Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_wilson_lower_bound float32
[ 4 ]	298	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.	null	Breast Neoplasms		null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal intervention 2: take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal	intervention 1: exemestane intervention 2: anastrozole	47	Toyohashi \| Aiche \| Japan \| 137.38333 \| 34.76667 Anjo \| Aichi-ken \| Japan \| 137.08054 \| 34.95828 Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Toyoake \| Aichi-ken \| Japan \| 136.99931 \| 35.038 Toyota \| Aichi-ken \| Japan \| 137.15 \| 35.08333 Chiba \| Chiba \| Japan \| 140.11667 \| 35.6 Sakura \| Chiba \| Japan \| 140.23333 \|...	298	NCT00143390	1COMPLETED	2010-12-01	2005-04-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	1FEMALE	true	The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition an...	Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a horm...	Panhypopituitarism		null	2	arm 1: Transdermal Testosterone Gel (2 mg per pump), 2 pumps per day for 6 months arm 2: Placebo 2 pumps per day for 6 months	[ 0, 2 ]	1	[ 0 ]	intervention 1: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.	intervention 1: Transdermal Testosterone gel	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	20	NCT00144391	1COMPLETED	2010-12-01	2003-07-01	Charles Drew University of Medicine and Science	7OTHER	false	false	false	null	0
[ 3 ]	18	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.	Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies. The investigators propose to study 10 heal...	Congestive Heart Failure	metabolism congestive heart failure allopurinol Adenosine triphosphate (ATP)	null	2	arm 1: One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes. arm 2: One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: intravenous infusion of allopurinol (300mg) intervention 2: intravenous infusion of 50 ml dose of 5% dextrose	intervention 1: Allopurinol intervention 2: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	16	NCT00181155	1COMPLETED	2010-12-01	2004-11-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 0 ]	75	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels. Acromegaly results when an area in the brain, called the...	The aim of the study is to evaluate the effects of physiologic growth hormone (GH) replacement on cardiovascular risk markers, cardiac autonomic function, arterial distensibility, body composition, and quality of life in men and women with GH deficiency following treatment of acromegaly. We hypothesize that this popula...	Acromegaly Growth Hormone Deficiency Pituitary Disease	Acromegaly Growth Hormone Deficiency Cardiovascular Risk Pituitary Hypothalamic	null	4	arm 1: Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm. arm 2: Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm. arm 3: None arm 4: None	[ 1, 2, 4, 4 ]	2	[ 0, 0 ]	intervention 1: Starting dose based on age, sex, and estrogen status and ranged from 3-6 mcg/kg/day. GH doses were adjusted based on IGF-1 levels to target the mid-normal range for age. intervention 2: To maintain study-subject blinding, doses were sham adjusted.	intervention 1: Recombinant human growth hormone intervention 2: Saline	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	75	NCT00182091	1COMPLETED	2010-12-01	2004-08-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 3 ]	36	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)	To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).	Leukemia, Mast-Cell Mantle-cell Lymphoma		null	1	arm 1: Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD)	[ 0 ]	11	[ 3, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Total lymphoid irradiation (TLI) administered at 80cGy for 10 days intervention 2: Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses. intervention 3: Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total do...	intervention 1: Total lymphoid irradiation intervention 2: Rituximab intervention 3: Anti-thymoglobulin, rabbit (ATG, rabbit ATG) intervention 4: Cyclosporine intervention 5: Mycophenylate mofetil intervention 6: Filgrastim intervention 7: Granisetron intervention 8: Solumedrol intervention 9: Acetaminophen interventio...	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	35	NCT00186628	1COMPLETED	2010-12-01	2005-06-01	Stanford University	7OTHER	false	false	false	null	0
[ 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in ...	null	Non-Small Cell Lung Cancer Carcinoma		null	1	arm 1: Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs	[ 0 ]	3	[ 0, 0, 3 ]	intervention 1: 500 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs intervention 2: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs intervention 3: All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.	intervention 1: pemetrexed intervention 2: cisplatin intervention 3: Radical Non-Small Cell Lung Cancer (NSCLC) surgery	3	Bystra \| N/A \| Poland \| 19.05973 \| 49.76042 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977	30	NCT00191308	1COMPLETED	2010-12-01	2005-05-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	53	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	2MALE	true	The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplas...	The primary aim of this study is to determine whether correction of hypogonadism using a combination of testosterone and dutasteride spares subjects from increases in prostate size and symptoms of BPH which may be associated with T alone. We will also determine the effects of changes in serum T and dihydrotestosterone...	Hypogonadism Benign Prostatic Hyperplasia	androgen deficiency testosterone Benign Prostatic Hyperplasia hypogonadism prostate BPH	null	2	arm 1: Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily arm 2: Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Dutasteride 0.5 mg orally daily intervention 2: Testosterone gel 7.5 g daily topical intervention 3: placebo dutasteride orally daily	intervention 1: Dutasteride intervention 2: Testosterone gel intervention 3: Placebo dutasteride	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	53	NCT00194675	1COMPLETED	2010-12-01	2005-03-01	University of Washington	7OTHER	false	false	false	null	0
[ 5 ]	72	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.	The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observati...	Zollinger-Ellison Syndrome Multiple Endocrine Neoplasia		null	1	arm 1: This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this tre...	[ 0 ]	1	[ 0 ]	intervention 1: Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.	intervention 1: Lansoprazole (Prevacid)	0	null	72	NCT00204373	1COMPLETED	2010-12-01	2003-03-01	Charles Mel Wilcox, MD	7OTHER	false	false	false	null	0
[ 3 ]	48	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs...	PRIMARY OBJECTIVES: I. To evaluate the rate of complete or partial remission from treatment with a combination of lenalidomide and prednisone in patients with myelofibrosis with myeloid metaplasia. SECONDARY OBJECTIVES: I. To examine drug toxicity. II. To examine duration of response. III. To examine the effect of t...	Essential Thrombocythemia Polycythemia Vera Primary Myelofibrosis		null	1	arm 1: For courses 1 and 2, patients receive oral lenalidomide once daily and oral prednisone once daily on days 1-28. For course 3, patients receive oral lenalidomide once daily on days 1-28 and oral prednisone once on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Patients with stable or responding disea...	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given orally (PO) intervention 2: Given PO intervention 3: Correlative studies	intervention 1: lenalidomide intervention 2: prednisone intervention 3: laboratory biomarker analysis	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	47	NCT00227591	1COMPLETED	2010-12-01	2005-12-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 5 ]	1,701	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	There are many medications available for the treatment of high blood pressure (hypertension), but finding the right one for a specific patient can be challenging. In fact, it is estimated that only 34% of people with hypertension have their blood pressure under control. The hypothesis is that genetic differences betwee...	The proposed work should help move toward the long-term goal of selection of antihypertensive drug therapy based on a patient's genetic make-up. Hypertension (HTN) is the most common chronic disease for which drugs are prescribed, and the most prevalent risk factor for heart attack, stroke, renal failure and heart fail...	Hypertension	hypertension pharmacogenetics pharmacogenomics beta-blocker atenolol diuretic hydrochlorothiazide blood pressure metabolic adverse effects	null	2	arm 1: atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70 arm 2: HCTZ 12.5 mg then HCTZ 25 mg if BP \< 120/70, then add atenolol 50 mg if BP \< 120/70, then atenolol 100 mg if BP \< 120/70.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: atenolol 50 or 100 mg hydrochlorothiazide 12.5 or 25 mg intervention 2: atenolol 50 mg, then 100 mg if BP \< 120/70, then add HCTZ 12.5 mg if BP \< 120/70, then HCTZ 25 mg if BP \< 120/70	intervention 1: Hydrochlorothiazide intervention 2: Atenolol	3	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	768	NCT00246519	1COMPLETED	2010-12-01	2005-10-01	University of Florida	7OTHER	false	false	false	null	0
[ 4 ]	485	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.	null	Acute Myeloid Leukemia	Acute Myeloid Leukemia Dacogen Decitabine Poor or intermediate-risk cytogenetics	null	2	arm 1: Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.) arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one interv...	intervention 1: Cytarabine or Supportive Care intervention 2: Dacogen (decitabine) only	108	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Lakeland \| Florida \| United States \| -81.9498 \| 28.03947 Miami \| Florida \| U...	475	NCT00260832	1COMPLETED	2010-12-01	2005-11-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	28	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	true	The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.	The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood test...	Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Metastases	Zometa bone metastasis lung cancer non-small cell lung cancer small cell lung cancer bone metabolic markers tartrate resistant acid phosphatase	null	1	arm 1: 3.0-4.0 mg by IV (in the vein), once a month for 6 months	[ 0 ]	1	[ 0 ]	intervention 1: 3.0-4.0 mg by IV (in the vein), once a month for 6 months	intervention 1: zoledronic acid	1	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	28	NCT00265200	6TERMINATED	2010-12-01	2005-02-01	University of Louisville	7OTHER	false	false	false	null	0
[ 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	2MALE	false	This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.	Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks follo...	Prostate Cancer		null	1	arm 1: Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol	[ 0 ]	1	[ 0 ]	intervention 1: 250 ug/m2 daily for 2 weeks followed by 2 weeks of rest	intervention 1: GM CSF	1	Park Ridge \| Illinois \| United States \| -87.84062 \| 42.01114	15	NCT00274287	1COMPLETED	2010-12-01	2006-01-01	Oncology Specialists, S.C.	7OTHER	false	false	false	null	0
