Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_count_Accidental overdose int64	METADATA_count_Drug administration error int64	METADATA_count_Intentional overdose int64	METADATA_count_Medication error int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 5 ]	308	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.	null	Colonoscopy	colonoscopy bowel preparation	null	2	arm 1: Active control arm 2: Investigational dose	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: multi dose formulation (tablet/solution) for oral administration prior to colonoscopy intervention 2: multi dose preparation (tablet/solution) for oral administration prior to colonoscopy	intervention 1: PEG electrolyte lavage solution + bisacodyl - reformulation intervention 2: PEG electrolyte lavage solution + bisacodyl	6	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Orange \| California \| United States \| -117.85311 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 New Smyrna Beach \| Florida \| United States \| -80.927 \| 29.02582 Laurel \| Maryland \| United States \| -76.84831 \| 39.09928 Franklin \| Tennessee \| United States \| -86.86889 \| 35.92506	308	0	0	0	NCT00857272	1COMPLETED	2009-05-01	2009-02-01	Braintree Laboratories	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 4 ]	10	RANDOMIZED	SINGLE_GROUP	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this research study is to see how certain hormones cause changes in mood and thinking in some depressed patients and to determine the effectiveness of mifepristone in treating some forms of depression. This study is conducted in conjunction with an observational study "Clinical and Biological Characteristics of Psychotic Depression".	Eligibility Procedures: Before entering the study and prior to any other procedures, you will be asked to read and sign this consent form. To determine if you are eligible for our study, you will then have a general medical (including menstrual cycle history on female patients) and psychiatric history taken, a physical examination, your vital signs (blood pressure, pulse), height, weight and waist/hip ratio will be measured, as well as various psychiatric evaluations will be conducted. You will be randomly (by chance) assigned to receive mifepristone or placebo (an inactive substance). Half of the participants in this research study will receive placebo, and half will receive mifepristone. Neither you nor your study doctor will know which of the two you are receiving. Treatment will begin in the morning of Treatment Day 1 and conclude on Treatment Day 8 for a total treatment period of 8 days. You will take the medication once a day in the morning. The dose was originally 600 mg but was changed to 1200 mg per day after the 4th patient. You will not be able to take any new medications (other than the study drug) or make changes to your current medications while participating in this part of the study unless ordered by the study physician. On treatment Day 1, you will come to our office for an interview and we will evaluate your mood and other psychiatric symptoms. Additionally, we will take your vital signs and draw blood to administer clinical laboratory tests. You will meet with the study physician and will then be given 4-days of medication to take home with you and self-administer each morning. On Treatment Day 4, you will come back to our office. We will evaluate your mood, take your vital signs and you will meet with the study physician. It is important that you discuss with your study physician or the research study staff all unpleasant or unusual symptoms that you may experience. Any positive effects that are experienced should be discussed as well. You will be given an additional 4-days of medication to take home with you to self-administer each morning. On Treatment Day 8, we will re-evaluate your mood, take your vital signs and repeat the blood and urine lab tests. You will also meet with the study physician to discuss any side effects. If you are participating in the blood draw portion of this study, you will be admitted to the GCRC on this day for an overnight stay. At 2pm on Treatment Day 8, you will have an IV line inserted into one arm for hourly blood samples from 2pm, 4pm, then 6pm until 9am on Treatment Day 9. At 9am on treatment Day 9, 10 mls of blood will be taken for Mifepristone concentration. A total of 82mls (approximately 5.5 tablespoons) of blood will be drawn. You will be discharged from the GCRC following breakfast. On Treatment Day 15, we will re-evaluate your mood and you will meet with the study physician to discuss any side effects. On Treatment Day 22, you will be readmitted to the GCRC, where nurses will take your vitals signs and repeat the clinical laboratory tests. We will also reevaluate your mood, and you will meet with the study physician to discuss any side effects. If you have participated in portions or all of the baseline protocol (protocol # 13088) you will repeat neuropsychological, MRI and blood draw procedures accordingly. If you did not participate in the baseline protocol, you will be assessed for safety and discharged. You will have another functional MRI (a picture taken of your brain using a magnet while you are administered a series of tasks). This MRI scan procedure will take approximately 1 hour. You will be given a series of neuropsychological tests to assess your memory and concentration. You will be asked to complete several questionnaires during your hospital stay. These questionnaires ask for your views about your personality, your childhood, your quality of life, your mood and a variety of aspects of your daily functioning. The questionnaires may be completed anytime during your overnight stay and will take about 2.5 hours to finish. On treatment Day 22, you will have an IV line inserted into one arm for hourly blood samples taken at 2pm, 4pm and then hourly from 6pm to 9am. A total of 72 ml's (approximately 5 tablespoons) of blood will be drawn. At 2pm on Treatment Day 23, you will have another IV line placed in your arm to draw hourly blood samples used for the measure of ACTH and cortisol. These blood samples are taken in small amounts (approximately 1 teaspoon) and will be collected at 2pm and then on the hour, every hour, starting at 3pm and ending at 7pm, then every 30 minutes until 12pm. At 3pm, you will be given 0.5mg (five 0.1mg tablets) of Fludrocortisone. At 4pm, 10 mls of blood will be taken for Mifepristone concentration. Following the last blood draw at 12pm, a blood sample will be taken for clinical laboratory assessment to ensure your safety following Fludrocortisone administration. A total of 76ml's (approximately 5 tablespoons) of blood will be drawn. The IV line will then be removed and your vital signs will be assessed. The following morning, the study physician will contact the experimental pharmacy and find out whether you have received placebo (no medication) or mifepristone. If you have been treated with mifepristone, this will mark the end of your study participation and the research coordinator will discuss follow-up assessments with you. The follow up assessments will be as follows: mood assessments will be performed via phone on weeks 1 and 2 and months 1, 3, 6, and 12 after completion of the study. These assessments will take a maximum of 1 hour to complete. The physician will also confirm your continued care and treatment with your primary treating psychiatrist. You will then be discharged from the GCRC and the hospital. If you have been on the placebo, you will be offered an 8-day open-label trial of mifepristone.	Affective Disorders, Psychotic Depressive Disorder		null	2	arm 1: Receive mifepristone for 8 days arm 2: Receive placebo rather than mifepristone	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: Placebo medication	intervention 1: Mifepristone (RU-486) intervention 2: Placebo	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	10	0	0	0	NCT00867360	6TERMINATED	2009-05-01	2005-08-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.	null	Diabetes Mellitus, Type 2		null	2	arm 1: MK-0941 arm 2: Placebo Comparator	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water. intervention 2: Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.	intervention 1: MK-0941 intervention 2: Comparator: Placebo	0	null	44	0	0	0	NCT00873821	1COMPLETED	2009-05-01	2008-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	2MALE	false	The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.	Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.	Smokeless Tobacco Use	tobacco chew nrt nicotine lozenges self-help	null	2	arm 1: Self-help counseling material and 4 mg nicotine lozenges arm 2: self help counseling material and placebo nicotine lozenges	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 4 mg nicotine lozenges, ad lib, for 12 weeks. intervention 2: Placebo nicotine lozenges	intervention 1: nicotine replacement therapy intervention 2: placebo NRT	2	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207	60	0	0	0	NCT00888459	1COMPLETED	2009-05-01	2008-04-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.	null	Allergic Conjunctivitis		null	2	arm 1: active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). arm 2: Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 0.25% Ophthalmic Solution, one drop in each eye at each of two visits. intervention 2: Vehicle without active, one drop in each eye at each of two visits.	intervention 1: alcaftadine intervention 2: Placebo	2	Fairfield \| Ohio \| United States \| -84.5605 \| 39.34589 Mason \| Ohio \| United States \| -84.30994 \| 39.36006	60	0	0	0	NCT00889330	1COMPLETED	2009-05-01	2009-04-01	Vistakon Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	40	null	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).	null	Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)		null	2	arm 1: Participants in the Pharmacokinetic Phase received a single 10 mg oral dose of lenalidomide on Day -7. During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment. arm 2: Following the enrollment of the first 25 patients into the Monotherapy Phase, a second group of 15 patients with low- or intermediate-1-risk MDS not associated with a del 5q (non-del 5q) cytogenetic abnormality were enrolled to receive 15 mg of lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Lenalidomide 5-mg capsules for oral administration intervention 2: Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units.	intervention 1: Lenalidomide intervention 2: Recombinant human erythropoietin	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	39	0	0	0	NCT00910858	1COMPLETED	2009-05-01	2005-01-01	Celgene Corporation	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome. This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.	Background: Irritable bowel syndrome (IBS) affects about 15% of the U.S. population, about 5% having predominant diarrhea; current treatment is suboptimal as it may not be tolerated, lead to side effects or insufficient benefit. Bile acid malabsorption (BAM) is recognized as a cause of chronic diarrhea and has been investigated as a mechanism for the phenotype of diarrhea predominant IBS (D-IBS). Increased exposure of the colon to bile acids which may result from accelerated small bowel transit or abnormal function of the apical sodium bile acid transporter (ASBT) has been postulated to cause functional diarrhea or symptoms of D-IBS by a number of mechanisms, such as increase colonic secretion, and mucosal permeability. Recent preliminary data suggest that doses of chenodeoxycholate (CDC) that are approved for the dissolution of gall stones are associated with accelerated colonic emptying and looser stool consistency. Hypothesis: The bile acid binding agent, Colesevelam HCl, decreases colonic transit and permeability in patients with D-IBS. Specific Aim: To investigate the effect of Colesevelam, which binds bile acids in the small intestine and reduces the concentration of bile acids in the colon, on colonic transit, permeability and the bowel function of patients with D-IBS. Methods: Twenty-four D-IBS participants will be randomized to placebo or treatment with Welchol (Colesevelam HCL) 1.875 gram b.i.d. for 12-14 days. A baseline colon transit, 24 hour urine for colon permeability, and blood for serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO) will be measured and venous blood DNA will be collected and stored. The measurement of serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO), which is a measurement of hepatic cholesterol synthesis, is closely related to the fecal loss of bile acids, and is a validated method for screening for BAM. Following treatment for 12 days, transit and permeability studies will be repeated. Bowel function symptoms will be recorded for the duration of the study.	Irritable Bowel Syndrome Diarrhea	bile acid malabsorption permeability diarrhea IBS stool	null	2	arm 1: Participants received colesevelam 1.875 g twice daily arm 2: Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days intervention 2: Inert capsule matching the study drug, given twice daily	intervention 1: Colesevelam intervention 2: Placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	24	0	0	0	NCT00911612	1COMPLETED	2009-05-01	2009-01-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	26	RANDOMIZED	SINGLE_GROUP	0TREATMENT	1SINGLE	true	1FEMALE	false	A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.	At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.	Acne Vulgaris	acne irritation objective sensory methods	null	1	arm 1: Once daily use in a split face model: 1. Tretinoin gel 2. Adapalene Benzoyl peroxide	[ 0 ]	2	[ 0, 0 ]	intervention 1: Tretinoin gel 0.04% used once daily in a split-face model intervention 2: Adapalene .1% and Benzoyl peroxide 2.5%	intervention 1: Tretinoin gel intervention 2: Adapalene and Benzoyl peroxide	1	Broomall \| Pennsylvania \| United States \| -75.35658 \| 39.9815	26	0	0	0	NCT00919191	1COMPLETED	2009-05-01	2009-04-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	10	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	true	Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.	The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.	Nystagmus	gabapentin memantine nystagmus Drug treatment	null	2	arm 1: Increasing dose to 300 mg four times per day (total of 1200 mg/day) arm 2: Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: increasing to 1200 mg/day intervention 2: increasing to 40 mg/day	intervention 1: gabapentin intervention 2: memantine	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	20	0	0	0	NCT00928954	1COMPLETED	2009-05-01	2005-02-01	Case Western Reserve University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	62	RANDOMIZED	FACTORIAL	null	0NONE	true	0ALL	false	The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle protein synthesis in the elderly similar to that of their younger counterparts.	The purpose of this study was to examine muscle protein metabolism in healthy young and elderly subjects during pharmacologic vasodilation of the lower limb vasculature in combination with increased amino acids delivery. We obtained femoral arteriovenous blood samples and v. lateralis muscle biopsies during a primed continuous infusion of L-\[ring-13C6\] Phenylalanine. Muscle protein kinetics were measured in the basal state and during a 180 min infusion of sodium nitroprusside (SNP) and amino acids (Premsol 10%) (SNP+AA). Skeletal muscle microvascular recruitment and flow were measured during the basal state and SNP+AA using contrast-enhanced ultrasound (CEU).	Aging	metabolism exercise sodium nitroprusside	null	5	arm 1: 45 minutes of treadmill walking at 40% VO2 peak arm 2: 45 minutes of treadmill walking at 40% VO2 peak arm 3: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min arm 4: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min arm 5: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5g amino acid drink taken orally	[ 1, 1, 1, 1, 1 ]	3	[ 10, 0, 7 ]	intervention 1: 45 minuties of treadmill walking was completed at 40% VO2 peak intervention 2: Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min intervention 3: 7.5 gram Amino Acid drink	intervention 1: Aerobic Exercise intervention 2: Sodium Nitroprusside intervention 3: Amino Acid Drink	0	null	62	0	0	0	NCT00945256	1COMPLETED	2009-05-01	2003-05-01	The University of Texas Medical Branch, Galveston	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.	At entry, patients will have a complete history and physical, blood tests, ultrasound, and will complete questionnaires. Eligible patients will take Thalidomide 400 mg once a day in the evening. Patients will start a dose of 100 mg per day for two weeks, increasing by 100 mg per day every two weeks to a maximum dose of 400 mg per day for 6 months. Patients will return at 6 months for an evaluation, blood tests and completion of questionnaires. Blood tests will be performed by mailed-in kits at 3 months. Patients will receive weekly phone calls for the first 2 months and bi-monthly thereafter.	Primary Sclerosing Cholangitis	PSC Thalidomide	null	1	arm 1: Participants will be treated with Thalidomide, starting at a dose of 100 mg per day, increasing the dose by 100 mg every 14 days to a maximum of 400 mg per day.	[ 0 ]	1	[ 0 ]	intervention 1: Titrate to 400 mg daily for 6 months	intervention 1: Thalidomide	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	1	0	0	0	NCT00953615	6TERMINATED	2009-05-01	2006-04-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	30	RANDOMIZED	SINGLE_GROUP	1PREVENTION	1SINGLE	true	0ALL	false	This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison. The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.	The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.	Healthy Skin		null	1	arm 1: None	[ 0 ]	2	[ 0, 10 ]	intervention 1: Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits. intervention 2: Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits.	intervention 1: adapalen 0.1% intervention 2: Cetaphil®	1	Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967	60	0	0	0	NCT00971282	1COMPLETED	2009-05-01	2008-12-01	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.	null	Major Depressive Disorder Soft Tissue Discomfort Syndrome Pain		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 30-60 mg daily for 8 weeks	intervention 1: Duloxetine	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	0	0	0	0	NCT01035073	1COMPLETED	2009-05-01	2006-04-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	208	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation	null	Growth Disorders Intrauterine Growth Retardation	Short height intra-uterine growth retardation Genotonorm continuous treatment intermittent treatment	null	3	arm 1: Continuous 0.7 IU/kg/week or 0.03 mg/kg/day arm 2: Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day arm 3: Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection intervention 2: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection intervention 3: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)	intervention 1: Genotonorm intervention 2: Genotonorm intervention 3: Genotonorm	31	Angers \| France \| France \| -0.55202 \| 47.47156 Grenoble \| France \| France \| 5.71479 \| 45.17869 Paris \| France \| France \| 2.3488 \| 48.85341 Amiens \| N/A \| France \| 2.3 \| 49.9 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Boulogne \| N/A \| France \| -1.3194 \| 46.79346 Brest \| N/A \| France \| -4.48628 \| 48.39029 Bron \| N/A \| France \| 4.91303 \| 45.73865 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Hyères \| N/A \| France \| 6.12857 \| 43.12038 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lille \| N/A \| France \| 3.05858 \| 50.63297 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Reims \| N/A \| France \| 4.02853 \| 49.26526 Rennes \| N/A \| France \| -1.67429 \| 48.11198 Rouen \| N/A \| France \| 1.09932 \| 49.44313 Saint-Priest-en-Jarez \| N/A \| France \| 4.37678 \| 45.4739 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Tarbes \| N/A \| France \| 0.07139 \| 43.23407 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Tours \| N/A \| France \| 0.70398 \| 47.39484 Vandœuvre-lès-Nancy \| N/A \| France \| 6.17114 \| 48.66115	206	0	0	0	NCT01073605	1COMPLETED	2009-05-01	1993-07-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	2MALE	false	This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.	Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo. All doses will be administered in the fasted state, except Panel A, Period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing. Panel A will begin first. At least 3 days will elapse before participants in the alternate panel (Panel B) will receive the next higher dose. In Panel C, 8 mild to moderate hypertensive male participants will receive single rising doses of MK-8892 or placebo. For all panels, there will be at least 7 days washout between treatment periods for any given participant. Participants may only be enrolled in one panel of the study. All participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another. As per the protocol allocation plan, the same participants will receive 0.25 mg MK-3612 in a fasted and fed state.	Hypertension		null	3	arm 1: Healthy participants receive single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast except for Period 3. Period 3 dose was administered after the ingestion of a high-fat breakfast. arm 2: Healthy participants receive single oral dose of MK-3614 0.5 mg. 0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast arm 3: Hypertensive participants receive single oral dose of MK-3614 0.75 mg. 0.5 mg. 0.75 mg, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing period. All doses were administered after an 8-hour fast	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: MK-3614 intervention 2: Comparator: Placebo	0	null	78	0	0	0	NCT01104545	1COMPLETED	2009-05-01	2008-11-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	288	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation. After the last treatment period, a follow-up phone call occurred approximately 30 days (range 25 to 35 days) after the last dose of study drug.	null	Menorrhagia	Menorrhagia Heavy Menstrual Bleeding Lysteda	null	1	arm 1: Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).	[ 0 ]	1	[ 0 ]	intervention 1: Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.	intervention 1: Tranexamic acid	92	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Searcy \| Arkansas \| United States \| -91.73625 \| 35.25064 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Lakewood \| California \| United States \| -118.13396 \| 33.85363 Los Alamitos \| California \| United States \| -118.07256 \| 33.80307 San Diego \| California \| United States \| -117.16472 \| 32.71571 Upland \| California \| United States \| -117.64839 \| 34.09751 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Crystal River \| Florida \| United States \| -82.5926 \| 28.90248 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 North Miami \| Florida \| United States \| -80.18671 \| 25.89009 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Bloomington \| Indiana \| United States \| -86.52639 \| 39.16533 Newton \| Kansas \| United States \| -97.34504 \| 38.04668 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Marrero \| Louisiana \| United States \| -90.10035 \| 29.89937 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Bingham Farms \| Michigan \| United States \| -83.27326 \| 42.51587 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Paw Paw \| Michigan \| United States \| -85.89112 \| 42.21782 Saint Clair Shores \| Michigan \| United States \| -82.88881 \| 42.49698 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Scottsbluff \| Nebraska \| United States \| -103.66717 \| 41.86663 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Moorestown \| New Jersey \| United States \| -74.94267 \| 39.96706 New York \| New York \| United States \| -74.00597 \| 40.71427 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Centerville \| Ohio \| United States \| -84.15938 \| 39.62839 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Gallipolis \| Ohio \| United States \| -82.20237 \| 38.8098 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Abington \| Pennsylvania \| United States \| -75.11795 \| 40.12067 Jenkintown \| Pennsylvania \| United States \| -75.12517 \| 40.09594 Levittown \| Pennsylvania \| United States \| -74.82877 \| 40.15511 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Phoenixville \| Pennsylvania \| United States \| -75.51491 \| 40.13038 Reading \| Pennsylvania \| United States \| -75.92687 \| 40.33565 Strafford \| Pennsylvania \| United States \| -75.40436 \| 40.05094 Wexford \| Pennsylvania \| United States \| -80.05589 \| 40.62646 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Clarksville \| Tennessee \| United States \| -87.35945 \| 36.52977 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 College Station \| Texas \| United States \| -96.33441 \| 30.62798 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Plano \| Texas \| United States \| -96.69889 \| 33.01984 Temple \| Texas \| United States \| -97.34278 \| 31.09823 The Woodlands \| Texas \| United States \| -95.48938 \| 30.15799 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Pleasant Grove \| Utah \| United States \| -111.73854 \| 40.36412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Sandy City \| Utah \| United States \| -111.8841 \| 40.59161 West Valley City \| Utah \| United States \| -112.00105 \| 40.69161 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Renton \| Washington \| United States \| -122.21707 \| 47.48288 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Menomonee Falls \| Wisconsin \| United States \| -88.11731 \| 43.1789	260	0	0	0	NCT01280981	1COMPLETED	2009-05-01	2007-04-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	2MALE	false	The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected.	null	Healthy Volunteers		null	3	arm 1: Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days arm 2: Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days arm 3: Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Tablets orally	intervention 1: Prasugrel	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	30	0	0	0	NCT01591317	1COMPLETED	2009-05-01	2009-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	59	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.	null	Hepatitis B, Chronic		null	1	arm 1: Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: 180 mcg subcutaneously weekly, 48 weeks	intervention 1: Peginterferon alfa-2a [Pegasys]	4	Casablanca \| N/A \| Morocco \| -7.61138 \| 33.58831 Casablanca \| N/A \| Morocco \| -7.61138 \| 33.58831 Rabat \| N/A \| Morocco \| -6.83255 \| 34.01325 Rabat \| N/A \| Morocco \| -6.83255 \| 34.01325	59	0	0	0	NCT01787279	1COMPLETED	2009-05-01	2006-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	164	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.	Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.	Smoking Cessation	Smoking cessation Tobacco abstinence hypnotherapy Nicotine replacement therapy	null	4	arm 1: Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. arm 2: Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. arm 3: The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge. arm 4: Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.	[ 0, 0, 0, 4 ]	2	[ 5, 0 ]	intervention 1: One 90 minute session within 2 weeks of hospital discharge intervention 2: free one month supply after hospital discharge	intervention 1: hypnotherapy intervention 2: Nicotine	1	Salem \| Massachusetts \| United States \| -70.89552 \| 42.51977	155	0	0	0	NCT01791803	1COMPLETED	2009-05-01	2006-01-01	North Shore Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.	null	Type 2 Diabetes		null	4	arm 1: ITCA 650 (exenatide in DUROS) arm 2: ITCA 650 (exenatide in DUROS) arm 3: ITCA 650 (exenatide in DUROS) arm 4: ITCA 650 (exenatide in DUROS)	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: ITCA 650 (exenatide in DUROS)	3	Miami Gardens \| Florida \| United States \| -80.2456 \| 25.94204 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	44	0	0	0	NCT01798264	1COMPLETED	2009-05-01	2009-02-01	Intarcia Therapeutics	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	79	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.	Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.	Hip Fracture	Hip fracture Nutritional supplement Bisphosphonates Bone mineral density Body composition	null	3	arm 1: 35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group) arm 2: Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group) arm 3: An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control)	[ 1, 1, 1 ]	3	[ 0, 10, 7 ]	intervention 1: The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months. intervention 2: The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12 months plus nutritional supplement (Fresubin® protein energy drink) during the first six months following hip fracture and also calcium (1000 mg) and vitamin D3 (800 IU) daily for 12 months. intervention 3: The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.	