This study will determine whether rituximab is an effective treatment for adult and pediatric patients with dermatomyositis or polymyositis. Study hypotheses: 1) The time to improvement in Group A patients (receiving rituximab first) will occur si...	Rituximab is a chimeric, murine-human, genetically engineered monoclonal antibody directed against the CD20 (cluster of differentiation antigen 20) antigen found on the surface of B-lymphocytes and is known to deplete B cells when administered intravenously. It is approved to treat non-Hodgkin's lymphoma. Rituximab has...	Myositis Dermatomyositis Polymyositis Juvenile Dermatomyositis	rituximab myositis dermatomyositis polymyositis refractory Juvenile Dermatomyositis	null	6	arm 1: Refractory adult polymyositis patients who will receive rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A) arm 2: Refractory adult polymyositis patients who will receive placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B) arm 3: Adult dermatomyosit...	[ 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Group B - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum does of 1 gram at Weeks 8 and 9 intervention 2: Treatment Group A: placebo infusion at Weeks 8 and 9...	intervention 1: Rituximab intervention 2: Placebo	31	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Stanford \| California \| United States \| -122.16608 \| 37.42411 Stanford \| California \| United States \| -122.16608 \| 37.42411 Miami \| Flori...	200	0	0	0	NCT00106184	1COMPLETED	2010-08-01	2006-03-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0
[ 3 ]	50	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tum...	OBJECTIVES: Primary * Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer. * Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients. Secondary \* Determine the time to d...	Breast Cancer	recurrent breast cancer stage IV breast cancer	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle intervention 2: 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle	intervention 1: Gemcitabine intervention 2: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	201	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado ...	50	0	0	0	NCT00110084	1COMPLETED	2010-08-01	2005-08-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0
[ 3 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Anaplastic thyroid cancers are rare, aggressive tumors. Standard treatment options include surgery and chemoradiation. Few treatment options are available once metastases develop. Recent data suggest that Imatinib (Gleevec) may be advantageous in this patient population. Patients who have been treated for anaplastic th...	Anaplastic thyroid carcinomas (ATC) are high grade neoplasms, which account for approximately 2% to 5% of primary malignant thyroid tumors but more than 50% of thyroid cancer deaths. Because therapies for anaplastic thyroid carcinoma are very limited with even early stage disease, new approaches for treating this devas...	Thyroid Cancer	Anaplastic Thyroid Cancer	null	1	arm 1: Patients will be treated with Imatinib (Gleevec) 400 mg two times a day for eight weeks after which radiologic imaging will be obtained to assess response. Patients who attained a complete response will be treated with four additional weeks of Imatinib. Patients who attain a partial response or stable disease wi...	[ 0 ]	1	[ 0 ]	intervention 1: Imatinib 400 mg capsules were administered twice daily with food for 4 week cycles.	intervention 1: Imatinib	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	11	0	0	0	NCT00115739	6TERMINATED	2010-08-01	2004-02-01	University of Michigan Rogel Cancer Center	7OTHER	false	false	false	null	0	0	0
[ 3 ]	11	RANDOMIZED	CROSSOVER	1PREVENTION	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.	An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant reci...	Hypogammaglobulinemia Lung Transplantation	Hypogammaglobulinemia Lung Transplantation	null	2	arm 1: Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. arm 2: Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve...	[ 0, 0 ]	2	[ 0, 10 ]	intervention 1: 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks intervention 2: 0.1% Albumin in an equal volume to the investigational product	intervention 1: IVIG intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	20	0	0	0	NCT00115778	1COMPLETED	2010-08-01	2005-06-01	Columbia University	7OTHER	false	false	false	null	0	0	0
[ 0 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This com...	Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnosti...	Carcinoma, Non-small-cell Lung	tarceva targretin non-small cell lung cancer carcinoma, non-small cell lung cancer nsclc	null	1	arm 1: Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.	[ 0 ]	1	[ 0 ]	intervention 1: Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy	intervention 1: erlotinib (Tarceva) and bexarotene (Targretin)	1	Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229	12	0	0	0	NCT00125372	1COMPLETED	2010-08-01	2005-12-01	Dartmouth-Hitchcock Medical Center	7OTHER	false	false	false	null	0	0	0
[ 5 ]	9,438	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart disease, non-hemorrhagic stroke and the need for revascularization procedures in patients with chronic kidney disease (CKD). It also aimed to ...	The SHARP (Study of Heart and Renal Protection) was a double-blind placebo-controlled trial which aimed to assess the safety and efficacy of reducing LDL cholesterol in more than 9,000 patients with chronic kidney disease (about 3,000 of whom were on dialysis at randomization). Patients were randomly assigned to simva...	Kidney Disease, Chronic	Kidney Disease, Chronic LDL cholesterol simvastatin ezetimibe cardiovascular disease atherosclerosis	null	3	arm 1: Placebo = Arm 1. A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all Arm 1 patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all Arm 1 patients took one ta...	[ 2, 1, 5 ]	3	[ 0, 0, 0 ]	intervention 1: Once daily intervention 2: Once daily intervention 3: Once daily	intervention 1: Simvastatin 20 mg intervention 2: Ezetimibe 10mg intervention 3: Placebo	1	Oxford \| N/A \| United Kingdom \| -1.25596 \| 51.75222	9,270	0	0	0	NCT00125593	1COMPLETED	2010-08-01	2003-06-01	University of Oxford	7OTHER	false	false	false	null	0	0	0
[ 3, 4 ]	455	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical procedures. While recent studies indicate tha...	AF is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative atrial fibrillation(AF), which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of CPB surgical procedures. While recent studies indicate that interruption of the reni...	Atrial Fibrillation	atrial fibrillation cardiac surgery	null	3	arm 1: matched placebo pills daily beginning 4-7 days before surgery and continuing through discharge arm 2: Ramipril daily (2.5mg, increased to 5mg) beginning 4 to 7 days before surgery and continuing through discharge arm 3: Spironolactone 25mg daily beginning 4 to 7 days before surgery and continuing through dischar...	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Matching placebo taken once a day intervention 2: Taken orally, once a day intervention 3: Taken orally, once a day	intervention 1: Placebo intervention 2: Ramipril intervention 3: Spironolactone	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	445	0	0	0	NCT00141778	1COMPLETED	2010-08-01	2005-04-01	Vanderbilt University	7OTHER	false	false	false	null	0	0	0
[ 3 ]	77	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life	Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this stud...	Ovarian Cancer	Pegylated liposomal doxorubicin PPE Ovarian Cancer	null	1	arm 1: 40 mg/m² biweekly	[ 0 ]	1	[ 0 ]	intervention 1: 40 mg/m² biweekly	intervention 1: Caelyx	0	null	64	0	0	0	NCT00170573	1COMPLETED	2010-08-01	2001-09-01	North Eastern German Society of Gynaecological Oncology	7OTHER	false	false	false	null	0	0	0
