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_Drug administration error int64	METADATA_count_Intentional overdose int64	METADATA_count_Medication error int64	METADATA_count_Multiple drug overdose intentional int64	METADATA_count_Overdose int64	METADATA_count_Treatment noncompliance int64	METADATA_wilson_lower_bound float32
[ 3 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all do...	null	Premature Ejaculation	Proof of Concept Double Blind	null	3	arm 1: placebo arm 2: 50 mg GSK557296 arm 3: 150 mg GSK557296	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 50 mg GSK557296 intervention 2: 150 mg GSK557296 intervention 3: placebo	intervention 1: GSK557296 intervention 2: GSK557296 intervention 3: placebo	8	San Diego \| California \| United States \| -117.16472 \| 32.71571 San Jose \| California \| United States \| -121.89496 \| 37.33939 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 New York \| New York \| United States \| -74.00597 \| 40.71427 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Philadelphi...	75	0	0	0	NCT01021553	1COMPLETED	2011-05-05	2009-12-23	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	409	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	1FEMALE	false	The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindro...	Safety issues are addressed in the Adverse Events section.	Contraception	Oral contraceptive Estradiol valerate and dienogest EV/DNG comparative tolerability	null	2	arm 1: Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) arm 2: Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradi...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, plac...	intervention 1: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Ortho Tri Cyclen Lo	59	Independence \| Arizona \| United States \| N/A \| N/A Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Encinitas \| California \| United States \| -117.29198 \| 33.03699 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Denver \| Colorado \|...	395	0	0	0	NCT00754065	1COMPLETED	2011-05-10	2008-09-08	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	38	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of ...	null	Myelodysplastic Syndromes Secondary Acute Myeloid Leukemia (AML)	Previously treated MDS oral clofarabine Intermediate-1, Intermediate-2 and High Risk MDS secondary AML (with history of MDS)	null	3	arm 1: Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). arm 2: Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cyc...	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Pharmaceutical form: Tablet, Route of administration: Oral	intervention 1: Clofarabine	6	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New York \| New York \| United States \| -74.00597 \| 40.71427 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United...	36	0	0	0	NCT00531232	1COMPLETED	2011-05-12	2007-05-07	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.	More than 50% of patients with advanced esophageal cancer present with disease that cannot be removed by surgery or has spread to other parts of the body. Improved therapies for patients with advanced esophageal cancer are therefore urgently needed. The epidermal growth factor receptor (EGFR) inhibitor erlotinib (in co...	Esophageal Cancer	metastatic esophageal cancer erlotinib folfox advanced esophageal cancer unresectable esophageal cancer	null	1	arm 1: COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses r...	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tarceva single agent therapy: 150 mg/day PO intervention 2: 5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks intervention 3: 400 mg/m2 IV once every 2 weeks for 16 weeks intervention 4: 85 mg/m2 IV once every 2 weeks ...	intervention 1: Erlotinib intervention 2: 5-fluorouracil intervention 3: Leucovorin intervention 4: Oxaliplatin	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	4	0	0	0	NCT00539617	6TERMINATED	2011-05-12	2007-10-05	University of California, San Francisco	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	1	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	2MALE	true	Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, includin...	null	Prostate Cancer	Prostate cancer prostatic vascularity External Beam Radiation treatment Contrast Enhanced transrectal Ultrasound	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \[Visit 2\]); week 5 (middle of treatment \[Visit 3\]); week 10 (end of trea...	intervention 1: Contrast Enhanced-Transrectal Ultrasound	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	1	0	0	0	NCT00635167	6TERMINATED	2011-05-12	2007-06-01	Sidney Kimmel Cancer Center at Thomas Jefferson University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	503	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444	null	Asthma		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Combination inhaled corticosteroid and long-acting beta2-agonist intervention 2: Inhaled corticosteroid	intervention 1: Fluticasone Furoate/GW642444 intervention 2: Fluticasone propionate	47	Oxford \| Alabama \| United States \| -85.83496 \| 33.61427 Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 Rolling Hills Estates \| California \| United States \| -118.35813 \| 33.78779 Stockton \| California \| United States \| -121.29078 \| 37...	503	0	0	0	NCT01018186	1COMPLETED	2011-05-12	2009-10-19	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.	null	CML Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels	Philadelphia chromosome positive Ph+ chronic myelogenous leukemia chronic phase CML-CP low imatinib trough levels	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours	intervention 1: nilotinib	3	Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Amarillo \| Texas \| United States \| -101.8313 \| 35.222 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	3	0	0	0	NCT01131325	6TERMINATED	2011-05-12	2010-10-21	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	10	NON_RANDOMIZED	SEQUENTIAL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is: * To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR). * To evaluate the pharmacokinetics (PK) of OPC-6768...	null	Tuberculosis	MDR-TB Dose Escalation Phase II Open Label Non Controlled Pulmonary Multidrug-Resistant Tuberculosis (MDR TB)	null	2	arm 1: Participants received delamanid five 50 milligrams (mg) (250 mg) tablets, twice a day (BID), along with at least 2 additional anti-TB medications per optimized background regimen (OBR) for up to 28 weeks. arm 2: Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional ant...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: OPC-67683 film-coated tablets intervention 2: OBR was selected at the discretion of the study investigator and included at least 2 anti-TB medications based on World Health Organization (WHO's) guidelines for the programmatic management of drug-resistant TB. Study investigator could change OBR for a par...	intervention 1: Delamanid intervention 2: Optimized Background Regimen (OBR)	3	Ogre \| N/A \| Latvia \| 24.61401 \| 56.8162 Šiauliai \| N/A \| Lithuania \| 23.31667 \| 55.93333 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916	10	0	0	0	NCT01131351	6TERMINATED	2011-05-12	2010-02-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	28	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen	This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.	Small Cell Lung Cancer	NGR-hTNF SCLC	null	1	arm 1: NGR-hTNF plus doxorubicin	[ 0 ]	2	[ 0, 0 ]	intervention 1: iv q3W 0.8 mcg/sqm NGR-hTNF intervention 2: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion	intervention 1: NGR-hTNF intervention 2: Doxorubicin	5	Rozzano \| Milan \| Italy \| 9.1559 \| 45.38193 Orbassano \| Turin \| Italy \| 7.53813 \| 45.00547 Genoa \| N/A \| Italy \| 8.94439 \| 44.40478 Genoa \| N/A \| Italy \| 8.94439 \| 44.40478 Milan \| N/A \| Italy \| 9.18951 \| 45.46427	28	0	0	0	NCT00483509	1COMPLETED	2011-05-17	2007-02-14	AGC Biologics S.p.A.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	11	NA	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	true	0ALL	true	RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.	OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are...	Healthy	healthy, no evidence of disease	null	1	arm 1: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.	[ 0 ]	5	[ 0, 0, 0, 10, 10 ]	intervention 1: Given topically intervention 2: Given topically intervention 3: Given topically intervention 4: Ancillary studies intervention 5: Correlative studies	intervention 1: lorazepam intervention 2: diphenhydramine hydrochloride intervention 3: haloperidol intervention 4: questionnaire administration intervention 5: laboratory biomarker analysis	1	Richmond \| Virginia \| United States \| -77.46026 \| 37.55376	10	0	0	0	NCT01204255	1COMPLETED	2011-05-17	2010-11-15	Virginia Commonwealth University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	2MALE	false	This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.	Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after o...	Herniorrhaphy Postoperative Pain Inguinal Hernia		null	2	arm 1: collagen sponges arm 2: Placebo collagen sponges	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Drug: Bupivacaine Collagen Sponge intervention 2: Drug: Placebo Collagen Sponge	intervention 1: Bupivacaine Collagen Sponge intervention 2: Placebo collagen Sponge	1	Bellaire \| Texas \| United States \| -95.45883 \| 29.70579	50	0	0	0	NCT01220024	1COMPLETED	2011-05-18	2010-12-02	Innocoll	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	8	NA	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	0ALL	true	The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).	Screening: All subjects eligible for screening must sign an informed consent for the study prior to any study related procedures. Study Design: This is an open-label, single-institutional clinical study of lenalidomide as a treatment for MGUS associated neuropathy. Eligible patients will be followed for 28 days befo...	Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)	Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS) MGUS	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.	intervention 1: Lenalidomide	1	Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229	8	0	0	0	NCT00665652	6TERMINATED	2011-05-19	2008-04-01	Dartmouth-Hitchcock Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Methamphetamine dependence is a significant drug use disorder in the Midwest. While a number of psychosocial and pharmacological treatments have been studied, no specific treatments for methamphetamine have been identified. This study is a collaborative pre-clinical and clinical partnership examining bupropion in the t...	Nearly 40% of adults seeking substance use disorders (SUD) treatment in Nebraska report methamphetamine is their drug of choice. In preliminary studies examining bupropion in methamphetamine use, it was well tolerated, reduced craving for methamphetamine and reduced methamphetamine related euphoria. Investigators at th...	Methamphetamine Use Disorder	Methamphetamine Bupropion SR (Sustained Release)	null	2	arm 1: receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day) arm 2: Not receiving bupropion	[ 0, 4 ]	1	[ 0 ]	intervention 1: 12 week course of bupropion SR 150 mg, BID	intervention 1: bupropion SR	2	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	34	0	0	0	NCT00572234	1COMPLETED	2011-05-20	2007-08-31	University of Nebraska	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 2 ]	39	RANDOMIZED	null	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose of the study is to observe how the drug enters the blood and tissues over time, how the body breaks down the drug and whether or not ...	B1991002 study is a phase 1 adaptive design study which terminated on 14Mar2011. Regular analyzes of psoriasis assessments conducted per the statistical plan indicate that even if every patient enrolled for the rest of the study respond (up to 23 additional subjects), the study can not meet its primary efficacy endpoin...	Plaque Psoriasis	Single dose psoriasis study	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Single dose of ILV-095 300 mg intervention 2: Single dose of Placebo	intervention 1: ILV-095 300 mg in a 4 to 1 ratio intervention 2: ILV-095 300 mg in a 4 to 1 ratio	9	Miami Gardens \| Florida \| United States \| -80.2456 \| 25.94204 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Fort Gratiot \| Michigan \| United States \| N/A \| N/A Winston-Salem \| North Ca...	39	0	0	0	NCT01010542	6TERMINATED	2011-05-20	2009-12-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	6	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of the study is to determine the progression-free survival \[PFS\] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who...	The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patient...	Hodgkin's Lymphoma		null	2	arm 1: Group A arm 2: Group B	[ 5, 5 ]	1	[ 0 ]	intervention 1: Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle	intervention 1: ABVD chemotherapy	1	New York \| New York \| United States \| -74.00597 \| 40.71427	0	0	0	0	NCT00901303	6TERMINATED	2011-05-23	2008-10-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	20,976	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	true	The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.	null	Atrial Fibrillation Atrial Flutter		null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0) intervention 2: Oral tablets, 5.0 mg or 2.5 mg, twice daily	intervention 1: warfarin intervention 2: apixaban	1,111	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| United...	18,140	76	0.00419	1	NCT00412984	1COMPLETED	2011-05-25	2006-12-31	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	5	1	2	1	0	66	1	0.003349
