Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_count_Accidental overdose int64	METADATA_count_Incorrect dose administered int64	METADATA_count_Multiple drug overdose int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 2 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.	null	Type 2 Diabetes (T2D)	Type 2 diabetes (T2D)	null	4	arm 1: Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A). arm 2: Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A). arm 3: Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B). arm 4: Obese pa...	[ 0, 2, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Once-weekly 50 mg capsule intervention 2: Once-weekly placebo capsule	intervention 1: Omarigliptin intervention 2: Placebo	0	null	32	0	0	0	NCT01088711	1COMPLETED	2010-05-11	2010-03-11	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	19	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium t...	OBJECTIVES: Primary * Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride. Secondary * Compare time-to-event efficacy variables in patients treated with these regimens. * Compare progr...	Lung Cancer	stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer	null	2	arm 1: Treat subjects with 2 dosings/cycle of Gemzar x6 cycles. arm 2: Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 1250 mg/m\^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 \& 8 of each cycle (21 days) x6 cycles. intervention 2: 500 mg/m\^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle. intervention 3: 1500 mg/m\^2 administered...	intervention 1: gemcitabine HCL intervention 2: pemetrexed disodium intervention 3: gemcitabine HCL	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	19	0	0	0	NCT00407550	1COMPLETED	2010-05-12	2006-11-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	286	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizure...	null	Refractory Partial Onset Seizures	Refractory Partial Onset Seizures, epilepsy	null	2	arm 1: None arm 2: None	[ 0, 0 ]	1	[ 0 ]	intervention 1: Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).	intervention 1: Rufinamide	27	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Loxahatchee Groves \| Florida \| United States \| -80.27977 \| 26.68368 Orlando \| Flo...	286	0	0	0	NCT00448539	6TERMINATED	2010-05-14	2007-03-15	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. This trial will investigate the effects of single doses of preladenant and pla...	null	Parkinson Disease		null	6	arm 1: Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participan...	[ 0, 0, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: one 10-mg capsule, orally, at hour 0 of treatment period intervention 2: single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period intervention 3: Placebo capsule, oral, at hour 0 of treatment period intervention 4: levodopa intravenous (IV) infusion (1 mg/kg body weight) was begi...	intervention 1: SCH 420814 10 mg intervention 2: SCH 420814 100 mg intervention 3: Placebo intervention 4: Levodopa intervention 5: Carbidopa	0	null	36	0	0	0	NCT00845000	1COMPLETED	2010-05-14	2009-04-21	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	25	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	true	2MALE	false	A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of subjects with mild to moderate hypertension. The primary hypotheses for the study are that MK-8266 given as single doses is sufficien...	Three panels, each consisting of either 8 or 9 participants (8 healthy young males in Panel A and Panel B; and 9 participants with mild to moderate hypertension in Panel C) will be randomized to receive either MK-8266 or matching placebo in either a 6:2 ratio (Panel A and Panel B) or 6:3 ratio (Panel C), respectively, ...	Hypertension		null	14	arm 1: MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: placebo/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose. arm 2: MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: placebo/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose. arm 3: MK-8266 in ...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant. Some participants will receive study drug with food. intervention 2: MK-8266 1.0 mg oral capsule....	intervention 1: MK-8266 0.1 mg intervention 2: MK-8266 1.0 mg intervention 3: Placebo	0	null	101	0	0	0	NCT01025791	1COMPLETED	2010-05-14	2009-11-18	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	20	RANDOMIZED	SINGLE_GROUP	1PREVENTION	4QUADRUPLE	false	0ALL	true	This study will determine the effectiveness of an antidepressant in preventing or reducing depressive symptoms in people with melanoma who are receiving Interleukin-2 (IL-2) treatment.	Melanoma is the most serious type of skin cancer, affecting nearly 54,000 people in the United States each year. Melanomas often develop in pre-existing moles or as new moles on the body. If left untreated, the cancerous cells can spread throughout the body. Fortunately, melanoma can be cured if a person is diagnosed a...	Depression	Cancer IL-2 therapy Antidepressant Immune system Neuroendocrine response	null	2	arm 1: Participants will receive escitalopram and IL-2 treatment arm 2: Participants will receive placebo and IL-2 treatment	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Participants will begin medication approximately 2 weeks before their first scheduled IL-2 treatment. The dosage for the first week will be 10 mg per day. If 10 mg is well tolerated by the participant, the dosage will be increased to 20 mg per day. The dosage for the remainder of the study will be 20 mg...	intervention 1: Escitalopram intervention 2: Placebo intervention 3: IL-2	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	20	0	0	0	NCT00352885	1COMPLETED	2010-05-17	2006-10-06	Emory University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	36	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	Duchenne muscular dystrophy (DMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during chi...	This Phase 2a, multicenter, open-label safety and efficacy study will be performed at 3 sites in the United States. The study will enroll up to 38 participants with nonsense mutation Duchenne muscular dystrophy who participated in a previous Phase 2a study of ataluren (Protocol Number PTC124-GD-004-DMD \[NCT00264888\])...	Duchenne Muscular Dystrophy	Duchenne muscular dystrophy Nonsense mutation Premature stop codon DMD PTC124 Ataluren	null	1	arm 1: Participants will receive ataluren 3 times per day with meals at doses of 20 milligrams per kilogram (mg/kg) (breakfast), 20 mg/kg (lunch), and 40 mg/kg (dinner) for up to 89 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: Ataluren will be provided as a vanilla-flavored powder to be mixed with milk. Dosing based on participant body weight	intervention 1: Ataluren	3	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	36	0	0	0	NCT00759876	6TERMINATED	2010-05-17	2008-08-13	PTC Therapeutics	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	173	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability...	This is a Phase 2b, international, multicenter, open-label extension study for participants who successfully completed blinded study drug in Study 007. This extension study will evaluate the long-term administration of ataluren administered 3 times per day (TID) at morning, midday, and evening doses of 20, 20, and 40 m...	Duchenne Muscular Dystrophy Becker Muscular Dystrophy	Duchenne muscular dystrophy Becker muscular dystrophy Nonsense mutation Premature stop codon DMD BMD Ataluren PTC124	null	1	arm 1: All participants will receive ataluren suspension orally three times a day (TID), 20 mg/kg at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for up to 96 weeks in this study. Any participant who was receiving a reduced dose of ataluren at the end of treatment visit in study PTC1...	[ 0 ]	1	[ 0 ]	intervention 1: Ataluren oral powder for suspension will be administered as per dose and schedule specified in the arm.	intervention 1: Ataluren	37	Sacramento \| California \| United States \| -121.4944 \| 38.58157 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Gulf Breeze \| Florida \| United States \| -87.16386 \| 30.35714 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Boston \| Massachusetts...	346	2	0.00578	1	NCT00847379	6TERMINATED	2010-05-24	2009-01-31	PTC Therapeutics	4INDUSTRY	false	false	false	null	0	0	0	2	0.001587
[ 5 ]	130	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.	null	Pulmonary Arterial Hypertension		null	4	arm 1: None arm 2: None arm 3: None arm 4: Open label extension from week 12 to week 24.	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: oral, 20 mg, tid intervention 2: oral 1 mg, tid intervention 3: oral 5 mg, tid intervention 4: oral 20 mg, tid	intervention 1: Sildenafil citrate intervention 2: Sildenafil citrate intervention 3: Sildenafil citrate intervention 4: Sildenafil citrate	46	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Elk Grove Village \| Illinois \| United States \| -87.97035 \| 42.00392 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Chapel Hill \| Nort...	129	0	0	0	NCT00430716	6TERMINATED	2010-05-25	2008-04-08	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherap...	null	Rheumatoid Arthritis		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 8mg/kg iv every 4 weeks for 24 weeks	intervention 1: tocilizumab [RoActemra/Actemra]	3	Hämeenlinna \| N/A \| Finland \| 24.46434 \| 60.99596 Hyvinkää \| N/A \| Finland \| 24.86667 \| 60.63333 Riihimäki \| N/A \| Finland \| 24.77726 \| 60.73769	14	0	0	0	NCT00810277	1COMPLETED	2010-05-26	2008-11-30	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	16	RANDOMIZED	null	0TREATMENT	0NONE	false	1FEMALE	false	This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects...	This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.	Breast Cancer		null	2	arm 1: Combination of Bosutinib and Letrozole arm 2: Letrozole	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs intervention 2: 2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdra...	intervention 1: Bosutinib intervention 2: Letrozole intervention 3: Letrozole	11	Whittier \| California \| United States \| -118.03284 \| 33.97918 Joliet \| Illinois \| United States \| -88.0834 \| 41.52519 Niles \| Illinois \| United States \| -87.80284 \| 42.01892 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Wilrijk \| N/A \| Belgium \| ...	16	1	0.0625	1	NCT00880009	6TERMINATED	2010-05-31	2009-07-30	Pfizer	4INDUSTRY	false	false	false	null	1	0	0	0	0.011119
[ 0 ]	4	RANDOMIZED	PARALLEL	9OTHER	0NONE	false	2MALE	true	This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy. Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms...	null	HIV Infections	HIV Lipodystrophy Lipoatrophy Lipohypertrophy Human Immunodeficiency Virus	null	2	arm 1: 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg arm 2: 10 male patients with lipodystrophy not taking daily Pioglitazone	[ 0, 3 ]	2	[ 0, 10 ]	intervention 1: Participants will take oral Pioglitazone 45 mg daily for 16 weeks. intervention 2: Participants will be observed for 16 weeks but will not receive drug	intervention 1: Pioglitazone intervention 2: Observation	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	0	0	0	0	NCT01023620	1COMPLETED	2010-05-31	2009-10-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	712	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.	null	Osteoporosis, Postmenopausal Back Pain Spinal Fracture		null	2	arm 1: Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo arm 2: Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 20 ug/day, subcutaneous, 18 months intervention 2: 35 mg/once weekly, oral, 18 months intervention 3: once weekly, oral, 18 months intervention 4: daily, subcutaneous, 18 months	intervention 1: teriparatide intervention 2: risedronate intervention 3: placebo intervention 4: placebo	72	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Oakland \| California \| United States \| -122.2708 \| 37.80437 Farmington \| Conne...	710	1	0.001408	1	NCT00343252	1COMPLETED	2010-06-01	2006-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	1	0.000249
