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 overdose int64	METADATA_count_Incorrect dose administered int64	METADATA_wilson_lower_bound float32
[ 5 ]	80	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).	This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale. Participants' safety will be monitored throughout the study.	Pain Fibromyalgia	Pain Fibromyalgia Ultracet Tramadol Hydrochloride Acetaminophen	null	1	arm 1: Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. intervention 2: Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.	intervention 1: Tramadol hydrochloride intervention 2: Acetaminophen	0	null	80	0	0	0	NCT00766675	1COMPLETED	2009-04-01	2008-10-01	Johnson & Johnson Taiwan Ltd	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	38	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	4QUADRUPLE	false	0ALL	false	The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).	null	Bronchiectasis	bronchiectasis Phase II	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 2 x 30 mg, oral tablet, twice daily for 28 days intervention 2: 2 x Matched placebo, oral tablet, twice daily for 28 days	intervention 1: AZD9668 intervention 2: Placebo	9	Chemin Sainte-Foy \| Quebec \| Canada \| N/A \| N/A Calgary \| N/A \| Canada \| -114.08529 \| 51.05011 Montreal \| N/A \| Canada \| -73.58781 \| 45.50884 Ontario \| N/A \| Canada \| N/A \| N/A Vancouver \| N/A \| Canada \| -123.11934 \| 49.24966 Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Cambridge \| N/A \| United Kingdom \| 0.11667 \| 52.2 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Newcastle \| N/A \| United Kingdom \| -5.88979 \| 54.21804	38	0	0	0	NCT00769119	1COMPLETED	2009-04-01	2008-09-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	15	RANDOMIZED	SINGLE_GROUP	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis.	Superpotent topical corticosteroids such as clobetasol propionate are highly effective in treating plaque psoriasis but are not indicated for long term use due to their side effects. Therefore, steroid-sparing combination and sequential regimens, in which the corticosteroid gets supplemented with a non-steroid medication, such as calcipotriol or tazarotene, have become the standard of care, especially in the management of localized psoriasis lesions. A new steroid-free 15% liquor carbonis distillate (LCD) solution (Psorent) was recently found to be more successful than 0.005% calcipotriol cream (Dovonex) at improving and delaying worsening of psoriasis symptoms in a controlled clinical trial. The goal of this pilot study is to evaluate if this LCD solution can be used in combination with acute topical corticosteroid therapy as a new steroid-sparing / enhancing regimen. We hope to explore the compatibility, patient tolerability, and clinical benefit of using LCD solution during and after treatment with clobetasol propionate in adults with moderate to severe plaque psoriasis. This is a randomized, double-blind, vehicle-controlled, bilateral study. Men and women 18 years of age or older, with chronic plaque psoriasis affecting less than or equal to 10% body surface area (BSA) in areas other than the scalp, face, palms, soles, axillae, and groin, are recruited. Those with a Physician Global Assessment (PGA) score greater than 3 and are in general good health will qualify as candidates. On one side of the body, LCD solution and clobetasol propionate will be administered twice daily for the first 2 weeks of treatment, followed by 4 weeks of LCD solution only, followed by 6 weeks of no treatment. On the second half of the body, subject will apply a vehicle solution and clobetasol propionate twice daily for the first 2 weeks, only the vehicle solution twice daily for the next four weeks, and then no treatment for the next 6 weeks. Subjects will be evaluated at weeks 2, 4, 6, 8, 10 and 12. investigators will use the PGA scale \[Clear (0) - Severe (5)\] to determine treatment effects as well as Target Lesion assessments of Erythema, Scaling, Induration and overall severity \[None (0) - Very Severe (4)\]. patients will also be required to complete Self-Assessment questionnaires on their psoriasis \[None (0) - Severe (6)\]. as well as an assessment of the study solution \[Excellent (9) - Poor (1)\]. . Photographs will be taken at each study visit and adverse events will be monitored throughout the study.	Psoriasis	chronic plaque psoriasis	null	2	arm 1: corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks) arm 2: corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks)	[ 0, 2 ]	3	[ 0, 10, 0 ]	intervention 1: One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day intervention 2: One side of body: Placebo Solution: 2 applications / day along with clobetasol 2 applications/day intervention 3: One side of body: LCD Solution: 2 applications / day along with clobetasol 2 applications/day	intervention 1: Corticosteroid intervention 2: Placebo intervention 3: LCD	1	East Windsor \| New Jersey \| United States \| -74.54043 \| 40.268	30	0	0	0	NCT00769184	1COMPLETED	2009-04-01	2008-10-01	NeoStrata Company, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	60	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.	null	Healthy Asthma	Xolair Asthma Skin Tests	null	2	arm 1: Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. arm 2: Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were in SWFI. intervention 2: In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were made in saline.	intervention 1: Cohort I intervention 2: Cohort 2	0	null	60	0	0	0	NCT00777764	1COMPLETED	2009-04-01	2008-08-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	false	The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.	The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.	Healthy	Healthy volunteers	null	2	arm 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart arm 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart intervention 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart	intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine	1	North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899	56	0	0	0	NCT00789360	1COMPLETED	2009-04-01	2008-11-01	Alexza Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	2	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.	null	Fibromyalgia	fibromyalgia milnacipran Forest Laboratories	null	2	arm 1: Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. arm 2: Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Twice daily oral administration of Milnacipran for 5 weeks. intervention 2: Twice daily oral administration of placebo for 5 weeks. intervention 3: Twice daily oral administration of placebo for 5 weeks. intervention 4: Twice daily oral administration of Milnacipran for 5 weeks.	