[ 4 ]	619	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients wit...	This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all...	Rheumatoid Arthritis	Rheumatoid Arthritis	null	6	arm 1: Subjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase. arm 2: Subjects received 40 mg adalimumab subcutaneously (SC) every other week (eow) and concomitant methotrexate (MTX) during the double-blind (DB) phase. Subjects recei...	[ 0, 0, 2, 0, 0, 0 ]	6	[ 2, 2, 0, 2, 2, 2 ]	intervention 1: Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks. intervention 2: Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks. intervention 3: Self-administered, subcutaneou...	intervention 1: Adalimumab intervention 2: Adalimumab intervention 3: Placebo intervention 4: Adalimumab intervention 5: Adalimumab intervention 6: Adalimumab	87	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Escondido \| California \| U...	1,172	0	0	0	NCT00195702	1COMPLETED	2010-08-01	2000-02-01	Abbott	4INDUSTRY	false	false	false	null	0	0	-0
[ 0 ]	105	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	null	Smokers report that they often smoke cigarettes during stressful times. The combined effect of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart rate and other measures of stress response. This combination may result in greater cardiovascular harm than either smoking or stress alone...	Smokers report that they often smoke cigarettes during stressful times. Smoking and stress produce similar physiological responses such as increases in heart rate, blood pressure, and adrenaline levels. The combination of smoking and stress results in greater increases in these physiological responses compared to smoki...	Tobacco Use Disorder	Smoking	null	2	arm 1: Active medication for 4 weeks followed by placebo for 4 weeks arm 2: Placebo for 4 weeks followed by active for 4 weeks	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 10 mg for 1 week followed by 20 mg for 3 weeks intervention 2: None	intervention 1: Paroxetine intervention 2: Placebo	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	124	0	0	0	NCT00218439	1COMPLETED	2010-08-01	2005-10-01	University of Minnesota	7OTHER	false	false	false	null	0	0	0
[ 4 ]	241	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	1FEMALE	false	Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).	null	Metastatic Breast Cancer (MBC)		null	4	arm 1: Docetaxel and Gemcitabine (Tri-weekly) arm 2: Paclitaxel and Gemcitabine (Tri-weekly) arm 3: Docetaxel and Gemcitabine (Weekly) arm 4: Paclitaxel and Gemcitabine (Weekly)	[ 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=smal...	intervention 1: Gemcitabine intervention 2: Docetaxel intervention 3: Paclitaxel	34	Avellino \| N/A \| Italy \| 14.79103 \| 40.91494 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Brescia \| N/A \| Italy \| 10.21472 \| 45.53558 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Candiolo-Torino \| N/A \| Italy \| N/A \| N/A Casale Monferrato \| N/A \| Italy \| 8.4525 \| 45.13338 Castelfranco Veneto \| N/A \| Italy \| 11.92755 \| 45...	238	0	0	0	NCT00236899	1COMPLETED	2010-08-01	2005-09-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	16	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.	Hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. It is estimated that one in three individuals in the United States has high blood pressure, though many do not know it because there are usually no symptoms. Uncontrolled hypertension may lead t...	Sleep Disorders Hypertension	Sleep disorders High blood pressure	null	2	arm 1: Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks) arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks intervention 2: Placebo	intervention 1: Melatonin intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	16	0	0	0	NCT00238108	1COMPLETED	2010-08-01	2005-10-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0	0	0
[ 0 ]	13	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	3TRIPLE	true	0ALL	false	The purpose of this study is to determine whether nonalcoholic fatty liver disease (NAFLD) is associated with altered peripheral and hepatic insulin sensitivity and to investigate potential mechanisms underlying insulin resistance in NAFLD by determining associations between hepatic and peripheral insulin sensitivity, ...	NAFLD and nonalcoholic steatohepatitis (NASH) are common liver disorders that are strongly associated with obesity, type 2 diabetes and dyslipidemia. The underlying pathophysiology of fatty infiltration of the liver is thought to be related to insulin resistance, which is an almost universal finding in patients with NA...	Fatty Liver Insulin Resistance	beta cell function fenofibrate non-alcoholic steatohepatitis rosiglitazone insulin sensitivity	null	3	arm 1: matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd arm 2: rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd arm 3: micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid	[ 2, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: PPAR-gamma agonist, insulin sensitizer intervention 2: PPAR-alpha agonist, reduces triglycerides intervention 3: placebo tablets that are matched to look like rosiglitazone intervention 4: placebo matched to look like fenofibrate tablets	intervention 1: rosiglitazone intervention 2: fenofibrate intervention 3: placebo for rosiglitazone intervention 4: placebo for fenofibrate	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	13	0	0	0	NCT00252499	6TERMINATED	2010-08-01	2005-10-01	US Department of Veterans Affairs	1FED	false	false	false	null	0	0	0
[ 4 ]	402	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor c...	PRIMARY OBJECTIVE: I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine. SECONDARY OBJECTIVES: I. Compare overall survival of patients treated with these regimens. II. Compare the toxici...	Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer		null	2	arm 1: Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). arm 2: Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Given IV intervention 2: Given IV	intervention 1: cisplatin intervention 2: tirapazamine	282	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Fayetteville \| Arkansas \| Uni...	370	0	0	0	NCT00262821	6TERMINATED	2010-08-01	2006-02-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 2, 3 ]	65	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke.	All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines, and who have an occluded middle cerebral artery documented on TCD, receive standard dose IV rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 1.75 X baseline. Follow up CT scanning and TCD every 3...	Ischemic Stroke	stroke thrombin inhibition thrombolysis bleeding outcome	null	1	arm 1: Argatroban IV Infusion 1 mcg/kg/min for 48 hours	[ 0 ]	1	[ 0 ]	intervention 1: Argatroban IV Infusion at 1mcg/kg/min for 48 hours.	intervention 1: argatroban	6	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| Unite...	65	0	0	0	NCT00268762	1COMPLETED	2010-08-01	2003-02-01	The University of Texas Health Science Center, Houston	7OTHER	false	false	false	null	0	0	0
[ 5 ]	92	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The use of intravenous immunoglobulin G (IVIG) therapy has been reported in hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human Immunoglobulin is considered an alternative to delay the hemolytic process and consequently reduce the number of exchange transfusions and transfusions ...	The Hemolytic Anemia due to Rh alloimmunization is characterized by the hemolysis of Rh (D) fetal red cells caused by the action of anti Rh (D) maternal antibodies in the fetal circulation. The perinatal hemolytic disease due to Rh alloimmunization is almost extinct all over the world. The administration of Specific H...	Hyperbilirubinemia Erythroblastosis, Fetal	Immunoglobulins, Intravenous Hyperbilirubinemia Erythroblastosis, Fetal Exchange Transfusion, Whole Blood	null	2	arm 1: Intravenous Immunoglobulin arm 2: Normal Saline solution	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Intravenous Immunoglobulin intervention 2: Normal saline solution 10 ml/Kg	intervention 1: Intravenous Immunoglobulin intervention 2: Normal saline solution	1	Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642	92	0	0	0	NCT00288600	1COMPLETED	2010-08-01	2006-10-01	Oswaldo Cruz Foundation	7OTHER	false	false	false	null	0	0	0