[ 3 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well giving O6-benzylguanine together with temozolomide works in treating young patients with recurrent or progressive gliomas or brain stem tumors. Drugs used in chemotherapy, such as O6-benzylguanine and temozolomide , work in different ways to stop the growth of tumor cells, eithe...	PRIMARY OBJECTIVES: I. Determine the sustained objective response rate to the combination of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brain stem tumors. SECONDARY OBJECTIVES: I. Determine the toxicity of this regimen in these patients. OUTLINE: Thi...	Brain and Central Nervous System Tumors	recurrent childhood brain stem glioma recurrent childhood brain tumor	null	1	arm 1: O6-benzylguanine (O6-BG) and temozolomide (TMZ)	[ 0 ]	2	[ 0, 0 ]	intervention 1: Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. O6-Benzylguanine, 120 mg/m\^2, will be administered as a one-hour intravenous (IV) infusion, daily for 5 days. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks f...	intervention 1: O6-benzylguanine intervention 2: temozolomide	11	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Durham \| North Carolina \| United States \| -78.89862 \| 3...	41	NCT00275002	1COMPLETED	2010-12-01	2006-02-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	26	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the potential benefit of adding Digoxin to erlotinib (Tarceva) treatment for patients with non-small cell lung cancer.	Non-small cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases. The majority of NSCLC patients have advanced disease at the time of diagnosis, which usually requires treatment beyond standard first-line chemotherapy. Until recently, patients were limited in the number of options available for second-line ...	Carcinoma, Non-Small Cell Lung	non-small cell lung cancer Erlotinib Digoxin	null	1	arm 1: Erlotinib plus Digoxin	[ 0 ]	1	[ 0 ]	intervention 1: Each subject will receive erlotinib and digoxin daily until progression.	intervention 1: Erlotinib plus Digoxin	0	null	24	NCT00281021	6TERMINATED	2010-12-01	2006-02-01	University of Louisville	7OTHER	false	false	false	null	0
[ 4 ]	228	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	2MALE	null	This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate * Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone ...	The study consisted of the following: * Randomization of eligible participants within 120 days of prostatectomy * For participants assigned to immediate therapy, a treatment period up to 18 months within 8 days of randomization * For participants assigned to deferred treatment, a treatment period up to 18 months after...	Prostatic Neoplasms		null	4	arm 1: Participants administered docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months immediately following prostatectomy. arm 2: Participants administered leuprolide acetate every 3 months for 18 months immediately following prostatectomy. arm 3: Participan...	[ 0, 1, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 75 mg/m\^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization. Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 dose...	intervention 1: Docetaxel (TAXOTERE®) Chemotherapy intervention 2: Leuprolide acetate ( ELIGARD®) Hormonal Therapy intervention 3: Docetaxel (TAXOTERE®) Chemotherapy intervention 4: Leuprolide acetate ( ELIGARD®) Hormonal Therapy intervention 5: Leuprolide acetate ( ELIGARD®) Hormonal Therapy	17	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Macquarie Park \| N/A \| Australia \| 151.12757 \| -33.78105 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Québec \| N/A \| Canada \| -71.21454 \| 46.81228 Paris \| N/A \| France \| 2.3488 \| 48.85341 Frankfurt \| N/A \| Ge...	138	NCT00283062	1COMPLETED	2010-12-01	2005-12-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk.	The study evaluates if a 6-month course of oral lovastatin at 80 mg/day (as 40 mg twice-a-day) would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk. Breast duct cytology was assessed as hyperplasia or hyperplasia with atypia, as measured by random periareolar fine needle aspira...	Breast Cancer	duct cytology	null	1	arm 1: Lovastatin 80 mg/day as 40 mg orally twice daily, for 6 months.	[ 0 ]	1	[ 0 ]	intervention 1: Lovastatin 80 mg/day as 40 mg orally twice daily. Lovastatin is approved by FDA as a cholesterol-lowering agent.	intervention 1: Lovastatin	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	30	NCT00285857	6TERMINATED	2010-12-01	2005-11-01	Stanford University	7OTHER	false	false	false	null	0
[ 5 ]	1,346	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.	Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to ...	Tobacco Dependence		null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 1, 1, 1, 1, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Decreasing dosages from 21 to 7 mg over 12 week period intervention 2: Decreasing dosage from 21 to 7 mg over 12 weeks intervention 3: 4 mg nicotine lozenge: dosage according to package directions for 16 weeks intervention 4: dosage according to prescription directions: 12 weeks intervention 5: dosage o...	intervention 1: nicotine patch intervention 2: nicotine patch intervention 3: nicotine lozenge intervention 4: bupropion intervention 5: patch + lozenge intervention 6: bupropion + lozenge	1	Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	1,346	NCT00296647	1COMPLETED	2010-12-01	2004-09-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 3, 4 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy ...	Profound osteopenia is a frequent and often irreversible complication of anorexia nervosa (AN). Adolescents with AN often have a reduced peak bone mass and are at increased risk for early osteoporosis and fractures. These young women have subnormal serum levels of gonadal steroids and the adrenal androgen dehydroepiand...	Anorexia Nervosa	anorexia nervosa adolescents dual-energy x-ray absorptiometry dehydroepiandrosterone (DHEA) osteoporosis	null	2	arm 1: Placebo (sugar pill); identical to treatment medication capsule arm 2: Combined therapy of dehydroepiandrosterone (DHEA) and hormone replacement therapy (ERT). Patients randomized to the DHEA + HRT arm will receive micronized oral DHEA in a dose of 50 mg daily + HRT (0.3 mg Premarin, 1 tablet daily for 3 months,...	[ 2, 0 ]	3	[ 0, 10, 0 ]	intervention 1: Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel) intervention 2: Placebo (sugar pill) intervention 3: 50 mg tablet, 1 daily	intervention 1: Hormone replacement therapy (estrogen/progestin) intervention 2: Placebo (Sugar Pill) intervention 3: Dehydroepiandrosterone (DHEA)	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	80	NCT00310791	1COMPLETED	2010-12-01	2004-04-01	Boston Children's Hospital	7OTHER	false	false	false	null	0
[ 0 ]	28	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Objective: To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy. Background: Diabetic nephropathy is a world wide public health concern of increasing prop...	null	Type 2 Diabetes Overt Diabetic Nephropathy	type 2 diabetes, glomerular filtration rate, renal plasma flow, endothelial dysfunction, proteinuria, diabetic nephropathy	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 4 mg tablets, bid, 12 months intervention 2: 2 tablets per day	intervention 1: Rosiglitazone intervention 2: Placebo	1	Dresden \| N/A \| Germany \| 13.73832 \| 51.05089	28	NCT00324675	1COMPLETED	2010-12-01	2006-08-01	Technische Universität Dresden	7OTHER	false	false	false	null	0
[ 4 ]	354	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key ...	null	Pulmonary Hypertension	Pulmonary Arterial Hypertension	null	2	arm 1: Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets. arm 2: Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours intervention 2: Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours	intervention 1: Oral treprostinil (UT-15C) sustained release tablets intervention 2: Placebo	72	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 Sacramento \| Cali...	350	NCT00325442	1COMPLETED	2010-12-01	2006-10-01	United Therapeutics	4INDUSTRY	false	false	false	null	0
[ 0 ]	41	NON_RANDOMIZED	SEQUENTIAL	4SUPPORTIVE_CARE	0NONE	false	0ALL	false	RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron hydrochloride, and palonosetron hydrochloride, may help lessen or prevent nausea and vomiting caused by chemotherapy. PURPOSE: This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride ...	PRIMARY OBJECTIVES: I. To determine the proportion of patients achieving a complete response (CR), defined as no emesis and no rescue medications in the 0-24 hour time period following weekly intravenous doxorubicin. SECONDARY OBJECTIVES: I. To determine the proportion of patients achieving a complete response (CR),...	Male Breast Cancer Nausea and Vomiting Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer		null	2	arm 1: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride). arm 2: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide...	[ 1, 0 ]	9	[ 0, 0, 0, 0, 3, 3, 3, 0, 10 ]	intervention 1: Given IV intervention 2: Given orally intervention 3: Given orally or IV intervention 4: Given IV intervention 5: Ancillary studies intervention 6: Given IV intervention 7: Given IV intervention 8: Given IV intervention 9: Ancillary studies	intervention 1: palonosetron hydrochloride intervention 2: cyclophosphamide intervention 3: dexamethasone intervention 4: doxorubicin hydrochloride intervention 5: quality-of-life assessment intervention 6: nausea and vomiting therapy intervention 7: management of therapy complications intervention 8: ondansetron hydro...	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	41	NCT00343863	1COMPLETED	2010-12-01	2006-01-01	University of Washington	7OTHER	false	false	false	null	0
[ 4 ]	956	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.	null	Diabetic Macular Edema		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 3 ]	3	[ 0, 0, 3 ]	intervention 1: 0.5 mg fluocinolone acetonide intravitreal insert intervention 2: 0.2 mg fluocinolone acetonide intravitreal insert intervention 3: Laser photocoagulation	intervention 1: fluocinolone acetonide intervention 2: Fluocinolone Acetonide intervention 3: Standard of care laser photocoagulation	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	953	NCT00344968	1COMPLETED	2010-12-01	2007-09-01	Alimera Sciences	4INDUSTRY	false	false	false	null	0
[ 5 ]	60	NON_RANDOMIZED	SINGLE_GROUP	1PREVENTION	1SINGLE	false	0ALL	null	Comparison of 1 day versus 1 hour application of topical Zymar.	null	Ophthalmic Surgery		null	1	arm 1: presence of conjunctival bacteria 1 hour after administration of topical gatifloxacin	[ 1 ]	1	[ 0 ]	intervention 1: zymar qid	intervention 1: Zymar	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	60	NCT00350363	1COMPLETED	2010-12-01	2007-01-01	Stanford University	7OTHER	false	false	false	null	0
[ 2 ]	181	RANDOMIZED	FACTORIAL	0TREATMENT	2DOUBLE	true	0ALL	true	This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).	This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatmen...	Cocaine Abuse	disulfiram cognitive behavioral therapy contingency management drug abuse therapy educational/resource design/development	null	4	arm 1: Placebo (plus Cognitive Behavioral Therapy- CBT) arm 2: Disulfiram (plus CBT) arm 3: Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). arm 4: Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).	[ 2, 1, 2, 1 ]	4	[ 0, 0, 5, 0 ]	intervention 1: 250mg per day of Disulfiram plus CBT intervention 2: Placebo plus CBT intervention 3: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT intervention 4: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance p...	intervention 1: disulfiram intervention 2: Placebo intervention 3: Placebo plus Contingency Management intervention 4: Disulfiram plus Contingency Management	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	99	NCT00350870	1COMPLETED	2010-12-01	2005-04-01	Yale University	7OTHER	false	false	false	null	0