intervention 1: Milnacipran intervention 2: Placebo intervention 3: Placebo intervention 4: Milnacipran	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	2	0	0	0	NCT00793520	6TERMINATED	2009-04-01	2008-11-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	45	RANDOMIZED	FACTORIAL	null	0NONE	true	0ALL	false	To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL112775 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, fasting, HIV-negative adults after administration of a 7-day regimen of RTG 400mg BID alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/RTV 100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period	This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for pharmacokinetics (PK) sampling and a follow-up visit. The screening visit will be conducted within 30 days prior to receiving the first dose. Subjects will then be randomized into 1 of 6 treatment groups as shown below: Cohort Size Period 1 Period 2 Period 3 Sample Days 1 to 7 Days 1-14 Days 1-14 A 8 RTG 400mg BID, FPV 1400mg BID, FPV 1400mg BID + RTG 400mg BID B 8 RTG 400mg BID, FPV 1400mg BID + RTG 400mg BID , FPV 1400mg BID C 8 RTG 400mg BID, FPV 700mg BID + RTV 100mg BID, FPV 700mg BID + RTV 100mg BID + RTG 400mg BID D 8 RTG 400mg BID, FPV 700mg BID + RTV 100mg BID + RTG 400mg BID, FPV 700mg BID + RTV 100mg BID E 8 RTG 400mg BID, FPV 1400mg QD + RTV 100mg QD, FPV 1400mg QD + RTV 100mg QD + RTG 400mg BID F 8 RTG 400mg BID, FPV 1400mg QD + RTV 100mg QD + RTG 400mg BID, FPV 1400mg QD + RTV 100mg QD Study subjects will enter the clinic in the morning prior to dosing in a fasting state and remain at the center for 12 hours following each dose. Fourteen to 21 days following completion of the third dosing period, study subjects will return to the clinic for follow-up assessment. The total duration of the study will be approximately 86 days from screening through follow up. Blood samples for drug concentration measurement of amprenavir (APV) and raltegravir (RTG) concentrations will be collected over 12 hours at the end of each dosing period (at 0 \[baseline\], 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose). Subjects will undergo a physical examination, CBC with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests except those for HIV and hepatitis B/C will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period. Evaluable patients will be required to have adhered to at least 95% of their study drug doses. Plasma APV concentrations will be analyzed using a validated high-performance liquid chromatography method with tandem mass spectrometric detection (HPLC/MS/MS) and plasma RTG concentrations by triple quadruple mass spectrometry. Plasma APV and RTG pharmacokinetic parameters measured will include maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration (Cmin), and area under the concentration-time curve (AUC). All these parameters, except Tmax, will be log-transformed before statistical analysis. Analysis of variance, considering treatment as a fixed effect and subject as a random effect will be performed using Statistical Analysis Software (SAS), and assuming a treatment ratio for steady-state APV PK parameters as 1.0, the 90% confidence intervals will be within the range 0.81-1.24	Healthy	Healthy Subjects Pharmacokinetics study Pharmacokinetics of medications	null	6	arm 1: Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID arm 2: Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID arm 3: Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID arm 4: Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID arm 5: Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID arm 6: Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD	[ 1, 1, 1, 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 400mg BID intervention 2: 1400mg BID, 700 mg BID or 1400 mg QD intervention 3: 100 mg BID or QD	intervention 1: Raltegravir intervention 2: Fosamprenavir intervention 3: Ritonavir	1	Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795	41	0	0	0	NCT00802074	1COMPLETED	2009-04-01	2008-12-01	Garden State Infectious Disease Associates, PA	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	160	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Warfarin is very effective for the prevention of blood clots (thrombosis). A test of coagulation, the prothrombin time (PT) is used to monitor the effect. The PT response to warfarin can fluctuate as a result of interactions with a large number of other drugs, food or herbal agents as well as for no apparent reason. Thus, frequent monitoring of the PT and dose adjustments according to the results are required. One third of our patients remain on the same maintenance dose over 6 months. However, also these patients sometimes have a PT result moderately outside the therapeutic range without any obvious explanation. Too short PTs may be due to missed dose(s) or more dark green vegetables in the diet. Too long PTs may be due to a course of antibiotic therapy or less dark green vegetables. Laboratory errors may also occur and can cause deviations in any direction. Most likely, unnoticed fluctuations in the PT occur as well between the time points of monitoring. There are no guidelines on how to manage the treatment in this situation but there are some typical "behaviours". Behavior A: Some physicians simply let the patient continue with the same dose. "It is extremely unlikely that the very temporary dose adjustment has any effect on the PT result 4 weeks later and this is a "cosmetic procedure"." Behavior B: Others recommend the patients to take ½ - 1 additional dose in case of short PT and to skip a dose or take half dose in case of long PT, and thereafter to continue with the usual dose. "The investigators need to quickly correct the temporary aberration in order to avoid thrombotic or bleeding complications the next few days. This may seem like an issue of no importance. The investigators are however performing a series of studies to evaluate if these stable patients can be managed with blood tests less often than every 4 weeks. For that purpose it is important to know how often and why aberrant results occur, the implication and to what extent they can be ignored. The investigators hypothesis is that in patients with very stable PT-results and unchanged dose for 3 months, should continue with exactly the same maintenance dose, even when the result unexpectedly is slightly above or below the therapeutic range. The investigators believe that most of these occasional PT-results outside the therapeutic range are due to laboratory errors, perhaps missed doses by the patient or temporary change in diet or medications.	Setting: Thrombosis Service at HHS - General Hospital. This center monitors the warfarin treatment for 1300 patients in the region. These patient regularly go to a laboratory where they live. Test results (INR-results) are faxed to the Thrombosis Service, which calls the patient the same day to inform them of the results, how to continue dosing the warfarin and when to go for the following blood test.	Atrial Fibrillation Venous Thromboembolism Ischemic Stroke Myocardial Infarction	warfarin dosing prothrombin time Heart valve prosthesis	null	2	arm 1: Intervention Drug warfarin no change in the dose is performed arm 2: Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: No change: Continue without any change in spite of prothrombin time outside the therapeutic range. intervention 2: Change: Increase one dose in case prothrombin time is below the therapeutic range; delete or reduce one dose in case prothrombin time is above the therapeutic range.	intervention 1: warfarin intervention 2: warfarin	1	Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011	160	0	0	0	NCT00814177	1COMPLETED	2009-04-01	2006-07-01	Hamilton Health Sciences Corporation	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.	null	Glaucoma, Open-Angle Ocular Hypertension		null	3	arm 1: device worn continuously for 14 days arm 2: device worn continuously for 14 days arm 3: device worn continuously for 14 days	[ 0, 0, 2 ]	3	[ 0, 0, 1 ]	intervention 1: inserted for 14 days intervention 2: inserted for 14 days intervention 3: inserted for 14 days	intervention 1: High Dose Device intervention 2: Low Dose Device intervention 3: Placebo Device	4	Artesia \| California \| United States \| -118.08312 \| 33.86585 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407	51	0	0	0	NCT00824720	1COMPLETED	2009-04-01	2008-12-01	Vistakon Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	78	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.	null	Pediculus Humanus Capitis (Head Lice)	head lice Pediculus humanus capitis ivermectin	null	4	arm 1: Participant on 0.15% ivermectin treatment conditioner arm 2: Participants on 0.25% ivermectin treatment conditioner arm 3: Participants on 0.50% ivermectin treatment conditioner arm 4: participants on Placebo (Vehicle control)	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Application followed by thorough rinsing of the hair and scalp with water. intervention 2: Application followed by thorough rinsing of the hair and scalp with water.	