[ 4 ]	1,047	NON_RANDOMIZED	null	0TREATMENT	null	false	0ALL	true	To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.	null	HIV Infections	HIV Infections	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer ...	intervention 1: maraviroc	361	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Hobson City \| Alabama \| United States \| -85.84413 \| 33.62149 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Beverly Hills \| Ca...	1,032	2	0.001938	1	NCT00426660	1COMPLETED	2010-06-01	2007-02-01	ViiV Healthcare	4INDUSTRY	false	false	false	null	0	0	0	2	0.000532
[ 3 ]	51	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	true	This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.	null	Congenital Bleeding Disorder Haemophilia A Haemophilia B		null	6	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None	[ 0, 0, 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: 90 mcg/kg, injected i.v. intervention 2: 5 mcg/kg, injected i.v. intervention 3: 10 mcg/kg, injected i.v. intervention 4: 20 mcg/kg, injected i.v. intervention 5: 40 mcg/kg, injected i.v. intervention 6: 80 mcg/kg, injected i.v.	intervention 1: eptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: vatreptacog alfa (activated) intervention 6: vatreptacog alfa (activated)	45	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Boston \| Massachusetts...	96	3	0.03125	1	NCT00486278	1COMPLETED	2010-06-01	2007-06-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0	3	0	0	0.010684
[ 4 ]	481	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind period. The secondary objective is to assess, within the time frame of the...	null	Multiple Sclerosis	Clinically Definite Multiple Sclerosis Clinically Isolated Syndrome Multiple Sclerosis	null	2	arm 1: Glatiramer acetate 20 mg once daily by subcutaneous injection is administered in both the double-blind and open label periods. arm 2: Placebo matching glatiramer acetate once daily by subcutaneous injection during the double-blind period (DB). Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection du...	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS). intervention 2: Double blind period (DB): subcutaneous injection of placebo, once daily, for up to 36 months or until c...	intervention 1: Glatiramer Acetate (DB) intervention 2: Placebo intervention 3: Glatiramer Acetate (OL)	0	null	935	1	0.00107	1	NCT00666224	1COMPLETED	2010-06-01	2004-01-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	1	0	0.000189
[ 3 ]	526	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	Purpose of the study is to evaluate dose response relationship, efficacy, safety and tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment of migraine headache. Once subjects complete the baseline and meet the randomization criteria, they will complete a 5-wk flexible titration pe...	MPX111381 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, flexible-dose evaluation of GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day compared with placebo in the prophylactic treatment of migraine headache. Subjects 18 years of age must have experienced at least three ...	Migraine Disorders Migraine	migraine prophylaxis prevention	null	5	arm 1: PBO arm 2: 600 or 1200 mg/day arm 3: 600 or 1200 or 1800 mg/day arm 4: 600 or 1200 or 1800 or 2400 mg/day arm 5: 600 or 1200 or 1800 or 2400 or 3000 mg/day	[ 2, 1, 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day intervention 2: Placebo-control	intervention 1: GSK1838262 intervention 2: Placebo	59	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Redlands \| Califo...	523	1	0.001912	1	NCT00742209	1COMPLETED	2010-06-01	2008-08-01	XenoPort, Inc.	4INDUSTRY	false	false	false	null	1	0	0	0	0.000338
[ 4 ]	241	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventin...	null	Intercritical Gout	Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout	null	3	arm 1: Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept ...	[ 2, 1, 1 ]	3	[ 10, 0, 0 ]	intervention 1: Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks. intervention 2: Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks. intervention 3: Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.	intervention 1: Placebo intervention 2: Rilonacept 80 mg intervention 3: Rilonacept 160 mg	91	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Searcy \| Arkansas \| United States \| -91.73625 \| 35.25064 Concord \| California \| United States \| -122.03107 \| 37.97798 San Diego \| California \| Uni...	240	1	0.004167	1	NCT00829829	1COMPLETED	2010-06-01	2009-02-01	Regeneron Pharmaceuticals	4INDUSTRY	false	false	false	null	1	0	0	0	0.000736
[ 4 ]	720	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.	null	Acute Coronary Syndrome		null	6	arm 1: Loading dose 60 mg followed by maintenance dose 10 mg/day arm 2: Loading dose 30 mg followed by maintenance dose 7.5 mg/day arm 3: Loading dose 30 mg followed by maintenance dose 5 mg/day arm 4: Loading dose 300 mg followed by maintenance dose 75 mg/day arm 5: Loading dose 30 mg followed by maintenance dose 5 mg...	[ 0, 0, 0, 1, 0, 1 ]	2	[ 0, 0 ]	intervention 1: Oral, daily, 90 days intervention 2: Oral, daily, 90 days	intervention 1: Prasugrel intervention 2: Clopidogrel	19	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Nanjing \| N/A \| China \| 118.77778 \| 32.06167 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shenyang \| N/A \| China \| 123.43278 \| 41.79222 Wenzhou \| N/A \| China \| 120.66682 \| 27.99942 Xi'a...	692	2	0.00289	1	NCT00830960	1COMPLETED	2010-06-01	2009-02-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	2	0.000793
[ 4 ]	584	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infu...	null	Gastric Cancer		null	2	arm 1: Participants received an initial loading dose of 8 milligrams per kilogram (mg/kg) trastuzumab i.v. on Day 1 of cycle, followed by 6 mg/kg i.v. every 3 weeks until disease progression; 800 mg/m2 fluorouracil i.v. on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle e...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression intervention 2: 800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles intervention 3: 80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks f...	intervention 1: Trastuzumab intervention 2: Fluorouracil intervention 3: Cisplatin intervention 4: Capecitabine	142	Adelaide \| N/A \| Australia \| 138.59863 \| -34.92866 Kurralta Park \| N/A \| Australia \| 138.56702 \| -34.95142 Melbourne \| N/A \| Australia \| 144.96332 \| -37.814 Milton \| N/A \| Australia \| 153.00312 \| -27.47039 Perth \| N/A \| Australia \| 115.8614 \| -31.95224 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Leuven \| N/A \| Bel...	584	1	0.001712	1	NCT01041404	1COMPLETED	2010-06-01	2005-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	1	0.000302
[ 2, 3 ]	45	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Drugs such as amifostine may protect norma...	OBJECTIVES: * Determine the feasibility and tolerability of external beam radiotherapy, brachytherapy, and cisplatin in patients with para-aortic or high common iliac lymph node-positive carcinoma of the uterine cervix. * Determine the feasibility and tolerability of this regimen with the addition of amifostine in the...	Cervical Cancer Radiation Toxicity	radiation toxicity stage III cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma	null	2	arm 1: Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin. arm 2: Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy wi...	[ 0, 0 ]	4	[ 0, 0, 4, 4 ]	intervention 1: Amifostine will be delivered before each radiation treatment. Amifostine (500 mg) will be given as two equally-divided subcutaneous injections. intervention 2: Cisplatin will be given weekly with external beam radiation therapy and once with brachytherapy for a total of six doses. Patients receive 40 mg...	intervention 1: Amifostine trihydrate intervention 2: Cisplatin intervention 3: Intracavitary brachytherapy intervention 4: External beam radiation therapy	17	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville Beach \| Florida \| United States \| -81.39314 \| 30.29469 Jascksonville \| Florida \| United States \| N/A \| N/A Orange Park \| Florida \| United States \| -81.70648 \| 30.16607 Palatka \| Flori...	41	0	0	0	NCT00012012	1COMPLETED	2010-06-01	2001-08-01	Radiation Therapy Oncology Group	5NETWORK	false	false	false	null	0	0	0	0	0
[ 5 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will examine the effectiveness of pegylated interferon, or peginterferon (a long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1) infection with and without kidney disease.	Up to 105 patients with chronic hepatitis C will be enrolled in a study of the combination of pegylated alpha interferon and ribavirin for 48 weeks with the option of early discontinuation of therapy for patients who do not respond within 24 weeks of starting therapy. Adult patients will be chosen who have chronic hepa...	Chronic Hepatitis C	Chronic Hepatitis Cirrhosis Hepatitis C Virus Hemolysis Ribavirin Alpha Interferon Peginterferon Antiviral Agents Viral Hepatitis Hemolytic Anemia Renal Failure Renal Dialysis Hepatitis Hepatitis C	null	2	arm 1: Patients with chronic hepatitis C virus (HCV) infection genotype 1 peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients \<75 kg and 1200 mg daily for patients \>=75 kg) for 48 weeks arm 2: patients with chronic hepatitis C virus (HCV) infection genot...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Eligible patients were given peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients \<75 kg and 1200 mg daily for patients \>=75 kg) for 48 weeks intervention 2: Eligible patients were given peginterferon-alpha-2a, 180 ug subcutaneous once wee...	intervention 1: Peginterferon alfa-2a with Ribavirin intervention 2: Peginterferon alfa-2a	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	50	0	0	0	NCT00028093	1COMPLETED	2010-06-01	2001-12-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null	0	0	0	0	0
[ 3 ]	94	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks) with GM1 on disease progression, and to examine the extent to which GM1 treatment influences the underlying disease process in PD.	The study is designed to further examine the extent to which GM1 ganglioside can improve symptoms, delay disease progression, and, perhaps, partially restore damaged brain cells in PD patients. GM1 ganglioside is a chemical that is normally found in the brain and is a normal part of the outer covering or membrane of ne...	Parkinson Disease	Parkinson's disease PD GM1 Ganglioside Sygen	null	3	arm 1: Subjects were randomized to receive GM1 ganglioside for 24 weeks. arm 2: Subjects were randomized to receive placebo for 24 weeks. arm 3: A separate group of Parkinson's disease patients who received standard of care were followed for one to two years to provide comparative information about natural disease prog...	[ 1, 2, 4 ]	2	[ 0, 0 ]	intervention 1: 100 mg twice per day by subcutaneous injection intervention 2: Twice per day subcutaneous injection, equal volume as active drug	intervention 1: GM1 ganglioside intervention 2: Placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	94	0	0	0	NCT00037830	1COMPLETED	2010-06-01	1999-11-01	Thomas Jefferson University	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	171	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.	The study design for this clinical trial was chosen to evaluate adalimumab in subjects who were either methotrexate (MTX)-naive or had been withdrawn from MTX at least 2 weeks prior to study drug administration (non-MTX stratum) or were inadequate responders to MTX and continued MTX treatment (MTX stratum). The study c...	Arthritis, Juvenile Idiopathic	Polyarticular Juvenile Idiopathic Arthritis	null	8	arm 1: Subjects who were inadequate responders to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screenin...	[ 0, 2, 0, 2, 0, 0, 0, 0 ]	4	[ 2, 2, 0, 0 ]	intervention 1: Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg. intervention 2: Subcutaneous injection of 24 mg ada...	intervention 1: Double-Blind Adalimumab/Placebo + MTX intervention 2: Double-Blind Adalimumab/Placebo intervention 3: OLE BSA Adalimumab +/- MTX intervention 4: OLE FD Adalimumab +/- MTX	31	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Stanford \| California \| United States \| -122.16608 \| 37.42411 Delray Beach \| Florida \| United States \| -80.07282 \| 26.46146 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Chicago...	367	0	0	0	NCT00048542	1COMPLETED	2010-06-01	2002-09-01	Abbott	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	58	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure.	Sixty patients with chronic hepatitis C infected with HCV genotype 2 or 3 will be treated using the combination of either low- or standard dose peginterferon and ribavirin for 24 weeks, with re-treatment using the standard doses and a longer duration (48 weeks) for those who do not respond to or relapse after initial l...	Hepatitis C	Hepatitis C Virus Antiviral Agents Hemolysis Neutropenia Cirrhosis Hemolytic Anemia Viral Hepatitis Ribavirin Alfa Interferon Pegylated Interferon Hepatitis C HCV	null	2	arm 1: Patients receive a lower dose of peginterferon alfa-2a (90 mcg per week) and standard dose of ribavirin (800 mg/d) for chronic hepatitis C, genotype 2/3, for 24 weeks. arm 2: Patients receive the standard, recommended doses of peginterferon alfa-2a (180 mcg per week) and ribavirin (800 mg/d) for chronic hepatiti...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Peginterferon alfa-2a 90 mcg/week intervention 2: 180 mcg/week intervention 3: 800 mg/day	intervention 1: Peginterferon alfa-2a intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	57	0	0	0	NCT00056862	1COMPLETED	2010-06-01	2003-03-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null	0	0	0	0	0