[ 3 ]	48	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8...	null	Mantle Cell Lymphoma		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 375mg/m2 iv every 3 weeks intervention 2: As prescribed	intervention 1: rituximab [MabThera/Rituxan] intervention 2: First line chemotherapy	7	Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Győr \| N/A \| Hungary \| 17.63512 \| 47.68333 Kaposvár \| N/A \| Hungary \| 17.8 \| 46.36667 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Szeged \| N/A \| Hungary \| 20.14824 \| 46.253 Zalaegerszeg \| N/A \| Hungary \| 16.84389 \| 46.84	48	0	0	0	NCT00472420	1COMPLETED	2011-05-25	2007-06-27	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	545	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 week...	null	Non-Hodgkin's Lymphoma		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 375mg/m2 iv every 8 weeks	intervention 1: rituximab [MabThera/Rituxan]	178	Tirana \| N/A \| Albania \| 19.81866 \| 41.32744 Bahía Blanca \| N/A \| Argentina \| -62.26545 \| -38.7176 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Corrientes \| N/A \| Argentina \| -58.8344 \| -27.46784 Córd...	534	0	0	0	NCT00430352	1COMPLETED	2011-05-26	2006-09-04	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 2 ]	45	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study of MK-8776 (SCH 900776) will evaluate its safety and tolerability when given as monotherapy or in combination with gemcitabine to participants with advanced solid tumors or lymphoma. Participants will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard d...	null	Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms		null	9	arm 1: Participants received MK-8776 10 mg/m\^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m\^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle. arm 2: Participants received MK-8776 20 mg/m\^2 given as monotherapy as an IV i...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: IV infusion intervention 2: IV infusion	intervention 1: MK-8776 intervention 2: Gemcitabine	0	null	43	0	0	0	NCT00779584	1COMPLETED	2011-05-28	2008-10-17	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	243	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.	null	Raynaud's Disease Peripheral Vascular Disease	Raynaud's phenomenon vasospasm scleroderma systemic sclerosis CREST phosphodiesterase inhibitor	null	8	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period intervention 2: Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 we...	intervention 1: PF-00489791 intervention 2: PF-00489791 intervention 3: PF-00489791 intervention 4: PF-00489791 intervention 5: PF-00489791 intervention 6: PF-00489791 intervention 7: PF-00489791 intervention 8: PF-00489791	55	Redwood City \| California \| United States \| -122.23635 \| 37.48522 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Rockford \| Illinois \| United States \| -89.094 \| 42.27113 ...	458	0	0	0	NCT01090492	1COMPLETED	2011-05-31	2010-08-04	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 2 ]	56	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the e...	null	Apnea, Sleep		null	4	arm 1: Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period. arm 2: Particip...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: one or two 10 mg capsules, orally, single dose intervention 2: one or two capsules, orally, single dose intervention 3: two 100 mg tablets, orally, single dose intervention 4: two 100 mg tablets, orally, single dose	intervention 1: MK-7288 intervention 2: Placebo to MK-7288 intervention 3: Modafinil intervention 4: Placebo to modafinil	0	null	214	0	0	0	NCT01092780	1COMPLETED	2011-05-31	2010-05-26	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	442	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.	null	Breast Neoplasms		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal fr...	intervention 1: Sunitinib + Capecitabine intervention 2: Capecitabine	169	Downey \| California \| United States \| -118.13257 \| 33.94001 Fresno \| California \| United States \| -119.77237 \| 36.74773 Montebello \| California \| United States \| -118.10535 \| 34.00946 Whittier \| California \| United States \| -118.03284 \| 33.97918 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Boynton Beach \|...	432	5	0.011574	1	NCT00435409	1COMPLETED	2011-06-01	2007-02-01	Pfizer	4INDUSTRY	false	false	false	null	3	0	0	0	0	2	0	0.004954
[ 4 ]	248	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.	null	Gastrointestinal Stromal Tumors	GIST adults imatinib resistant sunitinib resistant AMN107 nilotinib treatment Gastrointestinal stromal tumor (GIST)	null	2	arm 1: 400mg twice daily in core and extension phases of the study. arm 2: In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotin...	[ 0, 1 ]	2	[ 0, 10 ]	intervention 1: Nilotinib 400 mg twice daily (bid) intervention 2: Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.	intervention 1: Nilotinib intervention 2: Best Supportive Care (BSC) +/- imatinib or sunitinib	35	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 De...	315	1	0.003175	1	NCT00471328	1COMPLETED	2011-06-01	2007-03-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	1	0	0.000561
[ 3 ]	260	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant	null	Immunosuppression in Solid Organ Transplant		null	5	arm 1: None arm 2: None arm 3: None arm 4: Other arm 5: None	[ 0, 0, 0, 5, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\]) intervention 2: Intravenous (IV), 20 mg, Day1 and Day 5 intervention 3: Intravenous (IV), 10 mg...	intervention 1: Tacrolimus intervention 2: Basiliximab intervention 3: Belatacept More Intensive (MI) intervention 4: Belatacept Less Intensive (LI) intervention 5: Mycophenolate Mofetil (MMF)	42	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Geo...	145	2	0.013793	1	NCT00555321	6TERMINATED	2011-06-01	2008-01-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0	0	2	0	0.003791
[ 4 ]	2,333	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.	null	Coronary Atherosclerosis	Coronary artery disease	null	4	arm 1: Rosuvastatin 20 mg distributed in 2-week run-in period arm 2: Atorvastatin 40 mg distributed in 2-week run-in period arm 3: Rosuvastatin 40 mg distributed in core 2-year study arm 4: Atorvastatin 80 mg distributed in core 2-year study	[ 0, 1, 0, 1 ]	2	[ 0, 0 ]	intervention 1: capsule, oral, once daily intervention 2: capsule, oral, one daily	intervention 1: Rosuvastatin intervention 2: Atorvastatin	195	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Mountain View \| California \| United States \| -122.08385 \| 37.38605 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San...	2,958	2	0.000676	1	NCT00620542	1COMPLETED	2011-06-01	2008-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	1	0	0	1	0	0.000185
[ 4 ]	920	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).	null	Multiple Sclerosis	Multiple sclerosis. Relapse-remitting Fingolimod	null	5	arm 1: Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study. arm 2: Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. arm 3: Pat...	[ 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Patients self-administered fingolimod 0.5 mg capsules orally once daily. intervention 2: Patients self-administered fingolimod 1.25 mg capsules orally once daily.	intervention 1: Fingolimod 0.5 mg intervention 2: Fingolimod 1.25 mg	103	Chatswood \| N/A \| Australia \| 151.18333 \| -33.8 Fitzroy \| N/A \| Australia \| 144.97833 \| -37.79839 Heidelberg \| N/A \| Australia \| 145.06667 \| -37.75 North Gosford \| N/A \| Australia \| 151.3516 \| -33.414 Woodville \| N/A \| Australia \| 138.54291 \| -34.877 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium ...	920	1	0.001087	1	NCT00662649	1COMPLETED	2011-06-01	2008-02-01	Novartis	4INDUSTRY	false	false	false	null	0	0	0	0	0	1	0	0.000192
[ 4 ]	1,030	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee	null	Osteoarthritis	Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability	null	2	arm 1: SMC021 Oral Calcitonin arm 2: SMC021 Placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 0.8mg SMC021, twice daily intervention 2: 0.8mg Placebo, twice daily	intervention 1: Oral Salmon Calcitonin intervention 2: Oral Salmon Calcitonin (Placebo)	18	Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 City of Saint Peters \| Missouri \| United States \| -90.62651 \| 38.80033 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 B...	1,028	1	0.000973	1	NCT00704847	6TERMINATED	2011-06-01	2008-06-01	Nordic Bioscience A/S	4INDUSTRY	false	false	false	null	0	0	0	0	0	1	0	0.000172
[ 4 ]	784	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.	There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes a...	Diabetes Mellitus, Type 2	Type 2 Diabetes mellitus Non-insulin dependent diabetes mellitus Drug Therapy Hypoglycemia, Hyperglycemia	null	7	arm 1: Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. arm 2: Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. arm 3: Alogliptin 12.5 mg, tablets, ...	[ 2, 0, 0, 1, 1, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Alogliptin tablets. intervention 2: Metformin capsules intervention 3: Alogliptin placebo-matching tablets. intervention 4: Metformin placebo-matching capsules.	intervention 1: Alogliptin intervention 2: Metformin intervention 3: Alogliptin Placebo intervention 4: Metformin Placebo	201	Dothan \| Alabama \| United States \| -85.39049 \| 31.22323 Muscle Shoals \| Alabama \| United States \| -87.66753 \| 34.74481 Pell City \| Alabama \| United States \| -86.28609 \| 33.58621 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United S...	768	1	0.001302	1	NCT01023581	1COMPLETED	2011-06-01	2009-11-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0	1	0	0	0.00023
[ 3 ]	301	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Primary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was effective on: * assessment of higher level of response \[AS...	The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.	Ankylosing Spondylitis		null	6	arm 1: Placebo (for sarilumab) weekly (qw) for 12 weeks. arm 2: Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks. arm 3: Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. arm 4: Sarilumab 100 mg SC injection qw for 12 weeks. arm 5: Sariluma...	[ 2, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous intervention 2: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous	intervention 1: Sarilumab intervention 2: Placebo	80	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Uplan...	300	12	0.04	1	NCT01061723	1COMPLETED	2011-06-01	2010-02-01	Sanofi	4INDUSTRY	false	false	false	null	12	0	0	0	0	0	0	0.023027
[ 5 ]	770	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.	null	Erectile Dysfunction	Erectile Dysfunction	null	3	arm 1: 10 milligrams (mg) or 20 mg on demand arm 2: 5 mg or 2.5 mg once a day arm 3: 50 mg, 100 mg, or 25 mg on demand	[ 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: Administered orally for 24 weeks. intervention 2: Administered orally for 24 weeks.	intervention 1: Tadalafil intervention 2: Sildenafil Citrate	45	Carpentras \| N/A \| France \| 5.04813 \| 44.05507 Chambéry \| N/A \| France \| 5.92079 \| 45.56628 La Bouëxière \| N/A \| France \| -1.43843 \| 48.18404 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 M...	767	81	0.105606	1	NCT01122264	1COMPLETED	2011-06-01	2010-05-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	29	0	0	52	0	0.085787