[ 3 ]	21	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well belinostat works in treating patients with myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.	OBJECTIVES: I. Establish the efficacy and safety of PXD101 (belinostat) in patients with myelodysplastic syndromes that progressed after or is ineligible for azacitidine treatment. II. Assess the biological activity of PXD101 in these patients via assays of histone acetylation, gene expression profiling, and DNA meth...	de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes		null	1	arm 1: Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.	[ 0 ]	1	[ 0 ]	intervention 1: Given IV	intervention 1: belinostat	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	21	NCT00357162	1COMPLETED	2010-12-01	2006-05-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well vorinostat works in treating patients with locally recurrent or metastatic cancer of the urothelium.	PRIMARY OBJECTIVES: I. To determine response rate measured by RECIST criteria for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. SECONDARY OBJECTIVES: I. To determine the time to progression and overall survival for SAHA in patients with recurrent or metastatic transitio...	Localized Transitional Cell Cancer of the Renal Pelvis and Ureter Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Regional Transitional Cell Cancer of the Renal Pelvis and Ureter Transitional Cell Carcinoma of the Bladder		null	1	arm 1: Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Correlative studies	intervention 1: vorinostat intervention 2: laboratory biomarker analysis	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	14	NCT00363883	6TERMINATED	2010-12-01	2006-06-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 4 ]	398	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 \[NCT00160165\] or N01221 \[NCT00280696\].	null	Epilepsies Partial	Epilepsies Partial Keppra levetiracetam	null	1	arm 1: Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).	[ 0 ]	1	[ 0 ]	intervention 1: Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).	intervention 1: Levetiracetam	53	Aichi-gun \| Aichi-ken \| Japan \| N/A \| N/A Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Hirosaki \| Aomori \| Japan \| 140.4725 \| 40.59306 Matsudo \| Chiba \| Japan \| 139.90144 \| 35.77995 Kitakyushu \| Fukuoka \| Japan \| 130.85034 \| 33.85181 Koga \| Fukuoka \| Japan \| 130.46667 \| 33.73333 Kurume \| Fukuoka \| Japan \| 130.5166...	398	NCT00367432	1COMPLETED	2010-12-01	2006-07-01	UCB Japan Co. Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	61	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	null	This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cance...	PRIMARY OBJECTIVES: I. Compare the change in histologic grade of bronchial dysplasia, as determined from mucosal biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscopy exams, in current or former smokers with bronchial dysplasia treated with sulindac vs placebo. SECONDARY OBJECTIVES: ...	Precancerous Condition Stage I Non-small Cell Lung Cancer Tobacco Use Disorder		null	2	arm 1: Patients receive oral sulindac twice daily for 6 months. arm 2: Patients receive oral placebo twice daily for 6 months.	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Given orally	intervention 1: sulindac intervention 2: placebo	6	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Burlington \| Massachusetts \| United States \| -71.19561 \| 42.50482 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Vancouver \| British Col...	61	NCT00368927	1COMPLETED	2010-12-01	2006-08-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 0 ]	13	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	1FEMALE	false	The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal status (NRFS). Our hypothesis is that treatment of...	This trial is a randomized, non-placebo controlled, assessment of whether acetaminophen can lower maternal temperature and baseline fetal heart rate in laboring patients with fetal tachycardia. Term singleton cephalic pregnancies in active phase labor (spontaneous or induced) with fetal tachycardia will be recruited. ...	Fever Heart Rate, Fetal (FHR)	Fetal tachycardia Fever in labor Acetaminophen Non reassuring fetal status	null	2	arm 1: None arm 2: Acetaminophen 975 mg once	[ 4, 1 ]	1	[ 0 ]	intervention 1: Acetaminophen 975 mg by mouth once only	intervention 1: Acetaminophen 975 mg	1	Flushing \| New York \| United States \| -73.81736 \| 40.76538	13	NCT00377832	6TERMINATED	2010-12-01	2007-07-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0
[ 3, 4 ]	277	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sug...	The primary objective of the first stage of the TINSAL-T2D trial is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The trial is a multicenter, single mask lead-in, double masked placebo controlled dose ranging study, comparing salsalte to place...	Type 2 Diabetes	Type 2 Diabetes Inflammation Obesity Metabolic Syndrome	null	4	arm 1: Placebo, appearance matched to active drug arm 2: Salsalate 3.0 grams daily, divided arm 3: Salsalate 3.5 g daily, divided arm 4: Salsalate 4.0 g daily, divided	[ 2, 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided intervention 2: Placebo to Salsalate	intervention 1: Salsalate intervention 2: Placebo	16	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Il...	108	NCT00392678	1COMPLETED	2010-12-01	2006-10-01	Joslin Diabetes Center	7OTHER	false	false	false	null	0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The goal of this clinical research study is to learn if cetuximab can help to control the disease in patients who have recurrent endometrial cancer. Primary Objective: 1\. To determine the overall disease control rate of cetuximab in patients with progressive or recurrent endometrial cancer. Secondary Objectives: 1...	The epidermal growth factor receptor (EGFR) is a large protein that plays an important role in tumor growth. When EGFR is stimulated or "overexpressed," a series of chemical reactions happen that result in a tumor being "told" to grow. Researchers know that EGFR is overexpressed in many types of endometrial cancer. Cet...	Endometrial Cancer	Endometrial Cancer Progressive or Recurrent Endometrial Cancer Cetuximab C225 Erbitux™ IMC-C225 Epidermal growth factor receptor EGFR Endometrioid Tumor Serous Tumor Clear cell Tumor Mixed malignant Mullerian Tumors	null	1	arm 1: 400 mg/m\^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m\^2 IV over 60 minutes.	[ 0 ]	1	[ 0 ]	intervention 1: Initial Dose = 400 mg/m\^2 IV Over 120 Minutes, Followed by Weekly Infusions at 250 mg/m\^2 IV Over 60 Minutes.	intervention 1: Cetuximab	2	New York \| New York \| United States \| -74.00597 \| 40.71427 Houston \| Texas \| United States \| -95.36327 \| 29.76328	33	NCT00392769	1COMPLETED	2010-12-01	2006-10-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 2, 3 ]	67	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.	Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound, 130 nanometer particle form of paclitaxel designed to avoid the problems associated with solvents used in Taxol(Abraxane prescribing information 2005). Albumin has a number of properties that make it an attractive molecule to combine with paclitaxel. Alb...	Metastatic Pancreatic Cancer	Metastatic Pancreatic Cancer, Abraxane, Gemcitabine	null	3	arm 1: Participants received albumin-bound paclitaxel 100 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity. arm 2: Participants received albumin-bound paclitaxel 125...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Administered by intravenous infusion over 30 minutes. intervention 2: Administered by intravenous infusion over 30 minutes.	intervention 1: Gemcitabine intervention 2: Albumin-bound paclitaxel	5	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	67	NCT00398086	1COMPLETED	2010-12-01	2006-11-01	Celgene	4INDUSTRY	false	false	false	null	0
[ 3 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if the addition of the medication, deferasirox, to standard antifungal therapy for the infection, mucormycosis, is safe and effective	Because of its extremely high morbidity and mortality, it is imperative to look for new antifungal therapies to treat mucormycosis. The agents of mucormycosis are exquisitely sensitive to iron availability, and we and others have demonstrated that iron chelation therapy improves the survival of rodents with mucormycosi...	Mucormycosis	zygomycosis Rhizopus iron iron-chelation adjunctive therapy	null	2	arm 1: Deferasirox arm 2: None	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 20 mg/kg enterally per day intervention 2: None intervention 3: None	intervention 1: deferasirox intervention 2: Placebo intervention 3: Liposomal amphotericin B	7	Duarte \| California \| United States \| -117.97729 \| 34.13945 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Houston \| Texas \| Unite...	20	NCT00419770	1COMPLETED	2010-12-01	2007-10-01	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	551	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 ...	null	Hepatitis B, Chronic		null	4	arm 1: Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. arm 2: Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. arm 3: Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. arm 4: Participant...	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: 90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.	intervention 1: peginterferon alfa-2a [Pegasys]	55	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 San Jose \| California \| United States \| -121.89496 \| 37.33939 ...	547	NCT00435825	1COMPLETED	2010-12-01	2007-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	750	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease m...	The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 mon...	Smoking Cessation		null	3	arm 1: High intensity disease management, free nicotine replacement therapy or bupropion arm 2: Low intensity disease management, free nicotine replacement therapy or bupropion arm 3: Comparison group, free nicotine replacement therapy or bupropion	[ 0, 0, 5 ]	4	[ 5, 5, 5, 0 ]	intervention 1: Health education mailings, 6 motivation interviews/counseling intervention 2: Health education mailings, one motivation interview/counseling intervention 3: Health education mailings intervention 4: Buproprion or Nicotine Replacement Therapy	intervention 1: High intensity disease management intervention 2: Low intensity disease management intervention 3: Comparison group intervention 4: Bupropion	1	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417	750	NCT00440115	1COMPLETED	2010-12-01	2009-06-01	University of Kansas Medical Center	7OTHER	false	false	false	null	0