[ 3 ]	72	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	1FEMALE	true	This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.	Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in pre-menopausal women that may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like Gonadotropin releasing hormone,GnRH analog) cause fibroids to...	Leiomyoma	Endometrium Progesterone Estrogen Fibroid Hysterectomy Leiomyoma Uterine Fibroids Fibroids	null	6	arm 1: 20 mg daily dose ulipristal acetate for three menstrual cycles or up to 102 days arm 2: 10 mg daily dose ulipristal acetate for three menstrual cycles or up to 102 days arm 3: Placebo taken daily for three menstrual cycles or up to 102 days arm 4: Subjects were studied during one baseline cycle without any inter...	[ 1, 1, 2, 4, 4, 4 ]	3	[ 0, 0, 0 ]	intervention 1: ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic intervention 2: 10 mg given daily for three menstrual cycles or 90 - 102 days intervention 3: placebo given once daily for 3 menstrual cycles or 90 - 102 days	intervention 1: ulipristal acetate 20 mg intervention 2: ulipristal acetate 10 mg intervention 3: placebo	2	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	84	0	0	0	NCT00290251	1COMPLETED	2010-08-01	2006-02-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null	0	0	0
[ 4 ]	163	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis. Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the ...	The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients. Primary endpoints: Primary endpoints of the study are the evaluation of global spontaneous pain (H...	Osteoarthrosis	symptomatic OA of the hand	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: 800 mg/day for 6 months intervention 2: 800 mg placebo/day for 6 months	intervention 1: Chondroitin 4&6 sulfate (Condrosulf) intervention 2: Placebo	0	null	163	0	0	0	NCT00291499	1COMPLETED	2010-08-01	2005-06-01	IBSA Institut Biochimique SA	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	53	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab	Secondary endpoints will include: objective response rate overall survival In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response.	Mesothelioma	mesothelioma bevacizumab chemotherapy	null	1	arm 1: cisplatin, pemetrexed, and bevacizumab	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 15 mg/kg IV every 3 weeks intervention 2: 75 mg/m2 IV every 3 weeks intervention 3: 500 mg/m2 every 3 weeks	intervention 1: bevacizumab intervention 2: cisplatin intervention 3: pemetrexed	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	53	0	0	0	NCT00295503	1COMPLETED	2010-08-01	2006-02-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0	0	0
[ 3 ]	38	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	null	We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a 12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in non-diabetic patients with the metabolic syndrome ...	This is a two-arm, parallel, double-blind randomized prospective clinical trial. The subjects will be asked to provide informed consent, and then undergo screening for enrollment criteria at the first visit (-5 weeks). The subjects who are eligible, and provide informed consent will return for Visit 2 baseline data (-4...	Metabolic Syndrome	HDL cholesterol Metabolic syndrome	null	2	arm 1: Intervention: Pioglitazone, initially 30mg, then titrated to 45mg + niacin ER 2.0 g/day + aspirin 325 mg/day arm 2: Intervention: Pioglitazone Placebo + 2.0 g/day Open-Label Niacin + 325 mg/day Aspirin	[ 0, 2 ]	4	[ 0, 10, 0, 0 ]	intervention 1: Pioglitazone, initially 30 mg, then titrated to 45 mg/day intervention 2: Pioglitazone placebo intervention 3: Niacin ER 2.0 g/day intervention 4: asprin 325 mg/day	intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Niacin ER intervention 4: Aspirin	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	78	0	0	0	NCT00300365	1COMPLETED	2010-08-01	2005-11-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0
[ 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.	PRIMARY OBJECTIVES: I. Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma treated with PXD101. SECONDARY OBJECTIVES: I. Determine the toxicity of this drug in these patients. II. Estimate the 6-month progression-free survival rate in patients treated with this dru...	Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma		null	1	arm 1: Patients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment. After finishing treatment, patients will be evaluated every 3-6 months for ...	[ 0 ]	1	[ 0 ]	intervention 1: Given IV	intervention 1: belinostat	123	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Castro Valley \| California \| United States \| -122.08635 \| 37.6941 Castro Valley \| Cali...	20	0	0	0	NCT00303953	1COMPLETED	2010-08-01	2006-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 5 ]	1,269	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.	This is a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization will be stratified, within site, according to normal versus abnormal screeni...	Opiate-related Disorders		null	2	arm 1: For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according t...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Participants receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending ...	intervention 1: Buprenorphine/naloxone intervention 2: Methadone	9	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 B...	1,247	0	0	0	NCT00315341	1COMPLETED	2010-08-01	2006-04-01	University of California, Los Angeles	7OTHER	false	false	false	null	0	0	-0
[ 3 ]	135	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The primary purpose of this study is to help answer the following research questions: * whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long * to learn more about the side...	null	Breast Cancer		null	2	arm 1: Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC (Area under the plasma drug concentration versus time curve) 5.0 mg\*min/...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity. intervention 2: AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity. intervention 3: 1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 ...	intervention 1: Pemetrexed intervention 2: Carboplatin intervention 3: Gemcitabine intervention 4: Vinorelbine	22	Gütersloh \| N/A \| Germany \| 8.37853 \| 51.90693 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Stuttgart \| N/A \| Germany \| 9.17702 \| 48.78232 Bergamo \| N/A \| Italy \| 9.66721 \| 45.69601 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Livorno \| N/A \| Italy \| 10.32615 \| 43.54427 Meldola \| N/A \| Italy \| 12.0626 \| 44.12775 Rome \| ...	131	0	0	0	NCT00325234	1COMPLETED	2010-08-01	2006-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	32	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.	A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as...	Malignant Ascites	Ascites Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Malignant Ascites Ovarian Cancer Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma Peritoneal Cancer Peritoneal Carcinoma Recurrent Ascites Recurren...	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Catumaxomab is administered intraperitoneally via an indwelling catheter (or port) as a 3-hour infusion 4 times (Days 0, 3, 7, and 10) in ascending doses (10 mcg, 20 mcg, 50 mcg, and 150 mcg, respectively).	intervention 1: catumaxomab	18	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Stanford \| California \| United States \| -122.16608 \| 37.42411 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 South Bend \| Indiana \| Unite...	