intervention 1: ivermectin treatment conditioner intervention 2: Placebo, vehicle control	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	78	0	0	0	NCT00857948	1COMPLETED	2009-04-01	2009-03-01	Topaz Pharmaceuticals Inc	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	277	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. This suggests that memantine treatment in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.	The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). The study also included secondary imaging, cognitive and behavioural measures.	Alzheimer's Disease	Memantine Neuroimaging MRI Brain atrophy	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 10 mg tablets twice daily intervention 2: Tablets twice daily	intervention 1: Memantine intervention 2: Placebo	0	null	277	0	0	0	NCT00862940	1COMPLETED	2009-04-01	2005-09-01	H. Lundbeck A/S	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	156	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.	null	Pain	propofol lidocaine injection pain	null	3	arm 1: Saline pretreatment, saline admixture arm 2: Lidocaine pretreatment / saline-propofol admixture arm 3: saline pretreatment / Lidocaine-propofol admixture	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 3.3 mL normal saline intervention 2: lidocaine 50 mg plus propofol 50 mg intravenous (iv) intervention 3: lidocaine 50 mg iv under tourniquet-control	intervention 1: Saline intervention 2: Lidocaine / propofol admixture intervention 3: lidocaine pretreatment	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	156	0	0	0	NCT00864682	1COMPLETED	2009-04-01	2008-01-01	Benaroya Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This is an open label single arm feasibility trial. A combination of two oral agents (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be administered at doses and schedule currently applied in pediatrics. These agents all target farnesylation pathways at different points. Our goal is to inhibit farnesylation of abnormal lamin, the disease-causing protein in Hutchinson-Gilford Progeria Syndrome and progeroid laminopathies (henceforth "progeria"). The drugs will include the intravenous bisphosphonate zoledronic acid, oral HMG co-reductase inhibitor pravastatin and the oral farnesyltransferase inhibitor (FTI) lonafarnib (SCH 66336). Patients with genetically confirmed progeria will be eligible for this protocol. Treatment will be initiated for 4 weeks duration and may be extended depending on tolerability. This study will assess the feasibility of this treatment regimen in the first 4 weeks. If tolerated for 4 weeks, patients can be treated with this regimen for up to 6 months.	Progerias are rare "premature aging" diseases in which children die of severe atherosclerosis leading to strokes and heart attacks. It is a multisystem disease with objective clinical markers for disease progression. These include abnormalities in growth and body composition, bone mineral density, join function, endocrine function, alopecia, and vascular disease. There is currently no therapy proven effective for any of the progressive and deleterious aspects of this disorder. Progeria is caused by a gene defect in the gene LMNA, coding for the nuclear protein lamin A. Lamin A is normally expressed by most differentiated cells, and requires posttranslational farnesylation to incorporate into the nuclear membrane. This trial proposes to use three agents (zoledronic acid, pravastatin, and lonafarnib) to inhibit farnesylation of abnormal lamin, the disease causing protein in Progeria. The primary objective of this study is to evaluate the feasibility of administering intravenous zoledronic acid, oral pravastatin and oral lonafarnib, to patients wtih Progeria for a minimum of 4 weeks.	Progeria Hutchinson-Gilford Syndrome	Hutchinson-Gilford Progeria Syndrome HGPS Progeria FTI Farnesyltransferase Inhibitor Lonafarnib Zoledronic Acid Pravastatin	null	1	arm 1: Lonafarnib;Zoledronic acid;Pravastatin	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy interruption or supportive care measures will be dose reduced by one dose level. intervention 2: Zoledronic acid will be administered intravenously at week one of this treatment trial. Week one administration will consist of one infusion over a 30 minute period, 0.0125 mg/kg body weight. intervention 3: Pravastatin will begin at 5 mg by mouth once daily for children weighing less than 10 kg, and 10 mg by mouth once daily for children weighing 10 kg or greater.	intervention 1: Lonafarnib intervention 2: Zoledronic Acid intervention 3: Pravastatin	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	5	0	0	0	NCT00879034	1COMPLETED	2009-04-01	2009-03-01	Boston Children's Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	102	RANDOMIZED	SINGLE_GROUP	0TREATMENT	4QUADRUPLE	true	0ALL	true	Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions (3). Spine surgery provides a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid consumption in patients with chronic pain. The goal of this double blinded, prospective, randomized placebo controlled trial is to quantify the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to postoperative opioid use.	Noxious stimuli occurring intra-operatively and post-operatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors that have been implicated in the prolongation of painful states in animal models. The N-methyl-d-aspartate (NMDA) receptor is one such excitatory amino acid receptor (1, 2). The underlying mechanism of central sensitization is thought to involve c-fiber associated injury occurring with incision. Crile and Wall brought about the concept that attenuation of central sensitization could be accomplished via the provision of analgesic interventions (opioids, local anesthesia) prior to the noxious insult. They termed the central sensitization attenuation preemptive analgesia. The concept of preemptive analgesia was later expanded to implicate both pre and post-incisional noxious stimuli as part of this process, resulting in studies designed to provide interventions throughout the surgical intervention (peri-procedural) (3). Reduction in analgesic requirements or pain scores for more than five half-lives (1st order kinetics) following the provision of the intervening analgesic agent peri-procedurally is now known as preventative analgesia. The term preemptive analgesia is now reserved for interventions that occur only before the noxious stimuli. Multiple studies have investigated the concepts of preemptive analgesia and preventative analgesia by providing a variety of analgesic interventions at various times throughout the surgical insult in addition to more conventional means of anesthesia provision, including opioids, Non-Steroidal Anti-Inflammatory Drugs (NSAID)s, Cyclooxygenase-II (COX-2) inhibitors, alpha-2 agonists, and ketamine (4, 5, 6). Preemptive and preventative analgesia using a variety of pharmacological agents with at least partially known mechanisms of actions has provided some insight into potential mechanisms of central sensitization. Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions with variable routes of administration. It has also been shown to be effective in the presence and absence of opioids, suggesting that it has more than one mechanism of action in preemptive and preventative analgesia, including but not limited to decreasing central excitability, decreasing acute post-operative opioid tolerance, and a possible modulation of opioid receptors (7). Ketamine is a common anesthetic agent and has been in use since the Vietnam War. Clinically, ketamine provides pain relief with minimal respiratory depression, and at higher doses (1-2mg/kg) can induce general anesthesia while maintaining blood pressure and cardiac output. Recently, a qualitative systematic review of the role of NMDA receptor antagonists was completed. Twenty-four studies investigating the role of ketamine met the inclusion criteria of the study, 58% of which demonstrated a preemptive or preventative analgesic effect. Patients underwent a variety of surgical procedures, both ambulatory and inpatient, and there was no obvious effect of either surgical type or dose of ketamine (range 0.15 to 1mg/kg) on the success of preventative intervention. However, the authors were unable to quantify the degree of reduction in primary end-points (opioid consumption, pain scores, both) due to variability in recording of such data. In addition, most inpatient studies were limited to abdominal procedures while the outpatient studies investigated mainly knee arthroscopies, providing no insight into the degree of impact of NMDA receptor antagonism in the setting of high pre-operative opioid tolerance combined with surgical procedures known to be associated with an invariably high degree of post-operative pain. Of note, only 1/24 studies documented a significant difference in side effects related to ketamine provision in patients who had received 20mg of epidural ketamine (7). Laminectomy procedures provide a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of acute post-operative pain scores and opioid consumption in a patient population with opioid dependence and a high degree of post-operative and intra-operative noxious stimuli. The goal of this double blinded, randomized placebo controlled trial will be to test for the presence of, and quantify, the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to post-operative opioid use including but not limited to respiratory depression, constipation, and delirium.	Chronic Low Back Pain	chronic pain back surgery opioid dependent NMDA receptor antagonism Ketamine Central sensitization	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 10 ]	intervention 1: Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure intervention 2: Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).	intervention 1: Ketamine intervention 2: Normal saline	1	Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229	102	0	0	0	NCT00899600	1COMPLETED	2009-04-01	2007-02-01	Dartmouth-Hitchcock Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	101	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.	The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.	Osteoarthritis, Knee	periarticular multimodal drug injection	null	2	arm 1: Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime arm 2: usual postoperative care without periarticular injection	[ 0, 4 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 300mg (0.75%, 40cc) intraoperative periarticular injection intervention 2: 10mg intraoperative periarticular injection intervention 3: 30 mg intraoperative periarticular injection intervention 4: 300 microgram (1:1000) intraoperative periarticular injection intervention 5: 750mg intraoperative periarticular injection	intervention 1: ropivacaine intervention 2: morphine sulfate intervention 3: ketorolac intervention 4: epinephrine intervention 5: cefuroxime	1	Seongnam-si \| Gyeonggi-do \| South Korea \| 127.13778 \| 37.43861	101	0	0	0	NCT00901628	1COMPLETED	2009-04-01	2008-04-01	Seoul National University Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	46	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing of the progression of atherosclerotic disease (measured by carotid intima media thickness \[CIMT\]).	Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot urine sample were entered into a one to three month run-in phase before randomization. (50 mg/g was used as the lower limit to allow room for improvement to reach normal.) Since hypertension and uncontrolled hyperglycemia will cause MA, blood pressure (BP) and hemoglobin A1c (AIC) levels were reduced to \<130/80 mm Hg and \<8.0%, respectively, during this period. All patients had been on various doses of an angiotensin converting enzyme inhibitor (ACE-I) which were reduced to 10 mg benazepril and BP controlled with other classes of anti-hypertensive drugs (except for angiotensin receptor blockers \[ARB's\]). Glycemia was treated with intensification of their current therapy. MA and BP were measured monthly. When goal levels of BP and AIC were achieved and MA was still present, patients were randomized to either low dose RAS inhibition (10 mg benazepril) (Standard) or aggressive inhibition of the RAS (Aggressive). MA continued to be measured monthly and the progressive increase in doses of an ACE-I and an ARB was as follows. Benazepril (the ACE-I) - 10 mg to 20 mg to 40 mg to adding losartan (the ARB) -25 mg to 50 mg to 100 mg to increasing benazepril to 80 mg with the goal of returning albumin excretion to normal. Other classes of drugs were reduced as necessary to keep systolic BP \> 100 mm Hg. Serum creatinine and potassium\[K+\] were measured monthly, AIC levels every 3 months and CIMT by ultrasound and endothelial function by post hyperemia and nitroglycerine (NTG) - induced peripheral artery tonometry (PAT) via finger plethysmography every six months.	Microalbuminuria	Microalbuminuria Carotid intima media thickness Endothelial dysfunction Renin angiotensin system Diabetic nephropathy	null	2	arm 1: Standard low dose inhibition of the RAS with 10 mg of benazepril orally daily to treat microalbuminuria arm 2: 40-80 mg benazepril plus 25-100 mg losartan both orally once or twice daily	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: benazepril 10 mg orally once daily intervention 2: 40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily	intervention 1: benazepril intervention 2: benazepril	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	27	0	0	0	NCT00907374	1COMPLETED	2009-04-01	2005-07-01	Charles Drew University of Medicine and Science	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	462	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.	A nationwide, multicenter, double-blind, vehicle-controlled parallel group comparison study of a Generic Imiquimod cream, 5% (Actavis Mid-Atlantic LLC) and currently marketed Aldara (imiquimod) cream, 5% (distributed by Graceway Pharmaceuticals, LLC) was conducted in subjects with actinic keratoses (AKs) on the face and/or anterior scalp in order to evaluate the therapeutic equivalence of these two active treatments and to establish superiority of the efficacy of these two products over a Vehicle cream. Subjects were randomized to one of three treatment groups on a 2:2:1 basis as follows: (1) Generic Imiquimod cream, 5%, (2) Aldara (imiquimod) cream, 5%, and (3) Vehicle cream. The duration of treatment was 16 weeks (± 7 days). The primary efficacy endpoint was the proportion of subjects in each treatment group with Complete Clearance (having no clinically visible actinic keratosis lesions in the 25 cm2 contiguous treatment area at the 8-week post-treatment visit) of AK lesions. The secondary efficacy endpoints were the Partial Clearance rates, defined as the proportion of subjects with at least a 75% reduction in the number of AK lesions counted at Baseline at the end-of-treatment visit (Week 16, EOT) and at the 8 weeks post-treatment visit/test-of-cure (Week 24, TOC), and the proportion of subjects with Complete Clearance of AK lesions at the end-of-treatment (Week 16, EOT) visit. A 90% Wald's confidence interval with Yate's continuity correction was constructed around the difference between the proportions of subjects with Complete Clearance of AK lesions in the active treatments (Generic