[ 0 ]	122	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary aim is to determine the difference in hospital length of stay between septic patients given etomidate and those given midazolam for induction during rapid sequence intubation (RSI) in the emergency department. To achieve this aim we plan to perform a prospective randomized trial measuring the length of stay...	Rationale: Although the use of the drug etomidate for continuous sedation in mechanically ventilated patients was found to have detrimental effects on patient mortality shortly after its introduction into clinical practice, etomidate continues to be widely used as an induction agent for endotracheal intubation. Recent ...	Sepsis Trauma	Sepsis Etomidate midazolam ketamine	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Etomidate at induction dose based on weight intervention 2: Midazolam at induction dose based on weight	intervention 1: Etomidate intervention 2: midazolam	1	Oak Lawn \| Illinois \| United States \| -87.75811 \| 41.71087	120	NCT00441792	1COMPLETED	2010-12-01	2007-10-01	Advocate Hospital System	7OTHER	false	false	false	null	0
[ 5 ]	54	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent tre...	Stopping and restarting highly active antiretroviral therapy (HAART) is not generally recommended because it has the potential to allow drug-resistant HIV to emerge. However, to prevent mother-to-child transmission (MTCT), HIV infected women who are pregnant are temporarily put on HAART, even if HIV treatment is not in...	HIV Infections		null	1	arm 1: Participants will efavirenz (600mg in pill form, taken orally, once daily) and emtricitabine/tenofovir disoproxil fumarate (200/300mg in pill form, taken orally, once daily), for 48 weeks	[ 0 ]	2	[ 0, 0 ]	intervention 1: 600-mg tablet taken orally daily intervention 2: 200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily	intervention 1: Efavirenz intervention 2: Emtricitabine/Tenofovir disoproxil fumarate	9	San Diego \| California \| United States \| -117.16472 \| 32.71571 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Chapel Hill \| Nor...	54	NCT00442962	1COMPLETED	2010-12-01	2007-05-01	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	5NETWORK	false	false	false	null	0
[ 5 ]	5	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	We will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. The study will provide six months of antidepressant pharmacotherapy as well as psycho...	Suicide is a significant public health problem. Depression, alcoholism (abuse or dependence), and a prior suicide attempt are risk factors for suicide. However, little information exists to guide clinicians in the choice of antidepressant medication for patients with comorbid major depression and alcoholism who are at ...	Depression Alcoholism Suicidal Behavior	Major depressive disorder Alcohol abuse Alcohol dependence Suicide	null	2	arm 1: fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings arm 2: bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relaps...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 6 months intervention 2: 6 months	intervention 1: fluoxetine intervention 2: bupropion	1	New York \| New York \| United States \| -74.00597 \| 40.71427	5	NCT00449007	6TERMINATED	2010-12-01	2006-02-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0
[ 3 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	true	This randomized phase II trial is studying how well pazopanib hydrochloride works after leuprolide or goserelin in treating patients with relapsed prostate cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. A...	PRIMARY OBJECTIVES: I. Determine if pazopanib hydrochloride is able to increase time to progression, as measured by prostate-specific antigen (PSA), after 6 months of limited gonadotropin-releasing hormone (GnRH) agonist therapy comprising leuprolide acetate or goserelin in patients with androgen-sensitive relapsed st...	Recurrent Prostate Cancer		null	2	arm 1: Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients undergo observation after treatment with leuprolide acetate and goserelin acet...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Given PO intervention 2: None intervention 3: None	intervention 1: pazopanib hydrochloride intervention 2: leuprolide acetate intervention 3: goserelin acetate	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	37	NCT00454571	1COMPLETED	2010-12-01	2006-06-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 5 ]	71	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.	Older people living in nursing homes do not sleep very well for many reasons including pain, sleep disorders like sleep apnea (when someone briefly stops breathing during sleep) and night time urination, as well as the environmental disturbances caused by living in the nursing home, such as noise and disruptive care ro...	Poor Quality Sleep	Aging Sleep Nursing Home Sleep in nursing homes	null	2	arm 1: Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration. arm 2: Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention. Weeks 3 and 4 this Placebo group crosses...	[ 0, 2 ]	1	[ 0 ]	intervention 1: Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4. Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.	intervention 1: Lunesta	0	null	31	NCT00460993	1COMPLETED	2010-12-01	2005-06-01	Emory University	7OTHER	false	false	false	null	0
[ 4 ]	196	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an im...	null	Sepsis		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs. intervention 2: NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day ...	intervention 1: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®" intervention 2: 0.9 % NaCl	24	Amiens \| N/A \| France \| 2.3 \| 49.9 Avignon \| N/A \| France \| 4.80892 \| 43.94834 Belfort \| N/A \| France \| 6.85385 \| 47.64218 Bicêtre \| N/A \| France \| 4.44181 \| 45.37764 Bobigny \| N/A \| France \| 2.45012 \| 48.90982 Bourg-en-Bresse \| N/A \| France \| 5.2258 \| 46.20574 Charleville-Mézières \| N/A \| France \| 4.72487 \| 49.7685 Co...	196	NCT00464204	1COMPLETED	2010-12-01	2007-07-01	Fresenius Kabi	4INDUSTRY	false	false	false	null	0
[ 0 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following ...	This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it wi...	Autism	Aggression Irritability Global severity	null	2	arm 1: Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. arm 2: The placebo will be dispensed to subjects in the control group	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. intervention 2: Same dosage as that of omega 3 fatty acids	intervention 1: Omega 3 fatty acids intervention 2: Placebo	1	Piscataway \| New Jersey \| United States \| -74.39904 \| 40.49927	17	NCT00467818	1COMPLETED	2010-12-01	2007-01-01	University of Medicine and Dentistry of New Jersey	7OTHER	false	false	false	null	0
[ 5 ]	577	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.	null	Toothache		null	3	arm 1: Placebo control arm 2: 10% benzocaine gel formulation arm 3: 20% benzocaine gel formulation	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: single dose (less than 1g) of a matching placebo gel intervention 2: single dose (less than 1g) of 10% benzocaine gel formulation intervention 3: single dose (less than 1g) of 20% benzocaine gel formulation	intervention 1: Placebo gel intervention 2: benzocaine intervention 3: benzocaine	8	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| New York \| United States \| -74.00597 \| 40.71427 Columbus \| Ohio \| Unite...	576	NCT00474175	1COMPLETED	2010-12-01	2007-05-01	Wyeth is now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0
[ 0 ]	218	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	true	0ALL	false	Retinal optical coherence tomography (OCT) is an established technology which enables a detailed cross-sectional visualization of the retinal micro-anatomy, and an objective measurement of its thickness in-vivo. Multifocal electroretinogram (MfERG) measures function of the central retina. Both technologies are relative...	Normal optical coherence tomography (OCT) and Multifocal electroretinogram (MfERG) measurements may vary with race, age, sex, parity and the use of hormone therapy in health. It has therefore been recommended to gather normative data on the individual OCT/MfERG equipment in each laboratory. This is the reason why we ga...	Uveitis Iritis Iridocyclitis Anterior Uveitis Macular Edema	Uveitis Iritis Macular Thickness HLA-B27 related Macular edema Macular thickening OCT mfERG Eye drops Dexamethosone Diclofenac Retinal aging	null	2	arm 1: Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT . arm 2: Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in o...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Preservative- free Diclofenac Na 0.1% eye drops (Voltaren Ophta SDU;Novartis Pharms). One drop four times daily in one eys for three days. The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention des...	intervention 1: Diclofenac intervention 2: Dexamethasone	2	Trondheim \| N/A \| Norway \| 10.39506 \| 63.43049 Trondheim \| N/A \| Norway \| 10.39506 \| 63.43049	0	NCT00476593	1COMPLETED	2010-12-01	2005-09-01	Norwegian University of Science and Technology	7OTHER	false	false	false	null	0
[ 3 ]	51	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study wi...	null	Metastatic Breast Cancer Neoplasms, Breast	dual kinase inhibitor, EGFR/ErbB1, ErbB2-overexpressing, GW572016, advanced/metastatic breast cancer, Lapatinib, HER-2/new, pharmacokinetics	null	1	arm 1: Lapatinib 1250mg once daily +capecitabine 2000mg/m\^2 twice daily (14 days out of 21 days)	[ 0 ]	2	[ 0, 0 ]	intervention 1: 1250mg once daily intervention 2: 2000mg/m\^2 twice daily (14 days out of 21 days)	intervention 1: Lapatinib intervention 2: capecitabine	15	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Ehime \| N/A \| Japan \| N/A \| N/A Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hokkaido \| N/A \| Japan \| N/A \| N/A Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Kagoshima \| N/A \| Japan \| 130.55 \| 31.56667 Osaka \| N/A \| Japan \| 135.50107 \| 34.6937...	51	NCT00477464	1COMPLETED	2010-12-01	2007-06-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	1	NA	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	0ALL	true	The purpose of this research study is to determine whether an experimental drug called AMD3100 used in combination with another medication called G-CSF is safe and can help to increase the amount of blood stem cells (called CD34+ stem cells) found in the peripheral blood of patients with Fanconi anemia. While AMD3100 h...	Fanconi anemia is a rare autosomal recessive syndrome comprised of progressive bone marrow failure, congenital anomalies and a predisposition to malignancy. The heterozygote rate in the United States may be as high as 1 in 300. The mean age for the onset of aplastic anemia is approximately eight years. Although improve...	Fanconi Anemia		null	1	arm 1: None	[ 0 ]	2	[ 0, 1 ]	intervention 1: 240 mcg/kg subcutaneously, minimum of two days; maximum of eight days intervention 2: CD34+ cell selection from peripheral collection	intervention 1: AMD3100 intervention 2: AmCell CliniMACs	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	1	NCT00479115	1COMPLETED	2010-12-01	2007-05-01	Children's Hospital Medical Center, Cincinnati	7OTHER	false	false	false	null	0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells ...	OBJECTIVES: Primary * Determine the response rate in patients with advanced hepatocellular carcinoma and hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab. Secondary * Determine the safety of this regimen in these patients. * Determine the overall survival of patients treated with this regim...	