32	0	0	0	NCT00326885	1COMPLETED	2010-08-01	2006-06-01	Neovii Biotech	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	1,504	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	false	The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.	This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helpi...	Nicotine Dependence		null	6	arm 1: nicotine patch alone treatment arm 2: nicotine lozenge alone treatment arm 3: nicotine patch + lozenge combination treatment arm 4: bupropion alone treatment arm 5: bupropion + nicotine lozenge combination treatment arm 6: placebo control (no active medication) treatment	[ 0, 0, 0, 0, 0, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: used according to FDA package label intervention 2: used according to FDA-approved package directions intervention 3: dosage of both according to FDA-approved dosing schedule intervention 4: dosage according to FDA-approved instructions intervention 5: dosage according to FDA approved standard instructi...	intervention 1: nicotine patch intervention 2: nicotine lozenge intervention 3: nicotine patch + nicotine lozenge intervention 4: bupropion intervention 5: bupropion + lozenge intervention 6: placebo	2	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	1,504	0	0	0	NCT00332644	1COMPLETED	2010-08-01	2004-09-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0	0	0
[ 4 ]	83	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were trea...	null	Osteoporosis Postmenopausal	Breast cancer postmenopausal bone mineral density Zoledronic acid Letrozole extended adjuvant treatment. Postmenopausal women with primary hormone receptor positive breast cancer	null	2	arm 1: Letrozole orally 2.5 mg/day for 3 years arm 2: Letrozole orally 2.5mg/day for 3 years; Zoledronic acid 4mg every 6 months by infusion	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 2.5 mg/day for 3 years intervention 2: 4 mg every 6 months	intervention 1: Letrozole intervention 2: Zoledronic acid	23	Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Deggendorf \| N/A \| Germany \| 12.96068 \| 48.84085 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Georgsmarienhütte \| N/A \| Germany \| 8.0448 \| 52.20296 Göttingen \| N/A \| Germany \| 9.93228 \| 51.53443 Halle \| N/A \| Ge...	81	0	0	0	NCT00332709	1COMPLETED	2010-08-01	2006-01-01	Novartis	4INDUSTRY	false	false	false	null	0	0	0
[ 4 ]	120	RANDOMIZED	FACTORIAL	4SUPPORTIVE_CARE	4QUADRUPLE	false	2MALE	true	RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes. PURPOSE: This randomized phas...	OBJECTIVES: Primary * Assess the effect of soy protein/isoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer. Secondary * Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of these patients. * M...	Hot Flashes Prostate Cancer	recurrent prostate cancer stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer hot flashes	null	4	arm 1: Patients receive oral placebo pill and oral placebo powder once daily. arm 2: Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily. arm 3: Patients receive oral Venlafaxine pill and placebo powder once daily. arm 4: Patients receive oral Venlafaxine pill and soy protein/isoflavon...	[ 1, 1, 0, 2 ]	4	[ 7, 0, 7, 0 ]	intervention 1: Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein intervention 2: Patients receive oral venlafaxine 75mg. intervention 3: Placebo powder (20gm casein protein) orally 0 mg of total isoflavones intervention 4: Patients receive oral placebo pill.	intervention 1: oral soy protein/isoflavones powder intervention 2: Venlafaxine intervention 3: Placebo Powder intervention 4: Placebo Pill	20	Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Decatur \| Illinois \| United States \| -88.9548 \| 39.84031 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Cedar Rapids \| Iowa \| United States \| -91.64407 \| 42.00833 New Orleans \| Louisiana \| Uni...	114	0	0	0	NCT00354432	6TERMINATED	2010-08-01	2007-02-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0	0	0
[ 3 ]	53	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may p...	The planned treatment duration for each participant is six 21-day treatment cycles of combination therapy; non-progressing participants will continue on bevacizumab monotherapy until progression. After discontinuation or after completion of all study treatments, all participants will be contacted every 3 months for a m...	Non-Small Cell Lung Cancer	Lung non-small cell chemotherapy tumor advanced recurrent metastatic Non-Small Cell Lung Cancer (NSCLC)	null	1	arm 1: Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 70 mg/m\^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks) intervention 2: 100 mg/m\^2 administered IV on Day 1 for Cycles 1-6 intervention 3: 15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of ...	intervention 1: Docetaxel intervention 2: Oxaliplatin intervention 3: Bevacizumab	1	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079	52	0	0	0	NCT00356122	1COMPLETED	2010-08-01	2006-07-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	172	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volu...	The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The secondary objective is to ...	Acute Respiratory Infections Acute Rhinosinusitis	rhinosinusitis, sinusitis, amoxicillin	null	2	arm 1: Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments arm 2: Placebo for 10 days in addition to symptomatic treatments	[ 0, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever intervention 2: Intervention drug: Dose: 500mg tid for 10 days intervention 3: Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough intervention 4: Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions ...	intervention 1: Acetaminophen intervention 2: Amoxicillin intervention 3: Dextromethorphan hydrobromide with guaifenesin intervention 4: Guaifenesin intervention 5: Pseudoephedrine Sustained Action intervention 6: Saline spray (0.65%)	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	166	0	0	0	NCT00377403	1COMPLETED	2010-08-01	2006-10-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0
[ 3 ]	49	RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	2DOUBLE	true	0ALL	null	The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (\< 25 mg) of naltrexone and increased by high-doses (\> 50 mg) of naltrexone.	Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related. We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone (50 mg) enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol (...	Marijuana Use	Naltrexone Smoked Marijuana	null	10	arm 1: During each session, one capsule containing placebo was administered to the participant in a size 00 opaque capsule with lactose filler. A marijuana cigarette (0% THC; ca. 800 mg) provided by the National Institute on Drug Abuse, was administered 45 minutes post capsule administration. arm 2: During each session...	[ 2, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	10	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes before marijuana administration. intervention 2: One capsule containing placebo was administered to the participant in a size 00 opaque capsules with lactose filler 45 minutes b...	intervention 1: Placebo + Inactive Marijuana (0% THC) intervention 2: Placebo + Active Marijuana (3.27% THC) intervention 3: Naltrexone 12 Mg+ Active Marijuana (3.27% THC) intervention 4: Naltrexone 25 Mg + Active Marijuana (3.27% THC) intervention 5: Naltrexone 50 Mg+ Active Marijuana (3.27% THC) intervention 6: Naltr...	0	null	490	0	0	0	NCT00403117	1COMPLETED	2010-08-01	2006-12-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0	0	0