[ 2 ]	115	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this...	null	HIV Infections		null	2	arm 1: TPV and RTV oral solution low dose arm 2: TPV and RTV oral solution high dose	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tipranavir oral solution intervention 2: Tipranavir oral solution intervention 3: Ritonavir oral solution intervention 4: Ritonavir oral solution	intervention 1: TPV oral solution intervention 2: TPV oral solution intervention 3: RTV oral solution intervention 4: RTV oral solution	30	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 North Worcester \| Massachusetts \| United States \| -71.81757 \| 42.31676...	115	0	0	0	NCT00076999	1COMPLETED	2010-06-01	2003-11-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	97	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin or Platinol, Adriamycin or doxorubicin, Cyc...	To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with D.T. PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of complete remission (CR)/near CR/ve...	Multiple Myeloma	Multiple Myeloma DTPACE Tandem Transplant Cisplatin Cyclophosphamide Dexamethasone Doxorubicin Etoposide Sargramostim Thalidomide Melphalan	null	2	arm 1: Autologous transplant with High Dose Melphalan alone arm 2: Melphalan plus Dexamethasone, Thalidomide, CisPlatinum, Adriamycin, Cyclophosphamide, and Etoposide	[ 1, 1 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 20mg/m2 continuous infusion days -3 and -2. intervention 2: 800 mg/m2 continuous infusion days -3 and -2. intervention 3: 20mg/m2 continuous infusion -3 and -2. intervention 4: 80mg/m2 continuous infusion -3 and -2. intervention 5: 200 mg/m2 IV over \<20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minute...	intervention 1: Cisplatin intervention 2: Cyclophosphamide intervention 3: Adriamycin intervention 4: Etoposide intervention 5: Melphalan intervention 6: Thalidomide intervention 7: Dexamethasone	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	97	0	0	0	NCT00083915	1COMPLETED	2010-06-01	2001-06-01	University of Arkansas	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	5	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	This study will determine whether uninterrupted treatment with birth control pills over several menstrual cycles prevents severe premenstrual syndrome (PMDD). Previous studies have shown that the hormones estrogen and progesterone regulate mood in women with MRMD. This study will use various treatment regimens with bi...	Results from previous protocols (#90-M-0088 and 92-M-0174) have demonstrated that women with menstrually-related mood disorder (MRMD), but not women lacking this disorder, experience mood deterioration within approximately one to two weeks after exposure to either estradiol or progesterone in the context of gonadal sup...	Premenstrual Syndrome PMS Premenstrual Dysphoric Disorder PMDD Depression	Depression Menstrual Cycle Gonadal Steroids Ethinyl Estradiol Drospirenone Menstrually Related Mood Disorder MRMD	null	3	arm 1: Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle. arm 2: Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm #...	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Drug administered dependent upon arm. intervention 2: None intervention 3: None	intervention 1: Ethinyl Estradiol/Drospirenone intervention 2: Placebo intervention 3: CDB 2914	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	5	0	0	0	NCT00089414	6TERMINATED	2010-06-01	2004-07-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0	0	0	0	0
[ 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells. PURPOSE: This phase I...	OBJECTIVES: Primary * Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas. Secondary * Determine preliminarily evidence of biologic activity of this regimen in these patients. * Determine the toxic effec...	Central Nervous System Tumor, Pediatric Neuroblastoma		null	1	arm 1: Thalidomide: Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated. Temozolomide: Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the b...	[ 0 ]	2	[ 0, 0 ]	intervention 1: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation. intervention 2: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Pati...	intervention 1: temozolomide intervention 2: thalidomide	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	15	0	0	0	NCT00098865	1COMPLETED	2010-06-01	2002-09-01	Dana-Farber Cancer Institute	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	19	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the ce...	PRIMARY OBJECTIVES: I. To determine the anti tumour activity of UCN-01 in combination with topotecan in patients with SCLC who relapsed or progressed \>= 3 months after completing first-line platinum-based chemotherapy (patient with sensitive disease) using objective response rates (complete and partial). SECONDARY O...	Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer		null	1	arm 1: Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Given IV intervention 2: Given IV	intervention 1: topotecan hydrochloride intervention 2: 7-hydroxystaurosporine	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	19	0	0	0	NCT00098956	1COMPLETED	2010-06-01	2005-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0
[ 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. D...	OBJECTIVES: * Determine the confirmed overall response rate (complete remission, remission, and partial remission) in patients with relapsed or refractory multiple myeloma treated with bortezomib, thalidomide, and dexamethasone. * Determine overall and progression-free survival of patients treated with this regimen. *...	Multiple Myeloma	stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma	null	1	arm 1: bortezomib with thalidomide and dexamethasone	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: induction: 1 mg/m2 IV push days 1, 4, 8, 11 every 21 days intervention 2: induction: 20 mg/d PO days 1, 2, 4, 5, 8, 9, 11, 12 every 21 days maintenance: 40 mg days 1-4 every 28 days until progression intervention 3: 100 mg/d PO days 1-21 every 21 days	intervention 1: bortezomib intervention 2: dexamethasone intervention 3: thalidomide	127	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Alton \| Illinois \| United States \| -90.18428 \| 38.8906 Mount Vernon \| Illinois \| United States \| -88.90312 \| 38.31727 Naperville \| Illinois \| United States \| -88.14729 \| 41.78586 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Beech Grove \| Ind...	7	0	0	0	NCT00124579	6TERMINATED	2010-06-01	2005-08-01	SWOG Cancer Research Network	5NETWORK	false	false	false	null	0	0	0	0	0
[ 4 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	true	The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.	This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse...	Leiomyoma	A benign tumor derived from smooth uterine muscle tissue.	null	2	arm 1: Mifepristone 5 MG capsule taken once daily by mouth arm 2: Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Mifepristone 5mg/day by mouth for 6 months intervention 2: sugar pill	intervention 1: Mifepristone intervention 2: Inert Capsule	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	42	0	0	0	NCT00133705	1COMPLETED	2010-06-01	2003-07-01	University of Rochester	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	170	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.	The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3 months after completing medications).	Alcoholism Cocaine Dependence	Topiramate alcoholism cocaine dependence	null	2	arm 1: topiramate capsules dose titrated up to 300 mg daily arm 2: placebo capsules identical in appearance to the topiramate capsules	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 300mg/day for 13 weeks intervention 2: placebo pills	intervention 1: Topiramate intervention 2: placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	170	0	0	0	NCT00167245	1COMPLETED	2010-06-01	2004-09-01	Kyle Kampman	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	437	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	null	30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease pro...	null	Non-Small-Cell Lung Cancer	Non-Small-Cell Lung Cancer Bisphosphonates Zoledronic acid Bone metastases Prevention of bone metastases	null	2	arm 1: Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment. arm 2: No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intrav...	[ 0, 5 ]	1	[ 0 ]	intervention 1: Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).	intervention 1: Zoledronic acid 4 mg	69	Jette \| N/A \| Belgium \| 4.33419 \| 50.87309 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Clamart \| N/A \| France \| 2.26692 \| 48.80299 Clémont \| N/...	437	0	0	0	NCT00172042	1COMPLETED	2010-06-01	2005-03-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3, 4 ]	135	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the safety and engraftment of donor hematopoietic cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming) cell transplant for an inherited metabolic storage disease.	Prior to transplantation, subjects will receive Busulfan intravenously (IV) via the Hickman line four times daily for 4 days, Cyclophosphamide intravenously via the Hickman line once a day for 4 days, and Anti-Thymocyte Globulin (ATG) intravenously (IV) via the Hickman line twice daily for three days before the transpl...	Adrenoleukodystrophy Metachromatic Leukodystrophy Globoid Cell Leukodystrophy Gaucher's Disease Fucosidosis Wolman Disease Niemann-Pick Disease Batten Disease GM1 Gangliosidosis Tay Sachs Disease Sandhoff Disease	Inborn errors Storage disease errors of metabolism stem cell transplant	null	1	arm 1: All patients treated with protocol regimen (chemotherapy and surgery).	[ 0 ]	2	[ 3, 0 ]	intervention 1: The purpose of hematopoietic cell transplantation is to introduce hematopoietic cells from a normal donor that contains an enzyme able to get rid of the substances that have accumulated in the body of patients with storage diseases. Hematopoietic cells can come from bone marrow, peripheral blood (i.e., ...	intervention 1: Stem Cell Transplant intervention 2: Busulfan, Cyclophosphamide, Antithymocyte Globulin	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	135	0	0	0	NCT00176904	1COMPLETED	2010-06-01	1995-01-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	28	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	true	The investigators will select 60 people who are 18-70 years of age with Crohn's disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigato...	Please refer to brief summary (above).	