Liver Cancer	advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma	null	1	arm 1: Single Arm Trial	[ 5 ]	3	[ 2, 0, 0 ]	intervention 1: 250 mg/m2, intravenously, once per week intervention 2: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle. intervention 3: 130 mg/m2, intravenously on Day 1 of each 21 day cycle	intervention 1: cetuximab intervention 2: capecitabine intervention 3: oxaliplatin	1	Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132	29	NCT00483405	1COMPLETED	2010-12-01	2006-10-01	UNC Lineberger Comprehensive Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	217	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.	null	Rheumatoid Arthritis		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 mi...	intervention 1: Abatacept	39	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Goshogawara-Shi \| Aomori \| Japan \| N/A \| N/A Chiba \| Chiba \| Japan \| 140.11667 \| 35.6 Fukui-shi \| Fukui \| Japan \| 136.22257 \| 36.06443 Fukui-shi \| Fukui \| Japan \| 136.22257 \| 36.06443 Fukui-shi \| Fukui \| Japan \| 136.2225...	217	NCT00484289	1COMPLETED	2010-12-01	2006-12-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	-0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of t...	An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle. The dose may be escalated at the investigator's discretion. Treatment will be continued until there is ...	Liver Cancer	Hepatocellular cancer (HCC) Sunitinib malate Vascular endothelial growth factor (VEGF) Platelet-derived growth factor (PDGF) Tyrosine kinases Liver	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.	intervention 1: Sunitinib Malate	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	33	NCT00495625	6TERMINATED	2010-12-01	2006-10-01	H. Lee Moffitt Cancer Center and Research Institute	7OTHER	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with lapatinib before...	OBJECTIVES: Primary * To determine the pathological complete response in patients with HER2-positive and hormone receptor-positive operable stage I-III breast cancer. Secondary * To determine tumor cell apoptosis in situ as measured by TUNEL analysis of tumor sections from fresh frozen or paraffin-embedded core bio...	Breast Cancer	stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer	null	2	arm 1: Patients receive Lapatinib and Letrozole once daily for two weeks, following tumor measurement patients receive Lapatinib and Letrozole once daily for 14 weeks. arm 2: Patients receive Letrozole and placebo once daily for 2 weeks, following tumor measurement patients receive Letrozole and Lapatinib once daily fo...	[ 0, 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given once daily, 1500mg, for 2 weeks; Given once daily, 1500mg, for 14 weeks in Arm II intervention 2: Given once daily, 2.5mg, for 2 weeks; Given once daily, 2.5mg, for 14 weeks intervention 3: Given once daily for 2 weeks	intervention 1: lapatinib ditosylate intervention 2: letrozole intervention 3: placebo	4	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	6	NCT00499681	6TERMINATED	2010-12-01	2007-07-01	Vanderbilt-Ingram Cancer Center	7OTHER	false	false	false	null	0
[ 0 ]	300	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus. In addition, this study will evaluate the efficiency of commonly prescribed decol...	Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections...	Abscesses Furunculosis Staphylococcus Aureus Staphylococcal Skin Infections		null	4	arm 1: Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") arm 2: Application of mupirocin in the nasal mucosa alone arm 3: A combination of nasal application of mupirocin and chlorhexidine showers arm 4: A combination of nasal application of mu...	[ 1, 1, 1, 1 ]	4	[ 0, 6, 3, 5 ]	intervention 1: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. intervention 2: Apply Clorhexidine wash to entire body once daily for 5 days. intervention 3: Pour 2 ounces of bleach in...	intervention 1: Mupirocin ointment intervention 2: Chlorhexidine showers intervention 3: Bleach baths (dilute) intervention 4: Intensive education on personal hygiene	2	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	282	NCT00513799	1COMPLETED	2010-12-01	2007-03-01	Washington University School of Medicine	7OTHER	false	false	false	null	0
[ 5 ]	79	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.	null	Obesity Binge Eating	Obesity Binge Eating Monolingual Hispanic Persons Orlistat Behavioral Weight Loss Treatment	null	2	arm 1: Xenical + behavioral intervention arm 2: Placebo + behavioral intervention	[ 0, 1 ]	2	[ 0, 5 ]	intervention 1: 120 mg TID; Behavioral weight loss in Spanish intervention 2: Behavioral weight loss treatment in Spanish Placebo TID	intervention 1: Xenical + behavioral intervention intervention 2: Behavioral intervention + placebo	2	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	79	NCT00516919	1COMPLETED	2010-12-01	2007-08-01	Yale University	7OTHER	false	false	false	null	0
[ 3 ]	49	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell grow...	OBJECTIVES: Primary * Estimate the 9-week progression-free survival rate for patients with stage IV malignant melanoma treated with everolimus and temozolomide. Secondary * Evaluate overall survival time. * Evaluate time to disease progression. * Evaluate confirmed response rate. OUTLINE: This is a multicenter stu...	Melanoma (Skin)	stage IV melanoma	null	1	arm 1: Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days...	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: everolimus intervention 2: temozolomide	198	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| U...	48	NCT00521001	1COMPLETED	2010-12-01	2008-01-01	Alliance for Clinical Trials in Oncology	7OTHER	false	false	false	null	0
[ 0 ]	14	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to: * Provide raltegravir to subjects with HIV and an undetectable viral load who are experiencing injection site reactions (ISR) to Enfuvirtide, * Monitor the safety and efficacy of raltegravir, and * Assess the change in quality of life in patients who have switched from Enfuvirtide to r...	We enrolled virologically suppressed HIV-1 infected patients with injection site reactions for a switch from enfuvirtide to raltegravir. At baseline, enfuvirtide was switched to raltegravir without additional changes to the antiretroviral regimen allowed. Viral load, T-cells, and toxicity were evaluated at baseline, 2,...	HIV Infections		null	0	null	null	1	[ 0 ]	intervention 1: 400 mg Twice daily for 24 weeks	intervention 1: Raltegravir	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	14	NCT00523237	1COMPLETED	2010-12-01	2007-10-01	Stanford University	7OTHER	false	false	false	null	0
[ 3 ]	7	NA	SINGLE_GROUP	1PREVENTION	0NONE	false	1FEMALE	true	The purpose of this study is to determine the efficacy and safety of rhIL-11, when given subcutaneously for six consecutive months, in reducing menstrual blood loss in women with type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by subjective bleeding severity scale and pictorial bleed...	This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in women with type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete this study. All aspects of this study, including the r...	Von Willebrand Disease	IL-11 von Willebrand disease von Willebrand factor VWFmRNA menorrhagia	null	1	arm 1: 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles	[ 0 ]	1	[ 0 ]	intervention 1: 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles	intervention 1: Oprelvekin, Interleukin 11, IL-11	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	7	NCT00524342	1COMPLETED	2010-12-01	2008-01-01	Margaret Ragni	7OTHER	false	false	false	null	0
[ 3 ]	69	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.	null	Metastatic Brain Cancer	Gliadel	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible)....	intervention 1: GLIADEL	17	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Evanston \| Illinois \| United S...	59	NCT00525590	1COMPLETED	2010-12-01	2007-12-12	Eisai Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	99	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic.	Emergence agitation is defined as a mental disturbance during the recovery from general anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It manifests in children as some combination of restlessness, moaning, inconsolable crying, involuntary physical activity, and thrashing about. Thi...	Emergence Agitation		null	2	arm 1: propofol arm 2: no propofol	[ 0, 3 ]	1	[ 0 ]	intervention 1: IV, single bolus at completion of anesthetic, 0.1 ml/kg	intervention 1: Propofol	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	99	NCT00535613	1COMPLETED	2010-12-01	2007-08-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 2, 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.	null	Carcinoma, Small Cell		null	1	arm 1: Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed ...	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Pomalidomide intervention 2: Cisplatin intervention 3: Etoposide	6	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.5088...	44	NCT00537511	6TERMINATED	2010-12-01	2008-02-01	Celgene	4INDUSTRY	false	false	false	null	0
[ 5 ]	155	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copeg...	null	Hepatitis C, Chronic		null	2	arm 1: Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 160...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 180 micrograms subcutaneous weekly for 48 weeks intervention 2: 1000-1600 mg day orally for 48 weeks. intervention 3: 30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.	intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin [Copegus] intervention 3: Pioglitazone	66	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Fresno \| California \| United States \| -119.77237 \| 36.74773 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Loma Linda \| Californi...	152	NCT00545233	1COMPLETED	2010-12-01	2008-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures ...	null	Schizophrenia Tobacco Use Disorder Nicotine Dependance	schizophrenia varenicline cognition cigarette smoking	null	1	arm 1: open label varenicline 2mg/day	[ 0 ]	1	[ 0 ]	intervention 1: Varenicline 1-2 mg/day	intervention 1: Varenicline	1	New York \| New York \| United States \| -74.00597 \| 40.71427	14	NCT00548470	1COMPLETED	2010-12-01	2007-06-01	Nathan Kline Institute for Psychiatric Research	7OTHER	false	false	false	null	0
[ 3 ]	165	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.	None provided	Liver Cirrhosis, Biliary	PBC, Primary Biliary Cirrhosis, Liver,	null	4	arm 1: INT-747 10 mg once daily in combination with URSO for 12 weeks. arm 2: INT-747 25 mg once daily in combination with URSO for 12 weeks. arm 3: INT-747 50 mg once daily in combination with URSO for 12 weeks. arm 4: Placebo once daily in combination with URSO for 12 weeks.	[ 0, 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Once a day (QD) by mouth (PO) intervention 2: Stable dose for at least 6 months prior to screening. Dose as prescribed by physician. intervention 3: Placebo	intervention 1: INT-747 intervention 2: Ursodeoxycholic Acid (URSO) intervention 3: Placebo	32	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Novi \| Michigan \| United States \| -83.47549 \| 42.48059 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 St Louis \| Missouri \| Unite...	243	NCT00550862	6TERMINATED	2010-12-01	2007-10-01	Intercept Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 5 ]	8	RANDOMIZED	SINGLE_GROUP	1PREVENTION	3TRIPLE	false	0ALL	false	The purpose of this study is to determine whether Restasis is an effective treatment for preventing the occurrence and progression of dry eye syndrome in patients who have recently received a bone marrow transplant and are at risk to graft-versus-host disease.	The purpose of this research study is to determine if early treatment using Restasis eye drops can prevent the development or delay the progression of dry eye syndrome in allogeneic bone marrow transplant (BMT) recipients.	Dry Eye	Dry Eye Graft versus Host Disease GVHD	null	2	arm 1: If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear) The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-u...	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months. intervention 2: Artificial Tear - three times a day for 18 months.	intervention 1: Cyclosporine A 0.05% intervention 2: Arificial Tear	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	8	NCT00553735	6TERMINATED	2010-12-01	2007-08-01	Massachusetts Eye and Ear Infirmary	7OTHER	false	false	false	null	0