[ 4 ]	2,201	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over an average...	BACKGROUND: The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of patients, and many patients with occluded infarct arteries do not mee...	Cardiovascular Diseases Heart Diseases Myocardial Infarction Heart Failure, Congestive Heart Failure		null	2	arm 1: Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification arm 2: Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous...	[ 1, 0 ]	4	[ 0, 0, 3, 0 ]	intervention 1: Participants will receive beta adrenergic blockers. intervention 2: Participants will receive platelet inhibitors. intervention 3: Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting. intervention 4: Participants will receive ACE inhibitors.	intervention 1: Beta adrenergic blockers intervention 2: Platelet inhibitors intervention 3: PTCA and stents intervention 4: ACE Inhibitors	1	New York \| New York \| United States \| -74.00597 \| 40.71427	2,201	0	0	0	NCT00004562	1COMPLETED	2011-06-01	1999-09-01	NYU Langone Health	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	2MALE	false	This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rec...	Normal tissue tolerance of the rectum limits the dose of radiation that can be delivered to the prostate for curative treatment of prostate cancer. Amifostine is a radioprotector, an agent that reduces tissue damage incurred by ionizing radiation. It has been well studied in humans and is approved for intravenous use. ...	Prostatic Neoplasms	Prostate Cancer Radiation Therapy Rectal Toxicity Amifostine Radioprotector	null	1	arm 1: 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).	[ 0 ]	2	[ 0, 4 ]	intervention 1: 1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses). inter...	intervention 1: Amifostine trihydrate intervention 2: Radiation therapy	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	30	0	0	0	NCT00040365	1COMPLETED	2011-06-01	2002-06-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	56	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy m...	OBJECTIVES: * Determine the 1-year progression-free survival probability in patients with previously untreated mantle cell lymphoma treated with courses of rituximab and cyclophosphamide, doxorubicin, vincristine, and dexamethasone alternating with courses of rituximab and high-dose cytarabine and methotrexate with le...	Lymphoma	stage III mantle cell lymphoma stage IV mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma	null	1	arm 1: 21-day cycles of Hyper-CVAD and high-dose methotrexate/cytarabine are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6. Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m\^2 on day 1, mesna 600 mg/m\^2 on days 2-4, cyclophosphamide 300 mg/m\^2 on days 2-4, doxorubic...	[ 0 ]	9	[ 2, 2, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 5 ug/kg intervention 2: 375 mg/m\^2 on day 1 of cycles 1-6 intervention 3: 300 mg/m\^2 on days 2-4 of cycles 1,3,5,7 intervention 4: 12 g/m\^2 over days 3-4 of cycles 2,4,6,8 intervention 5: 40 mg on days 2-5 and 12-15 of cycles 1,3,5,7 intervention 6: 16.6 mg/m\^2/day for days 5-7 of cycles 1,3,5,7 int...	intervention 1: filgrastim intervention 2: rituximab intervention 3: cyclophosphamide intervention 4: cytarabine intervention 5: dexamethasone intervention 6: doxorubicin intervention 7: leucovorin intervention 8: methotrexate intervention 9: vincristine	0	null	49	0	0	0	NCT00041132	1COMPLETED	2011-06-01	2002-09-01	SWOG Cancer Research Network	5NETWORK	false	false	false	null	0	0	0	0	0	0	0	0
[ 2, 3 ]	37	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface. Patients who require surgery or radiation the...	BACKGROUND: Metastatic breast cancer remains to this day a mostly incurable disease, with less than 10% of patients reaching a long-term disease free survival. This study proposes using an immune-depleting chemotherapy as platform for immunotherapy. It is based on the following hypotheses and understanding: * The comb...	Breast Neoplasms Metastases, Neoplasm	CEA vaccine Metastatic Breast Cancer T- Cell Repertoire High-dose Chemotherapy Breast Cancer	null	0	null	null	9	[ 2, 2, 2, 2, 0, 0, 0, 0, 0 ]	intervention 1: 4 x 10\^8 pfu given monthly subcutaneously for three doses in the first series and three doses on each of the intermediate and late re-immunizations (total 9 doses). intervention 2: rV-CEA (6D)/Tricom concomitantly with sargramostim (rGM-CSF). 1.2 x 10\^8 pfu x 1 dose subcutaneously. intervention 3: 5 m...	intervention 1: recombinant fowlpox-CEA(6D)/TRICOM vaccine intervention 2: recombinant vaccinia-CEA(6D)/TRICOM vaccine intervention 3: filgrastim intervention 4: sargramostim intervention 5: cyclophosphamide intervention 6: doxorubicin hydrochloride intervention 7: fludarabine phosphate intervention 8: paclitaxel inter...	2	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593	37	0	0	0	NCT00048893	6TERMINATED	2011-06-01	2002-11-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	55	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor ...	PRIMARY OBJECTIVES: I. To evaluate the correlation of fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) imaging early in the preoperative treatment program of locally advanced gastric cancer with histologic response assessment and patient outcome, defined as overall and progression-f...	Gastric Adenocarcinoma Stage II Gastric Cancer Stage III Gastric Cancer Stage IV Gastric Cancer		null	1	arm 1: Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemot...	[ 0 ]	7	[ 0, 3, 4, 10, 0, 3, 3 ]	intervention 1: Given IV intervention 2: Undergo FDG and FLT PET/CT intervention 3: Undergo FDG-PET/CT intervention 4: Undergo FLT-PET/CT intervention 5: Given IV intervention 6: Undergo FDG and FLT PET/CT intervention 7: Undergo radical subtotal or total gastrectomy with lymph node dissection	intervention 1: Cisplatin intervention 2: Computed Tomography intervention 3: Fludeoxyglucose F-18 intervention 4: Fluorothymidine F-18 intervention 5: Irinotecan Hydrochloride intervention 6: Positron Emission Tomography intervention 7: Therapeutic Conventional Surgery	1	New York \| New York \| United States \| -74.00597 \| 40.71427	55	0	0	0	NCT00062374	1COMPLETED	2011-06-01	2003-06-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	369	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.	The purpose of this multi-center, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polys...	Interstitial Cystitis	Interstitial Cystitis Urinary Bladder Pain	null	3	arm 1: One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks arm 2: One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks arm 3: Placebo One placebo capsule 3 times a day (morning afterno...	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks intervention 2: One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks intervention 3: One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placeb...	intervention 1: Pentosan polysulfate sodium 100 mg intervention 2: Placebo intervention 3: Pentosan polysulfate sodium 100 mg	65	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 San Bernardino \| California \| United States \| -117.28977 \| 34.10834 San Carlos \| California \| United States \| -122.26052 \| 37.50716 San Diego \|...	368	0	0	0	NCT00086684	6TERMINATED	2011-06-01	2003-09-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3, 4 ]	110	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	1FEMALE	true	This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in adolescents. Whether administration of estrogen, a normal hormone present during puberty, can help maintain bone development in girls with anorexia nervosa will be determined.	Adolescence is a critical time for bone mineral accretion as between 60-90% of peak bone mass is established during this period, and peak bone mass is a major determinant of bone density and osteoporosis risk during adulthood. Anorexia nervosa (AN) is the third most common chronic illness among adolescent girls, with a...	Anorexia Nervosa	Anorexia Nervosa Amenorrhea Bone Mass Growth hormone	null	2	arm 1: Mature girls with anorexia nervosa (AN) (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month). Immature girls with AN (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg...	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month intervention 2: Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month	intervention 1: Physiologic Estrogen/progesterone intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	110	0	0	0	NCT00088153	1COMPLETED	2011-06-01	2003-07-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	47	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	false	This study will examine the interaction of the HIV combination medication lopinavir/ritonavir with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection often take herbal products and dietary supplements in addition to their doctor-prescribed medicines to treat the disease, lessen the s...	Patients with HIV commonly use herbal products and dietary supplements in addition to medications prescribed by their physicians. Up to 73% of patients with HIV have reported using some form of complementary or alternative medicine. As such, the potential for clinically significant drug interactions between herbs and a...	Healthy	Antiretrovirals Protease Inhibitors Herbal Supplements Drug Interactions Metabolism Healthy Volunteer HV	null	3	arm 1: The primary outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba). arm 2: The primary outcome measurement for each study arm is the change in lopinavir area under the concentra...	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Ginkgo Biloba 120 mg twice daily for 14 days intervention 2: Echinacea purpurea 500 mg three times daily for 14 days intervention 3: Panax ginseng 500 mg twice daily	intervention 1: Gingko Biloba intervention 2: Echinacea purpurea intervention 3: Panax ginseng	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	47	0	0	0	NCT00103012	1COMPLETED	2011-06-01	2005-01-01	National Institutes of Health Clinical Center (CC)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	23	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone th...	null	Prostate Cancer	adenocarcinoma of the prostate recurrent prostate cancer	null	2	arm 1: Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break. arm 2: Pa...	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections. Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break intervention 2: given as a 3 month depo-injection interv...	intervention 1: Velcade intervention 2: LH-RH Agonist intervention 3: Androgen Receptor Antagonists	4	Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957	23	0	0	0	NCT00103376	6TERMINATED	2011-06-01	2004-10-01	Medical University of South Carolina	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	139	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	false	0ALL	true	The purpose of this study is to develop effective interventions that assist individuals with high blood pressure to quit smoking and prevent weight gain.	BACKGROUND: High blood pressure (BP), or hypertension, is a major risk factor for cardiovascular morbidity and mortality. Hypertension is associated with an elevated risk for several cardiovascular complications, including coronary heart disease, peripheral vascular disease, congestive heart failure, and stroke, as we...	Cardiovascular Diseases Heart Diseases Hypertension		ICF_002.pdf: Study Title: Blood Pressure Control in Hypertensive Smokers NCT: NCT00113074 Document: Informed Consent Document Document Approval Date: 11/02/2009 FOR IRB USE ONLY APPROVED BY: IRB-03 IRB ID #: 200611724 APPROVAL DATE: 11/02/09 EXPIRATION DATE: 11/02/10 Page 1 of 12 INFORMED CONSENT DOCUMENT ...	3	arm 1: Weight management and blood pressure control intervention arm 2: Self-help materials targeting lifestyle modification arm 3: Weight management intervention	[ 0, 1, 0 ]	2	[ 0, 5 ]	intervention 1: Nicotine replacement therapy program intervention 2: Diet program	intervention 1: Nicotine Replacement Therapy intervention 2: Diet	2	Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	139	0	0	0	NCT00113074	1COMPLETED	2011-06-01	2004-09-01	Mark Vander Weg	7OTHER	true	true	true	https://cdn.clinicaltrials.gov/large-docs/74/NCT00113074/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/74/NCT00113074/SAP_001.pdf https://cdn.clinicaltrials.gov/large-docs/74/NCT00113074/ICF_002.pdf	0	0	0	0	0	0	0	0