Imiquimod minus Aldara) to evaluate therapeutic equivalence in the primary efficacy analyses. Two-sided, continuity-corrected statistics were used to evaluate the superiority of each active treatment's Complete Clearance rate over that of the Vehicle treatment. The therapeutic comparability evaluations in the per-protocol (PP) population were considered primary while those in the intent-to-treat (ITT) population were considered supportive. The superiority comparisons in the ITT population were considered primary while those in the PP population were considered supportive. If the 90% confidence interval (CI) around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval 0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent. Secondary efficacy analyses were conducted on the proportion of subjects in each treatment group with Complete Clearance of AK lesions at the Week 16, EOT visit as well as evaluation of the Partial Clearance of AK lesions at both the EOT and TOC visits. The results at both the EOT visit (Week 16) and those at 8 weeks post-treatment (Week 24, TOC) were statistically analyzed by the same methods described for the primary efficacy variable. Both EOT and TOC analyses were conducted in the ITT population. The TOC analysis was conducted in the PP population and the EOT analysis was conducted in the EOT PP population.	Actinic Keratoses	actinic keratoses imiquimod therapeutic equivalence bioequivalence	null	3	arm 1: imiquimod cream, 5% arm 2: Aldara™ (imiquimod) cream, 5% arm 3: Vehicle cream (Actavis)	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks intervention 2: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks intervention 3: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks	intervention 1: imiquimod intervention 2: Aldara™ intervention 3: Vehicle Cream	20	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Fresno \| California \| United States \| -119.77237 \| 36.74773 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Newnan \| Georgia \| United States \| -84.79966 \| 33.38067 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 New York \| New York \| United States \| -74.00597 \| 40.71427 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 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 Spokane \| Washington \| United States \| -117.42908 \| 47.65966	449	0	0	0	NCT00948428	1COMPLETED	2009-04-01	2008-05-01	Actavis Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	24	NON_RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.	Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. Twenty-four healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 will be given one dose of colchicine (1 x 0.6 mg tablet) on Day 1, after an overnight fast. Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose to adequately define the baseline pharmacokinetics of colchicine. After a 14 day washout period, starting on the morning of Day 15 and continuing through Day 17, subjects will return to the clinic for consumption of an administered 240 ml dose of Seville orange juice in the morning and evening. At 8am on Day 18 after an overnight fast, all subjects will receive a co-administered single oral dose of colchicine (1 x 0.6 mg) and Seville orange juice (1 x 240 ml). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose to adequately define the pharmacokinetics of colchicine in the presence of Seville orange juice. Subjects will consume the final administered 240 ml dose of Seville orange juice in the evening on Day 18. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to dosing and at approximately 1, 2, and 3 hours following drug administration on Days 1 and 18 to coincide with peak plasma concentrations of colchicine. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	Healthy	blood levels over time colchicine seville orange juice pharmacokinetics	null	2	arm 1: baseline colchicine pharmacokinetics arm 2: colchicine pharmacokinetics in presence of Seville orange juice	[ 1, 0 ]	2	[ 0, 10 ]	intervention 1: A single dose of 0.6 mg colchicine administered alone in the morning on Day 1 and a single dose of 0.6 mg colchicine administered with Seville orange juice in the morning on Day 18 after an overnight fast of at least 10 hours. intervention 2: 240 mL of Seville orange juice administered in the morning and evening on Days 15 to 18.	intervention 1: Colchicine intervention 2: Seville Orange Juice	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	70	0	0	0	NCT00960193	1COMPLETED	2009-04-01	2009-02-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	133	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) \>3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the mean time to improve the overall cycle outcome.	Recombinant human follicle stimulating hormone (r-hFSH), which totally lacks LH activity, is widely used to induce multiple follicle development in women under pituitary desensitization, in order to submit them to treatment with assisted reproduction techniques (ART). Clinical experience from hypogonadotropic-hypogonadic women suggests that while FSH alone is sufficient to induce follicle development, LH plays a significant part in final follicle maturation, estrogen synthesis and optimal endometrium growth. This was a phase III, multicentre, randomized, open-label comparative study to evaluate if the addition of r-hLH (Luveris) in a 2:1 ratio to FSH from day 8 of ovarian stimulation is able to decrease the total FSH dose and to improve cycle outcome in 250 infertile women undergoing ART, who required high FSH dose in a previous cycle (≥ 3500 IU). Subjects who have met all the inclusion criteria, achieved pituitary desensitization and started controlled ovarian hyperstimulation (COH) treatment with FSH, on stimulation day 8 (S8) received an identification number and will be allocated to one of the two following arms: Arm : FSH + r-hLH (2:1 ratio of FSH:r-hLH), Arm : FSH alone. Treatment with Luveris was commenced on day 8 (S8) and continued until injection of hCG or cancellation of the treatment cycle. Monitoring of stimulation, FSH dose escalation, criteria for injection of hCG, ovum pick up, embryo transfer and pregnancy confirmation took place according to standard management practice. The in-vitro fertilization (IVF) or intracytosolic sperm injection (ICSI) procedure, including luteal phase support, was performed according to each centres' normal procedures. The subjects were followed up and the treatment outcome (menstruation or pregnancy) was recorded. The delivery outcome for any pregnant subjects was recorded in the Case Report Form (CRF). Information on the delivery outcome for each pregnancy was collected. Information on adverse events was collected during the study period. OBJECTIVES The primary objective of the study was: To determine whether the addition of r-hLH (Luveris) from day 8 of ovarian stimulation reduces the FSH dose needed to obtain/retrieve each oocyte. The secondary objectives of the study were: * To determine whether the addition of Luveris to FSH at day 8 of ovarian stimulation improves cycle outcome based on secondary endpoints * To determine the safety of Luveris in this indication	Reproductive Techniques, Assisted	Reproductive Techniques, Assisted Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH)	null	2	arm 1: Subjects treated with r-hFSH and r-hLH (2:1 ratio of r-hFSH:r-hLH) arm 2: Subjects treated with r-hFSH alone	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: One r-hFSH and one r-hLH injection subcutaneously (s.c.) once daily during the treatment phase from Day 8 of stimulation until injection of human chorionic gonadotropin (hCG) or cancellation of the treatment cycle. intervention 2: One r-hFSH injection s.c. once daily during the treatment phase from Day 8 of stimulation until injection of hCG or cancellation of the treatment cycle.	