[ 2, 3 ]	101	RANDOMIZED	FACTORIAL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require ...	* This study will compare the effect of Coreg CR and lisinopril, separately and together, on Rasmussen Disease Score in a controlled study with an inactive substance (placebo). * Study patients will have pre-hypertensive (slightly elevated) blood pressures not requiring therapy. * Lisinopril is an angiotensin convertin...	Pre-hypertension	cardiovascular disease prevention	null	4	arm 1: Coreg CR + lisinopril arm 2: Coreg CR + placebo arm 3: lisinopril + placebo arm 4: placebo + placebo	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months intervention 2: tablets, 10mg once daily for 1 month, 20mg once daily for 8 months intervention 3: carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril=...	intervention 1: carvedilol phosphate intervention 2: lisinopril intervention 3: carvedilol phosphate and lisinopril intervention 4: placebo and placebo	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	101	NCT00553969	1COMPLETED	2010-12-01	2007-11-01	University of Minnesota	7OTHER	false	false	false	null	0
[ 4 ]	233	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either m...	null	Anemia		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 120, 200 or 360 micrograms sc monthly (starting dose) intervention 2: As prescribed	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] intervention 2: Epoetin alfa	26	Belo Horizonte \| N/A \| Brazil \| -43.93778 \| -19.92083 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Campinas \| N/A \| Brazil \| -47.06083 \| -22.90556 Campo Grande \| N/A \| Brazil \| -54.64639 \| -20.44278 Cariacica \| N/A \| Brazil \| -40.42 \| -20.26389 Curitiba \| N/A \| Brazil \| -49.27306 \| -25.42778 Curitiba \| N/A \| Brazil ...	233	NCT00560404	1COMPLETED	2010-12-01	2008-04-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 2 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.	This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period. Pediatric populations may benefi...	Tetrology of Fallot Heart Ventricle Hypoplastic Left Heart	Precedex Open Heart Surgery Dexmedetomidine Sedation	null	1	arm 1: Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.	[ 0 ]	1	[ 0 ]	intervention 1: Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion	intervention 1: Dexmedetomidine	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	30	NCT00576381	1COMPLETED	2010-12-01	2006-04-01	Athena Zuppa	7OTHER	false	false	false	null	0
[ 5 ]	224	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least mode...	This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of quetiapine SR monotherapy compared to divalproex sodium ER monotherapy in outpatient subjects with a lifetime bipolar I, II, or not otherwsise specified (NOS) disorder, a lifetime panic or generalized anxiety disorder, and current d...	Bipolar Disorder Panic Disorder Generalized Anxiety Disorder	Randomized Double-Blind Placebo-Controlled Quetiapine DivalproexSodiumER Bipolar Anxiety Panic GAD	null	3	arm 1: Quetiapine SR (Quetiapine Sustained Release) arm 2: Divalproex Sodium ER (Divalproex Sodium Extended Release) arm 3: placebo	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks intervention 2: Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks intervention 3: placebo	intervention 1: quetiapine SR intervention 2: divalproex sodium ER intervention 3: placebo	3	Palo Alto \| California \| United States \| -122.14302 \| 37.44188 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	149	NCT00579280	1COMPLETED	2010-12-01	2007-07-01	University of South Florida	7OTHER	false	false	false	null	0
[ 5 ]	23	NON_RANDOMIZED	SINGLE_GROUP	null	0NONE	true	1FEMALE	true	The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.	Existing literature makes it unclear whether proton pump inhibitor therapy truly decreases intestinal calcium absorption. Up to 25 postmenopausal women will participate in this study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. The secon...	Osteoporosis Achlorhydria GERD Hip Fracture	Calcium Absorption Fractional Calcium Absorption Omeprazole Stable Calcium Isotopes Proton Pump Inhibitor Intestinal Absorption of Calcium	null	1	arm 1: Subjects will receive omeprazole 40 mg daily for 30 days	[ 0 ]	1	[ 0 ]	intervention 1: 40 mg po qAM one-half hour before breakfast for 30 days	intervention 1: Omeprazole	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	21	NCT00582972	1COMPLETED	2010-12-01	2008-01-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 5 ]	13	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The primary objective of this study is to examine the efficacy of infliximab for the treatment of persistent uveitis in children. Participants (4-18 years of age) will be randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by intravenous infusion at four week intervals. Participant respo...	Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this time there are no prospective studies for this use. Participants will be randomized to initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic...	Chronic Uveitis	Childhood Uveitis	null	2	arm 1: 5mg/kg/dose of infliximab IV every 4 weeks for 9 doses arm 2: 10mg/kg/dose of infliximab IV every 4 weeks for 9 doses.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 5mg/kg/dose IV at 4 week intervals intervention 2: 10mg/kg/dose IV at 4 week intervals	intervention 1: infliximab intervention 2: infliximab	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	13	NCT00589628	1COMPLETED	2010-12-01	2007-09-01	Egla C. Rabinovich	7OTHER	false	false	false	null	0
[ 3 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators core hypothesis is that therapy of patients with NASH w...	null	Nonalcoholic Steatohepatitis	Fatty Liver Nonalcoholic fatty liver disease (NALFD) NAFLD Nonalcoholic steatohepatitis (NASH) NASH pentoxifylline	null	2	arm 1: Pentoxifylline (PTX) 400 mg by mouth (PO) three times daily (TID) arm 2: Placebo three times daily (TID)	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 400 mg PO tid intervention 2: placebo tid	intervention 1: pentoxifylline (PTX) intervention 2: placebo	3	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	55	NCT00590161	1COMPLETED	2010-12-01	2006-12-01	Case Western Reserve University	7OTHER	false	false	false	null	0
[ 3 ]	32	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To...	STUDY ACTIVITIES AND POPULATION GROUP: This is an open-label, non-randomized, single center phase 2 trial. A treatment cycle will consist of 4 weeks of therapy. Sorafenib will be administered at a set dose of 400 mg (2 x 200 mg tablets) twice daily, without food (at least 1 hour before or 2 hours after eating). Temoz...	Recurrent Glioblastoma Multiforme	Recurrent Glioblastoma Multiforme GBM Glioblastoma Sorafenib Temozolomide Brain Tumor Recurrent GBM Temodar Gliosarcoma Glioma Nexavar	null	1	arm 1: Subjects receive 400mg of Sorafenib twice daily and 50mg/m\^2 of Temozolomide once daily Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness tha...	[ 0 ]	1	[ 0 ]	intervention 1: Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).	intervention 1: Sorafenib and Temozolomide	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	32	NCT00597493	1COMPLETED	2010-12-01	2007-09-01	Duke University	7OTHER	false	false	false	null	0
[ 5 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)	Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.	Chronic Fatigue Syndrome		null	2	arm 1: sidenafil arm 2: placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation. intervention 2: Placebo pills 3X/day for 6 weeks	intervention 1: Sildenafil (Viagra) intervention 2: Placebo	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	11	NCT00598585	1COMPLETED	2010-12-01	2002-07-01	Charles Drew University of Medicine and Science	7OTHER	false	false	false	null	0
[ 4 ]	369	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	2MALE	true	The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills. This kind of scientific study is the...	The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH). BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or a...	Urological	Serenoa repens Urological symptoms hyperplasia BPH	null	2	arm 1: Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). arm 2: Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelc...	[ 2, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. intervention 2: Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. intervention 3: Participants will take 640 mg (2) chocol...	intervention 1: Saw Palmetto - first 24 weeks intervention 2: Placebo - first 24 weeks intervention 3: Saw Palmetto - weeks 24 - 48 intervention 4: Placebo - weeks 24 - 48 intervention 5: Saw Palmetto - weeks 48 - 72 intervention 6: Placebo - weeks 48 - 72	11	Oakland \| California \| United States \| -122.2708 \| 37.80437 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Baltimore \| Maryland \| Un...	357	NCT00603304	1COMPLETED	2010-12-01	2008-02-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0
[ 0 ]	11	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	false	In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does no...	null	End Stage Renal Disease (ESRD)	Hemodialysis	null	2	arm 1: dialysate with added soluble ferric pyrophosphate (SFP) arm 2: standard dialysate without soluble ferric pyrophosphate (SFP)	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL). Control concentrate lacking SFP (C-HD) does n...	intervention 1: soluble ferric pyrophosphate (SFP) intervention 2: placebo	2	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	11	NCT00604565	6TERMINATED	2010-12-01	2008-01-01	Charles Drew University of Medicine and Science	7OTHER	false	false	false	null	0