[ 3 ]	10	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.	* Patients will be placed into one of two groups, "low risk" and "high risk". "Low risk" disease is defined as one area of disease measuring less than 10cm and a normal blood test called LDH (lactate hydrogenase). Patients not fitting the "low risk" criteria are considered "high risk". * If the patient has "low risk" d...	Burkitt Lymphoma Non-Hodgkins Lymphoma Atypical Burkitt Lymphoma	Burkitt Lymphoma atypical Burkitt lymphoma Non-Hodgkin's Lymphoma rituximab	null	2	arm 1: Low-risk patients receive 3 cycles of regimen A. Regimen A: Rituximab (375 mg/m\^2) on Days 1 and 3. Cyclophosphamide (800 mg/m\^2) on days 1 and 2. Vincristine (1.4 mg/m\^2) on days 1 and 10. Doxorubicin (50 mg/m\^2) on Day 1. Methotrexate (3000 mg/m\^2) on Day 10. Intrathecal Cytarabine (50mg) will be given ...	[ 0, 0 ]	10	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1 intervention 2: Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regime...	intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Methotrexate intervention 6: Leucovorin intervention 7: Ifosfamide intervention 8: Etoposide intervention 9: Cytarabine intervention 10: Mesna	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	10	0	0	0	NCT00126191	6TERMINATED	2011-06-01	2005-07-01	Dana-Farber Cancer Institute	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	7	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.	Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving lept...	HAART-induced Lipodystrophy and Metabolic Syndrome	leptin lipodystrophy insulin resistance hyperlipidemia metabolic syndrome	null	2	arm 1: r-MetHuLeptin SubQ once daily arm 2: SubQ once daily	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: r-metHuLeptin intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	12	0	0	0	NCT00140244	1COMPLETED	2011-06-01	2001-12-01	Beth Israel Deaconess Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	232	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.	ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem. The most common treatment for the condition is stimulant medication. However, there are an increasing number of children who are experiencing negative side effects from stimulants, such as dizz...	Attention Deficit Disorder With Hyperactivity	ADHD Child Adolescent School	null	2	arm 1: Participants will receive treatment for ADHD with the non-stimulant atomoxetine arm 2: Participants will receive treatment for ADHD with the stimulant methylphenidate	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of...	intervention 1: Atomoxetine intervention 2: Methylphenidate	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New York \| New York \| United States \| -74.00597 \| 40.71427	437	0	0	0	NCT00183391	1COMPLETED	2011-06-01	2005-07-01	Icahn School of Medicine at Mount Sinai	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	50	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and...	PRIMARY OBJECTIVES: I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of weekly doxorubicin (doxorubicin hydrochloride) and daily oral cyclophosphamide given with G-CSF (filgrastim) support for 12 weeks followed weekly paclitaxel f...	Estrogen Receptor-negative Breast Cancer Estrogen Receptor-positive Breast Cancer HER2-positive Breast Cancer Progesterone Receptor-negative Breast Cancer Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer		null	1	arm 1: See Detailed Description.	[ 0 ]	14	[ 0, 0, 0, 2, 0, 0, 0, 3, 3, 10, 2, 0, 0, 10 ]	intervention 1: Given IV intervention 2: Given PO intervention 3: Given IV intervention 4: Given SC intervention 5: Given PO intervention 6: Given IV intervention 7: Given IV intervention 8: Correlative studies intervention 9: Undergo definitive breast surgery intervention 10: Correlative studies intervention 11: Given...	intervention 1: doxorubicin hydrochloride intervention 2: cyclophosphamide intervention 3: paclitaxel intervention 4: filgrastim intervention 5: capecitabine intervention 6: methotrexate intervention 7: vinorelbine tartrate intervention 8: needle biopsy intervention 9: therapeutic conventional surgery intervention 10: ...	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	50	0	0	0	NCT00194779	1COMPLETED	2011-06-01	2003-10-01	University of Washington	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	22	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene expression of CYP19 in breast cancers collected from postmenopausal women that receive neoadjuvant exemestane.	Rationale: In postmenopausal women, the main source of estrogen is through the conversion of androgens, or sex hormones produced by the adrenal glands. An enzyme called aromatase carries out this process. Exemestane, an aromatase inhibitor, blocks production of estrogens. Research indicates that the gene responsible fo...	Breast Cancer	Post-Menopause Neoadjuvant Therapy	null	1	arm 1: Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: 25 mg orally once per day for 16 weeks. intervention 2: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food. intervention 3: None	intervention 1: Exemestane intervention 2: Celecoxib intervention 3: Correlative studies	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	44	0	0	0	NCT00201773	1COMPLETED	2011-06-01	2003-07-01	Ohio State University Comprehensive Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	648	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high...	The "Delivery room management of premature infants at high risk of respiratory distress syndrome" protocol compares three distinct methods of post-delivery stabilization and subsequent early respiratory care on chronic lung disease and survival in premature infants at high risk of respiratory distress syndrome. The thr...	Respiratory Distress Syndrome, Newborn	Prematurity respiratory distress syndrome surfactant nasal continuous positive airway pressure	null	3	arm 1: Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support. arm 2: Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications. arm 3: Intubation, prophy...	[ 1, 0, 0 ]	3	[ 0, 1, 0 ]	intervention 1: Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support. intervention 2: Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications. interve...	intervention 1: PS Group intervention 2: NCPAP Group intervention 3: ISX Group	1	Burlington \| Vermont \| United States \| -73.21207 \| 44.47588	648	0	0	0	NCT00244101	1COMPLETED	2011-06-01	2003-08-01	Vermont Oxford Network	5NETWORK	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	123	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years has substantially reduced the risk of rejection after kidney transplantation, has allowed the development of immuno-suppressive regimens that do not use long-term steroids (steroid avoidance), and has improved transplant success ...	RECENT EXPERIENCE AT ST MARY'S: The St Mary's Hospital Renal Unit (now combined with the Hammersmith Hospital Renal Unit at the West London Renal and Transplant Centre) introduced Tacrolimus based immunosuppression in 1995, developing a steroid avoidance regimen based on Tacrolimus, Mycophenolate, and IL-2R MoAb betwe...	Kidney Transplantation Kidney Diseases Kidney Failure	Kidney Transplantation Kidney Disease Kidney Failure Graft Rejection	null	2	arm 1: Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy arm 2: Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Monoclonal antibody induction therapy intervention 2: Monoclonal antibody induction therapy	intervention 1: Campath intervention 2: Daclizumab	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	123	0	0	0	NCT00246129	1COMPLETED	2011-06-01	2005-10-01	EMagnusson	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	217	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.	null	Breast Neoplasms		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression....	intervention 1: SU011248 intervention 2: Chemotherapy	113	Corona \| California \| United States \| -117.56644 \| 33.87529 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Glendora \| California \| United States \| -117.86534 \| 34.13612 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los A...	213	0	0	0	NCT00246571	1COMPLETED	2011-06-01	2006-01-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 2, 3 ]	25	null	SEQUENTIAL	0TREATMENT	0NONE	false	0ALL	false	Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific outcomes.	100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.	Major Depression Dysthymia Depressive Disorder Not Otherwise Specified	Major Depression Dysthymia Depression Not Otherwise Specified Dichotic Listening Fluoxetine Imipramine Predictors	null	1	arm 1: fluoxetine or Imipramine	[ 0 ]	2	[ 0, 0 ]	intervention 1: Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day \*All increases only if tolerated. intervention 2: Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days...	intervention 1: Fluoxetine intervention 2: Imipramine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	25	0	0	0	NCT00296725	1COMPLETED	2011-06-01	1994-04-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	136	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).	null	Metastatic Breast Cancer		null	1	arm 1: Patients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 30 mg/m2 IV on Day 1 of each 28 day cycle intervention 2: AUC=5 on Day 1 of each 28 day cycle intervention 3: 4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)	intervention 1: Pegylated liposomal doxorubicin intervention 2: Carboplatin intervention 3: trastuzumab	57	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sedona \| Arizona \| United States \| -111.76099 \| 34.86974 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Ocala \| Florida \| Unite...	129	0	0	0	NCT00303108	1COMPLETED	2011-06-01	2005-12-01	US Oncology Research	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	506	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to test the effectiveness of albuterol versus placebo with the following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce pulmonary edema, improve donor oxygenation, and increase the number of lungs available for transplantation, b) Developing a blood test t...	The donor lung utilization rate in the United States remains less than 15%, and the demand for donor lungs far exceeds the available supply. The most common reasons for failure to utilize donor lungs are donor hypoxemia and/or pulmonary infiltrates. Since pulmonary edema is a common, reversible cause of hypoxemia and i...	Brain Death Organ Donor Pulmonary Edema	brain death organ donor pulmonary edema albuterol hypoxia lung transplantation infiltrates	null	2	arm 1: Albuterol sulfate 5 mg dissolved in normal saline administered every 4 hours by nebulization arm 2: Saline administered every 4 hours by nebulization	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 5 mg nebulized q4h intervention 2: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours	intervention 1: Albuterol intervention 2: Saline	1	Oakland \| California \| United States \| -122.2708 \| 37.80437	506	0	0	0	NCT00310401	1COMPLETED	2011-06-01	2007-04-01	Vanderbilt University Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 2 ]	32	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.	The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metas...	Prostate Cancer	Locally advanced prostate cancer positive lymph nodes	null	6	arm 1: Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 2: Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 3: Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 4: Cohor...	[ 0, 0, 0, 0, 0, 0 ]	4	[ 0, 0, 0, 1 ]	intervention 1: Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD). intervention 2: Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androge...	