intervention 1: Risedronate intervention 2: Nutritional supplement intervention 3: Calcium and vitamin D3	1	Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938	79	0	0	0	NCT01950169	1COMPLETED	2009-05-01	2004-12-01	Karolinska Institutet	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.	null	Chronic Kidney Disease High Cholesterol	Chronic kidney disease High cholesterol	null	1	arm 1: Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Atorvastatin	0	null	0	0	0	0	NCT02133534	6TERMINATED	2009-05-01	2008-02-01	Duke University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	22	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	2MALE	false	To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).	Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.	Parkinson's Disease (PD)	Parkinson's disease (PD) Opicapone BIA 9-1067	null	4	arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 3: Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 4: Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)	[ 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: controlled-release levodopa 100 mg/benserazide 25 mg	intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Madopar® HBS	1	S. Mamede Do Coronado \| Trofa \| Portugal \| N/A \| N/A	86	0	0	0	NCT02169466	1COMPLETED	2009-05-01	2009-01-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers	null	Healthy		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Dabigatran etexilate pellets intervention 2: Dabigatran etexilate powder intervention 3: Dabigatran etexilate capsule	0	null	90	0	0	0	NCT02171611	1COMPLETED	2009-05-01	2009-03-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas are mostly based on observational studies. Here we present data from a prospective randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or placebo for 30 days. Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed CSDH were recruited from a single center and randomized in order to receive dexamethasone or placebo as a conservative treatment. Patients affected to the treatment group received oral dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for 6 months and the rate of success of conservative treatment versus placebo was measured. Parameters such as hematoma thickness and global impression of change were also compared before and after treatment with chi-square tests. Adverse events and complications were documented.	Patients Recruitment for this single-center double-blind randomized placebo-controlled study was performed between January 2007 and May 2009. Patients were enrolled based on the following inclusion criteria: 18 years and older with evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging) and classified between 0 and 2 using the Markwalder grading scale (17) (Grade 0 for normal neurological status, grade 1 for no neurological deficits but mild symptoms, grade 2 for focal or variable neurological deficits, grade 3 for several focal neurological signs, and grade 4 for comatose). Exclusion criteria included contraindications or intolerance to corticosteroid therapy or patients already undergoing steroid treatment for any other indication, previous neurological surgery up to one year prior to being considered for the study, concomitant cerebral pathology of neoplastic or presumed infectious origin, anticoagulant therapy that could not be stopped for 6 months and refusal to participate in the study. If at any time, patients developed a sudden increase in hematoma volume, a midline displacement of greater than 1cm or a deterioration of their level of consciousness, they were removed from the conservative study protocol in order to undergo surgery. This study was approved by the research ethics board at Centre Hospitalier Universitaire (CHU) de Quebec. Written and fully informed consent was obtained from each participant. Randomization Allocation to each group was done in a 1:1 ratio with block sizes ranging from 4 to 6, to one of the two arms ; a treatment arm in which participants received dexamethasone according to the protocol, and a control group in which they received placebo. Randomization was performed via a web-based service by a pharmacist, which was not involved in any other part of the study. Both investigators and participants were blind to treatment allocation. Treatment Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs). Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days. Participants were returned at home with blister packs containing their medication for each day of the trial and were asked to return empty packs to ensure compliance with the assigned treatment. The treatment (placebo or dexamethasone) was discontinued if a patient required surgical drainage of its hematoma or suffered from significant side effects. Evaluation and follow-up The primary outcome of this pilot study was to determine the efficacy of dexamethasone as compared with placebo in reducing the rate of surgical intervention for CSDH graded 0 to 2 on the Markwalder grading scale (Grade 0 for normal neurological status, grade 1 for no neurological deficits but mild symptoms, grade 2 for focal or variable neurological deficits, grade 3 for several focal neurological signs, and grade 4 for comatose). Eligible patients who consented for the study underwent the routine standard of care. This included 1) a complete medical history review and neurological physical exam ; 2) head computerized tomography (CT) or MRI with measurement of maximal hematoma thickness (in mm), midline shift ; 3) and a check of blood and vital parameters. In addition, patients were asked to complete detailed questionnaires measuring symptoms typically associated with subdural hematomas. Follow-up appointments were scheduled 2 weeks, 1, 2 and 6 months after initiation of treatment. At each visit, the three components of the clinical evaluation described above were repeated. Moreover, a seven point categorical scale was used to evaluate patient's global impression of change relative to the initial state (unchanged , very much improved, much improved, minimally improved, minimally worse, much worse, very much worse). Treatment-related side effects were also inquired about and collected. The rate of success of conservative management was defined as the percentage of patients not requiring surgery in each treatment group during the 6 months following enrollment. Radiological progression of the hematoma in terms of thickness and magnitude of midline shift, hematoma-related symptoms and medication-related side effects were carefully collected. Statistical analyses Demographical characteristics, baseline neurological status and hematoma size and location were compared for both groups using a Mann-Whitney test for continuous variable and a χ2 test for categorical variables. To compare the rate of success, a categorical frequency comparison with the Fisher's exact test was used. For the other outcome measures we used Mann-Whitney U test and Student's t-test for normally distributed variables and χ2 or Fisher's exact test for categorical frequencies. All statistical tests were done with the Statistical package for Social Sciences software version 16.0 and the significance threshold was set at p\<0.05.	Hematoma, Subdural, Chronic	[C10.228.140.300.535.450.400.120]	null	2	arm 1: Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs). arm 2: Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs). intervention 2: Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.	intervention 1: Dexamethasone intervention 2: Placebo	0	null	20	0	0	0	NCT02362321	6TERMINATED	2009-05-01	2007-01-01	CHU de Quebec-Universite Laval	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.	null	Hepatitis D, Chronic		null	2	arm 1: Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. arm 2: Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection. intervention 2: Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.	intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin	1	Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054	12	0	0	0	NCT02731131	1COMPLETED	2009-05-01	2004-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	14	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor \[KDR\]). Since MET overexpression has been associated with poorer prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.	null	Neoplasms, Head and Neck	VEGFR2 XL880 foretinib Squamous Cell Cancer of the Head and Neck MET GSK1363089	null	1	arm 1: Participants who qualified for study entry received 240 mg of GSK1363089 (foretinib) on a 5-day on 9-day off schedule every 2 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: Multitargeted tyrosine kinase inhibitor	intervention 1: GSK1363089 (foretinib)	11	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953	14	0	0	0	NCT00725764	1COMPLETED	2009-05-02	2007-08-27	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	140	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.	In those surgical procedures where a neuromuscular block is desired for intubation and/or avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the end of surgery, e.g. in open abdominal procedures or during laparoscopic procedures in order to improve surgical conditions. Reversal with sugammadex at a dose of 4.0 mg.kg-1 at 1-2 PTC after an intubation dose of 0.6 mg.kg-1 or maintenance dosing rocuronium has been found to be both safe and efficacious in previous clinical trials but has never been investigated exclusively in participants undergoing laparoscopic cholecystectomy or appendectomy. With sugammadex profound muscle relaxation may now be provided right up to the end of the surgical procedure. This may lead to improved Patient Outcomes, such as improvement in the time from end of surgery to the discharge to the PACU. In this multi-center, randomized, parallel-group, active-controlled, safety-assessor blinded trial such benefits will be further investigated.	Anesthesia, General		null	2	arm 1: 4.0 mg.kg-1 sugammadex at 1-2 PTC arm 2: 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1-0.2 mg.kg-1 rocuronium may be given. intervention 2: After the last dose of rocuronium has been administered, participants will receive, according to the randomization, a single bolus dose of 4.0 mg.kg-1 sugammadex at 1-2 PTC. intervention 3: After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2. intervention 4: After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.	intervention 1: Rocuronium intervention 2: Sugammadex intervention 3: Neostigmine intervention 4: Atropine	0	null	133	0	0	0	NCT00724932	1COMPLETED	2009-05-03	2008-07-16	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	2,080	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.	null	Pulmonary Disease, Chronic Obstructive		null	5	arm 1: Matching Placebo arm 2: Low dose arm 3: Medium dose arm 4: High dose arm 5: Tiotropium Bromide	[ 2, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Solution intervention 2: Solution intervention 3: Solution	intervention 1: BEA 2180 BR intervention 2: Tiotropium Bromide intervention 3: Placebo	178	Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Berkeley \| California \| United States \| -122.27275 \| 37.87159 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Lakewood \| California \| United States \| -118.13396 \| 33.85363 Riverside \| California \| United States \| -117.39616 \| 33.95335 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Sepulveda \| California \| United States \| -118.28285 \| 34.16167 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Fort Collins \| Colorado \| United States \| -105.08442 \| 40.58526 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Stamford \| Connecticut \| United States \| -73.53873 \| 41.05343 Bay Pines \| Florida \| United States \| -82.77816 \| 27.81419 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Panama City \| Florida \| United States \| -85.65983 \| 30.15946 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Stockbridge \| Georgia \| United States \| -84.23381 \| 33.54428 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 Olathe \| Kansas \| United States \| -94.81913 \| 38.8814 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Livonia \| Michigan \| United States \| -83.35271 \| 42.36837 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Reno \| Nevada \| United States \| -119.8138 \| 39.52963 Brick \| New Jersey \| United States \| -74.13708 \| 40.05928 Cherry Hill \| New Jersey \| United States \| -75.03073 \| 39.93484 Summit \| New Jersey \| United States \| -74.36468 \| 40.71562 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Larchmont \| New York \| United States \| -73.7518 \| 40.92788 Mineola \| New York \| United States \| -73.64068 \| 40.74927 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 New York \| New York \| United States \| -74.00597 \| 40.71427 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Johnston \| Rhode Island \| United States \| -71.50675 \| 41.82186 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Killeen \| Texas \| United States \| -97.7278 \| 31.11712 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Roanoke \| Virginia \| United States \| -79.94143 \| 37.27097 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Burlington \| Ontario \| Canada \| -79.83713 \| 43.38621 Downsview \| Ontario \| Canada \| -79.48291 \| 43.71681 Grimsby \| Ontario \| Canada \| -79.56631 \| 43.20011 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Cottbus \| N/A \| Germany \| 14.32888 \| 51.75769 Dortmund \| N/A \| Germany \| 7.466 \| 51.51494 Geesthacht \| N/A \| Germany \| 10.3779 \| 53.43575 Gelnhausen \| N/A \| Germany \| 9.18742 \| 50.20164 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Koblenz \| N/A \| Germany \| 7.57883 \| 50.35357 Lübeck \| N/A \| Germany \| 10.68729 \| 53.86893 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Marburg \| N/A \| Germany \| 8.77069 \| 50.80904 Minden \| N/A \| Germany \| 8.91455 \| 52.28953 Neumünster \| N/A \| Germany \| 9.98456 \| 54.07399 Neuruppin \| N/A \| Germany \| 12.80311 \| 52.92815 Oschersleben \| N/A \| Germany \| 11.22898 \| 52.03039 Rüdersdorf \| N/A \| Germany \| 13.78631 \| 52.46927 Rüsselsheim am Main \| N/A \| Germany \| 8.42251 \| 49.98955 Saarbrücken \| N/A \| Germany \| 7.00982 \| 49.23262 Schwetzingen \| N/A \| Germany \| 8.5823 \| 49.38217 Witten \| N/A \| Germany \| 7.35258 \| 51.44362 Witten \| N/A \| Germany \| 7.35258 \| 51.44362 Budakeszi \| N/A \| Hungary \| 18.92717 \| 47.51083 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Cegléd \| N/A \| Hungary \| 19.79952 \| 47.17266 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Deszk \| N/A \| Hungary \| 20.24322 \| 46.21802 Deszk \| N/A \| Hungary \| 20.24322 \| 46.21802 Érd \| N/A \| Hungary \| 18.91361 \| 47.39489 Gödöllö \| N/A \| Hungary \| N/A \| N/A Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Komárom \| N/A \| Hungary \| 18.11913 \| 47.74318 Mátraháza \| N/A \| Hungary \| 19.97981 \| 47.87124 Mosonmagyaróvár \| N/A \| Hungary \| 17.26994 \| 47.86789 Sopron \| N/A \| Hungary \| 16.59049 \| 47.68501 Szarvas \| N/A \| Hungary \| 20.55 \| 46.86667 Százhalombatta \| N/A \| Hungary \| 18.93878 \| 47.32949 Tatabánya \| N/A \| Hungary \| 18.39325 \| 47.58494 Zalaegerszeg \| N/A \| Hungary \| 16.84389 \| 46.84 Cuernavaca, Mor. México \| N/A \| Mexico \| -99.23075 \| 18.9261 Hermosillo, Sonora \| N/A \| Mexico \| N/A \| N/A Metepec \| N/A \| Mexico \| -99.60175 \| 19.25934 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Monterrey \| N/A \| Mexico \| -100.31721 \| 25.68435 Monterrey, Nuevo León \| N/A \| Mexico \| N/A \| N/A Zapopan, Jal. \| N/A \| Mexico \| N/A \| N/A Chrzanów \| N/A \| Poland \| 19.40203 \| 50.13546 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Miechów \| N/A \| Poland \| 20.02788 \| 50.35648 Ruda Śląska \| N/A \| Poland \| 18.85632 \| 50.2584 Tarnowskie Góry \| N/A \| Poland \| 18.86147 \| 50.44548 Wilkowice \| N/A \| Poland \| 19.08973 \| 49.76282 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Zabrze \| N/A \| Poland \| 18.78576 \| 50.32492 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Gyeonggi-do \| N/A \| South Korea \| 126.76917 \| 37.58944 Gyeonggi-do \| N/A \| South Korea \| 126.76917 \| 37.58944 Seongdong-gu \| N/A \| South Korea \| N/A \| N/A Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Badajoz \| N/A \| Spain \| -6.97061 \| 38.87789 Cáceres \| N/A \| Spain \| -6.37224 \| 39.47649 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Terrassa (Barcelona) \| N/A \| Spain \| 2.01667 \| 41.56667 Torrevieja \| N/A \| Spain \| -0.68222 \| 37.97872 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Vigo \| N/A \| Spain \| -8.72264 \| 42.23282 Changhua \| N/A \| Taiwan \| 120.5512 \| 24.0692 Chiayi City \| N/A \| Taiwan \| 120.44889 \| 23.47917 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 Kaohsiung County \| N/A \| Taiwan \| N/A \| N/A Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taoyuan \| N/A \| Taiwan \| 121.29696 \| 24.99368	2,080	0	0	0	NCT00528996	1COMPLETED	2009-05-05	2007-09-06	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	1	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant, and to quantify the percentage and donor sources of mixed donor chimerism following DUCBT in patients with selected malignant and non-malignant disorders.	Allogeneic stem cell transplantation from an human leukocyte antigen (HLA) matched related family donor is the treatment of choice for a wide variety of malignant and non-malignant disorders. Unfortunately, only 25% of potential recipients have an HLA matched related family donor, leaving approximately 75% of potential recipients requiring alternative sources of HLA matched allogeneic stem cells. One potential source of HLA matched allogeneic stem cells is from unrelated adult donors that have been identified in the national and international donor registries. However, several limitations restrict the uniform utilization of unrelated allogeneic adult donors including ethnic background of the recipient, acuity and timing of planned allogeneic transplant, availability of donor, and high risk of severe acute graft-versus-host disease (GVHD) (III/IV), among others. The investigators have recently identified a new alternative source of allogeneic stem cells, unrelated cryopreserved placental/cord blood stem cells.	Leukemia Lymphoma Neuroblastoma Immunodeficiencies Anemia	Cord Blood Transplant Allogeneic Stem Cell Transplant	null	6	arm 1: Patients will start their pre-conditioning regimen on Day -8. Fractionated total body irradiation (TBI) will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5 and-4, Cyclophosphamide on Days -3 and -2 and- rabbit antithymocyte globulin on Days -4, -3, -2 and -1.The double cord blood infusion will be performed on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus/mycophenolate mofetil (MMF). arm 2: Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with double cord blood infusion on Day 0. Granulocyte-macrophage colony-stimulating factor (GM-CSF) hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF. arm 3: Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF. arm 4: Patients will start their GVHD prophylaxis with Tacrolimus on Day -6. Patients will receive busulfan twice daily on Days -6, and-5; fludarabine on Days -6, -5, -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF. arm 5: Patients will start their pre-conditioning regimen on Day -6. Patients will receive TBI as a single fraction on Day -6. Patients will receive fludarabine and cyclophosphamide on Days - 5, -4, -3, and -2 and horse antithymocyte globulin on Days -5, -4, -3, -2 and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF. arm 6: Patients will begin fosphenytoin or phenytoin prophylaxis on Day -10. Patients will receive busulfan on days -9, -8, -7 and -6, cyclophosphamide on days -5, -4, -3, and -2 and rabbit antithymocyte globulin on days -4, -3, -2 and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.	[ 0, 0, 0, 0, 0, 0 ]	10	[ 0, 4, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Each dose of alemtuzumab is to be diluted in 5% dextrose in water (D5W) or normal saling (NS) (maximum concentration: 0.3 mg/mL) for intravenous (IV) infusion over two hours. intervention 2: None intervention 3: Melphalan 45mg/m2 (1.5 mg/kg IV for children \<1 year of age or \<10 kg) diluted in 0.9% NS to a concentration of 0.1- 0.45mg/ml, given IV over 30 minutes. intervention 4: (Busulfex) will be given IV in 0.9% sodium chloride or D5W to a final solution for infusion equal to 10 times the volume of diluent to Busulfex (to a concentration \>0.5 mg/mL), through a central venous access device over 2 hours. intervention 5: Fosphenytoin can be administered in D5W or 0.9% sodium chloride to a final concentration ranging from 1.5 to 25 mg PE/ml at a rate of 1-3 mg phenytoin sodium equivalents (PE)/kg/min up to 50-150 mg PE/minute. intervention 6: Fludarabine will be given IV in 50-100 ml of D5W or 0.9% sodium chloride, over 30 minutes. intervention 7: Cyclophosphamide should be infused over one hour. The drug can be diluted in D5W, NS, or other solutions (100-250 mL) to a maximum concentration of 20 mg/mL. intervention 8: Horse Antithymocyte Globulin (ATG \[horse\]) will be diluted in 0.9% sodium chloride or 0.45% sodium chloride for IV infusion (through an inline filter with pore size of 0.2 micrometer) to a concentration of 1-4 mg/ml and infused through a central venous catheter over 8 hours in Regimen E. intervention 9: Rabbit Anti-Thymocyte Globulin (rabbit ATG) will be diluted in 0.9% sodium chloride or D5W for IV infusion (through an in-line filter with pore size of 0.22 micrometer) to a concentration of 0.5 mg/ml and infused through a central venous catheter over 8 hours for all doses on Days -4, -3, -2, and -1 in Regimens A, B, D and F. intervention 10: Thiotepa should be diluted in NS (1-5 mg/ml) and infused over 2 hrs on Days -8, -4. IV fluids should be at maintenance rate (1500 ml/m2).	intervention 1: Alemtuzumab intervention 2: Total Body Irradiation intervention 3: Melphalan intervention 4: Busulfan intervention 5: Phenytoin intervention 6: Fludarabine intervention 7: Cyclophosphamide intervention 8: Horse Antithymocyte Globulin intervention 9: Rabbit Antithymocyte Globulin intervention 10: Thiotepa	1	New York \| New York \| United States \| -74.00597 \| 40.71427	1	0	0	0	NCT00801931	6TERMINATED	2009-05-05	2007-09-06	Columbia University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	1,050	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.	This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.	Pain, Postoperative	safety diclofenac pain, postoperative	null	1	arm 1: IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days	[ 0 ]	1	[ 0 ]	intervention 1: multiple doses up to 5 days	intervention 1: DIC075V (intravenous diclofenac sodium)	46	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Florence \| Alabama \| United States \| -87.67725 \| 34.79981 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Sheffield \| Alabama \| United States \| -87.69864 \| 34.76509 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Glendale \| California \| United States \| -118.25508 \| 34.14251 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Santa Barbara \| California \| United States \| -119.69819 \| 34.42083 Vista \| California \| United States \| -117.24254 \| 33.20004 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Steamboat Springs \| Colorado \| United States \| -106.83172 \| 40.48498 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Inverness \| Florida \| United States \| -82.33037 \| 28.83582 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Mooresville \| Indiana \| United States \| -86.37416 \| 39.61282 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Merriam \| Kansas \| United States \| -94.69357 \| 39.02362 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Great Falls \| Montana \| United States \| -111.30081 \| 47.50024 Albany \| New York \| United States \| -73.75623 \| 42.65258 Staten Island \| New York \| United States \| -74.13986 \| 40.56233 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Altoona \| Pennsylvania \| United States \| -78.39474 \| 40.51868 Altoona \| Pennsylvania \| United States \| -78.39474 \| 40.51868 Johnstown \| Pennsylvania \| United States \| -78.92197 \| 40.32674 Johnstown \| Pennsylvania \| United States \| -78.92197 \| 40.32674 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Somerset \| Pennsylvania \| United States \| -79.07808 \| 40.00841 State College \| Pennsylvania \| United States \| -77.86 \| 40.79339 Hendersonville \| Tennessee \| United States \| -86.62 \| 36.30477 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Temple \| Texas \| United States \| -97.34278 \| 31.09823	971	0	0	0	NCT00726388	1COMPLETED	2009-05-08	2008-09-15	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	204	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.	Prior to the implementation of Amendment 1/UK3 the study consisted of 3 phases - pre-randomization up to 35 days, up to 84 days placebo-controlled treatment and a 28-day observational follow up. After the implementation of Amendment 1/UK3, the study consisted of 4 phases - pre-randomization up to 35 days, up to 84 days treatment in the placebo controlled treatment phase, up to 84 days treatment in the active treatment extension phase and a 28 day follow up. Participants who completed the treatment phase prior to implementation of amendment 1/UK3 did not have the option of entering the extension phase.	Psoriatic Arthritis	psoriatic arthritis ACR PASI DAS pharmacokinetic biopsy	null	3	arm 1: Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. arm 2: Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. arm 3: Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Capsules for oral administration intervention 2: Capsules for oral administration	intervention 1: Apremilast intervention 2: Placebo	38	Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Diepenbeek \| N/A \| Belgium \| 5.41875 \| 50.90769 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Merksem \| N/A \| Belgium \| 4.44903 \| 51.24623 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Burlington \| Ontario \| Canada \| -79.83713 \| 43.38621 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Waterloo \| Ontario \| Canada \| -80.51639 \| 43.4668 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Pointe-Claire \| Quebec \| Canada \| -73.81669 \| 45.44868 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Bad Brückenau \| N/A \| Germany \| 9.78985 \| 50.30853 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Herne \| N/A \| Germany \| 7.22572 \| 51.5388 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Munich \| N/A \| Germany \| 11.57549 \| 48.13743 Münster \| N/A \| Germany \| 7.62571 \| 51.96236 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Leiden \| N/A \| Netherlands \| 4.49306 \| 52.15833 Nijmegen \| N/A \| Netherlands \| 5.85278 \| 51.8425 The Hague \| N/A \| Netherlands \| 4.29861 \| 52.07667 Salford \| Manchester \| United Kingdom \| -2.29042 \| 53.48771 Stoke-on-Trent \| Staffs \| United Kingdom \| -2.18538 \| 53.00415 Leeds \| N/A \| United Kingdom \| -1.54785 \| 53.79648 Newcastle upon Tyne \| N/A \| United Kingdom \| -1.61396 \| 54.97328	380	0	0	0	NCT00456092	1COMPLETED	2009-05-09	2007-03-05	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	60	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	false	The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis	null	Allergic Conjunctivitis		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 2 ]	2	[ 0, 10 ]	intervention 1: Ophthalmic Solution intervention 2: Ophthalmic Solution	intervention 1: Lifitegrast intervention 2: Placebo	1	Andover \| Massachusetts \| United States \| -71.137 \| 42.65843	60	0	0	0	NCT00882687	1COMPLETED	2009-05-10	2009-04-24	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	234	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.	null	Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura	splenectomy platelet AMG 531 thrombopoietin blood disorder bleeding disorder immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura TPO thrombopoietic protein	null	2	arm 1: Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks. arm 2: Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.	[ 0, 5 ]	2	[ 0, 2 ]	intervention 1: None intervention 2: None	intervention 1: Medical Standard of Care for ITP intervention 2: Romiplostim	0	null	229	0	0	0	NCT00415532	1COMPLETED	2009-05-11	2006-12-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	64	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.	Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients. This is a multi-national Phase 2 study of safety and tolerability of 28 days of daily dosing with two dose levels (280 mg and 560 mg) of Arikayce™ versus placebo in subjects with bronchiectasis and chronic Pseudomonas infection. Study subjects will be randomized to receive either study drug or placebo by inhalation via a PARI eFlow® nebulizer. Each subject will complete 28 days of daily dosing. All study subjects will be followed for microbiologic activity for 14 days after completion of treatment and for safety for 28 days post completion of study treatment. The total study duration will be 56 days, with the screening visit occurring within the preceding 14 days prior to study day 1. At Day 1 (baseline), subjects will be evaluated at pre-dose and during the first 4-5 hours post-dose. Subjects will return at Week 2 (day 14) after start of treatment and at the end of Week 4 (Day 28) treatment period to determine safety and efficacy of Arikayce™. Subjects will be followed up on study Days 42 and 56 (about 2 and 4 weeks after end of treatment) for safety determination. After completion of this study, subjects will be followed up for an additional 6 months via phone contacts and records review, if hospitalized or treated for pulmonary exacerbation (under the extension protocol). Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and tolerability of Arikayce™ compared to placebo. Serum, urine and sputum specimens will be collected at periodic intervals to assess pharmacokinetics (PK) in subjects who consent for the PK portion of the study. Additionally, sputum samples will be collected to determine changes in bacterial density. Total Pulmonary Symptom Severity Score (PSSS) will be assessed, and respiratory quality of life will be evaluated by using the St. George's Respiratory Questionnaire (SGRQ). Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and the other studies evaluating amikacin liposome inhalation suspension.	Bronchiectasis	Bronchiectasis Respiratory Infections Amikacin Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Pseudomonas aeruginosa Amikacin liposome inhalation suspension (ALIS)	null	4	arm 1: Subjects in this arm of the cohort 1 will receive 280 mg of Arikayce™ arm 2: Subjects in this arm of the cohort 1 will receive matching placebo. arm 3: Subjects in this arm of the cohort 2 will receive 560 mg of Arikayce™ arm 4: Subjects in this arm of the cohort 2 will receive matching placebo	[ 0, 2, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 2: Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 3: Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 4: Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.	intervention 1: 280 mg Arikayce™ intervention 2: Matching Placebo for Cohort 1 intervention 3: 560 mg Arikayce™ intervention 4: Matching Placebo for Cohort 2	18	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Mosdós \| N/A \| Hungary \| 17.98853 \| 46.35379 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Manipal \| N/A \| India \| 74.78333 \| 13.35 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Nagpur \| N/A \| India \| 79.08491 \| 21.14631 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Rabka-Zdrój \| N/A \| Poland \| 19.96654 \| 49.60889 Belgrade \| N/A \| Serbia \| 20.46513 \| 44.80401 Kragujevac \| N/A \| Serbia \| 20.91667 \| 44.01667 Niš \| N/A \| Serbia \| 21.90333 \| 43.32472 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Cambridge \| N/A \| United Kingdom \| 0.11667 \| 52.2 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	62	0	0	0	NCT00775138	1COMPLETED	2009-05-11	2008-06-24	Insmed Incorporated	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	3,834	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.	null	Heart Failure		null	2	arm 1: 50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years) arm 2: Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 50-mg losartan oral tablet intervention 2: 100-mg losartan oral tablet + 50-mg losartan oral tablet	intervention 1: Losartan 50 mg intervention 2: Losartan 150 mg	0	null	3,834	39	0.010172	1	NCT00090259	1COMPLETED	2009-05-13	2001-12-19	Organon and Co	4INDUSTRY	false	false	false	null	8	0	0	0	31	0.00745
[ 2 ]	18	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.	null	Type 2 Diabetes Mellitus		null	4	arm 1: None arm 2: None arm 3: Co-administration of sitagliptin and metformin arm 4: Co-administration of placebo to sitagliptin and placebo to metformin	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 2: Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 3: Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods. intervention 4: Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.	intervention 1: sitagliptin phosphate intervention 2: metformin hydrochloride intervention 3: Comparator: placebo sitagliptin intervention 4: Comparator: placebo metformin	0	null	72	0	0	0	NCT00830076	1COMPLETED	2009-05-14	2008-12-02	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	682	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.	This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The trial period per participant will cover 1, 2 or 3 COS treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed Embryo Transfer (FTET) cycles following either or both of the first two treatment cycles. In each stimulation cycle, participants receive a single injection of corifollitropin alfa and one week later, treatment is continued with a daily dose of any FSH-containing preparation up to the day of (rec)hCG administration for final oocyte maturation. Assessment of anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection are important safety endpoints in this trial.	In Vitro Fertilization	Infertility Pharmacological effects of drugs Hormones, Hormone Substitutes and Hormone Antagonists Pharmacological Actions Multi-center	null	1	arm 1: Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\[rec\]hCG) (5,000-10,000 IU/250 µg). Administration of (rec)hCG occurred when 3 follicles ≥17 mm were observed on ultrasound scan (USS). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone for luteal phase support was administered starting on the day of oocyte pick-up (34-36 hours after \[rec\]hCG) and continued for approximately 6 weeks. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur.	[ 0 ]	5	[ 0, 2, 2, 2, 0 ]	intervention 1: Corifollitropin alfa 150 µg administered as a single subcutaneous dose. intervention 2: FSH administerd subcutaneously at a dose not to exceed 225 IU/day. intervention 3: GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day. intervention 4: (rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg. intervention 5: Progesterone administered vaginally at a dose of at least 600 mg/day.	intervention 1: Corifollitropin alfa intervention 2: FSH intervention 3: GnRH antagonist intervention 4: (rec)hCG intervention 5: Progesterone	0	null	682	0	0	0	NCT00696878	1COMPLETED	2009-05-15	2006-09-26	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	356	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).	null	Epilepsy		null	2	arm 1: For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets will be administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet will be administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily. arm 2: For the 12-day Titration Phase, rufinamide will be administered orally in doses starting with 400 milligram (mg) twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily. intervention 2: For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).	intervention 1: Placebo intervention 2: Rufinamide	77	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Northport \| Alabama \| United States \| -87.57723 \| 33.22901 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Fresno \| California \| United States \| -119.77237 \| 36.74773 Oceanside \| California \| United States \| -117.37948 \| 33.19587 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Loxahatchee Groves \| Florida \| United States \| -80.27977 \| 26.68368 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Panama City \| Florida \| United States \| -85.65983 \| 30.15946 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Canton \| Georgia \| United States \| -84.49076 \| 34.23676 Honolulu \| Hawaii \| United States \| -157.85833 \| 21.30694 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Oak Lawn \| Illinois \| United States \| -87.75811 \| 41.71087 Park Ridge \| Illinois \| United States \| -87.84062 \| 42.01114 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Ames \| Iowa \| United States \| -93.61994 \| 42.03471 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Hopedale \| Massachusetts \| United States \| -71.54117 \| 42.13065 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Saint Paul \| Minnesota \| United States \| -93.09327 \| 44.94441 Hattiesburg \| Mississippi \| United States \| -89.29034 \| 31.32712 Hattiesburg \| Mississippi \| United States \| -89.29034 \| 31.32712 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Lawrence \| New York \| United States \| -73.72958 \| 40.61566 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Altoona \| Pennsylvania \| United States \| -78.39474 \| 40.51868 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Irving \| Texas \| United States \| -96.94889 \| 32.81402 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	356	0	0	0	NCT00334958	1COMPLETED	2009-05-20	2006-02-13	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	660	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.	null	Migraine		null	3	arm 1: Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks arm 2: Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks arm 3: Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks	[ 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: Telcagepant 140 mg intervention 2: Telcagepant 280 mg intervention 3: 140 mg telcagepant placebo intervention 4: 280 mg telcagepant placebo	0	null	656	0	0	0	NCT00797667	6TERMINATED	2009-05-20	2008-11-12	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	19	RANDOMIZED	CROSSOVER	2DIAGNOSTIC	2DOUBLE	false	0ALL	false	This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.	null	Allergic Rhinitis		null	3	arm 1: placebo arm 2: 10 mg prednisone arm 3: 25 mg prednisone	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks intervention 2: Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks. intervention 3: Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.	intervention 1: Placebo intervention 2: prednisone intervention 3: prednisone	0	null	57	0	0	0	NCT00828061	1COMPLETED	2009-05-21	2009-02-04	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	681	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	true	The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.	Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.	Cytomegalovirus Infections	prevention prophylaxis Cytomegalovirus CMV allogeneic stem cell transplant SCT	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 100 mg twice daily for up to 12 weeks intervention 2: twice daily for up to 12 weeks	intervention 1: maribavir intervention 2: placebo	97	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Duarte \| California \| United States \| -117.97729 \| 34.13945 La Jolla \| California \| United States \| -117.2742 \| 32.84727 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Stanford \| California \| United States \| -122.16608 \| 37.42411 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Beech Grove \| Indiana \| United States \| -86.08998 \| 39.72199 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Paris \| N/A \| France \| 2.3488 \| 48.85341 Pessac \| N/A \| France \| -0.6324 \| 44.80565 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Ulm \| N/A \| Germany \| 9.99155 \| 48.39841 Florence \| N/A \| Italy \| 11.24626 \| 43.77925 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Pescara \| N/A \| Italy \| 14.20283 \| 42.4584 Reggio Calabria \| N/A \| Italy \| 15.66129 \| 38.11047 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Salamanca \| N/A \| Spain \| -3.67975 \| 40.42972 Huddinge \| Stockholm County \| Sweden \| 17.98192 \| 59.23705 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	674	0	0	0	NCT00411645	1COMPLETED	2009-05-23	2006-12-13	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	66	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.	null	Hypertension	Children pediatrics High Blood Pressure Hypertension Valsartan	null	1	arm 1: Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: Extemporaneous suspension of valsartan, orally.	intervention 1: Valsartan	36	Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Laken \| N/A \| Belgium \| 4.34844 \| 50.87585 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Recife \| Pernambuco \| Brazil \| -34.88111 \| -8.05389 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Paris \| N/A \| France \| 2.3488 \| 48.85341 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Szeged \| N/A \| Hungary \| 20.14824 \| 46.253 Hyderabad \| Andh Prad \| India \| 78.45636 \| 17.38405 Mangalore \| Karnataka \| India \| 74.85603 \| 12.91723 Indore \| M.P. \| India \| 75.8333 \| 22.71792 Mumbai \| Maharashtra \| India \| 72.88261 \| 19.07283 Chennai \| Tamil Nadu \| India \| 80.27847 \| 13.08784 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Torino \| TO \| Italy \| 11.99138 \| 44.88856 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Gezina \| Gauteng \| South Africa \| 28.20673 \| -25.71867 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Potchefstroom \| N/A \| South Africa \| 27.1 \| -26.71667 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273	66	0	0	0	NCT00457626	1COMPLETED	2009-05-25	2007-04-09	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.	This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.	Attention Impairment	Attention cancer chemotherapy donepezil acetylcholinesterase inhibitor	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight. During the Blinded Extension Phase, all subjects will receive active treatment (donepezil). intervention 2: During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily. During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).	intervention 1: Donepezil hydrochloride intervention 2: Placebo	31	Stanford \| California \| United States \| -122.16608 \| 37.42411 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Cordoba Capital \| Córdoba Province \| Argentina \| N/A \| N/A Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Westmead, Sydney \| New South Wales \| Australia \| N/A \| N/A Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Antonio Varas \| Providencia Santiago \| Chile \| N/A \| N/A Santa María \| Providencia Santiago \| Chile \| -71.66667 \| -38.81667 Vandoeurvre Les Nancy \| N/A \| France \| N/A \| N/A Villejuif \| N/A \| France \| 2.35992 \| 48.7939 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Groningen \| N/A \| Netherlands \| 6.56667 \| 53.21917 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Utrecht \| N/A \| Netherlands \| 5.12222 \| 52.09083 Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Sutton \| Surrey \| United Kingdom \| -0.2 \| 51.35	130	0	0	0	NCT00688376	1COMPLETED	2009-05-26	2008-07-02	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	252	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	null	The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.	null	Breast Cancer Low Bone Mineral Density Osteopenia	Breast Cancer Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC osteopenia Low bone density	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months intervention 2: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months	intervention 1: Placebo intervention 2: AMG 162 / Denosumab	0	null	249	0	0	0	NCT00089661	1COMPLETED	2009-05-27	2004-10-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 3 ]	16	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.	null	Patients Undergoing Photodynamic Therapy Using Porfimer Sodium		null	2	arm 1: Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. arm 2: Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Afamelanotide intervention 2: Placebo	0	null	16	0	0	0	NCT04425746	1COMPLETED	2009-05-28	2008-08-05	Clinuvel Pharmaceuticals Limited	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	26	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.	Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged. Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250). Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells. This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.	Cancer of Kidney Kidney Cancer Renal Cancer Neoplasms, Kidney Renal Neoplasms Renal Cell Carcinoma (RCC) Clear Cell Renal Cell Carcinoma	Kidney Cancer Renal Cancer Neoplasms, Kidney cG250 antibody Iodine 124	null	1	arm 1: Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: 124-Iodine-cG250 (124I-cG250)	1	New York \| New York \| United States \| -74.00597 \| 40.71427	26	0	0	0	NCT00199888	1COMPLETED	2009-05-29	2005-06-01	Ludwig Institute for Cancer Research	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	287	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants. The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.	null	Osteoporosis Postmenopausal		null	4	arm 1: After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods. arm 2: After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods. arm 3: After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods. arm 4: After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.	[ 2, 0, 0, 2 ]	4	[ 0, 7, 7, 0 ]	intervention 1: Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks. intervention 2: Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks. intervention 3: Calcium carbonate 500 mg tablet taken orally every day for 52 weeks. intervention 4: Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.	intervention 1: Odanacatib intervention 2: Vitamin D3 intervention 3: Calcium carbonate intervention 4: Placebo	0	null	286	0	0	0	NCT00620113	1COMPLETED	2009-05-29	2007-12-03	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	616	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.	Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings collected over the course of the treatment period. Effectiveness measurements will be done at baseline and each visit until week 52 or end-of-treatment. A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis related to response to vilazodone.	Major Depressive Disorder		null	1	arm 1: Vilazodone titrated up to 40 mg/day for 1 year.	[ 0 ]	1	[ 0 ]	intervention 1: titration to 40 milligrams (mg) every day (qd) for 1 year	intervention 1: vilazodone	38	Garden Grove \| California \| United States \| -117.94145 \| 33.77391 San Diego \| California \| United States \| -117.16472 \| 32.71571 Torrance \| California \| United States \| -118.34063 \| 33.83585 Upland \| California \| United States \| -117.64839 \| 34.09751 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Coral Springs \| Florida \| United States \| -80.2706 \| 26.27119 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Lady Lake \| Florida \| United States \| -81.92286 \| 28.91749 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Smyrna \| Georgia \| United States \| -84.51438 \| 33.88399 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Libertyville \| Illinois \| United States \| -87.95313 \| 42.28308 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Farmington \| Michigan \| United States \| -83.37632 \| 42.46448 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Mount Kisco \| New York \| United States \| -73.72708 \| 41.20426 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Beachwood \| Ohio \| United States \| -81.50873 \| 41.4645 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Middleburg Heights \| Ohio \| United States \| -81.81291 \| 41.36144 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Bridgeville \| Pennsylvania \| United States \| -80.11006 \| 40.35618 Colmar \| Pennsylvania \| United States \| -75.25351 \| 40.26733 Media \| Pennsylvania \| United States \| -75.38769 \| 39.91678 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Woodstock \| Vermont \| United States \| -72.51843 \| 43.62424 Herndon \| Virginia \| United States \| -77.3861 \| 38.96955 Midlothian \| Virginia \| United States \| -77.64916 \| 37.50598	599	1	0.001669	1	NCT00644358	1COMPLETED	2009-05-31	2007-12-31	Forest Laboratories	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000295
[ 3 ]	25	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.	null	Psoriasis	psoriasis	null	3	arm 1: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. arm 2: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. arm 3: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Ruxolitinib 1.5% cream BID for 28 days	intervention 1: Ruxolitinib	4	Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Austin \| Texas \| United States \| -97.74306 \| 30.26715 College Station \| Texas \| United States \| -96.33441 \| 30.62798	50	0	0	0	NCT00617994	1COMPLETED	2009-05-31	2007-08-31	Incyte Corporation	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	517	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) \< 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.	This study was originally planned as a 48-week, Phase 3, randomized, open-label, multicenter study comparing EFV+FTC+TDF (administered as the individual component drugs) versus CBV (lamivudine/zidovudine) + EFV to assess the efficacy and safety of both treatments in ART-Naive, HIV-1 infected participants. The regimen of CBV (administered twice daily) + EFV (administered once daily) served as the active control treatment and was compared with the regimen of EFV+FTC+TDF; each component drug in the EFV+FTC+TDF regimen was administered once daily. Week 48 to Week 96: The study was extended and continued to evaluate the efficacy and safety of the two regimens up to a total treatment duration of 96 weeks. The regimen of EFV+FTC+TDF continued to be dosed as the component drugs (EFV + FTC + TDF), once daily, without regard to meals. The regimen of CBV+EFV was dosed as 2 pills (CBV, twice daily in the morning without regard to meals) + EFV (once daily, without regard to meals). Week 96 to Week 144: A further study extension changed the 3-pill EFV+FTC+TDF regimen to a 2-pill regimen of EFV + Truvada (\[TVD\]: a fixed-dose combination pill containing FTC/TDF), once daily without regard to meals, and continued to evaluate the efficacy and safety of the two regimens for a further 48 weeks up to a total study treatment duration of 144 weeks. The regimen of CBV+EFV continued to be dosed as 2 pills (CBV, twice daily in the morning without regard to meals) + EFV (once daily, without regard to meals). Week 144 to end of study (Week 240): A final study extension provided all study participants from both treatment regimens the option to switch their respective treatments to the 1-pill regimen of for a further 96 weeks up to a total study duration of 240 weeks (5 years) to further assess the efficacy and safety of ART regimen simplification. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	HIV Infections	Human Immunodeficiency Virus	null	2	arm 1: Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine 150 mg + zidovudine 300 mg) taken twice daily from the start of the study until Week 144. At Week 144 all participants who opted to roll over into the additional 96-week study extension received Atripla (\[ATR\]; the fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg) taken once daily until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. arm 2: Participants in this arm received 3 component drugs: efaviren (EFV; 600 mg) + emtricitabine (FTC; 200 mg) + tenofovir disoproxil fumarate (tenofovir DF \[TDF\]; 300 mg) as 3 separate pills once daily from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF \[200/300 mg\] once daily) replaced the 2 component drugs FTC + TDF; participants continued to receive EFV 600 mg once daily. At Week 144 all participants who opted to roll over into the further 96-week study extension received ATR. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.	[ 1, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Capsule containing 200 mg FTC, taken once daily, for 96 weeks intervention 2: Tablet containing 300 mg TDF, taken once daily, for 96 weeks intervention 3: Tablet containing 600 mg EFV, taken once daily, for 96 weeks intervention 4: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144 intervention 5: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240 intervention 6: Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks	intervention 1: Emtricitabine (FTC) intervention 2: Tenofovir Disoproxil Fumarate (TDF) intervention 3: Efavirenz (EFV) intervention 4: FTC/TDF intervention 5: FTC/TDF/EFV intervention 6: Lamivudine/zidovudine	5	Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Huntersville \| North Carolina \| United States \| -80.84285 \| 35.41069	957	2	0.00209	1	NCT00112047	1COMPLETED	2009-06-01	2003-07-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0	0	2	0	0	0.000573
[ 4 ]	463	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).	null	Colorectal Cancer Metastases	Metastatic Colorectal Cancer, Colon Colorectal, Rectal Cancer, Cancer Metastatic, EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen	null	2	arm 1: Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional guidelines. arm 2: Best supportive care will be defined in this study as the best care available as judged appropriate by the investigator and according to institutional guidelines and will include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care will not include anti-neoplastic chemotherapy.	[ 0, 5 ]	2	[ 10, 0 ]	intervention 1: Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases). intervention 2: Intravenous infusion at a dose of 6 mg/kg once every 2 weeks.	intervention 1: Best supportive care intervention 2: Panitumumab	0	null	463	1	0.00216	1	NCT00113763	1COMPLETED	2009-06-01	2004-01-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000381
[ 4 ]	344	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).	null	Schizophrenia	Open-label extension Ziprasidone study in Schizophrenia	null	0	null	null	1	[ 0 ]	intervention 1: 20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.	intervention 1: Ziprasidone	87	Sora \| Frosinone \| Italy \| 13.61356 \| 41.71829 Parma \| PR \| Italy \| 10.32618 \| 44.79935 Acri, CS \| N/A \| Italy \| 16.38635 \| 39.49624 Arezzo \| N/A \| Italy \| 11.88068 \| 43.46276 Arona (No) \| N/A \| Italy \| 8.55715 \| 45.7589 Bassano del Grappa \| N/A \| Italy \| 11.72739 \| 45.76656 Bisceglie (BA) \| N/A \| Italy \| 16.50104 \| 41.24264 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Bolzano \| N/A \| Italy \| 11.33982 \| 46.49067 Brindisi \| N/A \| Italy \| 17.93607 \| 40.63215 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Casalecchio Di Reno BO \| N/A \| Italy \| N/A \| N/A Caserta \| N/A \| Italy \| 14.33231 \| 41.07262 Catania \| N/A \| Italy \| 15.07041 \| 37.49223 Cefalu' (Pa) \| N/A \| Italy \| 14.02285 \| 38.03856 Cesena FO \| N/A \| Italy \| N/A \| N/A Chiari (Bs) \| N/A \| Italy \| 9.92699 \| 45.53763 Cremona \| N/A \| Italy \| 10.02129 \| 45.13325 Crotone \| N/A \| Italy \| 17.12764 \| 39.08077 Cuneo \| N/A \| Italy \| 7.54828 \| 44.39071 Dolo (Ve) \| N/A \| Italy \| 12.08429 \| 45.42528 Empoli \| N/A \| Italy \| 10.94758 \| 43.71795 Enna \| N/A \| Italy \| 14.27433 \| 37.5655 Fano (PS) \| N/A \| Italy \| 13.01665 \| 43.84052 Formia (LT) \| N/A \| Italy \| 13.60888 \| 41.25632 Frattaminore (NA) \| N/A \| Italy \| 14.27201 \| 40.9558 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Genzano (RM) \| N/A \| Italy \| 12.68904 \| 41.70706 Giarre, CT \| N/A \| Italy \| 15.18165 \| 37.7244 Guardiagrele (CH) \| N/A \| Italy \| 14.21939 \| 42.19406 Lamezia Terme \| N/A \| Italy \| 16.30938 \| 38.96255 Lecce \| N/A \| Italy \| 18.17244 \| 40.35481 Livorno \| N/A \| Italy \| 10.32615 \| 43.54427 L’Aquila \| N/A \| Italy \| 13.39954 \| 42.35055 Matera \| N/A \| Italy \| 16.60463 \| 40.66599 Melzo (MI) \| N/A \| Italy \| 9.42043 \| 45.4981 Merano (BZ) \| N/A \| Italy \| 11.15953 \| 46.66817 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Montebelluna (TV) \| N/A \| Italy \| 12.04904 \| 45.77504 Montecchio Maggiore (VI) \| N/A \| Italy \| 11.412 \| 45.50369 Montevarchi (AR) \| N/A \| Italy \| 11.57238 \| 43.5252 Monza MI \| N/A \| Italy \| N/A \| N/A Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Nocera Inferiore, SA \| N/A \| Italy \| 14.64542 \| 40.7454 Noto \| N/A \| Italy \| 15.06977 \| 36.89244 Novi Ligure, AL \| N/A \| Italy \| 8.787 \| 44.76246 Orbassano, to \| N/A \| Italy \| 7.53813 \| 45.00547 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Partinico (Pa) \| N/A \| Italy \| 13.11785 \| 38.04657 Passirana Di Rho (Mi) \| N/A \| Italy \| N/A \| N/A Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Perugia \| N/A \| Italy \| 12.38878 \| 43.1122 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Pordenone \| N/A \| Italy \| 12.66051 \| 45.95689 Portogruaro (Ve) \| N/A \| Italy \| 12.84052 \| 45.78071 Puglianello (BN) \| N/A \| Italy \| 14.45023 \| 41.22179 Ragusa \| N/A \| Italy \| 14.72443 \| 36.92574 Reggio Calabria \| N/A \| Italy \| 15.66129 \| 38.11047 Rivoli, to \| N/A \| Italy \| 7.51465 \| 45.07073 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Salerno \| N/A \| Italy \| 14.79328 \| 40.67545 San Benedetto Del Tronto, AP \| N/A \| Italy \| 13.87676 \| 42.9568 San Giorgio Di Piano BO \| N/A \| Italy \| N/A \| N/A San Marco in Lamis FG \| N/A \| Italy \| N/A \| N/A Sant'Arsenio (SA) \| N/A \| Italy \| 15.48401 \| 40.47109 Sassari \| N/A \| Italy \| 8.55552 \| 40.72586 Senigallia, AN \| N/A \| Italy \| 13.20882 \| 43.71626 Spoleto (PG) \| N/A \| Italy \| 12.73899 \| 42.74071 Taranto \| N/A \| Italy \| 17.24707 \| 40.46438 Tivoli (RM) \| N/A \| Italy \| 12.8016 \| 41.95952 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Treviso \| N/A \| Italy \| 12.2416 \| 45.66673 Udine \| N/A \| Italy \| 13.23715 \| 46.0693 Verona \| N/A \| Italy \| 10.9938 \| 45.43854 Viareggio \| N/A \| Italy \| 10.2502 \| 43.86693	331	3	0.009063	1	NCT00139737	1COMPLETED	2009-06-01	2002-03-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	1	2	0	0	0.003087