intervention 1: Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH) intervention 2: r-hFSH	1	Roma \| N/A \| Italy \| 11.10642 \| 44.99364	133	0	0	0	NCT01071200	6TERMINATED	2009-04-01	2005-03-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	40	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.	This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.	Tobacco Dependence	Smoking Cessation, Nicotine pharmacokinetics	null	5	arm 1: 2 Self-administrations of Experimental Nicotine once every hour arm 2: 2 administrations of Experimental Nicotine by study personnel once every hour arm 3: 2 administrations of Experimental Nicotine by study personnel once every 30 minutes arm 4: 1 NiQuitin™ lozenge, administered by study personnel once every hour arm 5: 1 piece Nicorette® gum, chewed for 30 minutes once every hour	[ 0, 0, 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Oral Nicotine either self-administered or provided by study personnel within 12 hours intervention 2: Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours intervention 3: Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours	intervention 1: Oral Nicotine intervention 2: Nicotine Lozenge intervention 3: Nicotine gum	1	Lund \| N/A \| Sweden \| 13.19321 \| 55.70584	183	0	0	0	NCT01084707	1COMPLETED	2009-04-01	2009-01-01	McNeil AB	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	214	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare the response between GHD children born appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4 weeks of Saizen therapy.	The response to growth hormone (GH) treatment, short-term as well as long-term, displays considerable inter individual variability. This is particularly evident for the endpoint of paediatric GH administration, that is (i.e.) the growth response, which is pronounced in children who are affected by GHD. This is an open-label, multicentric study in which subjects pre-diagnosed with GHD were treated for 4 weeks with Saizen. Two hundred fourteen GHD evaluable pre-pubertal subjects were planned to be recruited in approximately 9 sites in China. Demographic data, medical history, tanner stage, physical examination, body weight, height, bone age measurement, body mass index, review of baseline medications and procedures and blood sampling were performed at baseline visit, end of treatment visit (week 4) and at 4 week follow-up visit. OBJECTIVES Primary objective: * To compare the response between GHD children born AGA and those born SGA after 4 weeks of Saizen therapy Secondary Objectives: * To explore the contribution of selected genes to the phenotype of GHD children * To explore the impact of gene polymorphisms on the levels of specific serum biomarkers in GHD children after 4 weeks of Saizen therapy * To explore the relationships between changes in gene expression and changes in serum biomarkers after 4 weeks of Saizen therapy and the spectrum of gene polymorphisms in GHD children	Dwarfism, Pituitary	Dwarfism, pituitary Growth hormone	null	0	null	null	1	[ 0 ]	intervention 1: Recombinant human growth hormone (r-hGH) administered at dose of 0.033 milligram/kilogram (mg/kg) body weight (0.1 International Unit \[IU\]/kg body weight) per day by subcutaneous injection.	intervention 1: Recombinant human growth hormone (r-hGH)	0	null	205	0	0	0	NCT01187550	1COMPLETED	2009-04-01	2007-03-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	52	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.	The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body. We will look for these cells using a number of laboratory tests; It will require the subjects to each give 65mL of blood at each of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to participate in phase 2 depending on lab results. In phase 2, subjects will be randomized to one of the three following groups: Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group) Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be continued at the same dosage. Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued at the same dosage. There will be an analysis of these cells at different time point, pre and post kidney transplant. The data collection will allow us to study the stability over time of particular phenotypes (cell structures) and T cell function. We will also evaluate how the two different "minimizing protocols" effect the cell structure. Results from laboratory testing may allow us to define certain criteria that can be broadly applied in solid organ transplant recipients. This may allow for safe reduction of the anti-rejection medication that transplant recipients receive.	Kidney Transplant		null	1	arm 1: During Phase I Portion: Each kidney transplant recipient received one 30mg dose (IV push)of Alemtuzmab in the operating room per Standard of Care.	[ 0 ]	1	[ 0 ]	intervention 1: All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.	intervention 1: Alemtuzumab	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	51	0	0	0	NCT01213329	6TERMINATED	2009-04-01	2006-02-01	Northwestern University	7OTHER	false	false	false	null	0	0	0	0
[ 3, 4 ]	312	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.	Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite treatment with an sulfonylurea as well as diet and exercise therapies.	Type 2 Diabetes Mellitus	Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 3: Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.	intervention 1: Alogliptin and glimepiride intervention 2: Alogliptin and glimepiride intervention 3: Glimepiride	0	null	312	0	0	0	NCT01318083	1COMPLETED	2009-04-01	2008-08-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	288	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.	Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.	Type 2 Diabetes Mellitus	Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. intervention 3: Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.	intervention 1: Alogliptin and metformin intervention 2: Alogliptin and metformin intervention 3: Metformin	0	null	288	0	0	0	NCT01318109	1COMPLETED	2009-04-01	2008-08-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	66	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	2MALE	false	The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.	null	Intraepithelial Prostatic Neoplasia Prostatic Neoplasms	Intraepithelial Prostatic Neoplasia Prostatic neoplasms Male urogenital disease Prostate	null	2	arm 1: Lycopene 30 mg/day arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Lycopene 30 mg. intervention 2: Placebo	intervention 1: Lycopene 30mg intervention 2: Placebo	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	58	0	0	0	NCT01443026	1COMPLETED	2009-04-01	2006-02-01	University of Illinois at Chicago	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	64	RANDOMIZED	FACTORIAL	0TREATMENT	2DOUBLE	true	2MALE	false	The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.	Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.	Parkinson Disease	BIA 9-1067	null	9	arm 1: BIA 9-1067 (Opicapone, OPC) - 10 mg arm 2: BIA 9-1067 (Opicapone, OPC) - 25 mg arm 3: BIA 9-1067 (Opicapone, OPC) - 50 mg arm 4: BIA 9-1067 (Opicapone, OPC) - 100 mg arm 5: BIA 9-1067 (Opicapone, OPC) - 200 mg arm 6: BIA 9-1067 (Opicapone, OPC) - 400 mg arm 7: BIA 9-1067 (Opicapone, OPC) - 800 mg arm 8: BIA 9-1067 (Opicapone, OPC) - 1200 mg arm 9: Placebo (PLC): single-dose	[ 0, 0, 0, 0, 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects intervention 2: single-dose	intervention 1: BIA 9-1067 intervention 2: Placebo	1	Rennes \| N/A \| France \| -1.67429 \| 48.11198	64	0	0	0	NCT01520727	1COMPLETED	2009-04-01	2007-10-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2, 3 ]	41	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was preceded with an open-label investigation in a small group of patients (n=5) treated with two applications of DPK-060 1% ointment per day for four days to assess safety, local tolerability and systemic absorption of DPK-060. The secondary objectives were to evaluate severity of eczema and pruritus, to assess the tolerability and safety of the treatment and to assess the degree of systemic absorption of DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.	