intervention 1: Samarium-153 intervention 2: Total Androgen Suppression (TAS) with Bicalutamide intervention 3: Total androgen suppression (TAS) with Goserelin Acetate intervention 4: Radiation Therapy	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	30	0	0	0	NCT00328614	1COMPLETED	2011-06-01	2003-03-01	Sidney Kimmel Cancer Center at Thomas Jefferson University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Research Hypothesis: Subjects in the study population who are treated with cetuximab in combination with irinotecan will have higher response rates than subjects treated with irinotecan alone.	Primary Objective: ·The primary aim of this study is to assess the response rate of patients with previously treated colorectal cancer (CRC) Number of Subjects: 31 Study Population: Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and ...	Colon Cancer Rectum Cancer	Colon Cancer	null	1	arm 1: Cetuximab will be administered at the dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks, IV over 2 hours at an infusion rate not to exceed 5 ml/min. Followed immediately by Irinotecan administered at a dose of 180 mg/m2 IV over 60 minutes every two weeks.	[ 0 ]	2	[ 0, 0 ]	intervention 1: The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance s...	intervention 1: Cetuximab intervention 2: Irinotecan	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	32	0	0	0	NCT00336856	1COMPLETED	2011-06-01	2006-06-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	69	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival. The secondary objectives are: * To evaluate the local tumor response in patients treated wit...	Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be involved in certain types of cancer. When EGFR is stimulated, a series of chemical reactions starts that results in a tumor being "told" to grow. Cetuximab tries to stop these reactions by blocking EGFR. This may stop tumors from growi...	Pancreatic Cancer	Pancreatic Cancer Cetuximab C225 Erbitux Gemcitabine Oxaliplatin Eloxatin Capecitabine Xeloda	null	1	arm 1: Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m\^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day fo...	[ 0 ]	5	[ 0, 0, 0, 0, 4 ]	intervention 1: 500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. intervention 2: Induction Therapy: 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses. Chemotherapy Maintenance: 1 gm/m\^2/week over 100 minutes weekly for 3 weeks then 1 we...	intervention 1: Cetuximab intervention 2: Gemcitabine intervention 3: Oxaliplatin intervention 4: Capecitabine intervention 5: Radiotherapy	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	69	0	0	0	NCT00338039	1COMPLETED	2011-06-01	2005-09-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to determine whether patients with HIV lipodystrophy (fat wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by your fat cells). Our hope is that they will improve s...	Highly active antiretroviral therapy (HAART) induces profound and sustained suppression of human immunodeficiency virus (HIV) replication, and is thus very effective in reducing disease-associated morbidity and mortality in this patient population. However, HAART also results in the development of a lipodystrophic synd...	HIV Lipodystrophy	HIV lipodystrophy Leptin Fat wasting Pioglitazone Insulin resistance	null	2	arm 1: Leptin replacement therapy arm 2: Diabetes treatment therapy	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Leptin intervention 2: Pioglitazone or metformin intervention 3: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	9	0	0	0	NCT00362440	1COMPLETED	2011-06-01	2006-08-01	Beth Israel Deaconess Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	482	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated	Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary ...	Breast Neoplasms	advanced breast cancer metastatic breast cancer treatment resistant treatment failure	null	2	arm 1: 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles arm 2: 37.5 mg daily, continuous dosing	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles intervention 2: 37.5 mg daily, continuous dosing	intervention 1: Capecitabine intervention 2: Sunitinib malate	123	Córdoba \| Córdoba Province \| Argentina \| -64.18853 \| -31.40648 Bahía Blanca \| Prov. de Buenos Aires \| Argentina \| -62.26545 \| -38.7176 Viedma \| Río Negro Province \| Argentina \| -63.0004 \| -40.81519 Rosario \| Santa Fe Province \| Argentina \| -60.63932 \| -32.94682 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Bue...	478	0	0	0	NCT00373113	6TERMINATED	2011-06-01	2006-11-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	28	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but continue to experience symptoms. The purpose of this project is to find out if small doses of pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms (such as hearing voices, having trouble i...	If you choose to participate, you will first have screening tests to find out if you are eligible. The study physician will do a number of tests including a physical examination, a routine medical history, lab tests for blood and urine, and EKG (to monitor your heart) and interviews about your physical and mental healt...	Schizophrenia	schizophrenia pimozide clozapine	null	2	arm 1: placebo pimozide arm 2: active pimozide	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: half of the subjects are randomized to the active drug group intervention 2: half of the subjects are randomized to placebo group	intervention 1: Pimozide intervention 2: placebo	2	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 West Haven \| Connecticut \| United States \| -72.94705 \| 41.27065	28	0	0	0	NCT00374244	1COMPLETED	2011-06-01	2004-01-01	Yale University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this research study is to evaluate and compare the effects of experimental treatments aimed at improving insomnia and nightmares in men and women military veterans between the ages of 18 and 60 years old, and who have a condition called Posttraumatic Stress Disorder. Insomnia refers to difficulty falling...	Posttraumatic stress disorder (PTSD) is a prevalent disorder in military samples associated with adverse emotional and health impacts and enormous health care costs, and it is often resistant to treatment. Identification of PTSD-related factors that contribute to poor clinical and health outcomes is imperative to refin...	Anxiety Disorders Mood Disorders Insomnia Nightmares	Anxiety D/O Mood D/O	null	3	arm 1: Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoi...	[ 1, 1, 2 ]	3	[ 5, 0, 0 ]	intervention 1: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on P...	intervention 1: Behavioral Sleep Intervention intervention 2: Prazosin intervention 3: Placebo	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	41	0	0	0	NCT00393874	1COMPLETED	2011-06-01	2006-10-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	344	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	In this research study, the investigators are trying to find a better way to set the dose of a common blood-thinning medication. Patients with blood clots or a risk of blood clots (or stroke) sometimes have to take an approved medication called warfarin. Warfarin is a commonly prescribed, approved blood thinning medic...	This is Phase 1 of a 3-phase plan in which we will ultimately test whether rapid turnaround genetic testing can improve the safety and efficacy of warfarin anticoagulation in warfarin naïve patients who are being newly induced and maintained on warfarin. Each of the phases will address a specific and progressively more...	Pulmonary Embolism Deep Vein Thrombosis Atrial Fibrillation	Warfarin Thrombosis Genetics Nomogram Pulmonary Embolism Deep Vein Thrombosis Dosing INR Anticoagulation Therapy Orthopedic Surgery	null	1	arm 1: We will develop a nomogram for warfarin dosing that uses rapid turnaround genetic testing and monthly nomogram modification (if necessary) to achieve effective and safe warfarin induction and maintenance. More than 70% of the time, we will maintain warfarin naïve patients within the target therapeutic range. The...	[ 0 ]	1	[ 0 ]	intervention 1: 2 mg tablets take as directed by study staff (based on INR)	intervention 1: Warfarin	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	344	0	0	0	NCT00401414	1COMPLETED	2011-06-01	2007-01-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	79	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped that these combinations will keep the cancer from growing and spreading further.	Regimen A: Bevacizumab/anastrozole (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] and anastrozole (1 mg ora...	Breast Cancer Breast Neoplasms	Breast cancer Metastatic breast cancer Bevacizumab Anastrozole Fulvestrant	null	2	arm 1: Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)\] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles. arm 2: Bevac...	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Bevacizumab 10mg/kg IV every 2 weeks intervention 2: anastrozole (1 mg orally daily) intervention 3: fulvestrant (500 mg IM on Day 1 of Cycle 1, followed by 250 mg IM of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatmen...	intervention 1: Bevacizumab intervention 2: Anastrozole intervention 3: Fulvestrant	11	Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Bowling Green \| Kentuck...	79	0	0	0	NCT00405938	1COMPLETED	2011-06-01	2006-11-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	51	RANDOMIZED	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	0ALL	false	The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be st...	Palonosetron is a drug that is designed to prevent and treat nausea and vomiting that is caused by chemotherapy. If you are found to be eligible to take part in this study, you will have several blood samples taken (about 3 teaspoons each). Researchers will use the samples to monitor blood counts during chemotherapy a...	Sarcoma Nausea Vomiting	Sarcoma Palonosetron Aloxi Nausea Vomiting	null	2	arm 1: Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0). Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuou...	[ 1, 1 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 0.25 mg by vein for 1 dose (day 0). intervention 2: 0.25 mg by vein for 3 doses (days 0, 2, 4). intervention 3: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. intervention 4: Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose...	intervention 1: Palonosetron - Single Dose intervention 2: Palonosetron - Triple Dose intervention 3: Adriamycin intervention 4: Ifosfamide chemotherapy (AI) intervention 5: Zinecard intervention 6: Mesna intervention 7: Vincristine intervention 8: Dexamethasone	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	50	0	0	0	NCT00410488	1COMPLETED	2011-06-01	2006-12-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	60	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	Primary Objectives: * To determine the effectiveness of the 3-month depot leuprolide in inducing and maintaining secondary amenorrhea in patients undergo hematopoietic stem cell transplantation. * To determine the incidence of regained ovarian function manifested as spontaneous restoration of menstruation and normaliz...	All participants in this study will be scheduled for hematopoietic stem cell transplantation at The University of Texas (UT) MD Anderson Cancer Center. Within two months before the transplantation, all participants will have a medical history, physical exam, and blood tests for ovarian function and platelet count. Par...	Amenorrhea Premature Ovarian Failure Ovarian Function Insufficiency	Hematopoietic Stem Cell Transplantation GnRH Analogue Gonadotropin-releasing hormone analogue GnRH-a Ovarian Function Fertility Leuprolide Acetate Lupron Depot premature ovarian failure POF Abnormal suppression of menstruation absence of menstruation	null	1	arm 1: Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.	[ 0 ]	3	[ 0, 5, 3 ]	intervention 1: 22.5 mg IM injection 2 months before transplant and 3 months post-transplant. intervention 2: Questionnaires taking about 15 minutes to complete. intervention 3: Stem cell infusion on Day 0.	intervention 1: Leuprolide Acetate intervention 2: Questionnaire intervention 3: Hematopoietic Stem Cell Transplantation	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	59	0	0	0	NCT00429494	1COMPLETED	2011-06-01	2002-11-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	204	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall su...	null	Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.	