[ 5 ]	2,252	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.	null	Non-Squamous Non-Small Cell Lung Cancer		null	1	arm 1: Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.	[ 0 ]	2	[ 0, 0 ]	intervention 1: As prescribed intervention 2: 15 mg/kg IV on Day 1 of each 3 week cycle	intervention 1: Platinum-based chemotherapy intervention 2: Bevacizumab [Avastin]	369	Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Chaco-resistencia \| N/A \| Argentina \| N/A \| N/A Córdoba \| N/A \| Argentina \| -64.18853 \| -31.40648 Córdoba \| N/A \| Argentina \| -64.18853 \| -31.40648 San Miguel de Tucumán \| N/A \| Argentina \| -65.21051 \| -26.81601 St Leonards \| New South Wales \| Australia \| 151.19836 \| -33.82344 Waratah \| New South Wales \| Australia \| 151.72647 \| -32.90667 Auchenflower \| Queensland \| Australia \| 152.99213 \| -27.47443 Chermside \| Queensland \| Australia \| 153.03062 \| -27.38472 Tugun \| Queensland \| Australia \| 153.5 \| -28.15 Box Hill \| Victoria \| Australia \| 145.12545 \| -37.81887 Geelong \| Victoria \| Australia \| 144.36069 \| -38.14711 Malvern \| Victoria \| Australia \| 145.02811 \| -37.86259 Wodonga \| Victoria \| Australia \| 146.88809 \| -36.12179 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Sydney, New South Wales \| N/A \| Australia \| 151.20732 \| -33.86785 Bludesch \| N/A \| Austria \| 9.73306 \| 47.2 Bregenz \| N/A \| Austria \| 9.7471 \| 47.50311 Feldkirch \| N/A \| Austria \| 9.6 \| 47.23306 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Knittelfeld \| N/A \| Austria \| 14.81667 \| 47.21667 Kufstein \| N/A \| Austria \| 12.16667 \| 47.58333 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Natters \| N/A \| Austria \| 11.37342 \| 47.23414 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Sankt Veit an der Glan \| N/A \| Austria \| 14.36028 \| 46.76806 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vöcklabruck \| N/A \| Austria \| 13.65652 \| 48.00279 Wels \| N/A \| Austria \| 14.03333 \| 48.16667 Zams \| N/A \| Austria \| 10.5897 \| 47.15844 Banja Luka \| N/A \| Bosnia and Herzegovina \| 17.19386 \| 44.77842 Sarajevo \| N/A \| Bosnia and Herzegovina \| 18.35644 \| 43.84864 Fortaleza \| Ceará \| Brazil \| -38.54306 \| -3.71722 Vitória \| Espírito Santo \| Brazil \| -40.33778 \| -20.31944 Salvador, Bahia \| Estado de Bahia \| Brazil \| N/A \| N/A Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Belo Horizonte \| Minas Gerais \| Brazil \| -43.93778 \| -19.92083 Belo Horizonte \| Minas Gerais \| Brazil \| -43.93778 \| -19.92083 Recife \| Pernambuco \| Brazil \| -34.88111 \| -8.05389 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Ijuí \| Rio Grande do Sul \| Brazil \| -53.91472 \| -28.38778 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Campinas \| São Paulo \| Brazil \| -47.06083 \| -22.90556 Campinas \| São Paulo \| Brazil \| -47.06083 \| -22.90556 Jaú \| São Paulo \| Brazil \| -48.55778 \| -22.29639 Ribeirão Preto \| São Paulo \| Brazil \| -47.81028 \| -21.1775 Santos \| São Paulo \| Brazil \| -46.33361 \| -23.96083 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Bogotá \| N/A \| Colombia \| -74.08175 \| 4.60971 Manizales \| N/A \| Colombia \| -75.50684 \| 5.0668 Santiago de Cali \| N/A \| Colombia \| -76.5199 \| 3.43054 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Aarhus \| N/A \| Denmark \| 10.21076 \| 56.15674 Herlev \| N/A \| Denmark \| 12.43998 \| 55.72366 Hillerød \| N/A \| Denmark \| 12.30081 \| 55.92791 Næstved \| N/A \| Denmark \| 11.76092 \| 55.22992 Guayaquil \| N/A \| Ecuador \| -79.88621 \| -2.19616 Quito \| N/A \| Ecuador \| -78.52495 \| -0.22985 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Paimio \| N/A \| Finland \| 22.68694 \| 60.45671 Pori \| N/A \| Finland \| 21.78333 \| 61.48333 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Aix-en-Provence \| N/A \| France \| 5.44973 \| 43.5283 Avignon \| N/A \| France \| 4.80892 \| 43.94834 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Béziers \| N/A \| France \| 3.21402 \| 43.34122 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Brest \| N/A \| France \| -4.48628 \| 48.39029 Caen \| N/A \| France \| -0.35912 \| 49.18585 Chalon-sur-Saône \| N/A \| France \| 4.85372 \| 46.78112 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Gap \| N/A \| France \| 6.07868 \| 44.55858 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Le Chesnay \| N/A \| France \| 2.12213 \| 48.8222 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Meaux \| N/A \| France \| 2.87885 \| 48.96014 Nancy \| N/A \| France \| 6.18496 \| 48.68439 Neuilly-sur-Seine \| N/A \| France \| 2.26965 \| 48.8846 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Perpignan \| N/A \| France \| 2.89541 \| 42.69764 Reims \| N/A \| France \| 4.02853 \| 49.26526 Saint-Julien-en-Genevois \| N/A \| France \| 6.08256 \| 46.14434 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Toulon \| N/A \| France \| 5.92836 \| 43.12442 Toulon \| N/A \| France \| 5.92836 \| 43.12442 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Vandœuvre-lès-Nancy \| N/A \| France \| 6.17114 \| 48.66115 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Bad Berka \| N/A \| Germany \| 11.28245 \| 50.89982 Bayreuth \| N/A \| Germany \| 11.57893 \| 49.94782 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bielefeld \| N/A \| Germany \| 8.53333 \| 52.03333 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Coswig \| N/A \| Germany \| 13.58312 \| 51.13204 Donaustauf \| N/A \| Germany \| 12.20459 \| 49.03258 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Ebensfeld \| N/A \| Germany \| 10.95835 \| 50.0664 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Gauting \| N/A \| Germany \| 11.37703 \| 48.06919 Gerlingen \| N/A \| Germany \| 9.06316 \| 48.79954 Göttingen \| N/A \| Germany \| 9.93228 \| 51.53443 Großhansdorf \| N/A \| Germany \| 10.28333 \| 53.66667 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Karlsruhe \| N/A \| Germany \| 8.40444 \| 49.00937 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Leer \| N/A \| Germany \| 7.461 \| 53.23157 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Leverkusen \| N/A \| Germany \| 6.98432 \| 51.0303 Löwenstein \| N/A \| Germany \| 9.38 \| 49.09558 Magdeburg \| N/A \| Germany \| 11.62916 \| 52.12773 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Minden \| N/A \| Germany \| 8.91455 \| 52.28953 München \| N/A \| Germany \| 13.31243 \| 51.60698 Neuruppin \| N/A \| Germany \| 12.80311 \| 52.92815 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Oldenburg \| N/A \| Germany \| 8.21467 \| 53.14118 Rostock \| N/A \| Germany \| 12.14049 \| 54.0887 Treuenbrietzen \| N/A \| Germany \| 12.87258 \| 52.09754 Ulm \| N/A \| Germany \| 9.99155 \| 48.39841 Villingen-Schwenningen \| N/A \| Germany \| 8.49358 \| 48.06226 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Wolfsburg \| N/A \| Germany \| 10.7815 \| 52.42452 Würselen \| N/A \| Germany \| 6.1347 \| 50.81809 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Shatin \| N/A \| Hong Kong \| 114.18333 \| 22.38333 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Mátraháza \| N/A \| Hungary \| 19.97981 \| 47.87124 Pécs \| N/A \| Hungary \| 18.23083 \| 46.0725 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Törökbálint \| N/A \| Hungary \| 18.91356 \| 47.42931 Reykjavik \| N/A \| Iceland \| -21.89541 \| 64.13548 Beersheba \| N/A \| Israel \| 34.7913 \| 31.25181 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Ramat Gan \| N/A \| Israel \| 34.81065 \| 32.08227 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Ẕerifin \| N/A \| Israel \| 34.84852 \| 31.95731 Avezzano \| Abruzzo \| Italy \| 13.42641 \| 42.02896 Pescara \| Abruzzo \| Italy \| 14.20283 \| 42.4584 Bari \| Apulia \| Italy \| 16.86982 \| 41.12066 Brindisi \| Apulia \| Italy \| 17.93607 \| 40.63215 San Giovanni Rotondo \| Apulia \| Italy \| 15.7277 \| 41.70643 Potenza \| Basilicate \| Italy \| 15.80794 \| 40.64175 Rionero in Vulture \| Basilicate \| Italy \| 15.6711 \| 40.92328 Catanzaro \| Calabria \| Italy \| 16.60086 \| 38.88247 Avellino \| Campania \| Italy \| 14.79103 \| 40.91494 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Bologna \| Emilia-Romagna \| Italy \| 11.33875 \| 44.49381 Carpi \| Emilia-Romagna \| Italy \| 10.8777 \| 44.78237 Modena \| Emilia-Romagna \| Italy \| 10.92539 \| 44.64783 Rimini \| Emilia-Romagna \| Italy \| 12.56528 \| 44.05755 Aviano \| Friuli Venezia Giulia \| Italy \| 12.59472 \| 46.07056 Udine \| Friuli Venezia Giulia \| Italy \| 13.23715 \| 46.0693 Rome \| Lazio \| Italy \| 12.51133 \| 41.89193 Rome \| Lazio \| Italy \| 12.51133 \| 41.89193 Rome \| Lazio \| Italy \| 12.51133 \| 41.89193 Sora \| Lazio \| Italy \| 13.61356 \| 41.71829 Viterbo \| Lazio \| Italy \| 12.1056 \| 42.41937 Genoa \| Liguria \| Italy \| 8.94439 \| 44.40478 Genoa \| Liguria \| Italy \| 8.94439 \| 44.40478 La Spezia \| Liguria \| Italy \| 9.82375 \| 44.103 Bergamo \| Lombardy \| Italy \| 9.66721 \| 45.69601 Cremona \| Lombardy \| Italy \| 10.02129 \| 45.13325 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Pavia \| Lombardy \| Italy \| 9.15917 \| 45.19205 S Fermo Della Battaglia \| Lombardy \| Italy \| N/A \| N/A Sondrio \| Lombardy \| Italy \| 9.87134 \| 46.16852 Novara \| Piedmont \| Italy \| 8.62118 \| 45.44694 Cagliari \| Sardinia \| Italy \| 9.11917 \| 39.23054 Sassari \| Sardinia \| Italy \| 8.55552 \| 40.72586 Catania \| Sicily \| Italy \| 15.07041 \| 37.49223 Catania \| Sicily \| Italy \| 15.07041 \| 37.49223 Palermo \| Sicily \| Italy \| 13.3636 \| 38.1166 Taormina \| Sicily \| Italy \| 15.28851 \| 37.85358 Ancona \| The Marches \| Italy \| 13.5103 \| 43.60717 Arezzo \| Tuscany \| Italy \| 11.88068 \| 43.46276 Lido di Camaiore \| Tuscany \| Italy \| 10.2269 \| 43.90012 Pisa \| Tuscany \| Italy \| 10.4036 \| 43.70853 Camposampiero \| Veneto \| Italy \| 11.93534 \| 45.56368 Feltre - Bl \| Veneto \| Italy \| N/A \| N/A Negrar \| Veneto \| Italy \| 10.93899 \| 45.52918 Bologna, Umbria \| N/A \| Italy \| 11.33875 \| 44.49381 Forli, Emilia-Romagna \| N/A \| Italy \| 12.04144 \| 44.22177 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Beirut \| N/A \| Lebanon \| 35.50157 \| 33.89332 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Klaipėda \| N/A \| Lithuania \| 21.13912 \| 55.7068 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Chihuahua City \| N/A \| Mexico \| -106.08889 \| 28.63528 León \| N/A \| Mexico \| -113.78333 \| 28.51667 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Arnhem \| N/A \| Netherlands \| 5.91111 \| 51.98 Breda \| N/A \| Netherlands \| 4.77596 \| 51.58656 Eindhoven \| N/A \| Netherlands \| 5.47778 \| 51.44083 Groningen \| N/A \| Netherlands \| 6.56667 \| 53.21917 Haarlem \| N/A \| Netherlands \| 4.63683 \| 52.38084 Helmond \| N/A \| Netherlands \| 5.66111 \| 51.48167 Hoofddorp \| N/A \| Netherlands \| 4.68889 \| 52.3025 Nieuwegein \| N/A \| Netherlands \| 5.08056 \| 52.02917 Schiedam \| N/A \| Netherlands \| 4.38889 \| 51.91917 The Hague \| N/A \| Netherlands \| 4.29861 \| 52.07667 Tiel \| N/A \| Netherlands \| 5.42917 \| 51.88667 Zwolle \| N/A \| Netherlands \| 6.09444 \| 52.5125 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Zabrze \| N/A \| Poland \| 18.78576 \| 50.32492 Braga \| N/A \| Portugal \| -8.42005 \| 41.55032 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Porto \| N/A \| Portugal \| -8.61099 \| 41.14961 Porto \| N/A \| Portugal \| -8.61099 \| 41.14961 Santa Maria da Feira \| N/A \| Portugal \| -8.54839 \| 40.92726 Setúbal \| N/A \| Portugal \| -8.8882 \| 38.5244 Vila Nova de Gaia \| N/A \| Portugal \| -8.61241 \| 41.12401 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Timișoara \| N/A \| Romania \| 21.22571 \| 45.75372 Balashikha \| N/A \| Russia \| 37.94794 \| 55.79479 Engel's \| N/A \| Russia \| 46.10528 \| 51.48389 Irkutsk \| N/A \| Russia \| 104.29585 \| 52.29795 Kislino, Kursk Region \| N/A \| Russia \| 28.37629 \| 58.90195 Krasnodar \| N/A \| Russia \| 38.97603 \| 45.04484 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Smolensk \| N/A \| Russia \| 32.04371 \| 54.77944 Stavropol \| N/A \| Russia \| 41.9734 \| 45.0428 Tver' \| N/A \| Russia \| 35.90057 \| 56.85836 Tyumen \| N/A \| Russia \| 65.52722 \| 57.15222 Ulyanovsk \| N/A \| Russia \| 48.38657 \| 54.32824 Belgrade \| N/A \| Serbia \| 20.46513 \| 44.80401 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Košice \| N/A \| Slovakia \| 21.25808 \| 48.71395 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Poprad \| N/A \| Slovakia \| 20.29798 \| 49.06144 Golnik \| N/A \| Slovenia \| 14.33333 \| 46.33333 Ljubljana \| N/A \| Slovenia \| 14.50513 \| 46.05108 Alicante \| Alicante \| Spain \| -0.48149 \| 38.34517 Elche \| Alicante \| Spain \| -0.70107 \| 38.26218 Palma de Mallorca \| Balearic Islands \| Spain \| 2.65024 \| 39.56939 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Manresa \| Barcelona \| Spain \| 1.82399 \| 41.72815 Mataró \| Barcelona \| Spain \| 2.4445 \| 41.54211 Sabadell \| Barcelona \| Spain \| 2.10942 \| 41.54329 Terrassa \| Barcelona \| Spain \| 2.01667 \| 41.56667 Santander \| Cantabria \| Spain \| -3.80444 \| 43.46472 Girona \| Girona \| Spain \| 2.82493 \| 41.98311 Huesca \| Huesca \| Spain \| -0.4087 \| 42.13615 A Coruña \| La Coruña \| Spain \| -8.396 \| 43.37135 Lugo \| Lugo \| Spain \| -7.55602 \| 43.00992 Alcorcón \| Madrid \| Spain \| -3.82487 \| 40.34582 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Murcia \| Murcia \| Spain \| -1.13004 \| 37.98704 Pamplona \| Navarre \| Spain \| -1.64323 \| 42.81687 Salamanca \| Salamanca \| Spain \| -5.66388 \| 40.96882 San Cristóbal de La Laguna \| Tenerife \| Spain \| -16.32014 \| 28.4853 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Barakaldo \| Vizcaya \| Spain \| -2.98813 \| 43.29639 Zaragoza \| Zaragoza \| Spain \| -0.87734 \| 41.65606 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Örebro \| N/A \| Sweden \| 15.2066 \| 59.27412 Stokholm, Solna \| N/A \| Sweden \| N/A \| N/A Umeå \| N/A \| Sweden \| 20.25972 \| 63.82842 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Aarau \| N/A \| Switzerland \| 8.04422 \| 47.39254 Baden \| N/A \| Switzerland \| 8.30592 \| 47.47333 Genolier \| N/A \| Switzerland \| 6.21809 \| 46.43537 Locarno \| N/A \| Switzerland \| 8.79953 \| 46.17086 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Tainan City \| N/A \| Taiwan \| 120.21333 \| 22.99083 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Gaziantep \| N/A \| Turkey (Türkiye) \| 37.3825 \| 37.05944 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Sıhhiye, Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Aberdeen \| N/A \| United Kingdom \| -2.09814 \| 57.14369 Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682 Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Cambridge \| N/A \| United Kingdom \| 0.11667 \| 52.2 Cardiff \| N/A \| United Kingdom \| -3.18 \| 51.48 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Nottingham \| N/A \| United Kingdom \| -1.15047 \| 52.9536 Suffolk \| N/A \| United Kingdom \| N/A \| N/A Barcelona \| N/A \| Venezuela \| -64.68769 \| 10.1384 Barquisimeto \| N/A \| Venezuela \| -69.35703 \| 10.0647 Porlamar \| N/A \| Venezuela \| -63.86971 \| 10.95771	2,212	2	0.000904	1	NCT00451906	1COMPLETED	2009-06-01	2006-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	1	0	0	0	1	0.000248
[ 4 ]	1,467	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.	This study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg donepezil SR with the currently marketed donepezil formulation (10 mg donepezil IR) in patients with moderate to severe Alzheimer's disease. Patients must have been taking 10 mg IR (or a bioequivalent generic) for at least 3 months prior to Screening. The study will consist of 24 weeks of daily administration of study medication, with clinic visits at Screening, Baseline, 3 weeks (safety only), 6 weeks, 12 weeks, 18 weeks and 24 weeks or early termination. Patients will receive either 10 mg donepezil IR in combination with the placebo corresponding to 23 mg donepezil SR, or 23 mg donepezil SR in combination with the placebo corresponding to 10 mg donepezil IR. A total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1200 completed patients (Revised per Amendment 02). During the Baseline visit, patients will be randomized in a 2:1 ratio (23 mg donepezil SR to 10 mg donepezil IR). The study will be performed at approximately 200 global sites (Asia, Oceania, Europe, India, Israel, North America, South Africa, and South America) (Revised per Amendments 01 and 02). An Independent Data Monitoring Committee (IDMC) will be established to review safety aspects of the study and to evaluate the results of a planned interim analysis. Patients who complete the study may be eligible to undergo evaluation for enrollment into the open-label extension study, E2020-G000-328.	Alzheimer's Disease	Moderate to Severe Alzheimer's Disease	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation. intervention 2: Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation.	intervention 1: Aricept (donepezil SR 23 mg) intervention 2: Aricept (donepezil IR 10 mg)	1	Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319	1,434	1	0.000697	1	NCT00478205	1COMPLETED	2009-06-01	2007-06-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000123
[ 5 ]	289	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	null	Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion. Main Secondary objectives: To compare insulin glulisine, insulin aspart and insulin lispro on: * Unexplained hyperglycemia * Infusion set occlusion * Hypoglycemic episodes,7-point blood glucose profiles * Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis * Time to change the infusion set * HbA1c (Glycosylated hemoglobin) * Overall safety: incidence of adverse events	The maximal duration of the study participation for patients was 41 weeks and one day, split in: * a 2-week screening period, * a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart) * and a follow-up period of 24 hours.	Diabetes Mellitus, Type 1		null	3	arm 1: sequence 1: insulin glulisine / insulin aspart / insulin lispro. arm 2: Sequence 2: insulin aspart / insulin lispro / insulin glulisine arm 3: Sequence 3: insulin lispro / insulin glulisine / insulin aspart	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 2: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 3: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump	intervention 1: Insulin glulisine intervention 2: Insulin lispro intervention 3: Insulin aspart	12	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 Paris \| N/A \| France \| 2.3488 \| 48.85341 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Netanya \| N/A \| Israel \| 34.85992 \| 32.33291 Milan \| N/A \| Italy \| 9.18951 \| 45.46427 PE Gouda \| N/A \| Netherlands \| N/A \| N/A Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Bromma \| N/A \| Sweden \| 17.94 \| 59.34 Guildford Surrey \| N/A \| United Kingdom \| N/A \| N/A	809	2	0.002472	1	NCT00607087	1COMPLETED	2009-06-01	2008-01-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	0	0	2	0.000678
[ 4 ]	2,322	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	null	The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.	null	Chemotherapy-Induced Nausea and Vomiting (CINV)		null	2	arm 1: Arm 1: study medication arm 2: Arm 2: Active comparator	[ 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1. intervention 2: Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3). intervention 3: Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4. intervention 4: Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4. intervention 5: single IV dose of 32 mg of ondansetron on Day 1.	intervention 1: Comparator: fosaprepitant dimeglumine intervention 2: Comparator: Aprepitant intervention 3: Dexamethasone intervention 4: Dexamethasone intervention 5: Ondansetron	0	null	2,312	24	0.010381	1	NCT00619359	1COMPLETED	2009-06-01	2008-02-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	24	0	0	0	0	0.006986
[ 3 ]	35	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.	null	Pneumonia, Bacterial		null	3	arm 1: Loading dose of IV sulopenem with switch to oral PF-03709270 arm 2: IV sulopenem with switch to oral PF-03709270 arm 3: IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day intervention 2: Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day intervention 3: IV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)	intervention 1: sulopenem and PF-03709270 intervention 2: Sulopenem and PF-03709270 intervention 3: Ceftriaxone and amoxicillin/clavulanate	24	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Moline \| Illinois \| United States \| -90.51513 \| 41.5067 Rock Island \| Illinois \| United States \| -90.57875 \| 41.50948 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Provo \| Utah \| United States \| -111.65853 \| 40.23384 Provo \| Utah \| United States \| -111.65853 \| 40.23384 Brisbane \| Queensland \| Australia \| 153.02809 \| -27.46794 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Brzesko \| N/A \| Poland \| 20.60606 \| 49.96911 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Proszowice \| N/A \| Poland \| 20.28909 \| 50.19275 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	33	1	0.030303	1	NCT00797108	1COMPLETED	2009-06-01	2009-01-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	1	0	0.005369
[ 2, 3 ]	54	null	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)	null	Chronic Myelogenous Leukemia Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia		null	3	arm 1: CML - Chronic Phase arm 2: CML - Accelerated Phase and Blast Phase arm 3: Ph+ Acute Lymphoblastic Leukemia	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID	intervention 1: dasatinib	0	null	54	1	0.018519	1	NCT01030718	1COMPLETED	2009-06-01	2006-01-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.003276
[ 3 ]	2	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky procedure. For some non-cancerous conditions, the risks of this procedure outweigh the potential benefits. This protocol is designed to test a new approach to allogeneic stem cell transplantation. It is hoped that this approach will be better suited for patients with non-cancerous blood and bone marrow disorders.	OBJECTIVES: Primary Objective(s): 1. Evaluate the feasibility in terms of mortality, occurrence of acute graft versus host disease, and grades 3-4/4 toxicity of in vivo and in vitro Campath coupled with concomitantly administered nonmyeloablative fludarabine, cyclophosphamide and total body irradiation (TBI) followed by Human Leukocyte Antigen (HLA) 5-6/6 matched family member allo peripheral blood stem cell transplant (PBSCT). 2. Evaluate the engraftment rate of HLA 5-6/6 matched family member patients who receive in vivo Campath followed by concomitantly administered fludarabine, cyclophosphamide and total body irradiation (TBI) as a conditioning regimen with Campath-treated peripheral blood stem cells (in vitro and in vivo exposure). Secondary Objective(s): 1. Evaluate the response rate and survival of patients who receive a non-myeloablative conditioning regimen of in vivo Campath followed by concomitantly administered fludarabine, cyclophosphamide and total body irradiation (TBI) with Campath-treated peripheral blood stem cells. 2. Evaluate the recovery of immune function post engraftment with this regimen.	Sickle Cell Anemia Severe Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria (PNH) Pure Red Cell Aplasia	sickle cell anemia severe aplastic anemia	null	2	arm 1: Campath, Chemo and/or TBI Allo SCT arm 2: Campath, Chemo and/or TBI Allo SCT	[ 0, 0 ]	1	[ 0 ]	intervention 1: Allogeneic PBSC/marrow will be collected/harvested from the donor after granulocyte colony-stimulating factor (G-CSF) priming. The allogeneic PBSCs will be infused as per current institutional practice.	intervention 1: Campath, Chemo and/or TBI Allo SCT	2	Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	2	0	0	0	NCT00004143	1COMPLETED	2009-06-01	1999-09-01	David Rizzieri, MD	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	29	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease \[GvHD\] (grade III-IV). Secondary objectives include assessments of recipient having donor derived platelet engraftment, incidence of graft failure and chronic GvHD, overall and disease free survival, clinical safety and device performance of the CliniMACS CD34 selection device.	Donor Description: Before taking part in this study, donors will have an evaluation that is the standard for any bone marrow or blood stem cell donor. These include standard blood tests, an electrocardiogram (EKG), and a chest X-ray. Donors will also be given a general health questionnaire that is given to all blood donors in the United States. It should take no more than 10 minutes to complete the questionnaire. Donors in this study will receive standard mobilization therapy with daily G-CSF every 12 hours. The Granulocyte colony-stimulating factor (G-CSF) will be given as an injection under the skin. The mobilization phase starts on the first day that donors receive G-CSF and continues until the final day of the stem cell collection process (leukapheresis). Donors in this study will receive Neupogen (white blood cell growth factor) to stimulate the immature blood cells. They will receive two injections, twice a day for four days. On the fourth day, assuming they have enough immature white blood cells, researchers will start the stem cell collection process (leukapheresis). The stem cell collection will go from 1 to 4 days until enough immature cells have been collected, but will not be done on any day the donor's platelet count falls below 75,000. The stem cell is called a CD34(+) cell. These cells will then be processed over a cell-processing machine to try to purify the immature fraction of cells and remove the T-lymphocytes that are part of the fatal graft versus host disease. The T-cell is called a CD3(+) cell. Leukapheresis, with later CD34(+) cell selection, will start on the day when circulating CD34(+) count is at a high enough level. Leukapheresis will continue until the appropriate count is reached. If the CD3(+) count is too high, adjustments will be made. For those donors who cannot reach the collection goal in one series of collection attempts, researchers will wait until the donor recovers from the first stem cell collection and try again. If the donor is unable to reach the collection goal again, another attempt will be made with a different donor. The blood thinner used for the procedure will be acid citrate dextrose (ACD). Heparin may be substituted when clinically needed. No additional blood thinners or additives should be added beyond those normally used during leukapheresis. A unique identification and labeling system shall be used to track the leukapheresis product from collection to infusion. Samples will be taken from each leukapheresis product pre- and post-selection for quality analysis. This is an investigational study. No more than 90 donors will take part in this study. All will be enrolled at M. D. Anderson. Recipient Description: Before taking part in this study, recipients will have standard evaluations to determine the stage of their disease. These may include bone marrow aspirations and biopsies and if necessary, CT scans and chest x-rays. All recipients will go through cardiopulmonary evaluation. The recipients will have an allogeneic bone marrow transplant with pre-treatment of thiotepa, fludarabine, melphalan, and antithymocyte globulin. This will be followed by infusion of the peripheral blood progenitor cells. Recipients will have daily follow-up exams in the hospital. Recipients will be evaluated at least one to five times per week after they leave until Day 100. After that, they will have evaluations at least once every three months until about one year and then once every six months. The CliniMACS device is being provided by used of an investigational device exemption for the FDA. Without the CliniMACS device, this procedure would not be possible. This is an investigational study. A total of 40 patients will take part in this study. All will be enrolled at M. D. Anderson.	