Crohn's Disease		null	2	arm 1: either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks arm 2: either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks. intervention 2: placebo PO BID for e...	intervention 1: Celebrex intervention 2: placebo	0	null	0	0	0	0	NCT00177866	6TERMINATED	2010-06-01	2003-12-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	205	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q\[31\] cytogenetic abnormality. Study participants were randomized to one of the two tr...	MDS-004 was a multicenter, randomized, double-blind, placebo-controlled, 3-arm study of 2 doses of lenalidomide versus placebo administered to RBC transfusion-dependent adults with low- or intermediate-1 risk MDS associated with a del 5q\[31\] cytogentetic abnormality. Potential participants that had a del 5q\[31\] cyt...	Myelodysplastic Syndromes	MDS transfusion dependent anaemia cytogenetic abnormality 5q- erythroid response leukaemia CC-5013 Celgene revlimid lenalidomide	null	3	arm 1: Placebo matching to active study arms. arm 2: Lenalidomide 5 mg daily 28/28 days arm 3: Lenalidomide 10 mg daily 21/28 days	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Lenalidomide 5 mg daily 28/28 days intervention 2: Lenalidomide 10 mg daily 21/28 days intervention 3: Placebo, matching to active study drug arms	intervention 1: Lenalidomide 5 mg intervention 2: Lenalidomide 10 mg intervention 3: Placebo	38	Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Yvoir \| N/A \| Belgium \| 4.88059 \| 50.3279 Marseille \| Cedex 9 \| France \| 5.38107 \| 43.29695 Angers \| N/A \| France \| -0.55202 \| 47.47156 Bobigny \| N/A \| France \| 2.45012 \| 48.90982 Lille \| N/A ...	261	0	0	0	NCT00179621	1COMPLETED	2010-06-01	2005-07-01	Celgene Corporation	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to determine the dose of Maca Root effective for the treatment of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive Disorder. We propose to carry out a dose-finding pilot study to determine the minimum effective dose of Maca Root. We hypothesize that...	The purpose of this study is to determine whether Maca Root is effective for the treatment of antidepressant-induced sexual dysfunction, and to further determine whether higher doses of Maca Root powder would be more effective than lower doses in reducing the symptoms of antidepressant-induced sexual dysfunction. An ad...	Depression Sexual Dysfunction	antidepressant-induced sexual dysfunction	null	2	arm 1: Patients receiving 1500mg of maca root arm 2: Patients receiving 3000mg of maca root	[ 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Maca Root	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	16	0	0	0	NCT00181961	1COMPLETED	2010-06-01	2007-12-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study. We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will assess the effect of olanzapine on Young M...	Development and marketing of new therapies for bipolar disorders (BD) has typically entailed performing double-blind placebo-controlled trials in acute mania maintenance studies and more recently acute depression studies. Such an approach addresses BD primarily in terms of episodes and has the strength of studying leve...	Bipolar Disorder		null	2	arm 1: Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week arm 2: Placebo was taken in the same manner as olanzapine with up to 8 per day for 1 week	[ 0, 2 ]	1	[ 0 ]	intervention 1: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.	intervention 1: Olanzapine/Zyprexa	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	45	0	0	0	NCT00186017	1COMPLETED	2010-06-01	2005-07-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus erlotinib following radical prostatectomy.	This study explores the anti-tumor activity of adjuvant bevacizumab plus erlotinib in a select group of prostate cancer patients deemed at high risk for early relapse following radical prostatectomy.	Prostate Cancer		null	1	arm 1: Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses	[ 0 ]	1	[ 0 ]	intervention 1: Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses	intervention 1: Erlotinib + Bevacizumab	16	Alhambra \| California \| United States \| -118.12701 \| 34.09529 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 N...	22	0	0	0	NCT00203424	1COMPLETED	2010-06-01	2006-01-01	Translational Oncology Research International	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will test whether the immune-suppressing drug rituximab can increase blood counts and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the immune system turns against bone marrow ...	This study will test whether the immune-suppressing drug rituximab can increase blood counts and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the immune system turns against bone marrow ...	Anemia, Aplastic Red-Cell Aplasia, Pure Anemia, Diamond-Blackfan	rituxan Immunosuppression Bone Marrow Failure Monoclonal Antibody Therapy Diamond Blackfan Anemia (DBA) T -Cells B-Cells Hematopoiesis Moderate Aplastic Anemia (MAA) Diamond-Blackfan Anemia DBA Pure Red Cell Aplasia PRCA	null	1	arm 1: This is a non-randomized, off label, pilot study of humanized anti CD20 rituximab (Rituxan®) in patients with moderate aplastic anemia, pure red cell aplasia or Diamond-Blackfan anemia who have either failed to respond to at least one prior course of immunosuppressive therapy (PRCA/DBA patients only)or who have ...	[ 0 ]	1	[ 0 ]	intervention 1: Rituximab (Rituxan) 375mg/m2 intravenous infusion. The infusion will be once every week for a total of 4 doses.	intervention 1: Rituximab	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	11	0	0	0	NCT00229619	1COMPLETED	2010-06-01	2005-09-01	National Heart, Lung, and Blood Institute (NHLBI)	0NIH	false	false	false	null	0	0	0	0	0
[ 0 ]	252	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	1FEMALE	true	The purpose of this study is to determine whether treatments targeted to the hormonal factors and the cyclicity of TMD symptoms associated with the menstrual cycle are more effective in relieving TMD pain and symptoms than standard self management treatment.	Temporomandibular disorders (TMD) are a group of painful conditions involving the muscles of mastication and the temporomandibular joint. These pain problems are about twice as common in women as in men in the community, and prevalence peaks during the reproductive years. The etiology of TMD pain is unknown, but psycho...	Temporomandibular Joint Disorders	Temporomandibular Disorders TMJ Disorders	null	3	arm 1: Dental hygienist-delivered pain self-management treatment arm 2: Dental hygienist-delivered pain self-management treatment with a focus on menstrual cycle-related changes in pain and other symptoms arm 3: Oral contraceptive (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months with no "s...	[ 1, 0, 0 ]	3	[ 5, 5, 0 ]	intervention 1: Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions...	intervention 1: Self Management intervention 2: Targeted Self Management intervention 3: 20 mcg ethinyl estradiol and 100 mcg levonorgestrel	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	140	0	0	0	NCT00237042	1COMPLETED	2010-06-01	2005-10-01	University of Washington	7OTHER	false	false	false	null	0	0	0	0	0
[ 3, 4 ]	16	NON_RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in pe...	Despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. It must be appreciated however, that orthostatic hypotension may occ...	Hypotension Spinal Cord Injury	Blood Pressure Cardiovascular Autonomic Control Nitric Oxide NOS Inhibitor Orthostatic Hypotension Spinal Cord Injury Tetraplegia	null	1	arm 1: Placebo control (normal saline) is employed on a separate visit during procedure.	[ 2 ]	2	[ 0, 3 ]	intervention 1: A non-specific inhibitor of the nitric oxide synthase enzyme. intervention 2: Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase...	intervention 1: N-Nitro L-arginine-methylester (L-NAME) intervention 2: Head-up Tilt maneuver	1	The Bronx \| New York \| United States \| -73.86641 \| 40.84985	34	0	0	0	NCT00237770	1COMPLETED	2010-06-01	2003-06-01	US Department of Veterans Affairs	1FED	false	false	false	null	0	0	0	0	0
[ 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is to determine the ob...	This is a Phase II, open label study for either chemotherapy-naïve patients with extensive SCLC or patients who are refractory or have relapsed to 1st line therapy for SCLC. The primary objective is to determine the objective response rate. This study consists of 2 parts: Part I - Chemotherapy-naïve patients with ext...	Non-Small Cell Lung Cancer		null	2	arm 1: Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks) arm 2: Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) area under the concentration curve (AUC) 6; Day 1 (every 5 weeks) Neulast...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks) intervention 2: Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 ...	intervention 1: Intervention A: Irinotecan; Oxaliplatin; Neulasta intervention 2: Intervention B: Etoposide; Carboplatin; Neulasta	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	104	0	0	0	NCT00240097	1COMPLETED	2010-06-01	2005-06-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	317	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a ...	null	Carcinoma, Renal Cell		null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Sunitinib malate starting dose 37.5 mg daily continuous daily regimen. intervention 2: Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated.	intervention 1: Sunitinib Malate Continuous Daily Dosing intervention 2: Sunitinib Malate Schedule 4/2	156	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Baldwin Park \| California \| United States \| -117.9609 \| 34.08529 Bellflower \| California \| United States \| -118.11701 \| 33.88168 Duarte \|...	314	0	0	0	NCT00267748	1COMPLETED	2010-06-01	2005-12-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	-0
[ 4 ]	56	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	null	The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.	Kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. Presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the United States. To further compound this problem, as many ...	Kidney Failure, Chronic	kidney transplantation positive crossmatch antibody mediated rejection rejection induction therapy trial	null	2	arm 1: Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6. arm 2: Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).	[ 0, 0 ]	8	[ 0, 0, 10, 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered intervention 4: 2 gm/day. Standard of care intervention 5: To achieve serum level of 8-10 ng/ml. intervention 6: 100 mg intra-operati...	intervention 1: Thymoglobulin intervention 2: Daclizumab intervention 3: Plasmapheresis intervention 4: Mycophenolate mofetil intervention 5: Tacrolimus intervention 6: Dexamethasone intervention 7: Prednisone intervention 8: Cytogam	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	56	0	0	0	NCT00275509	1COMPLETED	2010-06-01	2007-01-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	45	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, 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 tumor cells. PURPOSE: This phase II trial is studying ho...	OBJECTIVES: Primary * Determine the overall (complete and partial) response rate in patients with recurrent or progressive metastatic pancreatic cancer treated with capecitabine and docetaxel. Secondary * Determine the overall and progression-free survival of patients treated with the chemotherapy combination. * De...	Pancreatic Cancer	recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer	null	1	arm 1: Capecitabine + Docetaxel (Taxotere)	[ 0 ]	2	[ 0, 0 ]	intervention 1: Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle intervention 2: 30 mg/m2, IV, days 1 and 8 every 3 weeks	intervention 1: Capecitabine intervention 2: Docetaxel	3	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami Beach \| Florida \| United States \| -80.13005 \| 25.79065	43	0	0	0	NCT00290693	1COMPLETED	2010-06-01	2004-07-01	University of Miami	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation.	Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary i...	End Stage Renal Disease	etanercept malnutrition inflammation hemodialysis	null	2	arm 1: Etanercept 25 mg injection twice a week arm 2: Saline injection twice a week	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week intervention 2: Hemodialysis patients will receive Saline by subcutaneous injection twice a week	intervention 1: Etanercept intervention 2: Placebo	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	10	0	0	0	NCT00293202	6TERMINATED	2010-06-01	2005-01-01	Kaysen, George A., M.D., Ph.D.	7OTHER	false	true	false	null	0	0	0	0	0