[ 5 ]	100	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	An open label, non-comparative study design is appropriate for this Phase 4 study designed to assess whether a core therapy of bosentan, either as monotherapy or with the addition of sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute walk distance (6 MWD) of ≥380 meters after ...	null	Pulmonary Arterial Hypertension	pulmonary arterial hypertension bosentan sildenafil combination therapy Compass 3	null	1	arm 1: Oral bosentan 62.5 mg twice daily (BID) first 4 weeks, followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated, with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16	[ 0 ]	2	[ 0, 0 ]	intervention 1: Oral bosentan 62.5 mg BID first 4 weeks followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated intervention 2: Oral sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16	intervention 1: Bosentan intervention 2: Sildenafil	0	null	100	0	0	0	NCT00433329	1COMPLETED	2010-08-01	2007-03-01	Actelion	4INDUSTRY	false	false	false	null	0	0	0
[ 4 ]	228	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa thera...	null	Anemia		null	2	arm 1: Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The ...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month. intervention 2: As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.	intervention 1: Mircera intervention 2: Darbepoetin alfa	91	Granada Hills \| California \| United States \| -118.52314 \| 34.26472 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Mineola \| New York \| United States \| -73.64068 \| 40.74927 Orchard Park \| New York \| United States \| -78.74392 \| 42.76756 Raleigh \|...	228	0	0	0	NCT00442702	1COMPLETED	2010-08-01	2007-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	28	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.	Individuals with diabetes mellitus (DM) are disproportionately affected by atherothrombotic disorders, including cardiovascular, cerebrovascular, and peripheral vascular diseases. Atherothrombotic disease risk and mortality are also increased with metabolic syndrome, a constellation of risk factors present in more than...	Type 2 Diabetes Insulin Resistance Metabolic Syndrome	Inflammatory cytokine Cardiovascular Disease Thrombotic factors Dyslipidemia	null	2	arm 1: Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. arm 2: Placebo tablets were used to match the active comparator drugs and dosing regimen.	[ 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: To minimize side effects the metformin will be initiated at 500 mg twice daily with meals and increased to 1 gm twice daily with meals after two weeks and continue to a total of 3 months of dosing. intervention 2: To minimize side effects, the pioglitazone will be initiated at 30 mg daily and increased ...	intervention 1: metformin intervention 2: pioglitazone intervention 3: Placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	25	0	0	0	NCT00443755	1COMPLETED	2010-08-01	2005-08-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0
[ 3 ]	127	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer. The primary objective of this study was to evaluate the cardiac safety, and the se...	null	Breast Neoplasms		null	2	arm 1: Human epidermal growth factor receptor-2 (HER2) negative participants stratified at registration, were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total o...	[ 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: 75 mg/m\^2 administered IV on Day 1 for Cycles 1-6 All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administ...	intervention 1: Docetaxel intervention 2: Doxorubicin intervention 3: Carboplatin intervention 4: Cyclophosphamide intervention 5: Trastuzumab intervention 6: Bevacizumab	1	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079	126	0	0	0	NCT00446030	1COMPLETED	2010-08-01	2007-03-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.	PRIMARY OBJECTIVES: I. Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma. II. Determine the progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the effect of this drug on...	Recurrent Lymphoepithelioma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx		null	1	arm 1: Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pharmacological study will be done on Day 1 and Day 28. Computed tomography will be done at baseline and day 28.	[ 0 ]	3	[ 0, 10, 3 ]	intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies	intervention 1: pazopanib hydrochloride intervention 2: pharmacological study intervention 3: computed tomography	3	Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967	33	0	0	0	NCT00454142	1COMPLETED	2010-08-01	2007-08-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 2, 3 ]	39	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	This clinical research study is being done because there is no effective treatment for advanced androgen-independent prostate cancer. This study will determine if the combination of medications (Taxotere and Doxil) are effective in this kind of cancer.	Each cycle of treatment will consist of four weeks. The 2 types of medicines are given intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is given once a week for the first 3 weeks of each cycle. This is followed by a week of rest until the next cycle starts. Treatment is given on an out...	Prostate Cancer	Androgen Independent Prostate Cancer Taxotere Doxil AIPC Advanced Androgen-Independent Prostate Cancer	null	1	arm 1: Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/mi...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. intervention 2: Treatment will be administered on an outpatient basis. Treatm...	intervention 1: Taxotere intervention 2: Doxil	1	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	39	0	0	0	NCT00456989	1COMPLETED	2010-08-01	2004-01-01	University of Louisville	7OTHER	false	false	false	null	0	0	0
[ 5 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated monocytes and target tissues in IMIDs. Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's disease, psoriatic and rheumatoid arthritis before and after infliximab therapy.	Our hypothesis is that hematopoietic stem cells are very sensitive to elevated levels of TNFa, which potentiates their differentiation into myeloid effector cells. During their migration from the bone marrow to the end organ, these cells express a unique set of genes that function to prime these cells to respond to cri...	Rheumatoid Arthritis Psoriatic Arthritis Psoriasis Crohn's Disease		null	0	null	null	1	[ 0 ]	intervention 1: Subjects will be on a stable dose of methotrexate 12.5 to 20 mg per week and will be started on infliximab 5 mg/kg.	intervention 1: Infliximab	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	31	0	0	0	NCT00462072	1COMPLETED	2010-08-01	2007-03-01	University of Rochester	7OTHER	false	false	false	null	0	0	0
[ 5 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.	Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduc...	HIV Infections Insomnia	HIV Insomnia Cytokines Adherence	null	3	arm 1: Placebo arm 2: Doxepin arm 3: Temazepam	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length intervention 2: Temazepam capsule 15 mg po nightly x duration of study intervention 3: Placebo capsule nightly for duration of study	intervention 1: Doxepin intervention 2: Temazepam intervention 3: Placebo	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	41	0	0	0	NCT00465972	1COMPLETED	2010-08-01	2007-03-01	Duke University	7OTHER	false	false	false	null	0	0	0
[ 3 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be safe in adolescents with Type 1 Diabetes and will lower LD...	Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance. In this trial of lipid-lowering medica...	Type 1 Diabetes Mellitus Dyslipidemia	Type 1 Diabetes Mellitus dyslipidemia adolescents	null	2	arm 1: Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin \[simvastatin\] + Zetia \[ezetimibe\]. arm 2: Vytorin(simvastatin \[Zocor} + ezetimibe \[Zetia\])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin \[simvastatin\]).	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: simvastatin 20 mg daily intervention 2: Ezetimibe (10mg)/Simvastatin (20mg)	intervention 1: Simvastatin intervention 2: Ezetimibe/Simvastatin	1	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943	9	0	0	0	NCT00477204	1COMPLETED	2010-08-01	2007-05-01	University of Colorado, Denver	7OTHER	false	false	false	null	0	0	0