Leukemia Lymphoma	Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Lymphocytic Leukemia Leukemia Lymphoma Non Hodgkin's Lymphoma T cell depletion CD34 selected progenitors cell GVHD	null	1	arm 1: CD34 peripheral blood progenitor cell (PBPC) transplants in 3 groups: 1) HLA-matched Sibling Transplant Patients; 2) Unrelated Donor Transplant Patients; 3) Haplo Identical Transplant Patients. Preparative regimen is 140 mg/m\^2 Melphalan on day -8, 10 mg/kg Thiotepa on day -7, 160 mg/m\^2 Fludarabine over 4 days on days -6, -5, -4, -3 and 1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.	[ 0 ]	5	[ 3, 0, 0, 0, 0 ]	intervention 1: Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0. intervention 2: 140 mg/m\^2 on day -8 intervention 3: 10 mg/kg on day -7 intervention 4: 160 mg/m\^2 over 4 days on days -6, -5, -4, -3 intervention 5: 1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.	intervention 1: Megadose of CD34 Selected Progenitor Cells intervention 2: Melphalan intervention 3: Thiotepa intervention 4: Fludarabine intervention 5: Rabbit ATG	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	28	0	0	0	NCT00038857	1COMPLETED	2009-06-01	2001-09-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	156	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.	MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo. Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine \[Effexor\] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment. Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.	Depression	Major Depressive Disorder	null	3	arm 1: Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8 arm 2: Participants will receive supportive-expressive psychotherapy. arm 3: Participants receive placebo.	[ 0, 1, 2 ]	4	[ 5, 0, 0, 0 ]	intervention 1: The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship. intervention 2: Participants will receive sertraline. intervention 3: Participants will receive a pill placebo. intervention 4: Participants will receive venlafaxine.	intervention 1: Supportive Expressive Therapy intervention 2: Sertraline intervention 3: Pill Placebo intervention 4: Venlafaxine	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	156	0	0	0	NCT00043550	1COMPLETED	2009-06-01	2001-11-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	449	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia. PURPOSE: This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment.	OBJECTIVES: * Compare the overall survival and progression-free survival of elderly patients with newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts (RAEB) in transformation, or high-risk RAEB treated with daunorubicin and cytarabine with or without zosuquidar trihydrochloride. * Compare the complete remission rate of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the systemic exposure of daunorubicin and cytarabine in patients treated with zosuquidar trihydrochloride vs placebo. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (60-69 years vs 70 years and over), disease (refractory anemia with excess blasts \[RAEB\] vs RAEB in transformation or acute myeloid leukemia \[AML\]), and disease type (de novo vs secondary). Patients are randomized to 1 of 2 treatment arms. * Induction: * Arm I: Patients receive daunorubicin via intravenous (IV) infusion over 10-15 minutes and zosuquidar trihydrochloride IV over 6 hours on days 1-3. Patients also receive cytarabine IV continuously on days 1-7. * Arm II: Patients receive daunorubicin and cytarabine as in arm I. Patients also receive placebo IV over 6 hours on days 1-3. Beginning on day 12, patients who achieve aplasia receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) or IV daily until blood counts recover. Patients who have evidence of persistent AML are eligible to receive a second identical course of induction chemotherapy. * Consolidation I (beginning within 8 weeks after documentation of complete remission \[CR\] or measurable remission \[MR\]): Patients who achieve a CR or MR receive cytarabine IV over 1 hour once or twice daily on days 1-6 and GM-CSF or G-CSF SC or IV beginning on day 7 and continuing until blood counts recover. * Consolidation II: Patients who have maintained peripheral blood evidence of a remission receive daunorubicin, cytarabine, and zosuquidar trihydrochloride or placebo as in induction chemotherapy. Patients also receive GM-CSF or G-CSF SC or IV beginning on day 8 or after last cytarabine dose and continuing until blood counts recover. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 450 patients (225 per treatment arm) accrued over 4.1 years.	Leukemia Myelodysplastic Syndromes	adult acute monocytic leukemia (M5b) adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) refractory anemia with excess blasts in transformation refractory anemia with excess blasts secondary acute myeloid leukemia untreated adult acute myeloid leukemia de novo myelodysplastic syndromes adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22)	null	2	arm 1: Induction treatment with daunorubicin, cytarabine and zosuquidar (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction. arm 2: Induction treatment with daunorubicin, cytarabine and placebo (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction.	[ 0, 1 ]	6	[ 2, 2, 0, 0, 0, 0 ]	intervention 1: 250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. intervention 2: 5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. intervention 3: 100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7). intervention 4: 45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3). intervention 5: Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. intervention 6: Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored.	intervention 1: filgrastim intervention 2: sargramostim intervention 3: cytarabine intervention 4: daunorubicin hydrochloride intervention 5: zosuquidar trihydrochloride intervention 6: Placebo	92	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Lone Tree \| Colorado \| United States \| -104.8863 \| 39.55171 Longmont \| Colorado \| United States \| -105.10193 \| 40.16721 Pueblo \| Colorado \| United States \| -104.60914 \| 38.25445 Thornton \| Colorado \| United States \| -104.97192 \| 39.86804 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Lakeland \| Florida \| United States \| -81.9498 \| 28.03947 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Decatur \| Illinois \| United States \| -88.9548 \| 39.84031 Evanston \| Illinois \| United States \| -87.69006 \| 42.04114 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Urbana \| Illinois \| United States \| -88.20727 \| 40.11059 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Ames \| Iowa \| United States \| -93.61994 \| 42.03471 Sioux City \| Iowa \| United States \| -96.40031 \| 42.49999 Sioux City \| Iowa \| United States \| -96.40031 \| 42.49999 Chanute \| Kansas \| United States \| -95.4572 \| 37.67921 Dodge City \| Kansas \| United States \| -100.01708 \| 37.7528 Kingman \| Kansas \| United States \| -98.11367 \| 37.64585 Liberal \| Kansas \| United States \| -100.921 \| 37.04308 Newton \| Kansas \| United States \| -97.34504 \| 38.04668 Pratt \| Kansas \| United States \| -98.73759 \| 37.64391 Salina \| Kansas \| United States \| -97.61142 \| 38.84028 Wellington \| Kansas \| United States \| -97.37171 \| 37.2653 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Winfield \| Kansas \| United States \| -96.99559 \| 37.23975 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Burnsville \| Minnesota \| United States \| -93.27772 \| 44.76774 Coon Rapids \| Minnesota \| United States \| -93.28773 \| 45.11997 Edina \| Minnesota \| United States \| -93.34995 \| 44.88969 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Robbinsdale \| Minnesota \| United States \| -93.33856 \| 45.03219 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483 Saint Paul \| Minnesota \| United States \| -93.09327 \| 44.94441 Waconia \| Minnesota \| United States \| -93.78691 \| 44.8508 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Red Bank \| New Jersey \| United States \| -74.06431 \| 40.34705 New York \| New York \| United States \| -74.00597 \| 40.71427 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Bethlehem \| Pennsylvania \| United States \| -75.37046 \| 40.62593 Danville \| Pennsylvania \| United States \| -76.61273 \| 40.96342 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Sayre \| Pennsylvania \| United States \| -76.5155 \| 41.97896 Scranton \| Pennsylvania \| United States \| -75.6649 \| 41.40916 State College \| Pennsylvania \| United States \| -77.86 \| 40.79339 Wilkes-Barre \| Pennsylvania \| United States \| -75.88131 \| 41.24591 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953 La Crosse \| Wisconsin \| United States \| -91.23958 \| 43.80136 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Marshfield \| Wisconsin \| United States \| -90.1718 \| 44.66885 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303	750	0	0	0	NCT00046930	1COMPLETED	2009-06-01	2002-09-17	Eastern Cooperative Oncology Group	5NETWORK	false	false	false	null	0	0	0	0	0	0
[ 3 ]	7	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron) alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself. Stopping the growth of new vessels can slow or prevent tumor growth. The Food and Drug Administration has approved various interferons for treating several diseases, including melanoma and some leukemias. These drugs block new vessel growth in patients with recurrent tumors, but in high doses they produce serious side effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high doses given several times a week. Thalidomide, currently approved to treat leprosy, also blocks development of new blood vessel formation. In a recent study of thalidomide given to 36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least 2 months, and at least 3 had responses to treatment lasting 6 to 14 months. Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing following standard treatment and does not respond to radiation therapy may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests (including a pregnancy test for women of childbearing potential), and magnetic resonance imaging (MRI) or computed tomography (CT) of the head. Patients will continue treatment cycles as long as the drug is tolerated without serious side effects and the tumor is not growing. While on the study, patients will undergo various tests and procedures as follows: Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure.	Background: There is a growing belief that angiogenesis inhibition represents a potentially promising, novel therapeutic approach to highly vascular solid tumors like malignant gliomas. Thalidomide and Peg-Intron (IFN - Interferon) are attractive drugs to use in combination to test the hypothesis of combination anti-angiogenesis therapy inhibition given their proven activity as single agents in patients with malignant gliomas and their spectrum of largely non-overlapping toxicities. Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects of low dose, continuous IFN administration, we are interested in evaluating the use of pegylated IFN in combination with thalidomide. Thus, we are proposing a phase II trial of pegylated IFN with thalidomide in patients with recurrent gliomas. Objectives: To obtain preliminary evidence of anti-tumor efficacy of PEG-Intron in combination with thalidomide in patients with recurrent high grade gliomas as assessed by prolongation of progression-free survival compared to historical controls. A secondary endpoint in this trial is to determine the response rate associated with the combination therapy in each of the two strata and to evaluate and document all toxicities from PEG-Intron in combination with thalidomide at the doses prescribed in this protocol in this patient population. Eligibility: Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified). Patients must not have received prior therapy with Peg-Intron or Thalidomide. Design: Patients will be treated with weekly PEG-Intron plus daily oral thalidomide. All patients will be treated for 6 weeks following which patients will have a repeat MRI scan to assess disease response.	Glioma	Brain Tumors Experimental Toxicities Efficacy Progression-Free Brain Tumor Glioma	null	2	arm 1: Glioblastoma multiforme is one of the most common and aggressive types of brain tumor. arm 2: Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.	[ 5, 5 ]	2	[ 2, 0 ]	intervention 1: 0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection intervention 2: Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.	intervention 1: PEG-interferon alfa-2b intervention 2: Thalidomide	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	7	0	0	0	NCT00047879	1COMPLETED	2009-06-01	2002-10-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0
[ 4 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer. PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer.	OBJECTIVES: Compare local control, failure-free survival, and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone, versus cisplatin and radiotherapy with hyperthermia . OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (IIB or IIIA vs IIIB or IVA) and age (\< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms. LIMITATIONS: There are integrity issues with the currently available data, involving international institutions, in that several pieces of information relating to patient accrual and outcomes cannot be verified. Therefore, it would be inappropriate to report outcome measures for this study. Baseline measures of age and gender are reported for the entire study cohort. Participant flow is reported by treatment arm assignment, which was available for a majority of patients in the currently available data. Adverse events are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.	Cervical Cancer	stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma	null	2	arm 1: Patients received cisplatin IV and concurrently underwent hyperthermia treatment over 60-90 minutes on day 1. Patients also underwent external beam radiation therapy once daily on days 1-5. Treatment repeated weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients underwent brachytherapy to the cervix for 2-3 days. arm 2: Patients received cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.	[ 0, 1 ]	4	[ 0, 3, 4, 4 ]	intervention 1: Given IV intervention 2: Patients undergo hyperthermia treatment over 60-90 minutes intervention 3: Patients undergo brachytherapy for 2-3 days intervention 4: Patients undergo external beam radiation therapy once daily on days 1-5	intervention 1: cisplatin intervention 2: hyperthermia treatment intervention 3: brachytherapy intervention 4: external beam radiation therapy	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	101	0	0	0	NCT00085631	6TERMINATED	2009-06-01	2003-03-01	Mark Dewhirst	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	260	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.	The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.	Tobacco Use Disorder	light smokers, smoking cessation treatment programs	null	4	arm 1: bupropion and MM counseling with placebo patch arm 2: bupropion and Mayo counseling with placebo patch. arm 3: patch and MM counseling with placebo pills arm 4: patch and Mayo counseling with placebo pills	[ 0, 0, 2, 0 ]	6	[ 0, 0, 5, 5, 0, 0 ]	intervention 1: starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks. intervention 2: 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks intervention 3: Brief manual based therapy; four 15 minute session over 10 weeks. intervention 4: Manual based therapy; Weekly 30 minute sessions for 10 weeks intervention 5: placebo patch containing no nicotine intervention 6: placebo pills	intervention 1: nicotine transdermal system intervention 2: bupropion intervention 3: Medication Management intervention 4: Mayo Counseling intervention 5: placebo patch intervention 6: placebo bupropion	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	260	0	0	0	NCT00086411	1COMPLETED	2009-06-01	2003-09-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	40	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.	PRIMARY OBJECTIVES: I. To determine the antitumor activity of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands using objective response rates (partial and complete responses). SECONDARY OBJECTIVES: I. To determine the duration of objective response, rate and duration of stable disease, progression-free, median and overall survival rates of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands. II. To estimate the antitumor activity of GW572016 in other epidermal growth factor receptor (EGFR)- and/or erbB2-overexpressing malignant tumors of the salivary glands using objective response rates (partial and complete responses). III. To document the safety and tolerability of GW572016 in these patient populations TERTIARY OBJECTIVES: I. To investigate if differences in baseline levels of EGFR and/or erbB2 expression, and receptor phosphorylation status in tumor specimens predict outcome to therapy. II. To investigate if the inhibitory effects of GW572016 on EGFR and/or erbB2 pathway activation in tumor specimens correlate with clinical outcome. III. To determine the steady state levels of GW572016 achieved, and their correlation with clinical and laboratory correlative endpoints. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients are followed for survival	High-grade Salivary Gland Carcinoma High-grade Salivary Gland Mucoepidermoid Carcinoma Low-grade Salivary Gland Carcinoma Low-grade Salivary Gland Mucoepidermoid Carcinoma Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Recurrent Salivary Gland Cancer Salivary Gland Acinic Cell Tumor Salivary Gland Adenocarcinoma Salivary Gland Adenoid Cystic Carcinoma Salivary Gland Malignant Mixed Cell Type Tumor		null	1	arm 1: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.	[ 0 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Correlative studies	intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	39	0	0	0	NCT00095563	1COMPLETED	2009-06-01	2004-09-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0
[ 0 ]	8,164	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.	Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression. Purpose: To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA). Methods: An international, multi-center, randomized, double-blind, placebo-controlled clinical trial. Subjects: Patients with stroke or TIA in the previous 7 months. Primary outcome measure: Non-fatal stroke, non-fatal myocardial infarction, or death due to vascular causes. Secondary outcome measures: TIA, Revascularisation procedures, Dementia, Depression. Sample size calculation: To reliably identify a 15% reduction in relative risk of the primary outcome event from 8% to 6.8% per year with an alpha of 0.05 and power of 80%, 8,000 patients need to be randomized and followed-up for an average of two years. Current progress: As of November, 2004, more than 4,400 patients have been randomized in 73 centers in 19 countries in five continents: Australia, Austria, Belgium, Brazil, Hong Kong, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia \& Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States. VITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.	Stroke Transient Ischemic Attack	VITATOPS stroke prevention multivitamins homocysteine	null	2	arm 1: Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study. arm 2: Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: multivitamin intervention 2: None	intervention 1: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo intervention 2: Placebo	111	New York \| New York \| United States \| -74.00597 \| 40.71427 Abington \| Pennsylvania \| United States \| -75.11795 \| 40.12067 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Gosford \| N/A \| Australia \| 151.34399 \| -33.4244 New South Wales \| N/A \| Australia \| N/A \| N/A New South Wales \| N/A \| Australia \| N/A \| N/A New South Wales \| N/A \| Australia \| N/A \| N/A Perth \| N/A \| Australia \| 115.8614 \| -31.95224 Queensland \| N/A \| Australia \| N/A \| N/A Queensland \| N/A \| Australia \| N/A \| N/A South Australia \| N/A \| Australia \| N/A \| N/A Tasmania \| N/A \| Australia \| N/A \| N/A Victoria \| N/A \| Australia \| N/A \| N/A Victoria \| N/A \| Australia \| N/A \| N/A Victoria \| N/A \| Australia \| N/A \| N/A Victoria \| N/A \| Australia \| N/A \| N/A Western Australia \| N/A \| Australia \| N/A \| N/A Western Australia \| N/A \| Australia \| N/A \| N/A Western Australia \| N/A \| Australia \| N/A \| N/A Graz \| N/A \| Austria \| 15.45 \| 47.06667 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 Tbilisi \| N/A \| Georgia \| 44.83412 \| 41.69143 Pokfulam \| N/A \| Hong Kong \| N/A \| N/A Shatin \| N/A \| Hong Kong \| 114.18333 \| 22.38333 Annāmalainagar \| N/A \| India \| 79.73333 \| 11.4 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Bikaner \| N/A \| India \| 73.31495 \| 28.01762 Calicut \| N/A \| India \| 92.73333 \| 11.6 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Indore \| N/A \| India \| 75.8333 \| 22.71792 Jaipur \| N/A \| India \| 75.78781 \| 26.91962 Kochi \| N/A \| India \| 76.26022 \| 9.93988 Kolkata \| N/A \| India \| 88.36304 \| 22.56263 Lucknow \| N/A \| India \| 80.92313 \| 26.83928 Ludhiana \| N/A \| India \| 75.85379 \| 30.91204 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Patiaala \| N/A \| India \| N/A \| N/A Perambūr \| N/A \| India \| 79.04059 \| 10.81137 Pune \| N/A \| India \| 73.85535 \| 18.51957 Pune \| N/A \| India \| 73.85535 \| 18.51957 Trichy \| N/A \| India \| 78.69875 \| 10.80289 Visakhapatnam \| N/A \| India \| 83.20161 \| 17.68009 Wardha \| N/A \| India \| 78.59784 \| 20.73933 Brescia \| N/A \| Italy \| 10.21472 \| 45.53558 Busto Arsizio \| N/A \| Italy \| 8.84914 \| 45.61128 Macerata \| N/A \| Italy \| 13.45293 \| 43.29789 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Perugia \| N/A \| Italy \| 12.38878 \| 43.1122 Perugia \| N/A \| Italy \| 12.38878 \| 43.1122 Vittoria \| N/A \| Italy \| 14.52788 \| 36.95151 Kelantan \| N/A \| Malaysia \| N/A \| N/A Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Chishinau \| N/A \| Moldova \| N/A \| N/A Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Goes \| N/A \| Netherlands \| 3.88889 \| 51.50417 Utrecht \| N/A \| Netherlands \| 5.12222 \| 52.09083 Auckland \| N/A \| New Zealand \| 174.76349 \| -36.84853 Hastings \| N/A \| New Zealand \| 176.84918 \| -39.6381 Palmerston North \| N/A \| New Zealand \| 175.61113 \| -40.35636 Takapuna \| N/A \| New Zealand \| 174.77583 \| -36.79167 Wellington South \| N/A \| New Zealand \| N/A \| N/A Islamabad \| N/A \| Pakistan \| 73.04329 \| 33.72148 Islamabad \| N/A \| Pakistan \| 73.04329 \| 33.72148 Karachi \| N/A \| Pakistan \| 67.0104 \| 24.8608 Karachi \| N/A \| Pakistan \| 67.0104 \| 24.8608 Wah Cantt \| N/A \| Pakistan \| 72.75116 \| 33.77094 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 East Santiago City \| N/A \| Philippines \| N/A \| N/A Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Estarreja \| N/A \| Portugal \| -8.57207 \| 40.75648 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Oliveira de Azeméis \| N/A \| Portugal \| -8.47555 \| 40.84101 Porto \| N/A \| Portugal \| -8.61099 \| 41.14961 Novisad \| N/A \| Serbia \| N/A \| N/A Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Colombo \| N/A \| Sri Lanka \| 79.84868 \| 6.93548 Ragama \| N/A \| Sri Lanka \| 79.917 \| 7.0292 Stoke-on-Trent \| Shaffordshire \| United Kingdom \| -2.18538 \| 53.00415 Aberdeen \| N/A \| United Kingdom \| -2.09814 \| 57.14369 Barking \| N/A \| United Kingdom \| 0.08333 \| 51.53333 Barnsley \| N/A \| United Kingdom \| -1.48333 \| 53.55 Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682 Ceredigion \| N/A \| United Kingdom \| N/A \| N/A Edinburgh \| N/A \| United Kingdom \| -3.19648 \| 55.95206 Exeter \| N/A \| United Kingdom \| -3.52751 \| 50.7236 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Huddersfield \| N/A \| United Kingdom \| -1.78416 \| 53.64904 Kent \| N/A \| United Kingdom \| 0.52021 \| 51.27893 Liverpool \| N/A \| United Kingdom \| -2.97794 \| 53.41058 Londonderry \| N/A \| United Kingdom \| -7.30934 \| 54.9981 Luton \| N/A \| United Kingdom \| -0.41748 \| 51.87967 Newcastle \| N/A \| United Kingdom \| -5.88979 \| 54.21804 North Shields \| N/A \| United Kingdom \| -1.44925 \| 55.01646 Nottingham \| N/A \| United Kingdom \| -1.15047 \| 52.9536 Paddington \| N/A \| United Kingdom \| -0.1763 \| 51.51558 Rotherham \| N/A \| United Kingdom \| -1.35678 \| 53.43012 Stirling \| N/A \| United Kingdom \| -3.93682 \| 56.11903 Stockport \| N/A \| United Kingdom \| -2.15761 \| 53.40979 Taunton \| N/A \| United Kingdom \| -3.10293 \| 51.01494 Torquay \| N/A \| United Kingdom \| -3.52522 \| 50.46198	8,164	0	0	0	NCT00097669	1COMPLETED	2009-06-01	1998-11-01	VITATOPS	2OTHER_GOV	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication. Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.	Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication. This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion.	Multiple Sclerosis Depression	Fatty Acids, Omega-3 Fish Oils Complementary Therapies	null	2	arm 1: Fish oil concentrate arm 2: Placebo oil	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA). intervention 2: soybean oil with 1% fish oil at a daily dose of 6 grams	intervention 1: Fish oil concentrate intervention 2: Placebo	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	39	0	0	0	NCT00122954	1COMPLETED	2009-06-01	2005-07-01	Oregon Health and Science University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	27	NON_RANDOMIZED	PARALLEL	7BASIC_SCIENCE	2DOUBLE	true	0ALL	false	The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.	Prescription opioid abuse is becoming an increasingly widespread and serious public health concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintupled since 1984. Despite this trend, little experimental research has been directed towards understanding who may be abusing these medications, and under what conditions. The study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.	Opioid-Related Disorders Substance-Related Disorders	Opiate Opioid Abuse Liability Abuse Potential	null	2	arm 1: Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random. arm 2: Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 15 mg/70 kg oxycodone administered once per day, orally. intervention 2: 30 mg/70 kg oxycodone administered once per day, orally. intervention 3: 0 mg placebo dose administered once a day, orally.	intervention 1: oxycodone 15 mg intervention 2: oxycodone 30 mg intervention 3: Placebo 0 mg	1	New York \| New York \| United States \| -74.00597 \| 40.71427	27	0	0	0	NCT00158184	1COMPLETED	2009-06-01	2004-06-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	38	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES), will result in a decreased number of NES. The purpose of this study is to provide pilot testing and data to inform the future randomized controlled trial based on the hypothesis.	This is a pilot, prospective, single center, randomized, placebo-controlled, double-blind trial, that assesses the number of NES in patients treated with flexible dose sertraline (Zoloft). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning. After being diagnosed with NES by video electroencephalogram monitoring (vEEG), up to 50 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be blindly randomized to the treatment arm with flexible dose sertraline (25 to 200mg) or to the placebo control arm. The dose will be titrated over 4 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning. Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary prospectively, to evaluate their daily seizure activity. They will be given two weeks of the medication at each visit. In the first phase of the study 12 patients were screened and 8 enrolled in an open label trial of flexible dose sertraline. In the second phase of the study, 38 patients enrolled in the pilot, randomized, placebo-controlled trial.	