[ 4 ]	8,882	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.	null	Myocardial Infarction (MI) Acute Coronary Syndromes (ACS)	Acute Coronary Syndrome (ACS) Percutaneous Coronary Intervention (PCI) non-ST-segment elevation myocardial infarction (NSTEMI) ST-segment elevation myocardial infarction (STEMI)	null	2	arm 1: placebo capsules (to match) + cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion arm ...	[ 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: IV bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever i...	intervention 1: Cangrelor (P2Y12 inhibitor) intervention 2: clopidogrel (oral P2Y12 inhibitor) intervention 3: Placebo bolus & placebo infusion intervention 4: Placebo capsules - end of infusion intervention 5: Placebo capsules - as soon as possible after randomization	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	8,739	0	0	0	NCT00305162	6TERMINATED	2010-06-01	2006-04-01	The Medicines Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	32	NON_RANDOMIZED	SEQUENTIAL	0TREATMENT	0NONE	false	2MALE	null	RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This clinical trial is studying the best dose of sirolimus and to see how well it works before surgery in treating patients with ad...	OBJECTIVES: Primary * Determine the pharmacodynamically optimal dose (POD) of continuous daily oral sirolimus (rapamycin) in patients with advanced localized prostate cancer when given prior to radical prostatectomy, as measured by tumor S6 kinase inhibition by immunohistochemistry (IHC). * Determine the proportion o...	Prostate Cancer	stage III prostate cancer stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer adenocarcinoma of the prostate	null	3	arm 1: Men \>18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy. Receive no intervention on Days 1-14. Surgery performed on Day 15. ...	[ 1, 0, 0 ]	3	[ 0, 0, 3 ]	intervention 1: Rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15). intervention 2: Rapamycin 6mg (Wyeth Pharmaceuticals, 2mg tablets) PO once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15). in...	intervention 1: Rapamycin 3mg intervention 2: Rapamycin 6mg intervention 3: Radical prostatectomy	3	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	32	0	0	0	NCT00311623	1COMPLETED	2010-06-01	2006-08-01	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	7	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevaci...	Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevaciz...	Colorectal Neoplasms	NSABP bevacizumab capecitabine oxaliplatin irinotecan rectal cancer colon cancer colorectal cancer	null	2	arm 1: None arm 2: None	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 7.5 mg/kg IV Day 1 every 21 days for eight cycles\* \*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression. intervention 2: 130 mg/m2 IV Day 1 every 21 days for eight cycles intervention 3: 850 mg/m2 po BID Days 1-14 every...	intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Capecitabine intervention 4: Irinotecan	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	0	0	0	0	NCT00314353	6TERMINATED	2010-06-01	2006-03-01	NSABP Foundation Inc	5NETWORK	false	false	false	null	0	0	0	0	0
[ 3 ]	58	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.	MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been show...	Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms	Ovarian Cancer Primary Fallopian Tube Cancer Peritoneal Cancer	null	2	arm 1: Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2). arm 2: Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Weekly Farletuzumab infusions Dose dependent on dosing group intervention 2: Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.	intervention 1: Farletuzumab intervention 2: Chemo Plus Far	20	San Diego \| California \| United States \| -117.16472 \| 32.71571 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Covington \| Louisiana \| United States \| -90.10042 \| 30.47549 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Metarie \| Louisiana \| United States \| N/A \| N/A Baltimore \| Maryland \| Uni...	54	0	0	0	NCT00318370	1COMPLETED	2010-06-01	2006-05-01	Morphotek	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuximab on disease progression. Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United States (Jem...	OBJECTIVES Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuximab on disease progression. Secondary Objectives: 1. To assess the frequency and severity of toxicities associated with...	Head and Neck Cancer	Head cancer Neck cancer cetuximab abraxane erbitux IMC-225 NSC-714692	null	1	arm 1: Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 260 mg/m2 IV over 30 minutes every 3 weeks intervention 2: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles	intervention 1: Abraxane intervention 2: Cetuximab	1	Orange \| California \| United States \| -117.85311 \| 33.78779	7	0	0	0	NCT00319839	6TERMINATED	2010-06-01	2006-03-01	University of California, Irvine	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.	Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983. Lymph node diss...	Malignant Melanoma Carcinoma, Squamous Cell	Groin dissection Axilla (or axillary) dissection Lymph node dissection Lymphadenectomy Seroma Wound drainage Fibrin sealant Malignant melanoma Squamous cell carcinoma	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 1, 0, 1 ]	1	[ 0 ]	intervention 1: For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK. For patients in the Active Comparator...	intervention 1: Fibrin Sealant (Tisseel) used in the Experimental Arm.	0	null	74	0	0	0	NCT00324272	1COMPLETED	2010-06-01	2003-01-01	Oxford University Hospitals NHS Trust	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patien...	The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that gabapentin can be effective to reduce sensitization and postoperative pain. Pregabalin (S-aminomethyl-...	Intervertebral Disk Displacement Disk Prolapse	Intervertebral disk displacement disk prolapse pregabalin	null	2	arm 1: 150 mg Pregabalin per orally about one hour before surgery arm 2: One capsule of saccharose (placebo) was administered orally about one hour before surgery.	[ 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: capsule 150 mg x 1 per orally one hour before surgery intervention 2: One capsule of saccharose (placebo) was administered about one hour before surgery intervention 3: All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registere...	intervention 1: pregabalin intervention 2: Placebo intervention 3: morphine	1	Rud \| N/A \| Norway \| 11.63333 \| 60.43333	46	0	0	0	NCT00353704	1COMPLETED	2010-06-01	2005-11-01	Asker & Baerum Hospital	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	56	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Oth...	PRIMARY OBJECTIVES: I. Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride. SECONDARY OBJECTIVES: I. Evaluate time to progression in these patients. II. Evaluate overall and progression-free survival of these patien...	Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Gastrointestinal Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer		null	1	arm 1: Patients receive 5 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15 and 150 mg oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies...	[ 0 ]	2	[ 0, 2 ]	intervention 1: Given orally, 150 mg, once daily. intervention 2: Given IV, 5mg/kg on days 1 and 15 every cycle	intervention 1: erlotinib hydrochloride intervention 2: bevacizumab	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	55	0	0	0	NCT00356889	1COMPLETED	2010-06-01	2006-05-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0
[ 4 ]	983	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife with an ever growing economic toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved anti-microbial treatment for decay is available to the Ame...	The Prevention of Adult Caries Study (PACS) is a randomized, double-blind, placebo-controlled Phase III clinical trial conducted under F.D.A. Investigational New Drug license #45,466, with a target enrollment of 1000 at four clinical centers with vastly different populations. The centers participating in this proposed ...	Caries, Dental		null	2	arm 1: Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition arm 2: 10% w/v chlorhexidine acetate coating FDA IND #45466. Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally...	[ 2, 1 ]	2	[ 0, 10 ]	intervention 1: Dental coating topically applied by dental professional supragingivally to the full dentition intervention 2: None	intervention 1: 10% w/v chlorhexidine acetate coating FDA IND #45466 intervention 2: Placebo	4	Tuba City \| Arizona \| United States \| -111.23986 \| 36.13499 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	983	0	0	0	NCT00357877	1COMPLETED	2010-06-01	2006-07-01	Tufts University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with advanced liver cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill...	PRIMARY OBJECTIVES: I. Evaluate the objective response rate in patients with advanced hepatocellular carcinoma treated with bevacizumab and erlotinib. SECONDARY OBJECTIVES: I. Evaluate the time to progression in patients treated with this regimen. II. Evaluate the overall and progression-free survival of patients tr...	Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer		null	1	arm 1: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein level...	[ 0 ]	2	[ 2, 0 ]	intervention 1: Given IV, 10 mg/kg, days 1 and 15 in every cycle intervention 2: Given orally, 150 mg, every day during each cycle.	intervention 1: bevacizumab intervention 2: erlotinib hydrochloride	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	27	0	0	0	NCT00365391	1COMPLETED	2010-06-01	2006-08-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0
[ 4 ]	148	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	true	RATIONALE: Methylphenidate may help relieve fatigue caused by cancer. It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer. PURPOSE: This randomized phase III trial is studying methylphenidate to see how well it works in...	OBJECTIVES: Primary * Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory. Secondary * Evaluate the tolerability and adverse events associated with this drug in these patients. * Study the effect of this drug on quality of...	Fatigue Unspecified Adult Solid Tumor, Protocol Specific	fatigue unspecified adult solid tumor, protocol specific	null	2	arm 1: Patients receive oral methylphenidate hydrochloride daily on days 1-28. arm 2: Patients receive oral placebo daily on days 1-28.	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Given orally	intervention 1: methylphenidate hydrochloride intervention 2: placebo	238	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 \| United States \| -104.9847 \| 39.73915 Denver \| Colorado...	137	0	0	0	NCT00376675	1COMPLETED	2010-06-01	2008-02-01	Alliance for Clinical Trials in Oncology	7OTHER	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first phase of the study will be two 6 weeks pe...	Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urin...	Cystinuria Nephrolithiasis, Calcium Oxalate	Cystone Uricare Computerized tomography Kidney calculi Supersaturation Nephrolithiasis Quantitative CT	null	3	arm 1: Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks arm 2: Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks arm 3: All subjects will receive Cystone for 46 weeks in the open-label peri...	[ 1, 2, 0 ]	2	[ 0, 0 ]	intervention 1: Participants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 m...	intervention 1: Cystone intervention 2: Sugar Pill (Placebo)	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	20	0	0	0	NCT00381849	1COMPLETED	2010-06-01	2006-04-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.	