[ 2, 3 ]	27	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose of oxaliplatin in this drug combination is...	The Study Drugs: Cytarabine is designed to insert itself into Deoxyribonucleic acid (DNA) (the genetic material of cells) and stop the DNA from repairing itself. Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying. Oxaliplatin is designed ...	Myelodysplastic Syndromes Acute Myeloid Leukemia Leukemia	High-Risk Myelodysplastic Syndromes Acute Myeloid Leukemia Leukemia Oxaliplatin Fludarabine Cytarabine AML MDS	null	1	arm 1: Oxaliplatin 30 mg/m\^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m\^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m\^2 IV days 2-6	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 30 mg/m\^2 IV days 1-4 intervention 2: 30 mg/m\^2 IV days 2-6 intervention 3: 500 mg/m\^2 by IV continuous infusion days 2-6	intervention 1: Oxaliplatin intervention 2: Fludarabine intervention 3: Cytarabine	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	27	0	0	0	NCT00480987	6TERMINATED	2010-08-01	2007-07-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0
[ 3 ]	11	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	null	Bevacizumab may reduce CNS side effects caused by radiation therapy. This randomized phase II trial is studying how well bevacizumab works in reducing CNS side effects in patients who have undergone radiation therapy to the brain for primary brain tumor, meningioma, or head and neck cancer.	PRIMARY OBJECTIVE: I. Determine to what extent bevacizumab can reduce active radiation toxicity to the CNS in patients who have undergone cranial irradiation for primary brain neoplasm, meningioma, or head and neck cancer. SECONDARY OBJECTIVES: I. Determine to what extent this drug can reduce dexamethasone dependenc...	Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Meningioma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Central Nervous System Germ Cell Tumor Adult Choroid Plexus Tumor Adult Diffuse Astrocytoma Adult Ependymoma Adult Grade II Meningioma Adult Grade III Meningioma Adult Ma...		null	2	arm 1: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of di...	[ 0, 2 ]	4	[ 0, 0, 3, 3 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: None intervention 4: None	intervention 1: bevacizumab intervention 2: placebo intervention 3: magnetic resonance imaging intervention 4: quality-of-life assessment	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	17	0	0	0	NCT00492089	1COMPLETED	2010-08-01	2007-06-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 3 ]	272	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.	Approximately 200 patients will be enroled into the initial, 16 week, open-label period using 1.5 mg/day dosing. Patients will receive tivozanib (AV-951) continuously for 3 weeks followed by 1 week off study drug. Patients will undergo disease assessment at baseline and after Cycles 2 and 4 and response will be determi...	Carcinoma, Renal Cell	Renal Cell Carcinoma AV-951 tivozanib	null	2	arm 1: Tivozanib (AV-951) administered as a solid dosage form daily for three weeks per month arm 2: solid oral capsule containing excipients dosed daily for three weeks per month	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: solid oral dosage form taken daily for three weeks per one month cycle intervention 2: solid oral capsule containing excipients dosed daily for three weeks per month	intervention 1: Tivozanib (AV-951) intervention 2: Placebo comparator	26	Vellore \| Tamil Nadu \| India \| 79.13255 \| 12.9184 Kolkata \| N/A \| India \| 88.36304 \| 22.56263 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Pune \| N/A \| India \| 73.85535 \| 18.51957 Astrakhan \| N/A \| Russia \| 48.04076 \| 46.34968 Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Moscow...	390	0	0	0	NCT00502307	1COMPLETED	2010-08-01	2007-10-01	AVEO Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	75	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if the combination of 6-Thioguanine, Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or glioblastoma multiforme in patients who have failed pre...	Capecitabine is a drug that damages the DNA (deoxyribonucleic acid) of tumor cells and blocks the function of DNA and RNA (ribonucleic acid) of tumor cells. These actions help to kill the tumor cells. Celecoxib is a drug that may help to prevent the development of some types of cancer by blocking a type of enzyme (COX...	Anaplastic Glioma of Brain Glioblastoma Multiforme Brain Cancer	Anaplastic Glioma Glioblastoma Multiforme Brain Cancer 6-Thioguanine Capecitabine Celecoxib Temozolomide Xeloda Temodar TMZ CCNU 6-TG	null	3	arm 1: Anaplastic Tumors - 6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8, after 6 day rest Capecitabine 825 mg/m\^2 and Celebrex 400 mg PO every 12 hours Day 14-27 for 28 day course. arm 2: Anaplastic Tumors - 6-TG 80 mg/m\^2 PO every 6 hours Day 1-3, Lomustine 100 mg/m\^...	[ 1, 1, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Arms 1,3 = 825 mg/m\^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m\^2 PO Every 12 Hours on Day 11-24. intervention 2: Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24. intervention 3: Arms 1,3 = 150 mg/m\^2 PO Daily On Day 4-8. interve...	intervention 1: Capecitabine intervention 2: Celecoxib (Celebrex) intervention 3: Temozolomide intervention 4: Lomustine intervention 5: 6-Thioguanine	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	74	0	0	0	NCT00504660	1COMPLETED	2010-08-01	2003-09-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer	PRIMARY OBJECTIVES: I. To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate). SECONDARY OBJECTIVES: I. To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma. II. To assess time to progression after initial response to s...	Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma		null	1	arm 1: Patients receive 37.5 mg oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.	[ 0 ]	1	[ 0 ]	intervention 1: Oral 37.5 mg each day of the 6-week cycle (continuous dosing).	intervention 1: sunitinib malate	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	13	0	0	0	NCT00514137	1COMPLETED	2010-08-01	2007-09-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 4 ]	376	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.	null	Epilepsy		null	1	arm 1: 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing	[ 0 ]	1	[ 0 ]	intervention 1: 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial	intervention 1: Lacosamide	54	Randwick \| New South Wales \| Australia \| 151.24895 \| -33.91439 Maroochydore \| Queensland \| Australia \| 153.09953 \| -26.66008 Woodville \| South Australia \| Australia \| 138.54291 \| -34.877 Clayton \| Victoria \| Australia \| 145.11667 \| -37.91667 Parkville \| Victoria \| Australia \| 144.95 \| -37.78333 West Heidelberg \| Victor...	376	0	0	0	NCT00515619	1COMPLETED	2010-08-01	2004-12-01	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0
[ 2, 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan hydrochloride and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors. Obatoclax mesylate may stop the growth of tumor cells by...	PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose, recommended phase II dose, and toxicity profile of obatoclax mesylate when administered with topotecan hydrochloride in patients with advanced solid tumors. (Phase I) II. Determine the response rate in patients with relapsed or refractory small cell lung can...	Recurrent Small Cell Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific		null	1	arm 1: Patients receive obatoclax mesylate IV over 3 hours on day 1 OR days 1 and 3 and topotecan hydrochloride IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies	intervention 1: obatoclax mesylate intervention 2: topotecan hydrochloride intervention 3: laboratory biomarker analysis	2	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 New York \| New York \| United States \| -74.00597 \| 40.71427	22	0	0	0	NCT00521144	1COMPLETED	2010-08-01	2007-08-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0