nonsquamous	null	4	arm 1: Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm arm 2: Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm arm 3: Group of participants with NSCLC of squamous histology who were assign...	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity intervention 2: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle intervention 3: 500 mg/m² iv over 10 minutes on the first day of eac...	intervention 1: Pemetrexed intervention 2: Erlotinib intervention 3: Pemetrexed intervention 4: Erlotinib	23	Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Gauting \| N/A \| Germany \| 11.37703 \| 48.06919 Gerlingen \| N/A \| Germany \| 9.06316 \| 48.79954 Hamburg \| N/A \| Germany \| 9.99302 ...	204	0	0	0	NCT00447057	1COMPLETED	2011-06-01	2007-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	904	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)	During follow-up, it was determined that there was one additional patient on placebo that was still receiving treatment as of 06 APR 2010 and therefore 10 patients' data are reported in the current CSR addendum, 6 in the sorafenib + GC group and 4 in the placebo + GC group, and as before all in the ITT (non-squamous) p...	Carcinoma, Non-Small-Cell Lung	Non-Small Cell Lung Cancer (NSCLC) Cancer	null	2	arm 1: Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiol...	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV intervention 2: Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV in...	intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo intervention 3: Gemcitabine intervention 4: Cisplatin	122	Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brasschaat \| N/A \| Belgium \| 4.49182 \| 51.2912 Bruxelles - Brussel \| N/A \| Belgium \| N/A \| N/A Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 ...	901	0	0	0	NCT00449033	1COMPLETED	2011-06-01	2007-02-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 2, 3 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.	This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the patient received one therapeutic dose. In the phase 1 portion, the study employed a 3 + 3 dose escalation design. Enrollme...	Pheochromocytoma Paraganglioma	MIBG iobenguane iodine I 131 radiotherapy radiopharmaceutical dosimetry neuroendocrine tumor Ultratrace no carrier added metaiodobenzyl-guanidine	null	1	arm 1: Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD. The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT). An additional 3 patients are to be treated at the MTD, for a total of 6.	[ 0 ]	1	[ 0 ]	intervention 1: Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose	intervention 1: Ultratrace Iobenguane (MIBG) I 131	3	New York \| New York \| United States \| -74.00597 \| 40.71427 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	21	0	0	0	NCT00458952	1COMPLETED	2011-06-01	2007-04-01	Molecular Insight Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	86	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of canc...	OBJECTIVES: Primary * Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplantation or alemtuzumab in patients with advanced or progressive chronic lymphocytic leukemia. Secondary * Determine ...	Leukemia	stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia	null	2	arm 1: Category of risk will be defined according to biological features. arm 2: Category of risk will be defined according to biological features.	[ 0, 0 ]	7	[ 0, 0, 3, 0, 0, 0, 0 ]	intervention 1: Induction therapy intervention 2: Induction therapy intervention 3: Post-induction therapy intervention 4: Post-induction therapy intervention 5: Induction therapy intervention 6: Induction therapy intervention 7: Post-induction therapy	intervention 1: Fludarabine intervention 2: Campath intervention 3: Transplant intervention 4: Campath intervention 5: Fludarabine intervention 6: Campath intervention 7: Campath	23	Alessandria \| N/A \| Italy \| 8.61007 \| 44.90924 Bari \| N/A \| Italy \| 16.86982 \| 41.12066 Campobasso \| N/A \| Italy \| 14.66737 \| 41.55947 Catania \| N/A \| Italy \| 15.07041 \| 37.49223 Catanzaro \| N/A \| Italy \| 16.60086 \| 38.88247 Cosenza \| N/A \| Italy \| 16.25307 \| 39.2989 Ferrara \| N/A \| Italy \| 11.62057 \| 44.83804 Florence...	86	0	0	0	NCT00462332	1COMPLETED	2011-06-01	2007-05-01	Gruppo Italiano Malattie EMatologiche dell'Adulto	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Major depression is increasingly recognized to be a chronic and highly recurrent condition, which results in significantly increased health problems. One possible mechanism that may contribute to treatment resistance is increased production and release of chemicals called proinflammatory cytokines in patients with majo...	Major depression has become a health crisis of epidemic proportions in the modern world. The prevalence of major depression has risen over the last several generations in every country examined, and age of symptom onset has decreased. Currently the fourth leading health burden worldwide, major depression will rank seco...	Depression	depression TNF-alpha antagonist infliximab treatment resistant depression major depressive disorder (MDD) bipolar I disorder bipolar II disorder	null	2	arm 1: Participants in this arm will receive an infusion of infliximab. arm 2: Participants in this arm will receive an infusion of normal saline.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Participants will receive three infusions 5mg/kg of infliximab (at Baseline, Week 2 and Week 6) intervention 2: Participants will receive three infusions of a placebo (at Baseline, Week 2 and Week 6)	intervention 1: Infliximab intervention 2: Placebo	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	60	0	0	0	NCT00463580	1COMPLETED	2011-06-01	2008-12-01	Emory University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	62	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"	null	Pulmonary Hypertension	PAH iloprost Ventavis Pulmonary Arterial Hypertension Actelion Pharmaceuticals Cotherix	null	1	arm 1: The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm desi...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®. intervention 2: Period II: Iloprost inhalation solution ...	intervention 1: Iloprost PD-6 intervention 2: Iloprost PD-15	12	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 New York \| New York \| ...	62	0	0	0	NCT00467896	6TERMINATED	2011-06-01	2006-09-01	Actelion	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	122	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	null	This randomized phase II trial is studying the effect of esomeprazole magnesium and aspirin on tissue PGE2 levels compared with esomeprazole and placebo. This type of chemoprevention treatment investigates the use of certain drugs to assess whether they assist in the prevention of cancer. The use of esomeprazole magnes...	PRIMARY OBJECTIVES: I. To assess the effects of a 28 day intervention with aspirin 81 mg placebo orally (PO) once daily (QD) + aspirin 325 mg placebo PO QD + esomeprazole 40 mg PO BID versus aspirin 81 mg PO QD + aspirin 325 mg placebo PO QD + esomeprazole 40 mg PO BID versus aspirin 325 mg PO QD + aspirin 81 mg place...	Barrett Esophagus Esophageal Cancer		null	3	arm 1: Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily). arm 2: Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily). arm 3: Patients receive both an oral placebo and acetylsalicylic...	[ 1, 0, 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally	intervention 1: acetylsalicylic acid intervention 2: esomeprazole magnesium intervention 3: placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	120	0	0	0	NCT00474903	1COMPLETED	2011-06-01	2007-04-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of \<15mL/min will receive a red...	null	Hepatitis C, Chronic		null	1	arm 1: Eligible participants will be administered peginterferon alpha-2a \[Pegasys\] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of \<15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcut...	[ 0 ]	1	[ 0 ]	intervention 1: 180 micrograms or 135 micrograms sc weekly for 48 weeks	intervention 1: peginterferon alfa-2a [Pegasys]	5	Chita \| N/A \| Russia \| 113.50087 \| 52.03171 Irkutsk \| N/A \| Russia \| 104.29585 \| 52.29795 Khabarovsk \| N/A \| Russia \| 135.08822 \| 48.48032 Khabarovsk \| N/A \| Russia \| 135.08822 \| 48.48032 Orenburg \| N/A \| Russia \| 55.0988 \| 51.7727	27	0	0	0	NCT00474955	1COMPLETED	2011-06-01	2007-07-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3, 4 ]	39	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	3TRIPLE	false	0ALL	true	RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin. PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin.	OBJECTIVES: Primary Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin. Secondary Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidat...	Ototoxicity Unspecified Adult Solid Tumor		null	2	arm 1: Receiving alpha-lipoic acid during cisplatin treatment. arm 2: Receiving placebo during cisplatin treatment	[ 0, 2 ]	4	[ 0, 5, 2, 0 ]	intervention 1: Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment. intervention 2: otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and ...	intervention 1: alpha-lipoic acid intervention 2: Audiology intervention 3: laboratory biomarker analysis intervention 4: Placebo	2	Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	39	0	0	0	NCT00477607	1COMPLETED	2011-06-01	2007-10-01	US Department of Veterans Affairs	1FED	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	19	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying dasatinib to see how well it works in treating patients with previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.	PRIMARY OBJECTIVES: I. Determine the progression-free survival of patients with metastatic colorectal cancer who have progressed on or following two prior chemotherapy regimens and are then treated with dasatinib. SECONDARY OBJECTIVES: I. Determine the objective response rates in patients treated with dasatinib. II....	Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer		null	1	arm 1: Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 10 ]	intervention 1: None intervention 2: Correlative studies	intervention 1: dasatinib intervention 2: laboratory biomarker analysis	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	19	0	0	0	NCT00504153	1COMPLETED	2011-06-01	2007-07-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	161	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.	After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on S...	Epilepsies, Partial	Epilepsy partial seizures pregabalin monotherapy double-blind and randomized trial	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: pregabalin 600 mg/day (300mg BID), duration is 20 weeks. intervention 2: pregabalin 150 mg/day (75mg BID), duration is 20 weeks.	intervention 1: pregabalin 600 mg/day intervention 2: pregabalin 150 mg/day	73	Northport \| Alabama \| United States \| -87.57723 \| 33.22901 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Fayetteville \| Arkansas \| United States \| -94.15743 \| 36.06258 Fullerton \| California ...	161	0	0	0	NCT00524030	6TERMINATED	2011-06-01	2007-09-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study will examine the safety and effectiveness of ranitidine (Zantac) in patients with Hyper-IgE recurrent infection syndrome, a disease characterized by recurrent infections of the ears, sinuses, lungs and skin, and abnormal levels of the antibody immunoglobulin E (IgE). Patients age 2 and older who have Hyper-...	Hyper-immunoglobulin E (IgE) syndrome (HIES) is a rare primary immunodeficiency characterized by eczema, recurrent skin and lung infections, elevated serum IgE, and multiple connective tissue and skeletal abnormalities. The autosomal dominant form of HIES is caused primarily by a mutation in the STAT3 gene. Patients wi...	JOB's Syndrome Hyper-IgE Recurrent Infection Syndrome Immune Deficiency	Hyper-IgE Recurrent Infection Syndrome Ranitidine Therapy Job's Syndrome Cross-Over Study Double-Blind Placebo Controlled Hyper-IgE Syndrome Job Syndrome Immune Deficiency	null	2	arm 1: Patients took placebo for 12 months and then ranitidine for 12 months arm 2: Ranitidine for one year followed by placebo for one year	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Double blinded, randomized placebo controlled crossover study. Patients received 12 months of placebo and 12 months of treatment medication (ranitidine). intervention 2: None	intervention 1: Ranitidine intervention 2: Placebo	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	23	0	0	0	NCT00527878	6TERMINATED	2011-06-01	2007-09-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	32	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.	There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatm...	Carcinoma, Non-Small-Cell Lung		Prot_SAP_000.pdf: Copyright©2012 Fox Chase Cancer Center® Extramural Research Program. All rights reserved. FER-TH-007 Amendment 4 October 1, 2012 1 Phase II Study of Bevacizumab and Erlotinib in Elderly Patients with Advanced Non- Small Cell Lung Cancer Support Provided By Genentech, Inc. Principal Inve...	1	arm 1: bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: bevacizumab intervention 2: Erlotinib	7	Galloway \| New Jersey \| United States \| -74.47598 \| 39.48788 Mount Holly \| New Jersey \| United States \| -74.78766 \| 39.99289 Paoli \| Pennsylvania \| United States \| -75.47631 \| 40.04205 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 P...	32	0	0	0	NCT00553800	1COMPLETED	2011-06-01	2007-07-05	Fox Chase Cancer Center	7OTHER	true	true	false	https://cdn.clinicaltrials.gov/large-docs/00/NCT00553800/Prot_SAP_000.pdf	0	0	0	0	0	0	0	0