[ 4 ]	197	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	null	The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients	null	Breast Cancer	Breast Cancer Breast Neoplasms Tumors or cancer of the human BREAST Tumor or cancer of the human MAMMARY GLAND	null	2	arm 1: Tamoxifen arm 2: Anastrazole (Arimidex)	[ 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 20 mg once daily oral dose intervention 2: 1 mg once daily oral dose intervention 3: 3.6mg/month depot injection	intervention 1: Tamoxifen intervention 2: Anastrazole (Arimidex) intervention 3: Goserelin acetate (Zoladex)	4	Hakata \| Fukuoka \| Japan \| N/A \| N/A Kumamoto \| Kumamoto \| Japan \| 130.69181 \| 32.80589 Nagoya \| Nagoya \| Japan \| 136.90641 \| 35.18147 Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379	196	NCT00605267	1COMPLETED	2010-12-01	2007-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	106	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer. A total of...	null	Non Small Cell Lung Cancer		null	2	arm 1: Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. arm 2: Best Supportive Care: Patients will receive best supportive c...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles intervention 2: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.	intervention 1: pemetrexed intervention 2: Best Supportive Care	5	Asyut \| N/A \| Egypt \| 31.18368 \| 27.18096 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Mounofia \| N/A \| Egypt \| N/A \| N/A Beirut \| N/A \| Lebanon \| 35.50157 \| 33.89332 Riyadh \| N/A \| Saudi Arabia \| 46.72185 \| 24.68773	161	NCT00606021	1COMPLETED	2010-12-01	2008-01-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 0 ]	40	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	4QUADRUPLE	true	1FEMALE	false	The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.	The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to t...	Contraception	intrauterine device cervical dilation nulliparous women pain management	null	2	arm 1: Cervical preparation with misoprostol prior to intrauterine device insertion arm 2: Cervical preparation with placebo prior to intrauterine device insertion	[ 0, 2 ]	2	[ 0, 7 ]	intervention 1: Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes. intervention 2: Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.	intervention 1: Misoprostol intervention 2: Magnesium Oxide	2	Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	35	NCT00613366	1COMPLETED	2010-12-01	2007-06-01	Oregon Health and Science University	7OTHER	false	false	false	null	0
[ 4 ]	65	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures	null	Epilepsies, Partial		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Orally administered gabapentin	intervention 1: gabapentin	22	Obu-shi,Morioka-machi \| Aichi-ken \| Japan \| N/A \| N/A Jonan-ku \| Fukuoka \| Japan \| N/A \| N/A Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Suma-Ku,Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Kanazawa \| Ishikawa-ken \| Japan \| 136.61667 \| 36.6 Zentsuuji \| Kagawa-ken \| Japan \| N/A \| N/A Yokohama \| Kanagawa Pref. \| Japan \| 139.65 ...	65	NCT00620555	1COMPLETED	2010-12-01	2008-05-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,560	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control	null	Diabetes Mellitus, Type 2		null	2	arm 1: patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride arm 2: patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Placebo tablet once daily intervention 2: Placebo tablets once daily intervention 3: 5mg, once daily in the morning for 104 weeks intervention 4: 1mg or 2mg or 3mg or 4mg in the morning for 104 weeks	intervention 1: Placebo identical to BI 1356 5mg intervention 2: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg intervention 3: BI 1356 intervention 4: Glimepiride	221	Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Gatos \| California \| United States \| -121.97468 \| 37.22661 West Pa...	1,551	NCT00622284	1COMPLETED	2010-12-01	2008-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	32	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepin...	Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.	ADHD With Sleep Onset Insomnia		null	2	arm 1: 8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks. arm 2: placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 8 mg tablets every night for 2 weeks intervention 2: placebo tablets for every night for 2 weeks	intervention 1: Ramelteon intervention 2: Placebo	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	32	NCT00622427	1COMPLETED	2010-12-01	2008-02-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0
[ 3 ]	199	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This was a randomized, placebo-controlled, double-blind study of vismodegib (GDC-0449) added to biochemotherapy standard-of-care regimens for metastatic colorectal cancer (CRC), with treatment until disease progression. Patients received either FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxalipl...	null	Metastatic Colorectal Cancer	Hedgehog CRC Colorectal Cancer Hedgehog Pathway Inhibitor	null	2	arm 1: Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil,...	[ 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Vismodegib 150 mg was provided in hard gelatin capsules in 3 different strengths, 25 mg, 125 mg, and 150 mg. intervention 2: Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size. intervent...	intervention 1: Vismodegib 150 mg intervention 2: Placebo to vismodegib intervention 3: Bevacizumab intervention 4: Modified FOLFOX intervention 5: FOLFIRI	0	null	196	NCT00636610	1COMPLETED	2010-12-01	2008-05-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is a randomized, double-blind, placebo-controlled clinical trial of propranolol combined with trauma memory reactivation, to determination if this approach is effective in treating PTSD symptoms. Participants will include male and female combat Veterans of the Afghanistan and Iraqi wars meeting DSM-IV criter...	OBJECTIVE: In the first of two preliminary studies, the investigators demonstrated in individuals with chronic PTSD that a single (combined 40 mg short- and 60 mg long-acting) 24-hour oral dose of propranolol, compared to placebo, given immediately following reactivation of the PTSD-related memory of the traumatic even...	Posttraumatic Stress Disorders	Stress Posttraumatic PTSD Propranolol Treatment	null	2	arm 1: Weekly doses of short and long acting propranolol following recollection of traumatic memory arm 2: Weekly doses of placebo following recollection of traumatic memory	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Weekly doses of short and long acting propranolol (Inderal, Inderal LA, Hemangeol, Inderal XL) following recollection of traumatic memory intervention 2: Weekly doses of placebo (inactive pill) following recollection of traumatic memory	intervention 1: Propranolol intervention 2: Placebo	1	Manchester \| New Hampshire \| United States \| -71.45479 \| 42.99564	9	NCT00645450	6TERMINATED	2010-12-01	2008-04-01	VA Office of Research and Development	1FED	false	false	false	null	0
[ 3 ]	1	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to compare lung function of patients who inhale steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients who continue with standard of care.	The Study Drug: Fluticasone propionate is designed to stop the inflammatory action of asthma cells in PTCB. Screening Tests: Before you can start treatment on this study, you will have a pulmonary function test (PFT). For this tests, you will be asked to breathe in several different ways while you have a mouthpiece ...	Bronchiolitis	Post-Transplant Constrictive Bronchiolitis Bronchiolitis Fluticasone Propionate Inhaled Corticosteroids Lung Condition PTCB	null	2	arm 1: 440 micrograms twice daily by oral inhalation. arm 2: Comparator group, no intervention.	[ 0, 4 ]	1	[ 0 ]	intervention 1: 440 micrograms twice daily by oral inhalation.	intervention 1: Fluticasone Propionate	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	1	NCT00656916	6TERMINATED	2010-12-01	2008-03-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	75	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients wil...	null	Anemia		null	1	arm 1: Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.	[ 0 ]	1	[ 0 ]	intervention 1: sc every month (starting dose 1.2 micrograms/kg)	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]	9	Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Denizli \| N/A \| Turkey (Türkiye) \| 29.0875 \| 37.77417 Edirne \| N/A \| Turkey (Türkiye) \| 26.55597 \| 41.67719 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \|...	75	NCT00661388	1COMPLETED	2010-12-01	2008-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate treatments for a rash caused by sorafenib.	This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.	Hand-foot Skin Reaction Rash	sorafenib rash hand foot skin reaction	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: urea 40% cream applied twice per day to affected areas intervention 2: fluocinonide 0.05% cream applied twice per day to affected areas intervention 3: tazarotene 0.1% cream applied twice per day to affected areas intervention 4: bland emollient cream applied twice per day to affected areas	intervention 1: urea 40% cream intervention 2: fluocinonide 0.05% cream intervention 3: tazarotene 0.1% cream intervention 4: bland emollient cream (Udderly smooth® Udder Cream)	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	6	NCT00667589	6TERMINATED	2010-12-01	2008-06-01	Northwestern University	7OTHER	false	false	false	null	0
[ 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.	PRIMARY OBJECTIVES: I. To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. SECONDAR...	Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma		null	1	arm 1: Patients receive oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Correlative studies	intervention 1: Dasatinib intervention 2: Laboratory Biomarker Analysis	20	Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Iowa City \| Iow...	34	NCT00671788	1COMPLETED	2010-12-01	2008-06-01	Gynecologic Oncology Group	5NETWORK	false	false	false	null	0
[ 3, 4 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar ...	This study compares the effect of a soybean oil-based versus an olive oil-based lipid emulsion in healthy volunteers and in critically ill patients. In healthy volunteers, your blood sugar levels, blood vessel function, and your ability to fight infections will be examined. In ICU patients, we examines whether use of t...	Parenteral Nutrition	parenteral nutrition lipid emulsion nosocomial infection mortality endothelial function inflammatory markers oxidative stress immune function autonomic nervous system insulin sensitivity carbohydrate metabolism	null	2	arm 1: Subjects who require Total Parenteral Nutrition TPN receiving Intralipid 20% (soybean-based) arm 2: Subjects who require Total Parenteral Nutrition TPN receiving ClinOleic 20% (olive oil based)	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake. intervention 2: It is made up of 20% Soybean oil, 1.2% egg yol...	intervention 1: ClinOleic 20% Intravenous Emulsion intervention 2: Intralipid, 20% Intravenous Emulsion	2	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	100	NCT00672854	1COMPLETED	2010-12-01	2008-11-01	Emory University	7OTHER	false	false	false	null	0