null	Atopic Dermatitis		null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 intervention 2: Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2	intervention 1: DPK-060 1% ointment intervention 2: Placebo for DPK-060 ointment	1	Luleå \| N/A \| Sweden \| 22.15465 \| 65.58415	41	0	0	0	NCT01522391	1COMPLETED	2009-04-01	2008-03-01	DermaGen AB	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	25	NON_RANDOMIZED	SINGLE_GROUP	2DIAGNOSTIC	1SINGLE	true	0ALL	false	This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).	null	Alzheimer's Disease	Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging	null	3	arm 1: Two bolus IV injections followed by brain PET scan up to 4 weeks apart arm 2: Two bolus IV injections followed by a brain PET scan up to 4 weeks apart. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). arm 3: Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: IV injection, 370MBq (10mCi)	intervention 1: florbetapir F 18	4	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Hallandale \| Florida \| United States \| -80.14838 \| 25.9812 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 North East \| Maryland \| United States \| -75.94133 \| 39.60011	25	0	0	0	NCT01565343	1COMPLETED	2009-04-01	2008-04-01	Avid Radiopharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	353	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.	This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.	Schizophrenia	Schizophrenia Paliperidone Extended Release (ER)	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.	intervention 1: Paliperidone ER	0	null	353	0	0	0	NCT01577160	1COMPLETED	2009-04-01	2008-05-01	Johnson & Johnson Taiwan Ltd	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 2 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.	null	Dentinal Hypersensitivity Dental Pain	dentinal sensitivity potassium nitrate dental pain	null	3	arm 1: Participants to receive 250 microlitres (μL) of sterile water. arm 2: Participants to receive 250 μL of potassium nitrate 5% solution. arm 3: Participants to receive 250 μL of potassium nitrate 2.5% solution.	[ 2, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 250 μL of Potassium nitrate solution (either 5% or 2.5%) intervention 2: Sterile Water	intervention 1: Potassium Nitrate intervention 2: Placebo	1	Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306	12	0	0	0	NCT01587950	1COMPLETED	2009-04-01	2009-02-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).	This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.	Osteoarthritis	Osteoarthritis Transdermal Therapeutic System (TTS)-fentanyl Durogesic	null	1	arm 1: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.	[ 0 ]	1	[ 0 ]	intervention 1: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.	intervention 1: TTS-fentanyl	1	Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398	35	0	0	0	NCT01774929	1COMPLETED	2009-04-01	2008-10-01	Janssen-Cilag Ltd.,Thailand	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	5	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	To determine the efficacy of escitalopram in treating depression in HIV seropositive women.	To determine the efficacy of escitalopram in treating depression in HIV seropositive women.	Depression HIV	Depression HIV	null	2	arm 1: Placebo arm 2: Escitalopram tablet, 10mg, daily, 9 weeks.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Placebo daily for duration of double-blind portion of trial intervention 2: Escitalopram 10 mg po daily for duration of double-blind portion of trial	intervention 1: Placebo intervention 2: Escitalopram	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	0	0	0	0	NCT01797380	6TERMINATED	2009-04-01	2008-01-01	Duke University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II patients were recruited for a randomised, placebo-controlled, double-blind study and were randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B; n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30). Scalp block was performed 5 min before head pinning. The primary outcome of the study was mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain was evaluated using a 10-cm visual analogue scale (VAS).	Following approval from the Research Ethics Committee of the Medical Faculty of Uludağ University, (the date and protocol number assigned by this ethics committee were March 4, 2008 and 5/30, respectively),written informed consent was obtained from patients undergoing elective scheduled operations involving craniotomy during anaesthesia consultations. Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I or II patients of either sex between 18-85 years of age were allocated to this randomised, prospective, placebo-controlled, double-blind study. The patients were randomly divided into three groups using a sealed-enveloped technique to receive either 20 ml of 0.5% bupivacaine (Group B (n=30)), 20 ml of 0.5% levobupivacaine (Group L (n=30)) or saline as a placebo (Group C (n=30)). Twenty-millilitre syringes for the block were prepared and numbered by a blinded assistant.	Hypertension	anaesthesia local anaesthesia hemodynamics bupivacaine levobupivacaine	null	3	arm 1: 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine arm 2: 20 ml of 0.5% levobupivacaine saline as a placebo arm 3: 20 ml of 0.5% bupivacaine saline as a placebo	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: local injection intervention 2: local injection intervention 3: local injection	intervention 1: Levobupivacaine intervention 2: Bupivacaine intervention 3: placebo	0	null	90	0	0	0	NCT02497040	1COMPLETED	2009-04-01	2008-03-01	Uludag University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	89	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (\>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.	null	Multiple Myeloma		null	2	arm 1: Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks. arm 2: Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks. intervention 2: Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.	intervention 1: Ibandronate intervention 2: Zoledronate	56	Ansbach \| N/A \| Germany \| 10.5931 \| 49.30481 Aschaffenburg \| N/A \| Germany \| 9.15214 \| 49.97704 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bremen \| N/A \| Germany \| 8.80717 \| 53.07582 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Duisburg \| N/A \| Germany \| 6.76516 \| 51.43247 Duisburg \| N/A \| Germany \| 6.76516 \| 51.43247 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Esslingen am Neckar \| N/A \| Germany \| 9.30473 \| 48.73961 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Göttingen \| N/A \| Germany \| 9.93228 \| 51.53443 Greifswald \| N/A \| Germany \| 13.40244 \| 54.08905 Güstrow \| N/A \| Germany \| 12.17337 \| 53.7972 Gütersloh \| N/A \| Germany \| 8.37853 \| 51.90693 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamm \| N/A \| Germany \| 7.82089 \| 51.68033 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Herne \| N/A \| Germany \| 7.22572 \| 51.5388 Hof \| N/A \| Germany \| 11.91261 \| 50.31297 Jena \| N/A \| Germany \| 11.5899 \| 50.92878 Karlsruhe \| N/A \| Germany \| 8.40444 \| 49.00937 Kassel \| N/A \| Germany \| 9.5 \| 51.31667 Kassel \| N/A \| Germany \| 9.5 \| 51.31667 Koblenz \| N/A \| Germany \| 7.57883 \| 50.35357 Krefeld \| N/A \| Germany \| 6.55381 \| 51.33645 Leer \| N/A \| Germany \| 7.461 \| 53.23157 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Ludwigshafen \| N/A \| Germany \| 9.06138 \| 47.81663 Lübeck \| N/A \| Germany \| 10.68729 \| 53.86893 Magedburg \| N/A \| Germany \| N/A \| N/A Minden \| N/A \| Germany \| 8.91455 \| 52.28953 Moers \| N/A \| Germany \| 6.6326 \| 51.45342 Mülheim \| N/A \| Germany \| 6.87967 \| 51.43218 München \| N/A \| Germany \| 13.31243 \| 51.60698 Münster \| N/A \| Germany \| 7.62571 \| 51.96236 Neumünster \| N/A \| Germany \| 9.98456 \| 54.07399 Offenbach \| N/A \| Germany \| 8.76647 \| 50.10061 Offenburg \| N/A \| Germany \| 7.94495 \| 48.47377 Oldenburg \| N/A \| Germany \| 8.21467 \| 53.14118 Oldenburg \| N/A \| Germany \| 8.21467 \| 53.14118 Stuttgart \| N/A \| Germany \| 9.17702 \| 48.78232 Stuttgart \| N/A \| Germany \| 9.17702 \| 48.78232 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Weiden \| N/A \| Germany \| 12.15613 \| 49.67682 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391 Zwickau \| N/A \| Germany \| 12.48839 \| 50.72724	89	0	0	0	NCT02739594	6TERMINATED	2009-04-01	2006-02-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	314	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.	