[ 5 ]	180	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	0ALL	false	This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creating 4 study arms; th...	The two treatment innovations in this study of immunosuppression in kidney transplantation are aimed at making the transplanted kidney function sooner and last longer than is usual with standard immunosuppression regimens, but without increasing the likelihood of rejection. The first innovation, delivering the inducti...	End-stage Renal Disease	Induction rATG Calcineurin-inhibitor withdrawal	null	4	arm 1: Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression. arm 2: Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for...	[ 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about t...	intervention 1: rabbit anti-thymocyte globulin - single dose intervention 2: mycophenolate mofetil intervention 3: rabbit anti-thymocyte globulin - 4 doses intervention 4: sirolimus intervention 5: tacrolimus	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	178	0	0	0	NCT00556933	1COMPLETED	2011-06-01	2004-04-01	University of Nebraska	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physical exams and laborat...	null	Rheumatoid Arthritis Interstitial Pneumonia	Rheumatoid Arthritis Interstitial Pneumonia Rheumatology Rituximab	null	1	arm 1: open label, all subjects will receive rituximab	[ 0 ]	1	[ 0 ]	intervention 1: Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.	intervention 1: Rituximab	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	10	0	0	0	NCT00578565	1COMPLETED	2011-06-01	2007-05-01	Eric Matteson	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma. Also, we pla...	Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib ...	Adenoid Cystic Carcinoma	Adenoid cystic carcinoma bortezomib doxorubicin	null	1	arm 1: Patients with incurable adenoid cystic carcinoma of the head and neck who receive doxorubicin and bortezomib	[ 5 ]	1	[ 0 ]	intervention 1: Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progress...	intervention 1: doxorubicin and bortezomib	21	Steubenville \| Ohio \| United States \| -80.63396 \| 40.36979 Beaver \| Pennsylvania \| United States \| -80.30478 \| 40.69534 Clairton \| Pennsylvania \| United States \| -79.88171 \| 40.29229 Greensburg \| Pennsylvania \| United States \| -79.53893 \| 40.30146 Greensburg \| Pennsylvania \| United States \| -79.53893 \| 40.30146 Indiana...	9	0	0	0	NCT00581360	1COMPLETED	2011-06-01	2007-11-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 2, 3 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Each year, there are over 400,000 cardiac surgical operations performed in the United States; of which 10,000 are performed on children. These operations are made possible by the use of the heart-lung bypass machine, also known as cardiopulmonary bypass. This machine allows for the body to be supported while the heart ...	I. Hypothesis Treatment of children during surgery employing cardiopulmonary bypass with inhaled, exogenous nitric oxide (iNO) delivered to the cardiopulmonary bypass circuit will: 1. Modulate ischemia/reperfusion injury 2. Influence endothelial dysfunction 3. Ameliorate the bypass-triggered systemic inflammatory res...	Congenital Heart Disease	Inhaled Nitric Oxide (NO) Anti-inflammatory Anti-reperfusion agent	null	2	arm 1: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued. arm 2: Placebo delivery of oxygen at standard dose.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.	intervention 1: Nitric Oxide	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	16	0	0	0	NCT00585013	1COMPLETED	2011-06-01	2008-01-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	274	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in the treatment of patients with ventilator-associated pneumonia.	This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), active-controlled (agent that is compared with a study medication to test whether the study medication has a real effect in a clinical study), double-dummy (plac...	Ventilator-Associated Pneumonia	Ventilator-Associated Pneumonia Pneumonia, hospital-acquired Doripenem Imipenem-cilastatin	null	2	arm 1: Doripenem from Days 1 to 7 and imipenem-cilastatin placebo from Days 1 to 10 arm 2: Imipenem-Cilastatin Days 1 to 10 and doripenem placebo from Days 1 to 7	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 4-hour infusion of doripenem will be administered every 8 hours for 7 days. intervention 2: Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 1-hour infusion of imipe...	intervention 1: Doripenem intervention 2: Imipenem-Cilastatin intervention 3: Placebo	100	Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Moline \| Illinois \| United States \| -90.51513 \| 41.5067 Hazard \|...	227	0	0	0	NCT00589693	6TERMINATED	2011-06-01	2008-04-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	31	RANDOMIZED	PARALLEL	2DIAGNOSTIC	4QUADRUPLE	false	2MALE	false	Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate infections, including prostate infections. It has been suggested that antibiotic treatment influences PSA levels due to the fact that an increase in PSA levels may be caused by inflammation or s...	This study is directed towards men who have been referred to the Urology clinic at the Johns Hopkins Outpatient Center in Baltimore, MD. If a patient fits the eligibility criteria and signs a consent form, the patient will have his blood drawn for the first PSA measurement. The patient must return to the Johns Hopkins ...	Prostate Infections	Prostate Specific Antigen (PSA) Elevated Prostate Specific Antigen (PSA)	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days intervention 2: Placebo twice a day for 14 days	intervention 1: Ciprofloxacin hydrochloride intervention 2: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	28	0	0	0	NCT00596453	6TERMINATED	2011-06-01	2008-01-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	8	NON_RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	true	2MALE	false	The study is being done to understand why some patients with epilepsy (disease of recurrence of seizures) do not respond very well to drug treatment with anticonvulsants. Despite the availability of many anticonvulsants, about 30% of patients with epilepsy are resistant to them. The cause of the resistance is not clea...	About 30% of patients with epilepsy are refractory to medical treatment (pharmacoresistant epilepsy). The cause of which is multifactorial. Multidrug resistance (MDR) causes decreased uptake of medicines in tissues. MDR occurs because of overexpression of a family of transporter proteins that act as a physiological def...	Epilepsy	pharmacoresistance healthy volunteers	null	2	arm 1: intravenous phenytoin alone arm 2: intravenous phenytoin plus probenecid	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: intravenous phenytoin (15 mg/kg) single dose intervention 2: intravenous phenytoin (15 mg/kg) single dose and oral probenecid 2000 mg single dose	intervention 1: phenytoin intervention 2: phenytoin and probenecid	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	15	0	0	0	NCT00610532	6TERMINATED	2011-06-01	2006-03-01	Jim McAuley	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 2, 3 ]	28	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.	null	Locally Advanced Non-Small Cell Lung Cancer	Proton Radiation	null	1	arm 1: Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks. Proton therapy - 76 Gy in 5 weeks to lung tumor.	[ 0 ]	3	[ 4, 0, 0 ]	intervention 1: A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy. intervention 2: 200 mg/m2, IV, ...	intervention 1: Proton Radiation Therapy intervention 2: Taxol intervention 3: Carboplatin	1	Loma Linda \| California \| United States \| -117.26115 \| 34.04835	28	0	0	0	NCT00614484	6TERMINATED	2011-06-01	1999-08-01	Loma Linda University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	16	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body a...	The study is an open-label study of 3-years duration. This study will be conducted at 4 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiret...	HIV Infection	Viral compartments integrase inhibitor therapy viral species	null	1	arm 1: tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day.	[ 0 ]	1	[ 0 ]	intervention 1: TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.	intervention 1: Tenofovir + emtricitabine + raltegravir.	4	Darlinghurst, Sydney \| New South Wales \| Australia \| N/A \| N/A Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785	16	0	0	0	NCT00641641	1COMPLETED	2011-06-01	2008-03-01	Kirby Institute	2OTHER_GOV	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	137	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medi...	Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medic...	HIV I Infection		null	2	arm 1: Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered int...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. intervention 2: Sterile water is used in place of Vacc-4x and in place of Leukine	intervention 1: Vacc-4x intervention 2: Sterile water	18	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Berlin \| State...	135	0	0	0	NCT00659789	1COMPLETED	2011-06-01	2008-08-01	Bionor Immuno AS	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	115	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorde...	This is a nonblinded, randomized phase II study to determine the activity of Novantrone (mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The Novantrone (mitoxantrone)-only treatment arm will serv...	Androgen-independent Prostate Cancer	Androgen-independent prostate cancer(AIPC)	null	2	arm 1: Erbitux (cetuximab) and Novantrone (mitoxantrone) arm 2: Novantrone (mitoxantrone)	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter intervention 2: Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all ...	intervention 1: cetuximab intervention 2: Mitoxantrone	55	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sedona \| Arizona \| United States \| -111.76099 \| 34.86974 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Melbourne \| Florida \| United States \| -80.60811 \| 28.08363 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Ocala \| Florida \| United...	114	0	0	0	NCT00661492	1COMPLETED	2011-06-01	2008-05-01	US Oncology Research	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3, 4 ]	631	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment	All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, approp...	Diabetes Mellitus, Type 2		null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Tablets, Oral, 10 mg, Once Daily, 104 weeks intervention 2: Tablets, Oral, 5 mg, Once Daily, 104 weeks intervention 3: Tablets, Oral, 0 mg, Once Daily, 104 weeks	intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo	96	Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Fresno \| California \| United States \| -119.77237 \| 36.74773 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Los Gatos \| California \| United States \| -121.97468 \| 37.22661 Northridge \| California \| United States \| -118.53675 \| 34.22834 Riverside \| Cali...	252	0	0	0	NCT00663260	1COMPLETED	2011-06-01	2008-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA administration and assessing the proportion of patients who experience a 50% decline in PSA.	