null	Esophageal Neoplasms		null	1	arm 1: * Pemetrexed 500 mg/m\^2 IV over 10 minutes * Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle * Each cycle will last 21 days.	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Pemetrexed intervention 2: Carboplatin	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	9	0	0	0	NCT00383266	6TERMINATED	2010-06-01	2006-10-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	5,364	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revasculari...	null	Atherosclerosis Acute Coronary Syndrome (ACS)	Percutaneous Coronary Intervention (PCI) ACS	null	2	arm 1: cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) imme...	[ 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: cangrelor bolus (30 mcg/kg) \& cangrelor infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) intervention 2: clopidogrel capsules (600 mg) at end of PC...	intervention 1: Cangrelor intervention 2: clopidogrel intervention 3: Placebo bolus & placebo infusion intervention 4: Placebo capsules - end of PCI intervention 5: Placebo capsules - end of infusion	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	5,312	0	0	0	NCT00385138	6TERMINATED	2010-06-01	2006-09-01	The Medicines Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	211	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.	null	Non-Small Cell Lung Cancer		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment intervention 2: 75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment	intervention 1: pemetrexed intervention 2: docetaxel	7	Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Nanjing \| N/A \| China \| 118.77778 \| 32.06167 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Tianjin \| N/A \| China \| 117.17667 \| 39.14222 Wuhan \| N/A \| China \| 114.26667 \| 30.58333	208	0	0	0	NCT00391274	1COMPLETED	2010-06-01	2006-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	46	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).	Autosomal Dominant Polycystic Kidney Disease is a genetic disease classified by the formation of fluid-filled cysts in the kidneys. The accumulation of these cysts causes the kidneys to enlarge several times the normal size and leads to the eventual loss of renal function and ultimately results in renal failure in end-...	Polycystic Kidney, Autosomal Dominant		null	2	arm 1: Participants received tolvaptan 45 mg orally in the morning and 15 mg orally 8 hours later for up to 4 years. arm 2: Participants received tolvaptan 60 mg orally in the morning and 30 mg orally 8 hours later for up to 4 years.	[ 0, 0 ]	1	[ 0 ]	intervention 1: Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additiona...	intervention 1: Tolvaptan	11	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Minneapolis \| Minnesota \| ...	46	0	0	0	NCT00413777	1COMPLETED	2010-06-01	2005-12-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	3	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile of MabThera after treatment and retreat...	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 po weekly	intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate	1	Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403	0	0	0	0	NCT00422942	6TERMINATED	2010-06-01	2006-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to trea...	Haploidentical hematopoietic stem cell transplant is a life-saving therapy for patients who are without well matched donors. This type of therapy has been associated with poor outcomes in the past due to complications such as infection. The Jefferson 2 Step approach was designed to allow the infusion of an exact dose o...	Hematologic Malignancies	Hematologic Malignancies Two Step Approach Haploidentical Transplant	null	1	arm 1: Patients undergoing hematopoietic stem cell transplant from a partially matched related donor	[ 0 ]	6	[ 4, 2, 0, 0, 0, 2 ]	intervention 1: TBI twice daily days 6-9 prior to transplant (HSCT) intervention 2: DLI given 6 days prior to transplant (HSCT). intervention 3: Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT). intervention 4: Tacrolimus given one day prior to transplant (HSCT). intervention 5: ...	intervention 1: Total Body Irradiation (TBI) intervention 2: Donor Lymphocyte Infusion (DLI) intervention 3: Cyclophosphamide (CY) intervention 4: Tacrolimus intervention 5: Mycophenolate Mofetil (MMF) intervention 6: Hematopoietic Stem Cell Transplant (HSCT)	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	27	0	0	0	NCT00429143	1COMPLETED	2010-06-01	2006-01-01	Sidney Kimmel Cancer Center at Thomas Jefferson University	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	32	RANDOMIZED	PARALLEL	null	0NONE	false	0ALL	false	Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears difficult to handle because of its high diffusion capacity outside the CVM and in the blood circulation. A less diffusible ethanol-based produc...	null	Congenital Venous Malformation		null	2	arm 1: Ethanol gel arm 2: Ethanol solution	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Ethanol 96% Gel intervention 2: Ethanol 98% Solution	2	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Tours \| N/A \| France \| 0.70398 \| 47.39484	31	0	0	0	NCT00462462	1COMPLETED	2010-06-01	2007-05-01	Orfagen	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	108	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	true	The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.	null	Prostate Cancer		null	3	arm 1: Regimen A: docetaxel 75 milligrams per square meter (mg/m\^2), intravenous (IV) is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 milligrams (mg) oral (po), twice daily (BID) every day. In Cycle 1, enzastaurin is given as a loading dose of 1125 mg on the day prior to ...	[ 0, 2, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years intervention 2: Loading dose, then po QD until unblinding intervention 3: 75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles intervention 4: 5 mg po BID, six 21-day cycles	intervention 1: enzastaurin intervention 2: placebo intervention 3: docetaxel intervention 4: prednisone	28	Fullerton \| California \| United States \| -117.92534 \| 33.87029 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Northridge \| California \| United States \| -118.53675 \| 34.22834 Redondo Beach \| California \| United States \| -118.38841 \| 33.84918 Santa Barbara \| California \| United States \| -119.69819 \| 34....	102	0	0	0	NCT00466440	1COMPLETED	2010-06-01	2007-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	7	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in compulsive sexual behavior. Twenty subjects with DSM-IV compulsive sexual behavior will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to act out sexua...	The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with compulsive sexual behavior.	Compulsive Sexual Behavior	Impulse Control Disorder Compulsive Sexual Behavior	null	2	arm 1: Naltrexone 50mg-150mg by mouth per day. arm 2: Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: daily intervention 2: daily	intervention 1: Naltrexone intervention 2: Sugar pill	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	7	0	0	0	NCT00467558	1COMPLETED	2010-06-01	2007-05-01	University of Minnesota	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	83	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.	null	Breast Neoplasms	Metastatic Breast Cancer	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: sunitinib (Sutent), 37.5 mg, daily dosing	intervention 1: sunitinib	31	Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Burbank \| California \| United States \| -118.30897 \| 34.18084 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Hawthorne \| California \| United States \| -118.35257 \| 33.9164 Long Beach \| California \| United States \| -118.18923 \| 33.76696...	83	0	0	0	NCT00471276	1COMPLETED	2010-06-01	2007-08-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	72	RANDOMIZED	PARALLEL	9OTHER	0NONE	false	0ALL	false	The purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (HSV) who have multiple sex partners. Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.	We plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes recurrences. We will enroll 500 HSV-2 seropositive single persons (250 per arm), stratified by gender and history of symptomatic genital ...	Genital Herpes		null	2	arm 1: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence arm 2: 400 mg acyclovir orally twice daily for 1 year	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence intervention 2: 400 mg acyclovir orally twice daily for 1 year	intervention 1: acyclovir intervention 2: acyclovir	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	72	0	0	0	NCT00495716	6TERMINATED	2010-06-01	2008-01-01	University of Washington	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of the study is to determine the efficacy of methylphenidate over placebo in treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD). Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly mo...	Objective: Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD). Based on promising preliminary data from our open-label pilot study we propose a double blind, placebo-controlled randomized clinical trial of methylphenidate for treatment of apathy in AD. Research Design:...	Alzheimer's Disease Apathy Dementia	Alzheimer's Disease Apathy Dementia Methylphenidate	null	2	arm 1: Methylphenidate arm 2: Placebo	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Subject will receive 5mg twice a day for two weeks then 10mg twice a day until week 12 of the study. intervention 2: Standard inactive pill.	intervention 1: Methylphenidate intervention 2: Placebo	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	60	0	0	0	NCT00495820	1COMPLETED	2010-06-01	2007-08-01	VA Office of Research and Development	1FED	false	false	false	null	0	0	0	0	0
[ 5 ]	282	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication un...	null	Candidiasis	candidemia invasive candidiasis fungal bloodstream infection	null	1	arm 1: Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if...	intervention 1: Eraxis (anidulafungin) intervention 2: Diflucan (fluconazole) intervention 3: Vfend (voriconazole)	43	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 San Fr...	282	0	0	0	NCT00496197	1COMPLETED	2010-06-01	2007-07-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	42	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxali...	OBJECTIVES: Primary * To evaluate the clinical response rate in patients with locally advanced squamous cell carcinoma of the head and neck treated with neoadjuvant pemetrexed disodium and oxaliplatin. Secondary * To evaluate the pathological complete response in patients who undergo surgical resection or post-indu...	Head and Neck Cancer	stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma...	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: Group I: Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery. Group II: Patients receive t...	intervention 1: oxaliplatin intervention 2: pemetrexed disodium	7	Owensboro \| Kentucky \| United States \| -87.11333 \| 37.77422 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee...	42	0	0	0	NCT00503997	1COMPLETED	2010-06-01	2006-12-01	Vanderbilt-Ingram Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	52	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML. We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotox...	The interaction of leukemic blasts with the bone marrow microenvironment is postulated to be an important mediator of chemoresistance in AML. Although a number of receptor / ligand pairs have been implicated, the CXCR4 / SDF-1 axis functions as the principal regulator of homing and retention of both normal and malignan...	Leukemia, Myeloid, Acute	Plerixafor CXCR4 Chemosensitization	null	2	arm 1: * AMD3100 SQ on days 0-5 * Mitoxantrone on days 1-5 * Etoposide on days 1-5 * Cytarabine on days 1-5 Dose Level 1 AMD3100 dose = 80 mcg/kg/d Dose Level 2 AMD3100 dose = 160 mcg/kg/d arm 2: * AMD 3100 SQ on days 0-5 * Mitoxantrone on days 1-5 * Etoposide on days 1-5 * Cytarabine on days 1-5 Dose Level 3 AMD310...	