[ 2, 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during plati...	OUTLINE: This is a multi-center study. * Topotecan: 4mg/m2 weekly, 3 weeks on and one week off. * Sorafenib: Assigned cohort dose for phase I (up to 12 patients) Maximum tolerated dose for phase II (21 total patients) Cycles will consist of 4 weeks (28 days) with disease evaluations every 8 weeks. Non-PD and accepta...	Ovarian Cancer		null	2	arm 1: Topotecan 3.5 mg/m\^2 + Sorafenib dose escalation: arm 2: Topotecan 3.5 mg/m\^2 + Sorafenib 400 mg po daily.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Phase I: Dose Escalation, Phase II: MTD Dose level -1: 200mg po daily Dose level 1: 400mg po daily (MTD) Dose level 2: 400mg po bid intervention 2: 3.5mg/m2 weekly, 3 weeks on and one week off.	intervention 1: Sorafenib intervention 2: Topotecan	8	Galesburg \| Illinois \| United States \| -90.37124 \| 40.94782 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lafayette \| India...	30	0	0	0	NCT00526799	6TERMINATED	2010-08-01	2007-09-01	Daniela Matei, MD	7OTHER	false	false	false	null	0	0	0
[ 3 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.	The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.	Polycystic Ovary Syndrome	Polycystic Ovary Syndrome	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 40mg caplets per day for six weeks intervention 2: 1 placebo caplet per day for six weeks.	intervention 1: Lipitor intervention 2: Placebo	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	20	0	0	0	NCT00529542	1COMPLETED	2010-08-01	2004-12-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0	0	0
[ 3 ]	25	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal g...	Outline: This is a multi-center study. Patients who meet eligibility criteria will receive treatment as follows until disease progression or excessive toxicities: * Erlotinib 150 mg p.o. daily on days 2-7, 9-14, 16-28 * Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8, 15 Treatment cycle = 28 days Pe...	Hepatocellular Carcinoma		null	2	arm 1: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 arm 2: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 intervention 2: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15	intervention 1: Erlotinib intervention 2: Docetaxel	12	Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Bloomington \| Indiana \| United States \| -86.52639 \| 39.16533 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Indianapolis \| Indiana \| Un...	25	0	0	0	NCT00532441	6TERMINATED	2010-08-01	2007-09-01	Gabi Chiorean, MD	7OTHER	false	false	false	null	0	0	0
[ 5 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.	To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.	Open Angle Glaucoma	ologen collagen matrix glaucoma trabeculectomy Mitomycin-C	null	2	arm 1: Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C. arm 2: 20 patients will be recruited according to the enrollment accept...	[ 1, 0 ]	2	[ 1, 0 ]	intervention 1: Collagen Matrix implantation in Glaucoma Filtering Surgery intervention 2: If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space tak...	intervention 1: Collagen Matrix in Glaucoma Filtering Surgery intervention 2: Mitomycin-C(MMC) and glaucoma filtering surgery	1	Cologne \| N/A \| Germany \| 6.95 \| 50.93333	20	0	0	0	NCT00538590	1COMPLETED	2010-08-01	2007-07-01	Pro Top & Mediking Company Limited	4INDUSTRY	false	false	false	null	0	0	0
[ 4 ]	632	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks	Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjec...	Chronic Kidney Disease Dialysis Hyperphosphatemia	Chronic Kidney Disease Dialysis Hyperphosphatemia	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose intervention 2: Current approved dosing recommendations for 12 weeks	intervention 1: MCI-196 intervention 2: Another Phosphate binder (Sevelamer)	115	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Frýdek-Místek \| N/A \| Czechia \| 18.35 \| 49.68333 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Ostrava \| N/A \| Czechia \| 18.28204 \| 49.83465 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Tábor \| N/A \| Czechia \| 14.6578 \| 49.41441 Ústí nad Labem \| N/A \| Czechia \| 14.03227 \| ...	632	0	0	0	NCT00542815	1COMPLETED	2010-08-01	2007-11-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	47	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The mechanism of action of sorafenib makes it an interesting drug to investigate in the treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic activity has already been demonstrated and the PDGF receptor target may also be pertinent in glioblastoma. The combination of temozolomide p...	All patients entering this study will initially undergo combined modality treatment with concurrent radiation therapy + temozolomide. Four weeks after completing radiation therapy, patients will begin 6 months of follow-up treatment with oral temozolomide plus sorafenib. Combined Modality Therapy - Radiation Therapy R...	Glioblastoma Multiforme	Concurrent Radiation Therapy Temozolomide Sorafenib First-line Glioblastoma Multiforme Phase II	null	1	arm 1: In the combined modality portion of the study, patients were administered: Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily Patients took a four week break before beginning follow-up systemic therapy: Temozolomide - 150 mg /m2 by mouth o...	[ 0 ]	3	[ 4, 0, 0 ]	intervention 1: 2 Gy/fraction, single daily fractions M-F, to 60 Gy total intervention 2: In Combined Modality Therapy, administered as 75 mg/m2 by mouth once daily In follow-up systemic therapy, administered as 150 mg/m2 by mouth on days 1-5 every 28 days for 6 cycles intervention 3: In follow-up systemic therapy, ad...	intervention 1: Radiation Therapy intervention 2: Temozolomide intervention 3: Sorafenib	10	Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Cincinnati \| Ohio \| U...	47	0	0	0	NCT00544817	1COMPLETED	2010-08-01	2007-04-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0
[ 2 ]	34	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.	null	Stomach Neoplasms		null	1	arm 1: None	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. intervention 2: Cisplatin is given 80 mg/m\^2 through a vein on day 1 every 21 days. Each 21...	intervention 1: 5-fluorouracil intervention 2: cisplatin intervention 3: sunitinib malate	3	Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 L'Hospitalet de Llobregat \| Barcelona \| Spain \| 2.10028 \| 41.35967 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165	34	0	0	0	NCT00555672	1COMPLETED	2010-08-01	2008-08-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.	This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the...	Primary Biliary Cirrhosis	PBC Primary Biliary Cirrhosis Fenofibrate Triglide	null	1	arm 1: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year	[ 0 ]	1	[ 0 ]	intervention 1: 160 mg per day for 1 year	intervention 1: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)	2	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	20	0	0	0	NCT00575042	1COMPLETED	2010-08-01	2007-08-01	University of Florida	7OTHER	false	false	false	null	0	0	0
[ 3 ]	59	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.	null	Crohn's Disease	Crohn's disease, moderate, severe, active, AIN457	null	2	arm 1: AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22. arm 2: Matching placebo to AIN457 was given as an infusion at day 1 and day 22.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 10 mg/kg intervention 2: Matching placebo to AIN457	intervention 1: AIN457 intervention 2: Placebo	2	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Stuttgart \| N/A \| Germany \| 9.17702 \| 48.78232	59	0	0	0	NCT00584740	6TERMINATED	2010-08-01	2008-08-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	176	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.	null	Metastatic Breast Cancer		null	2	arm 1: ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest arm 2: ixabepilone 40 mg/m\^2 every 3 weeks	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity. intervention 2: Injection, IV, Until progressive disease or intolerable to...	intervention 1: Ixabepilone intervention 2: Ixabepilone	57	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sedona \| Arizona \| United States \| -111.76099 \| 34.86974 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Murrieta \| California \| United States \| -117.21392 \| 33.55391 Hudson \| Florida \| United ...	171	0	0	0	NCT00593827	1COMPLETED	2010-08-01	2008-05-01	R-Pharm	4INDUSTRY	false	false	false	null	0	0	0