Convulsion, Non-Epileptic Conversion Disorder Depression Stress Disorders, Post-Traumatic	nonepileptic seizure pseudoseizure conversion disorder psychogenic Depression Anxiety Abuse post-traumatic stress disorder sertraline serotonin randomized controlled trial	null	2	arm 1: flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES arm 2: flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: flexible dose sertraline intervention 2: flexible dose placebo	intervention 1: sertraline intervention 2: placebo	1	Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399	38	0	0	0	NCT00159965	1COMPLETED	2009-06-01	2003-12-01	Rhode Island Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	97	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	This study will evaluate changes in brain energy metabolism due to treatment with escitalopram in people with major depressive disorder.	Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain. Antidepressant medications are often prescribed for treating MDD; however, 30% to 40% of individuals fail to respond adequately to medication. Preliminary research has shown that lower levels of brain energy metabolism are often associated with MDD. No studies have yet shown whether there is a difference in brain energy metabolism between individuals who respond well to antidepressants versus those who do not. Escitalopram is an antidepressant medication often used to treat MDD. It causes a calming effect and reduces anxiety by increasing the amount of serotonin in the brain. This study will compare the changes in brain energy metabolism due to treatment with escitalopram in individuals with MDD. In turn, these findings may aid in understanding the relationship between brain energy metabolism and depression, and may guide future antidepressant trials. This 12-week study will enroll individuals diagnosed with MDD, as well as healthy individuals. During Weeks 1 through 4, participants with MDD will receive 10 mg of escitalopram on a daily basis. If a participant does not respond well to the medication, as determined by the study clinician, the dose may be increased to 20 mg per day for Weeks 5 through 8. If a participant continues to not respond to the medication after 8 weeks, the dose may be increased to 30 mg per day for Weeks 9 through 12. Study visits will occur every other week throughout the 12 weeks. Laboratory tests, physical examinations, and vital sign measurements will be performed at each study visit. Outcome measurements will include depression levels as assessed by standardized psychological tests and questionnaires, as well as brain energy metabolite levels as assessed by magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) scans. The MRS and MRI scans will occur at baseline, Week 2, and Week 12; the entire scanning procedure will last 70-80 minutes. Following the end of the study, all participants will be offered follow-up medical care for 3 months. Participants who responded well to escitalopram will be offered continued treatment with the drug, while those who did not respond well to escitalopram will be offered treatment with another antidepressant.	Depression	Brain Bioenergetic Metabolism Magnetic Resonance Spectroscopy Major Depressive Disorder Treatment Response	null	1	arm 1: Participants will receive open treatment with escitalopram.	[ 0 ]	1	[ 0 ]	intervention 1: Escitalopram 10 to 30 mg per day for 12 weeks	intervention 1: Escitalopram	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	97	0	0	0	NCT00183677	1COMPLETED	2009-06-01	2003-07-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	35	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.	Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. However, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. In turn, depression may hinder a patient's recovery from an illness. This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition. This double-blind study will last for 12 months. Participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat Alzheimer's disease. Both memantine and placebo will be administered to participants for 12 weeks. All participants will be followed for an additional 40 weeks. Outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. In addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. All measurements will be taken at Week 12 and Month 12.	Depression	Major depressive disorder Rehabilitating Elderly Apathy	null	2	arm 1: Memantine for 12 weeks arm 2: Placebo for 12 weeks	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. intervention 2: Placebo distribution is planned to mimic the active drug.	intervention 1: Memantine intervention 2: Placebo	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	35	0	0	0	NCT00183729	1COMPLETED	2009-06-01	2005-08-01	Eric Lenze	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	198	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.	Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: * Paclitaxel + Carboplatin + Etoposide * Irinotecan + Gemcitabine Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.	Neoplasms, Unknown Primary	Neoplasms, Unknown Primary	null	2	arm 1: Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval arm 2: Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval	[ 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A intervention 2: 1000 mg/m2 IV, days 1 and 8, in regimen B intervention 3: 1000 mg/m2 IV days 1 and 8 in regimen B intervention 4: 200 mg/m2 by 1-hour IV infusion, day 1, regimen A intervention 5: Area under the curve (AUC) 6.0 IV, day 1, regimen A	intervention 1: Etoposide intervention 2: Gemcitabine intervention 3: Irinotecan intervention 4: Paclitaxel intervention 5: Carboplatin	31	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Lakeland \| Florida \| United States \| -81.9498 \| 28.03947 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Albany \| Georgia \| United States \| -84.15574 \| 31.57851 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Bowling Green \| Kentucky \| United States \| -86.4436 \| 36.99032 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Houma \| Louisiana \| United States \| -90.71953 \| 29.59577 Portland \| Maine \| United States \| -70.2589 \| 43.65737 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Pontiac \| Michigan \| United States \| -83.29105 \| 42.63892 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Drexel Hill \| Pennsylvania \| United States \| -75.29213 \| 39.94706 West Reading \| Pennsylvania \| United States \| -75.94743 \| 40.3337 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Abingdon \| Virginia \| United States \| -81.97735 \| 36.70983	198	0	0	0	NCT00193596	1COMPLETED	2009-06-01	2003-09-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	132	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will test the hypothesis that administration of granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) will improve the clinical course and outcome by shortening the duration of mechanical ventilation for these patients.	BACKGROUND: Respiratory failure due to ALI/ARDS remains a major health problem, despite significant progress in intensive care unit care and ventilator management. ALI/ARDS is characterized by unacceptably high mortality despite enormous expenditure of health care resources. Survivors face long-term consequences that may affect their quality of life. New therapies are needed to improve early survival and to decrease long-term sequelae of this syndrome. GM-CSF is a naturally occurring cytokine that is present in the normal lung, with important roles in pulmonary homeostasis. GM-CSF is essential for normal maturation and function of alveolar macrophages (resident inflammatory cells that are responsible for initial defense against pneumonia). Alveolar epithelial cells line the gas exchange surface of the lung. Acute lung injury and subsequent abnormal healing is linked to delayed repair of damage to the epithelium following initial injury. This can then lead to pulmonary fibrosis. GM-CSF has potent effects on alveolar epithelial cells, promoting proliferation and limiting epithelial cell death. Thus, GM-CSF has a distinctive combination of activities that make it an excellent candidate for a therapeutic intervention in ALI/ARDS. Preliminary studies for this project demonstrate that GM-CSF can protect experimental animals against acute lung injury, can decrease susceptibility to pneumonia, and is protective against pulmonary fibrosis following acute lung injury. There is extensive experience with the administration of recombinant human GM-CSF to human patients (this biological is approved by the FDA and has been well-tolerated in trials involving critically ill patients). This project is based on the hypothesis that administration of GM-CSF will improve clinical outcomes for patients with ALI/ARDS. DESIGN NARRATIVE: With the assent of the attending physician, informed consent will be obtained from the patient or next of kin as soon as possible after case identification. Physiologic measurements and specimen collection will begin at the time of entry into the study. Three days after the patient has met criteria for ALI/ARDS or at entry into the study (whichever is later), he/she will be randomized to receive recombinant human GM-CSF (250 mcg/M2) or placebo, administered by slow intravenous infusion once daily for 14 days. This study will allow entry of patients who have fulfilled criteria for ALI/ARDS for up to 7 days. Treatment will be initiated after patients have met criteria for at least 3 days. Treatment with GM-CSF may prove both safe and effective within the first 1-2 days of lung injury. However, the present study will not address that question. It is unlikely that the opportunity for improved outcome will be lost by delaying therapy for up to 3 days (based on the proposed mechanisms by which GM-CSF might benefit this patient population). Similarly, the decision to treat for 14 days will allow for improved outcome in patients with non-resolving ARDS by reducing the incidence of ventilator-associated pneumonia and by decreasing pathologic fibroproliferation. The primary endpoint for this study will be the duration of mechanical ventilation. Additional important endpoints will include changes in the severity of physiologic derangements of respiratory gas exchange, non-respiratory organ failure, and incidence of ventilator-associated pneumonia. Additional assessments designed to determine the mechanism of benefit of GM-CSF treatment will include measures of lung epithelial cell integrity and measures of alveolar macrophage (lung inflammatory cell) function.	Respiratory Distress Syndrome, Adult		null	2	arm 1: Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). arm 2: Participants will be randomized to receive placebo.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Placebo will be administered by slow intravenous infusion once daily for 14 days. intervention 2: Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.	intervention 1: Placebo intervention 2: GM-CSF	3	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	130	0	0	0	NCT00201409	1COMPLETED	2009-06-01	2004-07-01	University of Michigan	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	46	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	1FEMALE	null	Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol \< 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular events in OC users with emerging cardiovascular risk factors (such as obesity and the metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors in a single individual, and its underlying cause may be insulin resistance. Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied. This is a critical problem because the metabolic syndrome is prevalent in 24% of adults. Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC with the least harm would not be possible. The investigator's long-term goal is to understand the best way to prevent and treat cardiovascular disease in women. The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and cardiovascular risks in women taking OCs. The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use, when compared to normal weight women without the metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular events in women taking OCs, and will serve as pilot data for a National Institutes of Health (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians can make better informed decisions about contraceptive choices for their patients.	null	Metabolic Syndrome X Insulin Resistance Obesity Cardiovascular Diseases	Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 1 ]	1	[ 0 ]	intervention 1: Ortho Tri Cyclen, one tablet daily, for 6 cycles	intervention 1: Ortho Tri Cyclen	1	Richmond \| Virginia \| United States \| -77.46026 \| 37.55376	36	0	0	0	NCT00205504	1COMPLETED	2009-06-01	2005-06-01	Virginia Commonwealth University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	19	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.	Most liver transplant recipients receive an immunosuppressive drug regimen that contains either cyclosporine or tacrolimus. Although these drugs have revolutionized transplantation, in many patients their long-term use is a major cause of serious side effects, including kidney failure, hypertension, diabetes mellitus, hyperlipidemia, and/or neurologic side effects. Stopping or reducing the dose of cyclosporine or tacrolimus can ameliorate the above side effects but may increase the risk of rejection. Mycophenolate mofetil (MMF), a safe and effective immunosuppressant that does not cause the above side effects, is typically used in combination with cyclosporine or tacrolimus. Attempts in liver transplant recipients at using mycophenolate mofetil alone or with reduced dose cyclosporine or tacrolimus have been successful but some patients developed rejection, and a few patients suffered liver failure. Most rejections after liver transplantation are easy to successfully treat with increased immunosuppression, but such treatment may carry risks such as increased susceptibility to infection. There have not yet been any large trials to adequately assess the safety and efficacy of using mycophenolate mofetil this way (alone or with reduced dose calcineurin inhibitor (CNI)). The purpose of this trial is to evaluate whether mycophenolate mofetil as monotherapy or with reduced dose cyclosporine or tacrolimus long-term after liver transplantation is safe and decreases side effects related to calcineurin inhibitor use. Only liver recipients expected to have a relatively low risk of developing rejection and/or liver failure are eligible for this trial. Some reasons for considering them low risk are their stable liver function, having had the transplant for over a year, having had one or fewer prior rejection episodes, having had non-autoimmune liver disease, their currently requiring low dose/level cyclosporine or tacrolimus, and the plan to use high dose mycophenolate mofetil and to exclude patients that fail to attain target values for mycophenolic acid area under the concentration-time curve (MPA AUC - MycoPhenolic Acid Area Under the Curve). Eligible patients will be randomized to receive either mycophenolate mofetil monotherapy (MMF; CNI discontinued), or mycophenolate mofetil and half their baseline dose of calcineurin inhibitor (MMF; CNI decreased). The primary outcome is biopsy proven rejection and the secondary outcomes include patient and graft survival, adverse events, hepatic profile, blood pressure, renal function, diabetes, and lipid profile. Additionally, mycophenolic acid concentrations will be measured; a mycophenolate mofetil monotherapy trial provides unique opportunity to study the implications of such monitoring. Patients will be followed for 12 months; there will be 16 visits during the trial.	Liver Disease	Liver transplantation Calcineurin inhibitor withdraw mycophenolate mofetil Immunosuppression side effects Graft rejection	null	2	arm 1: mycophenolate mofetil monotherapy arm 2: mycophenolate mofetil and half their baseline dose of calcineurin inhibitor	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: mycophenolate mofetil and half their baseline dose of calcineurin inhibitor intervention 2: mycophenolate mofetil monotherapy	intervention 1: mycophenolate mofetil intervention 2: mycophenolate mofetil	3	Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	19	0	0	0	NCT00206076	1COMPLETED	2009-06-01	2006-08-01	Albert Einstein Healthcare Network	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment	In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).	Body Dysmorphic Disorder	Body Dysmorphic Disorder SRIs Cognitive Behavioral Therapy	null	1	arm 1: Participants with body dysmorphic disorder	[ 0 ]	2	[ 5, 0 ]	intervention 1: standard psychiatric evaluation intervention 2: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.	intervention 1: Cognitive Behavioral Therapy intervention 2: Venlafaxine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	17	0	0	0	NCT00211809	6TERMINATED	2009-06-01	2008-09-01	Icahn School of Medicine at Mount Sinai	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	264	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	1FEMALE	true	The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in recently quit female smokers in a randomized, double-blind, five-week clinical trial. According to the investigators, the new medication, GW468816, is thought to send certain signals in the brain that may be effective in helping people stay abstinent after they have recently quit smoking. GW468816 is a non-nicotine drug. The investigators of this study hypothesize that subjects receiving GW468816 will demonstrate a significantly longer time to relapse to smoking than those in the placebo group, as measured by the primary outcome measure (see below).	Smoking is the leading cause of preventable mortality in developed countries. Pharmacotherapy, including bupropion and nicotine replacement therapy (NRT), is universally recommended for smoking cessation treatment; however, even with treatment, the majority of smokers either fail to quit in the short term or relapse in the first year. The high failure rate reported for smoking cessation, then, presents a challenge to explore innovative approaches to treating relapse to smoking. The purpose of this study, then, is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in female outpatient smokers during a randomized, double-blind, five-week clinical trial. To do this, the investigators will conduct a two-phase study, in which 300 adult, female outpatient smokers will be enrolled. Phase I will consist of an 8-week smoking cessation study in which nicotine replacement therapy (NRT) and a behavioral intervention are openly administered on a tapered schedule. Participants who are able to quit smoking after 7 weeks in this preliminary study will then be eligible to enter Phase II. Phase II is a 5-week, double-blind, placebo-controlled, relapse prevention trial with the investigational medication, GW468816. Participants in the Phase I smoking cessation study will begin by receiving nicotine replacement therapy in the form of the patch and brief support to stop smoking. Participants will be required to schedule office visits every 1-2 weeks throughout Phase I. Subjects who are abstinent at the end of Phase I will be eligible to continue Phase II, in which they will be randomly assigned by chance to receive the investigational medication, GW468816, at 200 mg or placebo (a pill that looks exactly like the study drug but contains no active drug). Participants will be required to schedule weekly office visits throughout Phase II. Subjects who complete the 15-week trial (both Phases I and II) will enter the 6-Month Follow-Up to evaluate rates of long term abstinence from nicotine. They will have office visits at Weeks 20, 24, 28, 32, 36, and 40 after discontinuation of study medications. Participants who enter the study will be offered the opportunity to participate in an ancillary neuroimaging study of mechanisms and surrogate markers of relapse that includes BOLD fMRI and MR spectroscopy, to be carried out at the McLean Brain Imaging Center.	Nicotine Dependence	Drugs, Investigational Therapies for Relapse to Nicotine Relapse Prevention Nicotine Cessation Therapies Smoking Cessation Nicotine Dependence	null	2	arm 1: Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial arm 2: Placebo, 200 mg/day, for a 5-week trial	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Pharmacotherapies for Relapse Prevention intervention 2: None	intervention 1: GW468816 intervention 2: Placebo Comparator: Placebo	2	Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	98	0	0	0	NCT00218465	1COMPLETED	2009-06-01	2006-08-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	247	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.	This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be randomized on a 1:1 basis to either treatment Arm. In this trial, we will compare the efficacy, safety, and tolerability of this novel combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB) to the current standard of care, biweekly infusional 5-FU/leucovorin plus oxaliplatin and bevacizumab (Bev-FOLFOX). For practical purposes, this study will be a head to head comparison of oxaliplatin versus cetuximab, since the other components of both regimens will be the same.	Metastatic Colorectal Cancer		null	2	arm 1: (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle arm 2: (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU. Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU	[ 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 5 mg/kg over 30 minutes on Days 1 and 15 intervention 2: 85 mg/m2 on Days 1 and 15 intervention 3: 400 mg/m2 on Days 1 and 15 intervention 4: 400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period) intervention 5: 400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour	intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Leucovorin intervention 4: Fluorouracil intervention 5: Cetuximab	82	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sedona \| Arizona \| United States \| -111.76099 \| 34.86974 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Fresno \| California \| United States \| -119.77237 \| 36.74773 Monterey \| California \| United States \| -121.89468 \| 36.60024 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Greeley \| Colorado \| United States \| -104.70913 \| 40.42331 Torrington \| Connecticut \| United States \| -73.12122 \| 41.80065 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Melbourne \| Florida \| United States \| -80.60811 \| 28.08363 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Ocoee \| Florida \| United States \| -81.54396 \| 28.56917 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Griffin \| Georgia \| United States \| -84.26409 \| 33.24678 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Niles \| Illinois \| United States \| -87.80284 \| 42.01892 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Cedar Rapids \| Iowa \| United States \| -91.64407 \| 42.00833 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Columbia \| Maryland \| United States \| -76.83942 \| 39.24038 Clinton Township \| Michigan \| United States \| -82.91992 \| 42.58698 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Lambertville \| Michigan \| United States \| -83.62799 \| 41.76588 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Morristown \| New Jersey \| United States \| -74.48154 \| 40.79677 Albany \| New York \| United States \| -73.75623 \| 42.65258 East Setauket \| New York \| United States \| -73.10594 \| 40.94149 New York \| New York \| United States \| -74.00597 \| 40.71427 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Kettering \| Ohio \| United States \| -84.16883 \| 39.6895 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Kingston \| Pennsylvania \| United States \| -75.89686 \| 41.26175 Aiken \| South Carolina \| United States \| -81.71955 \| 33.56042 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Abilene \| Texas \| United States \| -99.73314 \| 32.44874 Arlington \| Texas \| United States \| -97.10807 \| 32.73569 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Beaumont \| Texas \| United States \| -94.10185 \| 30.08605 Bedford \| Texas \| United States \| -97.14307 \| 32.84402 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Denton \| Texas \| United States \| -97.13307 \| 33.21484 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Fredericksburg \| Texas \| United States \| -98.87198 \| 30.2752 Garland \| Texas \| United States \| -96.63888 \| 32.91262 Lewisville \| Texas \| United States \| -96.99417 \| 33.04623 Longview \| Texas \| United States \| -94.74049 \| 32.5007 McAllen \| Texas \| United States \| -98.23001 \| 26.20341 Mesquite \| Texas \| United States \| -96.59916 \| 32.7668 Midland \| Texas \| United States \| -102.07791 \| 31.99735 Odessa \| Texas \| United States \| -102.36764 \| 31.84568 Paris \| Texas \| United States \| -95.55551 \| 33.66094 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Sherman \| Texas \| United States \| -96.60888 \| 33.63566 Sugar Land \| Texas \| United States \| -95.63495 \| 29.61968 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Edmonds \| Washington \| United States \| -122.37736 \| 47.81065 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873 Yakima \| Washington \| United States \| -120.5059 \| 46.60207	239	0	0	0	NCT00252564	1COMPLETED	2009-06-01	2005-09-01	US Oncology Research	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	1,174	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline	null	Parkinson's Disease	Parkinson's Rasagiline Mesylate	null	3	arm 1: 1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) arm 2: 2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) arm 3: Each arm is followed by 36 weeks of placebo	[ 0, 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: tablet, 1mg once daily intervention 2: tablet, 2mg once daily intervention 3: Placebo	intervention 1: Rasagiline Mesylate intervention 2: Rasagiline Mesylate intervention 3: Placebo	0	null	1,174	0	0	0	NCT00256204	1COMPLETED	2009-06-01	2005-11-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	755	RANDOMIZED	FACTORIAL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better	The ultimate goal of RA is to eliminate symptoms, restoring the patient to normal physical, social, emotional, and vocational function, and preserving the structure and integrity of joints. While disease modifying anti-rheumatic drugs (DMARDs) have long been the cornerstone of RA therapy, the limitations of DMARDs have become increasingly apparent and investigators continue to gain insight into the pathogenesis of this disease. Recent evidence suggests that treatment earlier in the disease process with more aggressive approaches results in superior long-term outcomes compared to less intensive treatment regimens. Specifically, there is growing interest in the possibility that early "aggressive" treatment with combinations of DMARDs as initial treatment in efforts to potentially reduce the proportion of patients that advance to severe disability.	Rheumatoid Arthritis	RA painful joints swollen joints	null	4	arm 1: methotrexate (MTX) + etanercept arm 2: methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) arm 3: methotrexate (MTX) or MTX + Etanercept arm 4: methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)	[ 1, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: varies intervention 2: varies intervention 3: varies intervention 4: varies	intervention 1: methotrexate intervention 2: sulfasalazine intervention 3: hydroxychloroquine intervention 4: etanercept	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	755	0	0	0	NCT00259610	1COMPLETED	2009-06-01	2004-05-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	221	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.	On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.	Schizophrenia	Adolescent Subjects	null	1	arm 1: None	[ 5 ]	1	[ 0 ]	intervention 1: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.	