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: AMD3100 intervention 2: Mitoxantrone intervention 3: Etoposide intervention 4: Cytarabine	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	52	0	0	0	NCT00512252	1COMPLETED	2010-06-01	2007-07-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	432	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in p...	null	Pulmonary Fibrosis		null	5	arm 1: low dose BIBF1120 once daily arm 2: low dose BIBF 1120 twice daily arm 3: intermediate dose BIBF 1120 twice daily arm 4: high dose BIBF 1120 twice daily arm 5: placebo	[ 0, 0, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: low dose BIBF1120 once daily intervention 2: low dose BIBF 1120 twice daily intervention 3: intermediate dose BIBF 1120 twice daily intervention 4: high dose BIBF 1120 twice daily intervention 5: placebo	intervention 1: low dose BIBF1120 once daily intervention 2: low dose BIBF 1120 twice daily intervention 3: intermediate dose BIBF 1120 twice daily intervention 4: high dose BIBF 1120 twice daily intervention 5: placebo	92	Mendoza \| N/A \| Argentina \| -68.84582 \| -32.88946 South Brisbane \| Queensland \| Australia \| 153.02049 \| -27.48034 Toorak Gardens \| South Australia \| Australia \| 138.63639 \| -34.93478 Woodville \| South Australia \| Australia \| 138.54291 \| -34.877 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Brussels \| N/A...	428	0	0	0	NCT00514683	1COMPLETED	2010-06-01	2007-08-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 1 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiati...	Five subjects diagnosed with wet macular degeneration will be treated with standard of care, i.e. intravitreal Lucentis injection monthly for the first four months and as needed thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated with 24 Gy of proton beam divided into two fraction...	Age-related Macular Degeneration	Age-related macular degeneration Exudative age-related macular degeneration Wet macular degeneration Intravitreal injection Proton beam irradiation Lucentis Ranibizumab	null	1	arm 1: Intervention is 24Gy proton radiation in 2 fractions given within 6 weeks of first dose of intravitreal ranibizumab (0.5mg) drug combined with four monthly doses of intravitreal lucentis and monthly prn lucentis thereafter.	[ 0 ]	1	[ 0 ]	intervention 1: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.	intervention 1: Proton beam irradiation and ranibizumab	0	null	6	0	0	0	NCT00517010	1COMPLETED	2010-06-01	2007-05-01	University of California, Davis	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	250	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	1FEMALE	null	The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).	null	Osteoporosis	osteoporosis low bone mineral density alendronate denosumab adherence preference satisfaction postmenopausal women	null	2	arm 1: When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC fo...	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1. intervention 2...	intervention 1: alendronate intervention 2: denosumab	0	null	459	0	0	0	NCT00518531	1COMPLETED	2010-06-01	2007-09-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 3 ]	32	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition. * To assess how well treatment with pemetrexed works for patients with your type of cancer * To assess for any side effects that might be associated with peme...	null	Osteosarcoma		null	1	arm 1: Participants received pemetrexed 500 milligrams per square meter (mg/m\^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle.	[ 0 ]	1	[ 0 ]	intervention 1: 500 mg/m\^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.	intervention 1: Pemetrexed	13	Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Villejuif \| N/A \| France \| 2.35992 \| 48.7939 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Munich \| N/A \| Germany \| 11.57549 \| 48.13743 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Milan ...	32	0	0	0	NCT00523419	1COMPLETED	2010-06-01	2007-09-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 5 ]	519	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.	null	Pulmonary Disease, Chronic Obstructive Exercise		null	2	arm 1: Oral inhalation once daily of 18mcg tiotropium via handihaler arm 2: Oral inhalation once daily of placebo matching tiotropium via handihaler	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral inhalation once daily of 18mcg tiotropium via handihaler intervention 2: Oral inhalation of once-daily placebo matching tiotropium via handihaler	intervention 1: tiotropium 18 mcg intervention 2: Placebo	62	Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Fort Collins \| Colorado \| United States \| -105.08442 \| 40.58526 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Waterbury \| Con...	877	0	0	0	NCT00525512	1COMPLETED	2010-06-01	2007-08-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	7	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	true	This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis bet...	To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.	Venous Thrombosis	Randomized Clinical Trials Randomized Controlled Trial Venous thrombosis Anticoagulant Drugs Doppler Ultrasound Postoperative complications	null	2	arm 1: All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation o...	[ 1, 0 ]	2	[ 0, 1 ]	intervention 1: Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22. intervention 2: All patients will receive intermittent compression devices (ICD's) during the patient's entire...	intervention 1: Arixtra (fondaparinux sodium) intervention 2: Intermittent compression devices (ICD)	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	7	0	0	0	NCT00539942	6TERMINATED	2010-06-01	2007-04-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0	0	0	0	0
[ 0 ]	5	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine if use of Nortriptyline will improve symptoms and quality of life in patients who have nonulcer dyspepsia.	Nonulcer dyspepsia is a common complaint in clinical practice and its management should be based on the best evidence. Many clinical trials of nonulcer dyspepsia suffer from important weaknesses in trial design. This makes it difficult to determine whether truly efficacious therapies exist for this disorder. Once a di...	Non Ulcer Dyspepsia	Nonulcer dyspepsia Functional dyspepsia Antidepressant use in dyspepsia Nortriptyline Tricyclic antidepressants	null	2	arm 1: Patients in this group will receive Nortriptyline 25mg at night for 8 weeks. arm 2: Patients in this group will receive an identical placebo capsule at night for 8 weeks.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Nortriptyline 25mg capsule, orally administered, every night for 8 weeks intervention 2: An identical placebo capsule containing lactose, administered orally, every night for 8 weeks	intervention 1: Nortriptyline intervention 2: Placebo	1	Weston \| Florida \| United States \| -80.39977 \| 26.10037	4	0	0	0	NCT00547703	6TERMINATED	2010-06-01	2008-02-01	The Cleveland Clinic	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Inhibition of histone deacetylase (HDAC) provides a novel approach for cancer treatment. LBH589, an oral HDAC inhibitor, has been well tolerated in phase I trials and has shown activity against several types of cancer. In this nonrandomized phase II trial, we are investigating the activity of LBH589 in the treatment of...	Inhibition of histone deacetylase (HDAC) provides a potential target for cancer treatment. Histones are components of the core proteins of nucleosomes, and acetylation and deacetylation of these proteins play a role in the regulation of gene expression. HDAC activity is known to be increased in many types of malignant ...	Renal Cell Carcinoma	Renal Cell Carcinoma Refractory LBH589	null	1	arm 1: LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycl...	[ 5 ]	1	[ 0 ]	intervention 1: LBHLBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring (Section 3.5.2), all patients must begin treatment on a Monday, and continue Monday/Thursday dosing duri...	intervention 1: LBH589	10	Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Morristown \| New Jers...	20	0	0	0	NCT00550277	1COMPLETED	2010-06-01	2008-01-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0	0
[ 5 ]	56	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study t...	Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder. Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in...	Bipolar Disorder Alcohol Abuse	Adolescents	null	2	arm 1: Quetiapine and Placebo arm 2: Quetiapine and Topiramate	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1 Dosing Schedule and Titration of Topiramate: All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manne...	intervention 1: quetiapine and placebo intervention 2: Quetiapine and Topiramate	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	39	0	0	0	NCT00550394	1COMPLETED	2010-06-01	2008-04-01	University of Cincinnati	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	240	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) follo...	The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The prevalence of complex regional pain syndrome (CRPS) follo...	CRPS		null	2	arm 1: Half of the patients will receive PO placebo for 14 days arm 2: PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stop...	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped. intervention 2: Placebo for Given 2 hours prior to...	intervention 1: pregabalin intervention 2: Placebo	0	null	240	0	0	0	NCT00558753	1COMPLETED	2010-06-01	2006-04-01	Rush University Medical Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	184	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The i...	null	Anemia		null	1	arm 1: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the s...	[ 0 ]	1	[ 0 ]	intervention 1: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants...	intervention 1: Methoxy polyethylene glycol-epoetin beta	50	Ansbach \| N/A \| Germany \| 10.5931 \| 49.30481 Arnsberg \| N/A \| Germany \| 8.08333 \| 51.38333 Bad Aibling \| N/A \| Germany \| 12.01055 \| 47.8638 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bischofswerda \| N/A \| Germany \| 14.17974 \| 51.12771 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Cologne \| N/A \| Germany \| 6.95 \| 50.93333...	184	0	0	0	NCT00559637	1COMPLETED	2010-06-01	2008-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2 ]	28	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.	null	Metastatic Colorectal Cancer	colorectal cancer chemotherapy cancer metastatic irinotecan EGFr epidermal growth factor	null	1	arm 1: Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.	[ 0 ]	2	[ 0, 0 ]	intervention 1: The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter. intervention 2: The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as p...	intervention 1: Panitumumab intervention 2: Irinotecan	12	Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 P...	27	0	0	0	NCT00563316	1COMPLETED	2010-06-01	2008-03-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	27	RANDOMIZED	FACTORIAL	7BASIC_SCIENCE	2DOUBLE	false	0ALL	true	Whereas the smoking prevalence rates in the general population are declining, rates among people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be elevated. Smoking may be a form of self-medication in people with ADHD, which has specific reinforcing mechanisms such as improvement of ADHD cor...	null	ADHD	Smoking ADHD Stimulant medication	null	1	arm 1: For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication (e.g., Dextroamphetamine; Amphetamine mixed salts; Atomoxetine; O-Methylphenidate; Lisdexamfetamine). For the placebo condition, a placebo pill was administered.	[ 0 ]	2	[ 0, 0 ]	intervention 1: For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days. intervention 2: For the placebo condition, participants received placebo pills for two consecutive days.	intervention 1: ADHD medication intervention 2: Placebo	1	Irvine \| California \| United States \| -117.82311 \| 33.66946	27	0	0	0	NCT00573859	1COMPLETED	2010-06-01	2006-09-01	University of California, Irvine	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	200	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of...	null	Anemia		null	1	arm 1: Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administer...	