This study is a phase II trial of NDGA in patients with hormone-sensitive non-metastatic prostate cancer with a pharmacokinetics component. The first six patients enrolled will be treated with a single 750 mg dose of oral NDGA on day -7 with measurement of pharmacokinetic parameters over eight hours after the dose, the...	Prostate Cancer	NDGA Prostate Cancer	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: NDGA 2000mg daily	intervention 1: Nordihydroguaiaretic Acid (NDGA)	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	12	0	0	0	NCT00678015	6TERMINATED	2011-06-01	2008-05-01	University of California, San Francisco	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a pso...	See Brief Summary	Moderate to Severe Psoriasis		null	1	arm 1: Investigational intervention without random assignment	[ 0 ]	1	[ 0 ]	intervention 1: Patients enrolled in this study will receive intralesional alefacept injections to a single psoriatic plaque at week 0. After a two week observation period, patients will receive 15 mg intramuscular alefacept for 12 weeks.	intervention 1: Intralesional Alefacept	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	18	0	0	0	NCT00678470	1COMPLETED	2011-06-01	2007-09-01	University of California, San Francisco	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	13	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections Study Design Randomized Controlled Trial Study Protocol Only those patients meeting al...	Ethanol Lock Technique Protocol (adapted from the Children's Hospital Los Angeles) 1. Obtain a 3ml syringe made by the Baystate Pharmacy which will contain either sterile 70% ethanol solution or 10 units/ml heparin flush solution. Randomization into study groups will be performed by the pharmacy in patient blocks of 1...	Bloodstream Infection	central line infection 70% ethanol Sepsis	null	2	arm 1: 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days. arm 2: heparin f...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. ...	intervention 1: 70% ethanol intervention 2: heparin flush solution	1	Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148	13	0	0	0	NCT00680459	6TERMINATED	2011-06-01	2008-05-01	Baystate Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	123	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	0ALL	true	This project will evaluate the clinical and cost effectiveness of a novel, multidisciplinary approach to identify and treat pre-clinical cardiac dysfunction (PCCD) in asymptomatic hypertensive patients identified in a single center urban emergency department. Premature onset of pressure-related cardiac complications of...	null	Hypertension High Blood Pressure Ventricular Hypertrophy Diastolic Dysfunction Systolic Dysfunction	Hypertension High blood pressure Pre-clinical cardiac dysfunction	null	2	arm 1: This arm will target a blood pressure of \< 140/90 mmHg (or \< 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. arm 2: This arm will target a more aggressive blood pressure t...	[ 1, 0 ]	10	[ 5, 5, 5, 5, 5, 0, 5, 5, 5, 0 ]	intervention 1: Blood pressure (BP) target of \< 140/90 mmHg (or \< 130/80 mmHg for diabetics or with chronic kidney disease) as recommended by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7). BP control efforts will be open-label and will include a com...	intervention 1: Exercise intervention 2: Exercise intervention 3: Weight Loss intervention 4: Low Sodium Diet intervention 5: Smoking Cessation intervention 6: Pharmaceutical Therapy (no specific therapy; approach guided by the JNC 7 protocol guidelines) intervention 7: Weight Loss intervention 8: Low Sodium Diet inter...	1	Detroit \| Michigan \| United States \| -83.04575 \| 42.33143	123	0	0	0	NCT00689819	1COMPLETED	2011-06-01	2008-10-01	Wayne State University	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 2 ]	48	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Heart failure affects over 5.3 million Americans and, while other cardiovascular diseases have enjoyed a reduction in mortality rates over the last decade, the mortality from heart failure continues to rise\[1\]. Thus, identifying novel therapies that can reduce heart failure development and/or progression are warrante...	Altered regulation of the transition-metal copper (Cu) may lead to an overproduction of reactive oxygen species (ROS) with subsequent development of a nonischemic cardiomyopathy (NISCM). Myocardial Cu levels are elevated in NISCM, and Cu levels are highest in the "diabetic cardiomyopathy." In humans, zinc (Zn) is an es...	Heart Failure Cardiomyopathies	Heart Failure Cardiomyopathy Remodeling Antioxidant Zinc Copper	null	2	arm 1: Patients with CHF received zinc acetate 50 mg po TID. This is a pre-post study arm 2: Health controls; no zinc acetate administered.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Zinc acetate 50 mg po TID for 10 months. Dose will be titrated to achieve ceruloplasmin levels \~10-12.	intervention 1: Zinc Acetate	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	48	0	0	0	NCT00696410	1COMPLETED	2011-06-01	2008-06-01	University of Michigan	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 2 ]	16	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will be given to patients. PF-04217903 is taken ...	The study was prematurely discontinued due to a strategic development decision by Pfizer on 10FEB2012. The decision to terminate was not based on any safety concerns.	Neoplasms		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg BID to 1000 mg BID. A cycle is considered to be 21 days	intervention 1: PF-04217903	6	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan...	16	0	0	0	NCT00706355	6TERMINATED	2011-06-01	2008-08-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	108	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will...	The sponsor internal decision has been taken to close the study on 15 of July 2011, due to difficulties in enrollment. This decision was not based on any safety issues.	Pneumonia, Bacterial	Hospital-acquired pneumonia Ventilator-associated pneumonia	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: An initial intravenous (IV) loading dose of 150 mg of tigecycline, followed by 75 mg of IV tigecycline approximately every 12 hours (q12h), for up to 14 consecutive days. Ceftazidime 2 g IV approximately every 8 hours, an aminoglycoside (tobramycin 7mg/kg daily or amikacin 20 mg/kg daily) and vancomycin...	intervention 1: tigecycline intervention 2: tigecycline intervention 3: imipenem/cilastatin	40	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953 La Plata \| Buenos Aires \| Argentina \| -57.95442 \| -34.92126 La Plata \| Buenos Aires \| Argentina \| -57.95442 \| -34.92126 Godoy Cruz \| Mendo...	105	0	0	0	NCT00707239	6TERMINATED	2011-06-01	2008-12-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	27	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	0NONE	false	1FEMALE	true	Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or chemotherapy are at risk for experiencing premature menopause because of their treatment. The resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's quality of life. Treatment for menopausa...	Roughly half of women diagnosed with pre-menopausal breast cancer will have hormone receptor-positive tumors, which will make them candidates for anti-estrogen therapies. Both endocrine therapy and ovarian ablation have also been shown to improve outcomes in this population. Hot flashes are a frequent side effect in w...	Breast Cancer Hot Flashes	hot flashes breast cancer Hypnotherapy Quality of Life Gabapentin	null	2	arm 1: Patients randomized to the experimental arm were scheduled for three one-hour inductions by a single hypnotherapist, each one week apart. Standardized outlines were used for each induction. The second and third sessions also began with a standardized induction, followed by the establishment of an "anchor," or ph...	[ 0, 1 ]	2	[ 5, 0 ]	intervention 1: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. surveys. The therapist will be prohibited from asking subjects about clinical responses to the hypnosis sessions. The patients wi...	intervention 1: Hypnotherapy intervention 2: gabapentin	1	Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	27	0	0	0	NCT00711529	1COMPLETED	2011-06-01	2008-07-01	Women and Infants Hospital of Rhode Island	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine if administering temozolomide after completion of stereotactic radiosurgery helps control existing brain metastases and prevents the developement of new brain metastases.	Brain metastases represent a heterogenous group of system tumors whose presence in the central nervous system result in profound neurological devastation. Existing therapies for brain metastases are focused on improving both neurologic function and survival. Therapies aimed at controlling the tumor both at the site of ...	Brain Metastases	Brain Metastases Temozolomide Temodar TMZ Stereotactic Radiosurgery SRS	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 75 mg/m2 taken by mouth once a day for 14 out of 28 consecutive days until progression or unacceptable toxicity.	intervention 1: Temozolomide	1	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163	3	0	0	0	NCT00717275	6TERMINATED	2011-06-01	2008-09-01	University of Florida	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 0 ]	28	NA	SINGLE_GROUP	null	0NONE	false	0ALL	false	The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.	Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medicati...	HIV Infections	HIV Raltegravir pharmacokinetics Treatment Experienced	null	1	arm 1: Raltegravir 400 mg tablets twice daily	[ 0 ]	1	[ 0 ]	intervention 1: 400 mg tablets twice daily during duration of trial	intervention 1: Raltegravir	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	16	0	0	0	NCT00745368	1COMPLETED	2011-06-01	2008-09-01	University of Rochester	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 5 ]	49	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.	This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomiza...	HIV Infections	lopinavir ritonavir atazanavir fosamprenavir darunavir anti-retroviral AIDS HIV LARD triglyceride protease inhibitors treatment Experienced	null	2	arm 1: We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this arm the sbject switched to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will co...	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study. intervention 2: We designed a study to determine if switching virologically suppressed patients on a regimen containing LP...	intervention 1: ATV/r intervention 2: DRV/r	11	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Minneapolis...	49	0	0	0	NCT00756730	1COMPLETED	2011-06-01	2008-09-01	Community Research Initiative of New England	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 3 ]	38	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.	Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.	Pulmonary Hypertension	primary pulmonary hypertension secondary pulmonary hypertension due to left heart failure secondary pulmonary hypertension due to other causes patients without pulmonary disease or pulmonary hypertension	null	1	arm 1: BQ-123	[ 0 ]	1	[ 0 ]	intervention 1: 6-120 µg/min	intervention 1: BQ-123	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	38	0	0	0	NCT00759408	1COMPLETED	2011-06-01	1999-02-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0	0	0
[ 4 ]	484	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when ad...	Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the schedule date of Week 76 visit (Visit 25) for the last randomized patients.	Diabetes Mellitus Type 2	hyperglycemia GLP-1 pioglitazone	null	2	arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end ...	[ 0, 2 ]	5	[ 0, 0, 1, 0, 0 ]	intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Dose to be kept stable. intervention 5: Metformin, if given to be...	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Pioglitazone intervention 5: Metformin	150	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| Unite...	484	0	0	0	NCT00763815	1COMPLETED	2011-06-01	2008-09-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	0	0	0	0	0	0

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