[ 3, 4 ]	18	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo	null	Septic Shock	statin, sepsis, septic shock, simvastatin	null	2	arm 1: Simvastatin 40 mg PO or NGT arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Simvastatin 40mg PO or NGT intervention 2: Corn Starch	intervention 1: Simvastatin intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	18	NCT00676897	1COMPLETED	2010-12-01	2008-02-01	Beth Israel Deaconess Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	130	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1...	null	Hepatitis C		null	3	arm 1: pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks arm 2: pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks arm 3: pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks	[ 0, 0, 0 ]	2	[ 2, 0 ]	intervention 1: 1.5 ug/kg/week SC for 12 or 24 weeks intervention 2: Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks	intervention 1: Pegylated interferon alfa-2b intervention 2: Ribavirin	0	null	130	NCT00686517	1COMPLETED	2010-12-01	2003-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	75	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and we...	null	Hepatitis C, Chronic	hepatitis C	null	1	arm 1: Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.	[ 0 ]	2	[ 2, 0 ]	intervention 1: Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks intervention 2: Ribavirin 400 mg/day orally	intervention 1: Pegylated Interferon alfa-2b intervention 2: Ribavirin	0	null	75	NCT00686777	1COMPLETED	2010-12-01	2008-01-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: PTC299 may stop the growth of Kaposi sarcoma by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of PTC299 and to see how well it works in treating patients with HIV-related Kaposi sarcoma.	OBJECTIVES: Primary * To define the safety and toxicity of anti-VEGF small molecule PTC299 in patients with HIV-related Kaposi sarcoma. * To establish the maximum tolerated dose of this drug in these patients. * To estimate the response rate in patients treated with this drug. Secondary * To describe the pharmacoki...	Kaposi's Sarcoma	HIV infection AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma Treatment Experienced	Prot_SAP_001.pdf: AIDS MALIGNANCY CLINICAL TRIALS CONSORTIUM AMC PROTOCOL #059: A Phase 1/2 Trial of PTC299 in Patients with HIV-Related Kaposi's Sarcoma A Multi-Center Trial of the AIDS Malignancy Clinical Trials Consortium (AMC) Sponsored by: National Cancer Institute Division of Cancer Tr...	1	arm 1: Single arm study - all subjects received PTC299	[ 0 ]	8	[ 0, 6, 6, 6, 10, 10, 10, 3 ]	intervention 1: 20 mg capsules to be taken by mouth BID. Three dose levels will be evaluated: 40 mg, 80mg, and 100mg BID. Subjects will receive PTC299 in consecutive 28-day cycles for a maximum of 12 cycles. intervention 2: To describe the effects of PTC299 on viral gene expression and cellular gene transcription in KS...	intervention 1: VEGF inhibitor PTC299 intervention 2: gene expression analysis intervention 3: polymerase chain reaction intervention 4: protein expression analysis intervention 5: immunohistochemistry staining method intervention 6: laboratory biomarker analysis intervention 7: pharmacological study intervention 8: bi...	8	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York ...	17	NCT00686842	6TERMINATED	2010-12-01	2008-09-01	AIDS Malignancy Consortium	5NETWORK	true	true	false	https://cdn.clinicaltrials.gov/large-docs/42/NCT00686842/Prot_SAP_001.pdf	0
[ 5 ]	102	RANDOMIZED	PARALLEL	6HEALTH_SERVICES_RESEARCH	3TRIPLE	false	0ALL	true	Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and tre...	PAD occurring in the legs is a serious disease that affects about 8 million people in the United States. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes, high blood pressure, high cholesterol, or heart disease. Symptoms of PAD may include leg cramps or pain while walking,...	Peripheral Arterial Disease	Endovascular Intervention MRI Ultrasound Cholesterol Medications High Cholesterol Peripheral Arterial disease Claudication Leg Pain Niaspan Extended Release Niacin Zetia Ezetimibe Simvastatin Zocor Atorvastatin Lipitor	null	2	arm 1: Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan. arm 2: Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.	[ 0, 1 ]	9	[ 0, 0, 0, 5, 0, 0, 0, 0, 3 ]	intervention 1: Daily dose of 10 mg of Ezetimibe intervention 2: Daily dose of 1500 mg of Niaspan intervention 3: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.) intervention 4: Standard of medical care for PAD intervention 5: Daily dose of 32...	intervention 1: Ezetimibe intervention 2: Niaspan intervention 3: Statin therapy intervention 4: Standard care intervention 5: Aspirin intervention 6: Clopidogrel intervention 7: Placebo Niaspan intervention 8: Placebo Ezetimibe intervention 9: Percutaneous transluminal angioplasty (PTA)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	95	NCT00687076	1COMPLETED	2010-12-01	2004-04-01	Baylor College of Medicine	7OTHER	false	false	false	null	0
[ 5 ]	91	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis comp...	Hypothesis: The timing of administration of omeprazole/sodium bicarbonate (Zegerid) will impact nocturnal esophageal acid exposure and healing of esophagitis. Specifically, we hypothesize that omeprazole/sodium bicarbonate, taken at bedtime, will be superior in healing esophagitis compared to omeprazole/sodium bicarbon...	Erosive Esophagitis	Erosive Esophagitis Reflux Esophagitis Gastroesophageal reflux disease GERD proton pump inhibitor omeprazole/sodium bicarbonate	null	2	arm 1: 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning arm 2: 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime	[ 1, 0 ]	1	[ 0 ]	intervention 1: Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that were emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks.	intervention 1: Omeprazole/sodium bicarbonate	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	84	NCT00693225	1COMPLETED	2010-12-01	2008-01-01	Yvonne Romero	7OTHER	false	false	false	null	0
[ 0 ]	18	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The aim of the study is to find out if Rituximab, which is an antibody against specific white cells involved in rejection, when combined with standard anti-rejection treatment can more effectively reverse the rejection process. Our hypothesis is that with acute rejection there is activation of B cells and the subseque...	This is a two center, randomized pilot study of the effects of Rituximab on treatment of acute rejection. A total of 24 patients (including patients transplanted at University of California San Francisco and University of Alabama Birmingham) will be enrolled in the study, 16 randomized to Rituximab and 8 to no-Rituxima...	Renal Transplant Rejection	Rituximab Renal Transplant Rejection B cells Patients with biopsy proven acute rejection cellular infiltrate, B cells	null	2	arm 1: Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed up monthly for 1 year. Biopsy was done Baseline and Month 3 and other labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and se...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Rituximab infusion on Day 1 and Day 15 intervention 2: No Rituximab	intervention 1: Rituximab intervention 2: No Rituximab	2	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 San Francisco \| California \| United States \| -122.41942 \| 37.77493	15	NCT00695097	1COMPLETED	2010-12-01	2004-08-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 5 ]	19	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The primary objective is to determine whether erythrocyte polyglutamate levels are associated with objective clinical response in patients with rheumatoid arthritis after oral administration of low-dose methotrexate.The secondary aim of this study is to compare the efficacy and safety of standard dose methotrexate vers...	The folate antagonist methotrexate (MTX) is currently one of the most widely used drugs for the treatment of rheumatoid arthritis (RA).Although MTX is very effective and well tolerated, the major drawback is the large interpatient variability in the clinical response.MTX is intracellularly converted by folylpolyglutama...	Rheumatoid Arthritis	rheumatoid arthritis MTX polyglutamates clinical outcome	null	2	arm 1: Escalating dose arm 2: 25 mg	[ 5, 1 ]	2	[ 0, 0 ]	intervention 1: oral administration Escalating dose (15, 20, 25 mg) intervention 2: 25 mg oral administration	intervention 1: methotrexate intervention 2: methotrexate	2	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849	19	NCT00695188	1COMPLETED	2010-12-01	2008-05-01	Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation	7OTHER	false	false	false	null	0
[ 5 ]	9	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged area...	This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will...	Cardiovascular Disease Cardiomyopathy Heart Disease Myocardial Disease Myocardial Ischemia	Cardiovascular Disease Cardiomyopathy Heart Disease Myocardial Disease Myocardial Ischemia	null	3	arm 1: Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium). arm 2: NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment arm 3: Healthy subjects with no history of high cholesterol, heart disease, or heart attacks	[ 1, 1, 4 ]	1	[ 0 ]	intervention 1: Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and a...	intervention 1: Atorvastatin Calcium	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	5	NCT00701220	1COMPLETED	2010-12-01	2007-04-01	Philip Binkley	7OTHER	false	false	false	null	0
[ 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) ...	null	Non-small Cell Lung Cancer Metastatic		null	1	arm 1: Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any rea...	[ 0 ]	2	[ 0, 0 ]	intervention 1: 150 mg po daily intervention 2: 1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles	intervention 1: Erlotinib intervention 2: Gemcitabine	1	Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225	19	NCT00701558	1COMPLETED	2010-12-01	2008-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	200	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.	The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.	Diaper Rash	Diaper dermatitis complicated by candidiasis	null	1	arm 1: None	[ 1 ]	1	[ 0 ]	intervention 1: Topical Application	intervention 1: 0.25 % Miconazole Nitrate Ointment	8	San Diego \| California \| United States \| -117.16472 \| 32.71571 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Santo Domingo \| N/A \| Do...	368	NCT00702507	1COMPLETED	2010-12-01	2007-05-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0
[ 0 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.	Ambrisentan is an endothelin blocker approved for the treatment of pulmonary arterial hypertension. Patients with systemic sclerosis can have damage to their blood vessels, resulting in increased levels of endothelin in their bloodstream that then causes decreased blood flow to the digits. This can result in very painf...	n Ulcer Scleroderma, Systemic		null	1	arm 1: Ambrisentan	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Ambrisentan	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	20	NCT00725361	1COMPLETED	2010-12-01	2008-06-01	Stanford University	7OTHER	false	false	false	null	0
[ 3, 4 ]	51	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD). This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from...	Hypotheses: 1. There is a subset of patients with the diagnosis of EE who also have GERD. 2. Patients with both EE and GERD will respond symptomatically and histologically to aggressive gastric acid suppression with a proton pump inhibitor as monotherapy. 3. Swallowed budesonide suspension is effective in treating pat...	Eosinophilic Esophagitis Gastroesophageal Reflux Disease EE GERD		null	2	arm 1: Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study (GERD) arm 2: Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks intervention 2: Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negativ...	intervention 1: Esomeprazole intervention 2: Budesonide	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	46	NCT00728481	1COMPLETED	2010-12-01	2008-05-01	Mayo Clinic	7OTHER	false	false	false	null	0

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