[ 0 ]	1	[ 0 ]	intervention 1: 120, 200 or 360 micrograms iv monthly (starting dose)	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]	18	Kemerovo \| N/A \| Russia \| 86.08333 \| 55.33333 Krasnodar \| N/A \| Russia \| 38.97603 \| 45.04484 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow ...	200	0	0	0	NCT00576303	1COMPLETED	2010-06-01	2008-04-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 4 ]	391	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).	null	Parkinson Disease		null	2	arm 1: Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily arm 2: Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Pramipexole ER 0.375 -4.5 mg intervention 2: Placebo tablets identical to Pramipexole ER tablets	intervention 1: Pramipexole intervention 2: Placebo	70	Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Pardubice \| N/A \| Czechia \| 15.77659 \| 50.04075 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Rakovník \| N/A \| Czechia \| 13.7334 \| 50.1037 Rychnov nad Kněžnou \| N/A \| Czechia \| 16.27488 \| 50.16284 Valašské Meziříčí \| N/A \| Czechia \| 17.97113 \| 49.47181 Győr \| N/A \| Hungary \| 17...	782	0	0	0	NCT00577460	1COMPLETED	2010-06-01	2007-12-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 0 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences...	The need for this trial arises out of 1) the rapidly increasing number of pts \> 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without...	Atrial Fibrillation Arrhythmia	Atrial fibrillation Left Atrial Ablation Pulmonary Vein Isolation Catheter Ablation Antiarrhythmic Drug Therapy	null	2	arm 1: Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting ...	[ 1, 1 ]	15	[ 0, 1, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Metoprolol 50-100mg intervention 2: None intervention 3: Atenolol 50-100mg, intervention 4: Propranolol 40-80mg intervention 5: Acebutolol 200mg intervention 6: Carvedilol 6.25mg intervention 7: Diltiazem 180-240mg intervention 8: Verapamil 180-240mg intervention 9: Digoxin 0.125mg intervention 10: Prop...	intervention 1: Rate Control intervention 2: Ablation Therapy intervention 3: Rate Control intervention 4: Rate control intervention 5: Rate control intervention 6: Rate control intervention 7: Rate Control intervention 8: Rate Control intervention 9: Rate Control intervention 10: Rhythm Control intervention 11: Rhythm...	10	Birminham \| Alabama \| United States \| N/A \| N/A Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United S...	60	0	0	0	NCT00578617	1COMPLETED	2010-06-01	2006-09-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0
[ 0 ]	90	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods...	Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (com...	Head and Neck Cancer	Head and Neck cancer	null	1	arm 1: Chemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a...	[ 0 ]	5	[ 4, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None	intervention 1: IMRT intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: Cisplatin intervention 5: 5-Fluorouracil	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	73	0	0	0	NCT00580983	1COMPLETED	2010-06-01	2003-08-01	University of Michigan Rogel Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	19	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	This phase II trial studies how well androgen deprivation therapy and vorinostat followed by radical prostatectomy works in treating patients with prostate cancer that has not spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin...	PRIMARY OBJECTIVES: I. To determine the rate of pathologic complete response in patients with localized prostate cancer treated with androgen depletion therapy (ADT) and oral vorinostat administered for a minimum of 6 weeks and maximum of 8 weeks before radical prostatectomy. SECONDARY OBJECTIVES: I. To determine an...	Prostate Adenocarcinoma Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer		null	1	arm 1: Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open...	[ 0 ]	6	[ 0, 0, 10, 0, 3, 0 ]	intervention 1: Given PO intervention 2: Given SC intervention 3: Correlative studies intervention 4: Given IM intervention 5: Undergo radical prostatectomy intervention 6: Given PO	intervention 1: Bicalutamide intervention 2: Goserelin Acetate intervention 3: Laboratory Biomarker Analysis intervention 4: Leuprolide Acetate intervention 5: Therapeutic Conventional Surgery intervention 6: Vorinostat	15	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbo...	19	0	0	0	NCT00589472	1COMPLETED	2010-06-01	2007-11-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0
[ 3 ]	38	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells), and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate receptors. This study is being done to determi...	Patients meeting eligibility criteria(mutation +ve and having EEG spikes), will be admitted to the Pediatric Clinical Research Unit at Johns Hopkins Hospital and will have pharmacokinetics of DM determined to establish that they are rapid metabolizers of the drug. The baseline studies on initial admission include neuro...	Rett Syndrome	Rett Syndrome Dextromethorphan	null	3	arm 1: Dextromethorphan 0.25 mg/kg per day arm 2: Dextromethorphan 2.5 mg/kg/day arm 3: Dextromethorphan 5mg/kg/day	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial. intervention 2: Dextromethorphan polis...	intervention 1: Dextromethorphan intervention 2: Dextromethorphan	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	35	0	0	0	NCT00593957	6TERMINATED	2010-06-01	2004-08-01	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	50	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to find the safest and most effective dose of the drugs bevacizumab and everolimus given in combination for the treatment of metastatic colorectal cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a vein). Everolimus (also called RAD001) is a tablet t...	This open-label, non-randomized expanded cohort trial of bevacizumab and RAD001 for patients with refractory metastatic colorectal cancer is designed to assess preliminary efficacy as well as the safety and tolerability of this combination. Patients will be accrued to this study at Duke University Medical Center and Th...	Colorectal Adenocarcinoma	colorectal refractory adenocarcinoma bevacizumab everolimus	null	1	arm 1: 10 mg Everolimus(RAD001) daily by mouth, days 1-28 10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle	[ 0 ]	2	[ 0, 0 ]	intervention 1: 10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle intervention 2: 10 mg Everolimus(RAD001) daily by mouth, days 1-28	intervention 1: Bevacizumab intervention 2: Everolimus	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	50	0	0	0	NCT00597506	1COMPLETED	2010-06-01	2007-10-01	Herbert Hurwitz	7OTHER	false	false	false	null	0	0	0	0	0
[ 4 ]	511	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).	null	Parkinson Disease		null	2	arm 1: Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily arm 2: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase. intervention 2: ER 0.375-4,5 mg	intervention 1: Placebo intervention 2: Pramipexole	119	Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Oxnard \| California \| United States \| -119.17705 \| 34.1975 Danbury \| Connecticut \| United States \| -73.45401 \| 41.39482 Boca Raton \| Florida \| U...	511	0	0	0	NCT00601523	1COMPLETED	2010-06-01	2008-01-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	29	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work in treating patients with relapsed or refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. V...	OBJECTIVES: I. To determine maximally tolerated dose of vorinostat that can be combined with RICE chemotherapy in patients with relapsed lymphoid malignancies. II. To determine the safety and toxicity of the above regimen. III. To gain a preliminary assessment of the efficacy of the above regimen. IV. To determine th...	Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Contiguous Stage II Mantle Cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Noncontiguous ...		null	1	arm 1: Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disea...	[ 0 ]	8	[ 0, 2, 0, 0, 0, 10, 10, 6 ]	intervention 1: Given PO intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies	intervention 1: vorinostat intervention 2: rituximab intervention 3: ifosfamide intervention 4: carboplatin intervention 5: etoposide intervention 6: pharmacological study intervention 7: laboratory biomarker analysis intervention 8: gene expression analysis	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	29	0	0	0	NCT00601718	1COMPLETED	2010-06-01	2007-12-01	University of Washington	7OTHER	false	false	false	null	0	0	0	0	0
[ 3 ]	111	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing t...	null	Non Small Cell Lung Cancer		null	2	arm 1: Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. arm 2: Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily ...	[ 1, 0 ]	6	[ 0, 7, 7, 7, 0, 0 ]	intervention 1: 500 mg/m\^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles. intervention 2: 350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treat...	intervention 1: pemetrexed intervention 2: Folic acid intervention 3: Folic Acid intervention 4: Vitamin B12 intervention 5: dexamethasone intervention 6: dexamethasone	14	Bankstown \| New South Wales \| Australia \| 151.03333 \| -33.91667 Concord \| New South Wales \| Australia \| 151.10381 \| -33.84722 Kingswood Penrith \| New South Wales \| Australia \| N/A \| N/A Liverpool \| New South Wales \| Australia \| 150.92588 \| -33.91938 Redcliffe \| Queensland \| Australia \| 153.10648 \| -27.22649 Bologna \| N...	111	0	0	0	NCT00609518	1COMPLETED	2010-06-01	2008-02-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	1	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patie...	OBJECTIVES: Primary * To determine the incidence of 1-year disease-free survival in patients with juvenile myelomonocytic leukemia and who is undergoing a repeat stem cell transplantation. Secondary * To evaluate the incidence of regimen-related toxicity. * To evaluate the incidence of acute and chronic graft-versu...	Leukemia	juvenile myelomonocytic leukemia	null	1	arm 1: This is a phase I-II study designed to evaluate the efficacy of the administration of high dose cytosine arabinoside and mitoxantrone followed by HCT in patients with JMML who have residual disease or have relapsed after initial HCT.	[ 0 ]	9	[ 0, 0, 0, 0, 0, 0, 3, 3, 0 ]	intervention 1: Patients will receive CSA therapy beginning on day -3, with a taper commencing on day +60 (unless GVHD) and ending on day +90. For patients \>40 kg with normal renal function (creatinine \<1.3 mg/dL), the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children \<40 kg...	intervention 1: cyclosporine intervention 2: cytarabine intervention 3: filgrastim intervention 4: methotrexate intervention 5: methylprednisolone intervention 6: mitoxantrone hydrochloride intervention 7: allogeneic bone marrow transplantation intervention 8: umbilical cord blood transplantation intervention 9: Cis-Re...	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	1	0	0	0	NCT00609739	6TERMINATED	2010-06-01	1999-06-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0	0	0	0	0
[ 2, 3 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.	Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distr...	Major Depressive Disorder Partner Relational Disorder (V61.10)	Older Adults	null	2	arm 1: Medication management with a study doctor every other week. arm 2: Medication management with a study doctor every other week plus weekly marital therapy.	[ 1, 0 ]	2	[ 5, 0 ]	intervention 1: Weekly marital therapy for 6 months. intervention 2: Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approa...	intervention 1: Weekly marital therapy intervention 2: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	42	0	0	0	NCT00612807	1COMPLETED	2010-06-01	2006-07-01	Duke University	7OTHER	false	false	false	null	0	0	0	0	0

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