intervention 1: Ziprasidone oral capsules	68	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 Orange City \| Florida \| United States \| -81.29867 \| 28.94888 Smyrna \| Georgia \| United States \| -84.51438 \| 33.88399 Tucker \| Georgia \| United States \| -84.21714 \| 33.85455 Des Plaines \| Illinois \| United States \| -87.8834 \| 42.03336 Oakbrook Terrace \| Illinois \| United States \| -87.96451 \| 41.85003 Schaumburg \| Illinois \| United States \| -88.08341 \| 42.03336 Clinton Township \| Michigan \| United States \| -82.91992 \| 42.58698 Bridgeton \| Missouri \| United States \| -90.41151 \| 38.767 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Bothell \| Washington \| United States \| -122.2054 \| 47.76232 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Bello \| Antioquia \| Colombia \| -75.55795 \| 6.33732 Bogota \| Cundinamarca \| Colombia \| N/A \| N/A San José \| N/A \| Costa Rica \| -84.08489 \| 9.93388 Vijaywada \| Andhra Pradesh \| India \| N/A \| N/A Ahmedabad \| Guj \| India \| 72.58727 \| 23.02579 Mangalore \| Karnataka \| India \| 74.85603 \| 12.91723 Aurangabad \| Maharashtra \| India \| 75.34226 \| 19.87757 Mumbai \| Maharashtra \| India \| 72.88261 \| 19.07283 Pune \| Maharashtra \| India \| 73.85535 \| 18.51957 Pune \| Maharashtra \| India \| 73.85535 \| 18.51957 Ludhiana \| Punjab \| India \| 75.85379 \| 30.91204 Chennai \| Tamil Nadu \| India \| 80.27847 \| 13.08784 Kubang Kerian \| Kelantan \| Malaysia \| 102.27938 \| 6.09123 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lipetsk Region \| Russia \| Russia \| N/A \| N/A Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Nizhny Novgorod \| N/A \| Russia \| 44.00205 \| 56.32867 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Tver' \| N/A \| Russia \| 35.90057 \| 56.85836 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Simferopol \| Autonomous Republic of Crimea \| Ukraine \| 34.11079 \| 44.95719 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Luhansk \| N/A \| Ukraine \| 39.30553 \| 48.56814 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Poltava \| N/A \| Ukraine \| 34.55367 \| 49.58925 Vinnytsia \| N/A \| Ukraine \| 28.46871 \| 49.2322	221	0	0	0	NCT00265382	6TERMINATED	2009-06-01	2006-06-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.	Despite a lack of evidence to support their fears, a majority of parents, pediatricians, and pediatric nurses believe that fever can be dangerous to a child. This "fever phobia" has caused a majority of caregivers to aggressively treat fever with antipyretics such as ibuprofen and acetaminophen, often in combination. Although there is scant data to support the use of these medications together for fever control and none using alternating regimens, it was recently reported that 50% of pediatricians and 70% of pediatricians with less than 5 years of experience advise parents to alternate acetaminophen and ibuprofen as an attempt to achieve maximal antipyresis. While a combination of aspirin (no longer used for antipyresis in children) and acetaminophen has been shown to be superior to either agent alone for fever reduction, these data cannot be extrapolated to the pairing of ibuprofen and acetaminophen. There is evidence that combinations of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are more effective for the treatment of pain and can reduce opioid use when compared with a single agent. Improved activity and alertness in children have been reported after antipyretic administration. It is believed that acetaminophen and ibuprofen may be safely used together because the two medications have significantly different pathways of metabolism that are not affected by each other, and have been used abroad in combination form for over a decade. Both acetaminophen and ibuprofen have been shown to be safe when given individually or together in recommended doses for short term use. There are no reports of adverse effects from combination therapy with standard doses. In addition, while it now appears that fever itself is probably a protective physiologic response, under different circumstances it has the potential to be harmful. Fever increases the metabolic rate approximately 10% for every 1 degree C rise in body temperature. The myocardial depression,orthostatic dysfunction, and increases in oxygen consumption, respiratory minute volume, and respiratory quotient that occur may not be tolerated by all patients including some children. Because of the ubiquitous nature of the problem, childhood fever, this study has the potential to immediately impact the way clinicians and parents treat children with fever. If the combination regimens are not shown to be superior, it could limit improper medication administration and overdose. If it is superior, the combination of medications may improve other symptoms associated with fever such as discomfort. Either way, it will fill the gap that exists in the evidence-based approach to the management of childhood fever and immediately impact current practice.	Fever	fever treatment children	null	3	arm 1: At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) arm 2: At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and an appropriate dose of Acetaminophen (15 mg/kg) arm 3: At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and at time 3 hours is given an appropriate dose of Acetaminophen (15 mg/kg)	[ 1, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Given for fever control 15mg/kg intervention 2: Given for fever control 10 mg/kg	intervention 1: Acetaminophen intervention 2: Ibuprofen	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	60	0	0	0	NCT00267293	1COMPLETED	2009-06-01	2006-01-01	Penn State University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients who have had a heart attack.	Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots. Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.	Cardiovascular Diseases Atherosclerosis Myocardial Infarction	Cardiovascular diseases Aspirin Atherosclerosis Myocardial Infarction	null	5	arm 1: 81 mg Aspirin arm 2: 162 mg Aspirin arm 3: 325 mg Aspirin arm 4: 650 mg Aspirin arm 5: 1300 mg Aspirin	[ 1, 1, 1, 1, 1 ]	1	[ 0 ]	intervention 1: Dosage	intervention 1: Aspirin	2	Atlantis \| Florida \| United States \| -80.10088 \| 26.5909 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286	37	0	0	0	NCT00272337	1COMPLETED	2009-06-01	2006-10-01	Florida Atlantic University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	62	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).	null	Kidney Neoplasms Carcinoma, Renal Cell		null	1	arm 1: AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity	[ 0 ]	1	[ 0 ]	intervention 1: AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.	intervention 1: AG-013736 (axitinib)	5	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	62	0	0	0	NCT00282048	1COMPLETED	2009-06-01	2006-03-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	237	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.	null	Hyperlipidemia	Hyperlipidemia Proteinuria Diabetes Mellitus	null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Rosuvastatin intervention 2: Atorvastatin	107	Avondale \| Arizona \| United States \| -112.3496 \| 33.4356 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Riverside \| California \| United States \| -117.39616 \| 33.95335 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Columbia \| Maryland \| United States \| -76.83942 \| 39.24038 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 Orchard Park \| New York \| United States \| -78.74392 \| 42.76756 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Gig Harbor \| Washington \| United States \| -122.58013 \| 47.32926 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Blagoevgrad \| N/A \| Bulgaria \| 23.1 \| 42.01667 Burgas \| N/A \| Bulgaria \| 27.46781 \| 42.50606 Gabrovo \| N/A \| Bulgaria \| 25.33417 \| 42.87472 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Veliko Tarnovo \| N/A \| Bulgaria \| 25.62904 \| 43.08124 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Courtice \| Ontario \| Canada \| -78.76626 \| 43.91682 East York \| Ontario \| Canada \| -79.34044 \| 43.70388 Oakville \| Ontario \| Canada \| -79.68292 \| 43.45011 Oshawa \| Ontario \| Canada \| -78.84957 \| 43.90012 Richmond Hill \| Ontario \| Canada \| -79.43725 \| 43.87111 Scarborough Village \| Ontario \| Canada \| -79.22124 \| 43.73899 Thunder Bay \| Ontario \| Canada \| -89.25018 \| 48.38202 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Greenfield Park \| Quebec \| Canada \| -73.46223 \| 45.48649 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Fredericia \| N/A \| Denmark \| 9.75257 \| 55.56568 Herlev \| N/A \| Denmark \| 12.43998 \| 55.72366 Holbæk \| N/A \| Denmark \| 11.71279 \| 55.7175 Roskilde \| N/A \| Denmark \| 12.08035 \| 55.64152 Viborg \| N/A \| Denmark \| 9.40201 \| 56.45319 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Cloppenburg \| N/A \| Germany \| 8.045 \| 52.84754 Demmin \| N/A \| Germany \| 13.03142 \| 53.90762 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Elsenfeld \| N/A \| Germany \| 9.16355 \| 49.84289 Göttingen \| N/A \| Germany \| 9.93228 \| 51.53443 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391 Ajka \| N/A \| Hungary \| 17.55892 \| 47.10196 Baja \| N/A \| Hungary \| 18.95307 \| 46.18299 Balatonfüred \| N/A \| Hungary \| 17.87187 \| 46.96188 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Eger \| N/A \| Hungary \| 20.37329 \| 47.90265 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Gy�r \| N/A \| Hungary \| N/A \| N/A Keszthely \| N/A \| Hungary \| 17.24317 \| 46.76812 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Szolnok \| N/A \| Hungary \| 20.2 \| 47.18333 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Zalaegerszeg \| N/A \| Hungary \| 16.84389 \| 46.84 Bergamo \| BG \| Italy \| 9.66721 \| 45.69601 Bologna \| BO \| Italy \| 11.33875 \| 44.49381 Brescia \| BS \| Italy \| 10.21472 \| 45.53558 Acireale \| CT \| Italy \| 15.16577 \| 37.60886 Foggia \| FG \| Italy \| 15.55188 \| 41.45845 Florence \| FI \| Italy \| 11.24626 \| 43.77925 Parma \| PR \| Italy \| 10.32618 \| 44.79935 Reggio Calabria \| RC \| Italy \| 15.66129 \| 38.11047 Sassari \| SS \| Italy \| 8.55552 \| 40.72586 Teramo \| TE \| Italy \| 13.69901 \| 42.66123 Torino \| TO \| Italy \| 11.99138 \| 44.88856 Castelfranco Veneto \| TV \| Italy \| 11.92755 \| 45.67146 Treviso \| TV \| Italy \| 12.2416 \| 45.66673 Mestre \| VE \| Italy \| 12.24538 \| 45.49167 Zapopan \| Jalisco \| Mexico \| -103.38742 \| 20.72111 Mexico City \| Mexico City \| Mexico \| -99.12766 \| 19.42847 D.F \| Mexico \| Mexico \| N/A \| N/A San Luis Potos� \| Mexico \| Mexico \| N/A \| N/A Cuernavaca \| Morelos \| Mexico \| -99.23075 \| 18.9261 Aguascalientes \| N/A \| Mexico \| -102.2843 \| 21.88262 Durango \| N/A \| Mexico \| -104.65756 \| 24.02032 Brasov \| Brașov County \| Romania \| 25.60613 \| 45.64861 Cluj-Napoca \| Cluj \| Romania \| 23.6 \| 46.76667 Constanța \| Constanța County \| Romania \| 28.63432 \| 44.18073 Suceava \| Suceava \| Romania \| 26.25 \| 47.63333 Timișoara \| Timiș County \| Romania \| 21.22571 \| 45.75372 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Craiova \| N/A \| Romania \| 23.8 \| 44.31667 Iași \| N/A \| Romania \| 27.6 \| 47.16667 Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Pretoria \| South Africa \| South Africa \| 28.18783 \| -25.74486 Parow \| W Cape \| South Africa \| 18.59992 \| -33.89723 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Durban \| N/A \| South Africa \| 31.0292 \| -29.8579	236	0	0	0	NCT00296400	1COMPLETED	2009-06-01	2006-02-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	75	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.	On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc. The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.	Lymphoma, Follicular	Sargramostim Leukine NHL	null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab intervention 2: Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks	intervention 1: Sargramostim (Leukine) intervention 2: Rituximab	22	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Montebello \| California \| United States \| -118.10535 \| 34.00946 Pleasant Hill \| California \| United States \| -122.0608 \| 37.94798 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Elk Grove Village \| Illinois \| United States \| -87.97035 \| 42.00392 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 New Albany \| Indiana \| United States \| -85.82413 \| 38.28562 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 Fresh Meadows \| New York \| United States \| -73.79347 \| 40.73482 New York \| New York \| United States \| -74.00597 \| 40.71427 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	75	0	0	0	NCT00308087	6TERMINATED	2009-06-01	2006-05-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3, 4 ]	13	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.	Summary: A phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV. Scientific Rationale: Chloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficial in reducing viral burden and immune activation therefore delaying HIV disease progression. Sample Size: 25 Length of Study: 8 weeks, \[enrollment + 2 follow up visits\]. Intervention: * Arm 1a: Chloroquine 250mg orally once daily for 8 weeks. * Arm 1b: Chloroquine 500mg orally once daily for 8 weeks. * Arm 2: Placebo once daily for 8 weeks. Measurements: * Blood draws at weeks: 0, 4, and 8 weeks. * CD4, viral load measurements will be communicated to the referring provider (with subject consent).	HIV Infections	HIV chloroquine disease progression inflammation treatment naive	null	2	arm 1: Chloroquine 205mg or 500mg orally once daily (Results pooled) arm 2: Placebo once daily for 8 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 250mg or 500mg PO (by mouth) QDay intervention 2: Placebo once daily for 8 weeks	intervention 1: chloroquine phosphate intervention 2: Placebo	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	13	0	0	0	NCT00308620	6TERMINATED	2009-06-01	2006-03-01	University of Minnesota	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	115	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.	null	Non-Small Cell Lung Cancer Brain Neoplasms	Brain Cancer Brain Metastases Avastin NSCLC Lung Cancer PASSPORT	null	1	arm 1: None	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be \< 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity. intervention 2: Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily. All agents were dosed and administered per institutional standards using the respective package insert as a guideline. intervention 3: Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued. All agents were dosed and administered per institutional standards using the respective package insert as a guideline.	intervention 1: bevacizumab intervention 2: First-Line Chemotherapy Agents intervention 3: Second-Line Chemotherapy Agents	0	null	106	0	0	0	NCT00312728	1COMPLETED	2009-06-01	2006-03-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	7,287	RANDOMIZED	FACTORIAL	1PREVENTION	1SINGLE	false	0ALL	true	The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic control for type 2 diabetes (in ACCORD participants) on factors related to bone health, including, fractures, falls, and bone mineral density.	Recent studies have established that type 2 diabetes is a risk factor for fractures, particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these patients. More frequent falls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. The best approach to preventing fractures in type 2 diabetes is not yet understood. There is observational evidence to support our hypothesis that better glycemic control will preserve bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to determine whether intensive glycemic control will prevent fractures, falls, and bone loss in older diabetic adults, which may lead to improved treatment and prevention in the future.	Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus Coronary Disease	Diabetes Mellitus Fracture Falls Height Loss	null	2	arm 1: intensive glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level below 6.0%) arm 2: standard glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of 7 to 7.9%)	[ 1, 1 ]	1	[ 0 ]	intervention 1: type 2 diabetes treatments, per standard of care	intervention 1: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents	5	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011	0	0	0	0	NCT00324350	1COMPLETED	2009-06-01	2003-10-01	University of California, San Francisco	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of sleep problems and their impact on the life of these individuals, there has been, until recently, little research focus on the problem. This will be a multi-site, double blind, placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks. Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis is that eszopiclone will be superior to placebo for the treatment of insomnia in patients with Parkinson's disease	Introduction and Rationale Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. This difficulty with sleep maintenance is accompanied by a decrease in total sleep time and an increase in the number of awakenings and wakefulness after sleep. The interactions between PD and sleep are complicated and many PD patients with insomnia have concomitant sleep disorders such as REM Sleep Behavior Disorder (RBD), Periodic Limb Movements of Sleep (PLMS) and Sleep Disordered Breathing (SDB). Nonetheless, the majority of patients appear to have insomnia that is an integral symptom of PD rather than being related to specific sleep disorders. Sleep difficulties in patients with PD are independent and important predictors of poor quality of life. In addition, sleep disturbances contribute to excessive daytime sleepiness (EDS) and poor daytime functioning as well as patients' reduced enthusiasm for daily events and impairment in the quality of life of their spousal caregivers7. There are, therefore, a variety of reasons for us to address sleep problems in patients with PD. Despite the high prevalence of sleep problems and their impact on the life of these individuals, there has been, until recently, little research focus on the problem. While researchers have now begun to describe the phenomenology and epidemiology of sleep in PD, there have few treatment studies from which the clinical community can derive guidance. Despite this lack of evidenced-based clinical guidance, community surveys indicate that up to 40% of patients with PD are taking sleeping pills.3 Data published in 1999 indicate that the two most commonly used hypnotics in general practice were trazodone and zolpidem. More recent data continue to show that trazodone is prescribed even more frequently than zolpidem. We have recently completed a survey of 50 Parkinson's disease experts and found that the most commonly used hypnotics were zolpidem and trazodone. Of note is also that these experts estimated that 40% of their patients with PD were using sleep medications. We have then the following clinical problem in the treatment of patients with PD. Insomnia is very common and is strongly associated with a variety of adverse outcomes but there are no controlled data that can guide the approach to the treatment of these individuals. Nevertheless, clinicians appear to be using a number of hypnotics, principally zolpidem and trazodone, neither of which have been evaluated in PD or for long term use. Objectives To test the safety and efficacy of eszopiclone for the treatment of insomnia in patients with Parkinson's disease Hypothesis Eszopiclone will result in significantly greater improvement than placebo in patient reported total sleep time (diaries) in patients with PD in an six week trial. Study Design and Duration This will be a multi-site, double blind, placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks. Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three external sites) will be equally randomized to eszopiclone or placebo. Preliminary screening will be conducted by telephone. Inclusion and exclusion criteria are listed below. Those individuals appearing appropriate will be scheduled for an in-person screening visit and will sign informed consent. At the screening visit, a detailed sleep, medical and psychiatric history, and a variety of background demographic forms (See Schedule of Events - Appendix A) will be completed. Subjects meeting all entrance criteria will be scheduled for a polysomnogram at the end of a two-week baseline period during which they will keep sleep-wake diaries. Those who meet criteria for insomnia receive overnight polysomnographic evaluations to screen for primary sleep disorders of REM Sleep Behavior Disorder (RBD), Periodic Limb Movements of Sleep (PLMS), and Sleep Disordered Breathing (SBD). To minimize cost, we plan to obtain one or two nights of baseline PSG evaluation, depending on the amount of total sleep time observed on the first night of recording. Patients who show 4 hours or more of total sleep, including at least 30 min total of REM sleep, will receive only one night of PSG evaluation. These values were selected as the minimum necessary amount of sleep for evaluating concomitant sleep disorders. Patients who do not meet these criteria on the first night, or whose results are equivocal, will receive a second night of baseline evaluation. The exclusion criteria will apply to the either night. If there is not sufficient sleep on either night the patient will be excluded. Polysomnographic evaluation will be conducted using standard nocturnal polysomnographic procedures. This consists of 2 monopolar electroencephalographic (EEG) leads (C3-A2 and O1-A2), 2 monopolar electro-oculograms (EOG), bipolar submental (chin) and right and left tibialis (leg) electromyograms (EMG), and electrocardiogram (ECG). Respiratory airflow will be monitored through the use of a thermocouple (Pro-Tech Services, Inc.), placed at the nose and mouth. Respiratory effort will be measured by plethysmography using piezoelectric sensors (Pro-Tech Services, Inc.) Snoring will be recorded through the use of a snoring sensor (Pro-Tech Services, Inc.). Arterial oxygen saturation will be measured with a finger probe and pulse oximeter (Nonin). All subjects will be videotaped during the PSG evaluation to provide positional and behavioral information regarding their sleep episode. All sleep parameters will be collected simultaneously by a computerized acquisition system (REMbrandt, Medcare Diagnostics). Sleep will be scored in 30-second epochs according to the standard criteria of Rechtschaffen and Kales. Those meeting entrance criteria will then be equally randomly assigned to receive eszopiclone or placebo treatment for 6 weeks. Both groups will receive equal-appearing pills to be taken each night. The dosing in the trial will be fixed and stratified by age: those under 65 will receive 3 mg of eszopiclone or matching placebo at night; those 65 or older will receive 2 mgs of eszopiclone or placebo at night. Patients will have visits at screen, an interim phone contact to review the sleep diaries, PSG, baseline and weeks 2, 4, and 6, at which medication will be monitored and pill intake, therapeutic response and adverse events will be reviewed. The procedures done at each visit are listed in Appendix A. All groups will record sleep-wake diaries during the 2 week screening phase and for the first six weeks of the study. Patients will be asked but not be required to provide a care giver who will complete questionnaires at the screen visit and week 6 visit. Patients who terminate prematurely or who continue in the trial till the end will stop medication and continue to record diaries for one week at which time they will return for the final visit.	Parkinson's Disease Insomnia	Parkinson's insomnia drug eszopiclone placebo	null	2	arm 1: eszopiclone. Those under 65yo received 3mg of eszoplicone ( or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone ( or randomized to matching placebo)taken each night at bedtime arm 2: Those randomly assigned to matching placebo, took their dose each night at bedtime	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: eszopiclone intervention 2: matching placebo administered at night	intervention 1: eszopiclone intervention 2: placebo	4	Suwanee \| Georgia \| United States \| -84.0713 \| 34.05149 Edison \| New Jersey \| United States \| -74.4121 \| 40.51872 Piscataway \| New Jersey \| United States \| -74.39904 \| 40.49927 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	30	0	0	0	NCT00324896	1COMPLETED	2009-06-01	2006-05-01	University of Medicine and Dentistry of New Jersey	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	75	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute, moderate to severe pain, and who are to be treated with intravenous Patient controlled analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of patients will be post operative patients, and will start therapy and the investigational drug in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan on studying between 10 and 99, male and female patients over a 2 year period.	In patients of all ages, opioids are the cornerstone of management of moderate to severe pain. Regardless of method of administration, all opioids produce unwanted side effects, including pruritus, nausea and vomiting, constipation, urinary retention, cognitive impairment, tolerance, dependence, and (rarely) respiratory depression. Based on the results of a previously completed randomized controlled trial, children and adolescents with moderate to severe pain, are now routinely treated in the Children's Center of the Johns Hopkins Hospital with a low dose naloxone infusion (0.25 mcg/kg/HOUR) whenever morphine intravenous patient controlled analgesia (IVPCA) or parent/nurse controlled analgesia (IVPNCA) is initiated. Although the previous study showed a marked reduction in the incidence and severity of pruritus and nausea, approximately a third of the patients still experience these side effects. The primary purpose of this study is to reduce this failure rate by determining if there is an optimal dose of naloxone to prevent opioid induced side effects as determined by a dose finding classic up down dose escalation method. The second aim is to determine the pharmacokinetics of morphine and naloxone and their metabolites at each of the naloxone infusion rates attempted. The investigators will measure morphine, naloxone, and their metabolites using a liquid chromatographic-electrospray ionization-tandem mass spectrometric method (LC/MS/MS). The final aim is to determine the pharmacogenetics of responders and non-responders using DNA isolated from patient blood. To accomplish this the investigators will need a single blood collection from patients currently being treated with IVPCA morphine and low dose intravenous naloxone.	Pain Nausea Pruritus	morphine naloxone pediatrics adverse effects pain	null	1	arm 1: continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour	[ 0 ]	1	[ 0 ]	intervention 1: continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour	intervention 1: naloxone	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	59	0	0	0	NCT00330343	1COMPLETED	2009-06-01	2004-05-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	143	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.	null	Bladder, Neurogenic	tamsulosin pediatric neurogenic bladder	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: oral	intervention 1: tamsulosin hydrochloride	72	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 Lake Success \| New York \| United States \| -73.71763 \| 40.77066 Tarrytown \| New York \| United States \| -73.85875 \| 41.07621 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Santo André \| N/A \| Brazil \| -46.53833 \| -23.66389 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Halifax \| N/A \| Canada \| -63.57688 \| 44.64269 Montreal \| N/A \| Canada \| -73.58781 \| 45.50884 Montreal \| N/A \| Canada \| -73.58781 \| 45.50884 Toronto \| N/A \| Canada \| -79.39864 \| 43.70643 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Deggendorf \| N/A \| Germany \| 12.96068 \| 48.84085 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Ahmedabad \| N/A \| India \| 72.58727 \| 23.02579 Belagavi \| N/A \| India \| 74.50447 \| 15.85212 Bengaluru \| N/A \| India \| 77.59369 \| 12.97194 Hyderabaad \| N/A \| India \| N/A \| N/A Kochi \| N/A \| India \| 76.26022 \| 9.93988 Lucknow \| N/A \| India \| 80.92313 \| 26.83928 Lucknow \| N/A \| India \| 80.92313 \| 26.83928 Ludhiana \| N/A \| India \| 75.85379 \| 30.91204 Ludhiana \| N/A \| India \| 75.85379 \| 30.91204 Manipal \| N/A \| India \| 74.78333 \| 13.35 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Nadiād \| N/A \| India \| 72.86157 \| 22.69385 Nagpur \| N/A \| India \| 79.08491 \| 21.14631 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 Pune \| N/A \| India \| 73.85535 \| 18.51957 Pune \| N/A \| India \| 73.85535 \| 18.51957 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Florence \| N/A \| Italy \| 11.24626 \| 43.77925 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 León \| N/A \| Mexico \| -113.78333 \| 28.51667 Puebla City \| N/A \| Mexico \| -98.20723 \| 19.04778 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Pasig \| N/A \| Philippines \| 121.0614 \| 14.58691 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Bloemfontein \| N/A \| South Africa \| 26.214 \| -29.12107 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Roodepoort \| N/A \| South Africa \| 27.8725 \| -26.1625 Gwangju \| N/A \| South Korea \| 126.91556 \| 35.15472 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Pusan \| N/A \| South Korea \| 128.3681 \| 36.3809 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Chernivtsy \| N/A \| Ukraine \| N/A \| N/A	377	0	0	0	NCT00340704	1COMPLETED	2009-06-01	2006-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	145	RANDOMIZED	PARALLEL	2DIAGNOSTIC	3TRIPLE	false	0ALL	null	This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.	