[ 5 ]	100	NA	SINGLE_GROUP	1PREVENTION	0NONE	true	0ALL	false	This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.	This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a...	HIV Infections	HIV Prevention Non-occupational post-exposure prophylaxis HIV seronegativity	null	1	arm 1: TRUVADA	[ 5 ]	1	[ 0 ]	intervention 1: TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg	intervention 1: TRUVADA + Raltegravir	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	100	0	0	0	NCT00594646	1COMPLETED	2010-08-01	2008-02-01	Fenway Community Health	7OTHER	false	false	false	null	0	0	0
[ 0 ]	17	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	null	Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise...	All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel which will be applied daily to the skin of the abdomen or thighs every morning at the same time for 16 weeks. Two days after...	Kidney Failure Kidney Diseases		null	2	arm 1: Patients with chronic kidney disease between the ages of 55 and 75 years. arm 2: Control participants with baseline data collection only (for baseline comparator).	[ 0, 4 ]	1	[ 0 ]	intervention 1: Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.	intervention 1: Testim, 1% testosterone gel	2	Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Jose \| California \| United States \| -121.89496 \| 37.33939	17	0	0	0	NCT00645658	1COMPLETED	2010-08-01	2007-08-01	Palo Alto Veterans Institute for Research	7OTHER	false	false	false	null	0	0	0
[ 3, 4 ]	8	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	false	We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.	Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD Activity Score (NAS) prior to therapy and after 28 weeks of therapy. We used the following criteria to define our primary outcome: (i) ...	Nonalcoholic Fatty Liver Disease	Non-alcoholic steatohepatitis NASH	null	1	arm 1: liver biopsy score pre treatment with exenatide 5 micrograms SQ (sub-cutaneous) twice a day titrated to 10 mcg SQ twice a day as tolerated	[ 0 ]	1	[ 0 ]	intervention 1: 5 mcg twice a day titrated to 10 mcg twice a day	intervention 1: Exenatide	3	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	8	0	0	0	NCT00650546	1COMPLETED	2010-08-01	2006-08-01	Indiana University	7OTHER	false	false	false	null	0	0	0
[ 0 ]	24	RANDOMIZED	PARALLEL	2DIAGNOSTIC	0NONE	false	0ALL	false	We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize fats and sugars inappropriately, and that this may impair the heart's ability to pump blood. We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar metabolism in the hearts of HIV+ people with The...	We hypothesize that myocardial free fatty acid and glucose utilization and oxidation rates are dysregulated in HIV+ people with The Metabolic Syndrome in comparison to HIV+ people without The Metabolic Syndrome, and in comparison to HIV-seronegative people with and without The Metabolic Syndrome. We hypothesize that dy...	HIV Infections Cardiovascular Disease Insulin Resistance HIV Lipodystrophy The Metabolic Syndrome	HIV/AIDS Heart disease Diabetes Cardiovascular disease risk Dyslipidemia Visceral adiposity treatment experienced	null	2	arm 1: Pioglitazone (Actos, 30mg/day for 16 weeks) arm 2: Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks	[ 1, 1 ]	2	[ 0, 5 ]	intervention 1: 30mg/day for 16 weeks intervention 2: Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks	intervention 1: Pioglitazone intervention 2: Exercise Training	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	20	0	0	0	NCT00656851	1COMPLETED	2010-08-01	2005-09-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null	0	0	0
[ 0 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.	Aims: 1. To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses. 2. To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxici...	Post-operative Pain	Peripheral Nerve Infusion, continuous brachial plexus block, post-operative pain diaphragmatic paresis	null	3	arm 1: Initial Bolus 5 ml Ropivacaine arm 2: Initial Bolus 10 ml Ropivacaine arm 3: Initial Bolus 20 ml Ropivacaine	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Initial Bolus 5 ml Ropivacaine via interscalene injection intervention 2: Initial Bolus 10 ml Ropivacaine via interscalene injection intervention 3: Initial Bolus 20 ml Ropivacaine via interscalene injection	intervention 1: Ropivacaine intervention 2: Ropivacaine intervention 3: Ropivacaine	2	Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Troy \| Michigan \| United States \| -83.14993 \| 42.60559	36	0	0	0	NCT00672100	1COMPLETED	2010-08-01	2009-01-01	William Beaumont Hospitals	7OTHER	false	false	false	null	0	0	0
[ 3 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Vorinostat may stop the growth of cancer cells by interfering with various proteins needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin (GO), can block cancer growth in different ways. GO finds cancer cells and helps kill them by carrying a cancer-killing substance to them. Giving vo...	PRIMARY OBJECTIVES: I. To determine the CR/CRi rate after treatment with vorinostat plus GO. (Good risk group) II. To determine the 30-day survival after treatment with vorinostat plus GO. (Poor risk group) SECONDARY OBJECTIVES: I. To estimate the frequency and severity of regimen-associated toxicities, along with 3...	Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia ...		null	1	arm 1: REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive...	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given IV intervention 2: Given orally intervention 3: Correlative studies	intervention 1: gemtuzumab ozogamicin intervention 2: vorinostat intervention 3: laboratory biomarker analysis	4	Stanford \| California \| United States \| -122.16608 \| 37.42411 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	31	0	0	0	NCT00673153	6TERMINATED	2010-08-01	2008-03-01	Fred Hutchinson Cancer Center	7OTHER	false	false	false	null	0	0	0
[ 5 ]	26	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a p...	null	Neuroendocrine Tumour With Carcinoid Symptoms		null	0	null	null	1	[ 0 ]	intervention 1: 90 mg or 120 mg once every 28th day	intervention 1: lanreotide (Autogel formulation)	10	Aarhus \| N/A \| Denmark \| 10.21076 \| 56.15674 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Bergen \| N/A \| Norway \| 5.32415 \| 60.39299 Tromsø \| N/A \| Norway \| 18.95508 \| 69.6489 Trondheim \| N/A \| Norway \| 10.39506 \| 63.43049 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Linköping \| N/A \| Sweden \| 15.62157 \| 58.41086 St...	78	0	0	0	NCT00681187	1COMPLETED	2010-08-01	2008-06-01	Ipsen	4INDUSTRY	false	false	false	null	0	0	0
[ 3 ]	135	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.	null	Rectal Carcinoma	rectal rectum cancer carcinoma	null	2	arm 1: Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. arm 2: Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg...	[ 0, 0 ]	4	[ 0, 4, 3, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: 5FU intervention 2: Radiation intervention 3: Surgery of resectable lesions intervention 4: Irinotecan	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	131	0	0	0	NCT00682786	1COMPLETED	2010-08-01	2002-10-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0

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