null	Diagnostic Imaging	Multislice computed tomography (MSCT)indications	null	2	arm 1: The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) arm 2: The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 300 mg of iodine/ml intervention 2: 270 mg of iodine/ml	intervention 1: Xenetix intervention 2: Visipaque	1	Rouen \| N/A \| France \| 1.09932 \| 49.44313	145	0	0	0	NCT00347022	1COMPLETED	2009-06-01	2006-05-01	Guerbet	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	111	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes.	null	Autoimmune Disease	Autoimmune disease, mycophenolate, GI problems	null	1	arm 1: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.	intervention 1: Enteric-coated Mycophenolate Sodium	1	Various Cities \| N/A \| Germany \| N/A \| N/A	111	0	0	0	NCT00351377	1COMPLETED	2009-06-01	2006-06-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to evaluate the ability of Phenoptin to control blood phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4 deficiency and to evaluate the safety of Phenoptin in this population. Some subjects were receiving non-registered formulations of BH4 at enrollment and this treatment was suspended after Part 1 and within one day the subjects started Phenoptin at approximately the same dose.	Within 4 weeks of completing screening assessments to determine eligibility, subjects will be enrolled in the study. The study will be conducted in two parts. Part 1: After screening, all subjects will be followed for two weeks without modification of their baseline medical or dietary care. Part 2: Beginning at Week 2, subjects who were receiving non-registered formulations of BH4 at enrollment will suspend this treatment and within one day will start Phenoptin at approximately the same dose of the non-registered BH4 formulation. Subjects not receiving BH4 at enrollment will begin treatment with Phenoptin at approximately 5 mg/kg/day, given orally, prior to meals. At the discretion of the Investigator, the Phenoptin dose may be adjusted up or down at the Week 6 visit to control blood Phe levels (\<360 µmol/L), or to optimize the clinical effect. The maximum dose allowed will be approximately 20 mg/kg/day. All subjects will receive Phenoptin for a total of 8 weeks. Subjects will be instructed to continue their usual diet without modification. Study visits will occur every other week. Tyrosine, biopterin and neopterin will be analyzed at the following visits: Week 0 (enrollment), Week 2 (prior to dosing with Phenoptin), Week 8 (after 6 weeks of treatment with Phenoptin) and Week 10 (after 8 weeks of treatment with Phenoptin).During each visit, blood Phe level will be measured (2.5-5 hours after a meal), and safety evaluations will be performed. Safety will be assessed by monitoring adverse events and vital signs, performing physical examinations, assessing signs and symptoms of primary BH4 deficiency (i.e., neurological symptoms such as seizures, changes in muscle tone, weakness, etc.) and clinical laboratory tests (chemistry, hematology and urinalysis). Extension: Upon completion of 8 weeks of treatment (i.e., at the Week 10 visit), subjects will be offered the option to continue treatment with Phenoptin in an extension of this study. Participation in the study extension will continue until one of the following occurs: 1. the subject withdraws consent and discontinues from the study, 2. the subject is discontinued from the study at the discretion of the investigator, 3. the study drug is available through the appropriate marketing approval, or 4. the study is terminated. During the extension period, study drug will be dispensed to subjects monthly, and study visits will be required every 3 months. The Phenoptin dose may be adjusted at any visit during the study extension at the discretion of the Investigator. The maximum dose allowed will be approximately 20 mg/kg/day.	Tetrahydrobiopterin Deficiencies Hyperphenylalaninemia, Non-Phenylketonuric		null	1	arm 1: 5mg/kg/day orally, dose may be adjusted to between 5-20 mg/kg/day by investigator at week 6 to control blood Phe levels Outcomes were also evaluated by the subject's type of BH4 deficiency either defects in the genes encoding the enzymes involved in biosynthesis or defects in the genes encoding the enzymes involved in recycling.	[ 0 ]	1	[ 0 ]	intervention 1: 5mg/kg/day orally, dose may be adjusted to between 5-20 mg/kg/day by investigator at week 6 to control blood Phe levels	intervention 1: Phenoptin	10	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172	12	0	0	0	NCT00355264	1COMPLETED	2009-06-01	2006-08-01	BioMarin Pharmaceutical	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis (IPF) patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.	Idiopathic pulmonary fibrosis (IPF) is recognized as a predominantly noninflammatory paradigm of lung fibrosis, characterized by heterogeneous myofibroblast proliferation (usual interstitial pneumonia \[UIP\]) and a poor clinical prognosis. To date no therapies have been demonstrated in well-designed, randomized, controlled trials (RCT) to favorably influence functional status or survival of IPF patients. The need for effective therapies for VA patients with IPF is thus obvious and urgent. The overall goal of this VA Merit Review clinical research is to generate rigorous preliminary data for evaluation of a new and potentially effective therapy for IPF. The established, combined Miami Veterans Affairs Medical Center (VAMC) - University of Miami (UM) IPF program has participated productively in a number of clinical trials to assess new agents for the therapy of IPF (e.g., interferon gamma-lb, imatinib mesylate, etanercept, bosentan). Our program is uniquely qualified to enroll large numbers of IPF patients in clinical trials, because of its large metropolitan population base (\>5,000,000 people) and extensive referral network throughout South and Central America. The Veteran population of South Florida (Dade, Broward and Monroe Counties) is approximately 236,000 (U.S. Census Bureau). Of that number 39% are 65 years of age or older, making them at high risk for IPF. Because of its large Veteran and civilian population base, international referral network and previous experience as a "high enrollment center" in IPF clinical trials, the Miami VAMC-UM IPF program is uniquely qualified to anticipate the role of a CSP lead center. Our central hypothesis is that sildenafil, a vasodilator, will have a beneficial effect compared to placebo on disease progression, defined as a significant change in the 6-minute walk distance or dyspnea index, in patients with IPF. Specifically, we will test effects of sildenafil on IPF patients' exercise tolerance and level of dyspnea in a double blind, randomized, placebo controlled (one to one assignment) pilot study. Upon completion of this trial, it will be possible to assess efficacy of sildenafil on progression of disease in IPF and possibly introduce this agent into translational practice. Our specific objectives are: Specific Objectives 1: To assess the possible therapeutic benefit of a vasodilator, sildenafil, on exercise tolerance in IPF patients. The working hypothesis is that, compared to placebo, sildenafil will favorably affect rate of decline from baseline in exercise capacity (6-minutes walk). Specific Objective 2: To assess and compare changes from baseline in pre- and post-exercise dyspnea in sildenafil and placebo control groups. The working hypothesis is that application of this agent will lead to more sustained exercise and a more favorable clinical outcome in addition to a decrease in the degree of limiting dyspnea after exercise. The application of vasodilator therapy in IPF is unique in that it directly targets key pathophysiologic mechanisms of functional limitation: Increased pulmonary vascular resistance and dyspnea due to exercise. This novel approach will have a significant impact on field, because it promises both additional insight into mechanisms of disease and immediate therapeutic options.	Alveolitis, Fibrosing Fibrosis, Pulmonary Hypertension, Pulmonary	alveolitis, fibrosing exercise, aerobic fibrosis, pulmonary hypertension, pulmonary	null	2	arm 1: Sildenafil 20 mg tid orally arm 2: Identical Placebo 20 mg tid orally	[ 0, 2 ]	1	[ 0 ]	intervention 1: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.	intervention 1: sildenafil	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	29	0	0	0	NCT00359736	1COMPLETED	2009-06-01	2006-07-01	VA Office of Research and Development	1FED	false	false	false	null	0	0	0	0	0	0
[ 4 ]	330	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).	null	Autistic Disorder Behavioral Symptoms	Serious behavioral problems in children and adolescents with AD behavioral problems	null	3	arm 1: De novo participants (those who did not participate in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. arm 2: Participants who completed participation in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. arm 3: Participants who completed participation in protocol CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks	intervention 1: Aripiprazole	55	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Dothan \| Alabama \| United States \| -85.39049 \| 31.22323 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tuscon \| Arizona \| United States \| N/A \| N/A Costa Mesa \| California \| United States \| -117.91867 \| 33.64113 Rolling Hills Estate \| California \| United States \| N/A \| N/A Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 Stanford \| California \| United States \| -122.16608 \| 37.42411 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Smyrna \| Georgia \| United States \| -84.51438 \| 33.88399 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751 Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751 Wellsley \| Massachusetts \| United States \| N/A \| N/A Bloomfield Hills \| Michigan \| United States \| -83.24549 \| 42.58364 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Saint Paul \| Minnesota \| United States \| -93.09327 \| 44.94441 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Toms River \| New Jersey \| United States \| -74.19792 \| 39.95373 Bethpage \| New York \| United States \| -73.48207 \| 40.74427 New York \| New York \| United States \| -74.00597 \| 40.71427 Staten Island \| New York \| United States \| -74.13986 \| 40.56233 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Fairfax \| Virginia \| United States \| -77.30637 \| 38.84622 Herndon \| Virginia \| United States \| -77.3861 \| 38.96955 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Bothell \| Washington \| United States \| -122.2054 \| 47.76232 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	330	0	0	0	NCT00365859	1COMPLETED	2009-06-01	2006-09-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 5 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	true	The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile than that of the widely used tic-suppressing medication, clonidine. More specifically, the investigators hypothesize that in a 15 week placebo run-in, double-blind, medication cross-over trial; levetiracetam will be more effective and have fewer side-effects than clonidine.	This is a randomized, double-blind, 15 week (two treatment phase), 1 week run-in, cross-over study, in which the same patient receives 6 weeks of treatment with levetiracetam and a 6 week treatment course with clonidine, separated by a two week medication wash-out. The investigators plan to enroll twenty patients between the ages of 7 to 19 years with moderate to moderately-severe Tourette syndrome or chronic motor/vocal tics. The recruitment period is expected to be approximately 12 months (total study length of about 18 months). The study will begin with a screening evaluation to ensure that each subject satisfies all eligibility criteria, to allow subjects to become familiar with our assessment procedures, and to obtain informed consent. Following a baseline visit, there will be a one week "run-in" treatment period in order to screen for high placebo responders, in which all subjects will receive placebo. If the patient's tic severity score fails to improve he/she will begin the double blind treatment period (levetiracetam/clonidine), that will last for six weeks followed by a two week wash out period, and then by a second double blind treatment period (clonidine/levetiracetam) for an additional six weeks. A statistician not involved with the care of the subjects will be responsible for randomization. A six week trial treatment was chosen to allow for an adequate drug response period. Patients will be followed by phone at weekly intervals throughout the study and will be formally evaluated at the beginning and end of each treatment phase. At the completion of the study, patients/parents will be given the opportunity to continue a successful treatment. The primary outcome measure is the Yale Global Tic Severity Scale (YGTSS): A semi-structured clinical interview designed to measure current tic severity. Other outcome measures will include the Clinical Global Impression-Improvement Scale (CGI-I), the Child Yale-Brown Obsessive-Compulsive Scale (CYBOCS), the DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, Child Depression Inventory (CDI), Multi-Dimensional Anxiety Scale for Children (MASC), and an expanded Pittsburgh Side-Effect Scale. Subjects will be recruited from the Tourette Syndrome Clinic at the Johns Hopkins Hospital. This clinic, directed by Dr. Harvey Singer, currently follows more than 1000 chronic tic patients and averages 4 new referrals every week. The clinic staff has a longstanding successful record of designing and completing therapeutic protocols for the treatment of tics. Inclusion Criteria: see below Exclusion Criteria: see below Procedures: i) Screening visit: Determination of diagnostic eligibility criteria (medical history and complete physical examination; evaluation of tic severity, screening of females who have begun to menstruate with a urine pregnancy test, familiarization with assessment procedures, and obtaining informed consent. The urine pregnancy test will be obtained in females over 12 years of age. Parents will be told the results of these tests. If the patient is uncomfortable with our telling the results of the pregnancy test to her parent(s), then they may decide not to take part in this study. ii) Baseline Visit (Day 0): Evaluation prior to the run-in (placebo) phase will include weight, heart rate, blood pressure, respiratory rate, rating scales for: tics, the Yale Global Tic Severity Scale (YGTSS) and Childhood Global Impression-TS (CGI-TS); adverse effects, the Pittsburgh Side-Effect Rating Scale; obsessive-compulsive problems, Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS; attention deficit hyperactivity disorder, DuPaul ADHD Rating Scale, depression, Child Depression Inventory- Short Version (CDI-S); anxiety, the Multidimensional Anxiety Scale for Children (MASC; and episodic outbursts, Rage Attack Rating Scale. iii) Run-in Placebo Phase (days 0-7): Immediately after the baseline visit, the subject is started on placebo treatment for a one week period. All subjects will receive 1 capsule twice a day; capsules will be similar in appearance to that used in the drug treatment phase. The Run-in phase has been added to eliminate subjects whose treatment outcome could be influenced by only a transient exacerbation of tics or by the exposure to non-pharmacologic treatment. a) Post- Run in Period Evaluation (day 8): Subjects will return for a re-evaluation of symptoms, emphasis will be placed on rating scales for: tics, the Yale Global Tic Severity Scale (YGTSS) and Childhood Global Impression-TS (CGI-TS); and adverse effects, the Pittsburgh Side-Effect Rating Scale. If there is no tic improvement following the receipt of placebo, the patient will move on to the treatment phase of the study. In contrast, if tic symptoms are reduced by more than 15% or significant side effects are reported, all treatment will be discontinued and the subject will be withdrawn from the study. iv) Treatment phases (days 8 50 and days 65 107): A computer generated unequal randomized scheme will be used to assign patients to either levetiracetam or clonidine in the initial treatment phase. Research Pharmacy at Johns Hopkins will be responsible for packaging levetiracetam (supplied by UCB) and clonidine (purchased), randomizing its allocation, and distributing the medication. Levetiracetam and clonidine will be repackaged in look-alike capsules with different dosage levels: levetiracetam, 250 milligrams (mg) or 500 mg and clonidine, 0.05 mg or 0.1 mg. Patients will receive a six week supply of medication at the first treatment phase visit (day 8) and at the beginning of the second treatment phase (day 63). A study physician (Dr. Harvey Singer) will be responsible for changing medication dosage and monitoring side-effects. A Safety Monitoring Board has been established to oversee medication use and monitor side-effects. 1. Levetiracetam: The starting dose of levetiracetam will be 10 mg/kg/day for one week; administered as 5 mg/kg twice a day (B.I.D.)(rounded to the closest unit of 250 mg). If needed for tic suppression, the dose will be increased weekly by 5-10 mg/killigrams(kg)/day. The maximum dose will be 50 mg/kg/day (administered as 25 mg/kg BID), with a maximum dose of 2,500 milligrams per day. For reference, doses from 10 to 60 mg/kg/day of levetiracetam are currently being used in pediatric studies for the treatment of seizures and up to 2000 mg in TS children with a mean age of 12 years. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. No changes in dosage will be made during the final week of both treatment phases. 2. Clonidine: The starting dose of clonidine will be 0.05mg BID for one week. If needed for tic suppression, the dose will be increased weekly by 0.05-0.1 mg. The maximum dose will be 0.4 mg (administered as 0.2 mg BID). iv) Wash out phase: Between the two treatment phases, medication will be tapered over a ten day period. Levetiracetam will be tapered at the end of each treatment phase by 5-10 mg/kg/day every third day. The half life of levetiracetam is approximately 7-8 hours in healthy volunteers, 5 8 hours in epileptic patients, and about 10 hours in the elderly. Clonidine will be tapered by 0.05 - 0.1 mg every third day. Subjects will be off medication for 5 days before starting the second phase of the cross over study. v) End of study drug taper: At the completion of the second treatment phase, medication will be tapered over a ten-day period, reducing the medications in equal proportions every third day. vi) Early stopping rules: Subjects may be withdrawn from the study at any time at the discretion of the subject, attending physician, or investigator. 1. The investigator decides the subject should be withdrawn. This decision could be made because of an adverse effect or a failure to comply with the study protocol. 2. The subject or his/her personal physician requests that the subject be withdrawn from the study. 3. The subject, for any reason, requires treatment with another therapeutic agent that could conflict with the use of levetiracetam or clonidine. 4. A Drug Safety Monitoring Board will monitor side effects and assist in determining whether a subject should be withdrawn from the trial. Members of this board are full time Johns Hopkins Hospital faculty members and epilepsy fellows with experience in the use of levetiracetam. The Board will have access to the randomization codes maintained by the statistician. A quarterly update meeting will be scheduled for the Monitoring Board with topics to be reviewed including the number of subjects, dosage schedules, side effects, and therapeutic responses. Significant adverse events will be reported to the sponsor Union chimique belge, Inc (UCB, Inc), Johns Hopkins Joint Committee on Clinical Investigation (JCCI), and Food and Drug Administration (FDA) within 24 hours. vii) Evaluations: This is a 15 week study. Telephone evaluations will be performed by the blinded Research Assistant on day 14, 21, 28, 35, 42, 70, 77, 84, 91, and 98. At each telephone session clinical response, possible side effects, drug compliance, and medication adjustment will be discussed. Subjects will be formally evaluated at 4 separate times including baseline (day 0), at end of the run-in phase (day 8), end of the first treatment phase (day 49), at end of the drug wash out period (day 63), and at end of the study (day 105). Evaluations at each visit by the Research Assistant will include vital signs, weight, and an assessment of side effects using the Pittsburgh side effects scale. The blinded outcome evaluator, Dr. Harvey Singer, will administer and score the YGTSS, CGI I, DuPaul ADHD scale, CY BOCS, CDI S, and MASC. In addition, at each visit a pill count will be done to assure compliance. C. Outcomes Measures: i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity \[Leckman et al., 1989\]. This scale consists of the separate rating of severity for motor (total motor, 0 to 25) and vocal (total vocal, 0 to 25) tics. Ratings are made along 5 discriminant dimensions, on a scale of 0 to 5 for each including number, frequency, intensity, complexity, and interference. Summation of these scores (i.e., 0 to 50) provides a Total Tic Score (TTS) which will be the primary outcome measure. The YGTSS also contains a separate ranking of impairment (Tic Impairment Score or TIS), with a maximum of 50 points, based on the impact of the tic disorder on areas such as self esteem, family life, social acceptance, and school scores. Because the focus of this study is to evaluate the impact of levetiracetam and clonidine on tics and because the TIS may incorporate other components of TS, the Total Tic Score (TTS) has been selected as the primary outcome measure. ii) Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to "very much improved; @ 2 equals "much improved;" 3 denotes minimal change; and 4 represents "no change." Scores above 4 are used to indicate deterioration, i.e., 5 equals "minimally worse;" 6 is "much worse;" and 7 is "very much worse." iii) Child Yale-Brown Obsessive Compulsive Scale: The severity of OCD will be evaluated using the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) \[Scahill et al, 1997\]. Obsessions and compulsions are rated on 5 separate scales yielding three summary scores: Obsessions (0-20), Compulsions (0-20) and a Total score (0-40). The CY-BOCS is the most widely used instrument to assess the severity of obsessive-compulsive symptoms in research studies involving children. It includes a checklist of specific obsessions and compulsions followed by examiner ratings of time spent, interference, distress, resistance and control over the obsessions and compulsions assessed independently. The CY-BOCS has well established psychometric properties. iv) DuPaul ADHD Rating Scale: The presence of ADHD symptoms will be assessed using the DSM-IV version of the ADHD rating scale developed by DuPaul. This scale incorporates the symptom items for ADHD from the DSM into a rating scale format that quantifies symptom severity. Each item is rated as not at all, just a little, pretty much, and very much (0, 1, 2, and 3). This scale has been normed in large clinical and community samples and has excellent psychometric properties including a test-retest reliability over a 2-week period of 0.93 and significant correlations with direct observations of classroom behavior. v) Child Depression Inventory-Short Version (CDI-S): Depression severity will be rated by using the Child Depression Inventory-Short Version (CDI-S. This 10 item scale takes about 5 minutes to complete. It has excellent psychometric properties and is designed for repeated administrations over time. vi) Multidimensional Anxiety Scale for Children (MASC): The child's anxiety will be followed using the multidimensional Anxiety Scale for Children (MASC) and is now considered the preferred instrument for rating childhood anxiety. vii) Adverse effects: Side effects will be assessed by an expanded Pittsburgh Side Effect Scale modified to include side effects of levetiracetam and clonidine. Significant adverse events will be reported to the UCB, JCCI, and FDA within 24 hours. D. Open Label Continuation: At the completion of the study the subject will be given the option of continuing either levetiracetam or clonidine in an open labeled fashion. This will be enabled by having the subject seen by another physician who will have access to the study codes. This physician will continue to follow the subject until the entire study is completed. For members of the research team, the treatment code will not be broken until all subjects have completed the protocol. IV. Analytical Strategies A. Inclusion of a Run-in phase: The Run-in phase has been added to eliminate subjects whose treatment outcome could be influenced by a transient exacerbation of tics or by the exposure to non-pharmacologic treatment. B. Power calculations: As described, this is a pilot randomized, double-blind, placebo-controlled, cross-over project in which the investigators plan to enroll twenty patients between the ages of 7-19 years with Tourette Syndrome. Subjects with moderate to severe TS will be enrolled in this treatment protocol. Data from randomized, double-blind, placebo-controller trials of tics suggest that 6.0 points in the YGTSS total tic score is a reasonable estimate of the standard deviation of this outcome variable in the population of interest. The investigators estimate that approximately 19 subjects will provide a desired power of 0.9 to detect a difference of 4.2 points in the mean 6-week change in YGTSS total tic score between the two treatment arms, using a two-tailed t-test and a 5% level of significance. C. Statistical evaluations: The primary outcome measure is effective tic suppression as determined by the difference in Total Tic scores between treatment arms for levetiracetam and clonidine. Secondary outcome measures include the Tic Impairment Score, the Total YGTSS score, and the CGI-I. Data will be compared both as a change in absolute test score and as a percentage from baseline. Unpaired Student's t-tests will be used to compare treatment and placebo groups across all clinical variables at baseline. A paired t-test with a 95% confidence interval will be used to compare changes in outcome measures from baseline to endpoint between the two treatment groups (levetiracetam and clonidine) regardless of treatment order. Using a secondary assessment (Analysis of Variance (ANOVA) with levels within respective classes containing subjects completing study, 2 treatments, and 2 periods), the investigators will analyze each outcome measure as a two-period (days 8 to 49 or 63 to 105), two-treatment, two-sequence design with a test for the effects of treatment, first or second period, and treatment by period interaction. To evaluate the effect of levetiracetam and clonidine on blood pressure, pulse, weight, DuPaul ADHD scale, CYBOCS, CDI-S, and MASC, the investigators will conduct a series of repeated measures ANOVA to examine differences in each group across time. Statistical significance for all analyses will be set at alpha=0.05 for a two-tailed test. This protocol format has been used effectively in a prior study of baclofen and levetiracetam.	Tic Disorders Tourette Syndrome	Tics Tourette syndrome levetiracetam clonidine	null	2	arm 1: Levetiracetam (Keppra) is used in one phase of this cross-over study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase. arm 2: Clonidine is used in one phase of this cross-over study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase. intervention 2: The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.	intervention 1: Levetiracetam intervention 2: Clonidine	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	20	0	0	0	NCT00370838	1COMPLETED	2009-06-01	2007-02-01	Harvey S. Singer	7OTHER	false	false	false	null	0	0	0	0	0	0

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