null	Attention Deficit Hyperactivity Disorder (ADHD)		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. intervention 2: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. intervention 3: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. intervention 4: Placebo will be identical to test product.	intervention 1: LDX 30 mg intervention 2: LDX 50 mg intervention 3: LDX 70 mg intervention 4: Placebo	45	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 El Centro \| California \| United States \| -115.56305 \| 32.792 Rolling Hills Estates \| California \| United States \| -118.35813 \| 33.78779 San Diego \| California \| United States \| -117.16472 \| 32.71571 Wildomar \| California \| United States \| -117.28004 \| 33.59891 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Hialeah \| Florida \| United States \| -80.27811 \| 25.8576 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Libertyville \| Illinois \| United States \| -87.95313 \| 42.28308 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Newton \| Kansas \| United States \| -97.34504 \| 38.04668 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Owensboro \| Kentucky \| United States \| -87.11333 \| 37.77422 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Toms River \| New Jersey \| United States \| -74.19792 \| 39.95373 Mount Kisco \| New York \| United States \| -73.72708 \| 41.20426 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Salem \| Oregon \| United States \| -123.0351 \| 44.9429 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 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 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Woodstock \| Vermont \| United States \| -72.51843 \| 43.62424 Herndon \| Virginia \| United States \| -77.3861 \| 38.96955 Midlothian \| Virginia \| United States \| -77.64916 \| 37.50598 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038	310	0	0	0	NCT00735371	1COMPLETED	2009-04-06	2008-10-08	Shire	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	270	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.	null	Atopic Dermatitis	Atopic Dermatitis SUN13834	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Low dose, orally 3 times a day (tid) for 28 days of SUN13834 intervention 2: Placebo, orally (tid) for 28 days of SUN13834	intervention 1: SUN13834 intervention 2: Placebo	28	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Ormond Beach \| Florida \| United States \| -81.05589 \| 29.28581 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Clinton Township \| Michigan \| United States \| -82.91992 \| 42.58698 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Sylvania \| Ohio \| United States \| -83.71299 \| 41.71894 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Johnston \| Rhode Island \| United States \| -71.50675 \| 41.82186 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 College Station \| Texas \| United States \| -96.33441 \| 30.62798 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Draper \| Utah \| United States \| -111.86382 \| 40.52467 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Spokane \| Washington \| United States \| -117.42908 \| 47.65966	270	0	0	0	NCT00717769	1COMPLETED	2009-04-09	2008-07-16	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	343	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	To demonstrate the efficacy/safety of Fosamax Plus D	null	Osteoporosis Postmenopausal		null	2	arm 1: Alendronate sodium/Cholecalciferol arm 2: Alendronate sodium	[ 0, 1 ]	3	[ 0, 0, 7 ]	intervention 1: Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks intervention 2: Alendronate sodium; tablet, once weekly, for 16 weeks intervention 3: 500 mg oral tablet calcium once daily, for 16 weeks	intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: Alendronate sodium (Fosamax) intervention 3: Comparator: Calcium	0	null	341	0	0	0	NCT00729651	1COMPLETED	2009-04-10	2008-03-20	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	710	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	false	This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.	null	Nausea and Vomiting, Chemotherapy-Induced	vomiting colorectal cancer nausea oxaliplatin	null	2	arm 1: Placebo + standard antiemetics arm 2: Casopitant + standard antiemetics	[ 2, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Experimental NK-1 receptor antagonist intervention 2: Standard antiemetics intervention 3: Placebo to match IV casopitant intervention 4: Standard antiemetics	intervention 1: Casopitant intervention 2: Dexamethasone intervention 3: Placebo intervention 4: Ondansetron	96	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Corona \| California \| United States \| -117.56644 \| 33.87529 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Riverside \| California \| United States \| -117.39616 \| 33.95335 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Alexandria \| Louisiana \| United States \| -92.44514 \| 31.31129 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Jefferson City \| Missouri \| United States \| -92.17352 \| 38.5767 Great Falls \| Montana \| United States \| -111.30081 \| 47.50024 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Hilton Head Island \| South Carolina \| United States \| -80.73816 \| 32.19382 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 Sumter \| South Carolina \| United States \| -80.34147 \| 33.92044 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Duncanville \| Texas \| United States \| -96.90834 \| 32.6518 Ogden \| Utah \| United States \| -111.97383 \| 41.223 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Assebroek \| N/A \| Belgium \| 3.2623 \| 51.19367 Bonheiden \| N/A \| Belgium \| 4.54714 \| 51.02261 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Ottignies \| N/A \| Belgium \| 4.56679 \| 50.66535 Shumen \| N/A \| Bulgaria \| 26.92286 \| 43.27064 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Sault Ste. Marie \| Ontario \| Canada \| -84.33325 \| 46.51677 Thunder Bay \| Ontario \| Canada \| -89.25018 \| 48.38202 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Greenfield Park \| Quebec \| Canada \| -73.46223 \| 45.48649 Laval \| Quebec \| Canada \| -73.692 \| 45.56995 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Rimouski \| Quebec \| Canada \| -68.52396 \| 48.44879 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Chomutov \| N/A \| Czechia \| 13.41779 \| 50.46048 Havlíčkův Brod \| N/A \| Czechia \| 15.57937 \| 49.6069 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Semily \| N/A \| Czechia \| 15.33552 \| 50.60191 Freiburg im Breisgau \| Baden-Wurttemberg \| Germany \| 7.85222 \| 47.9959 Ulm \| Baden-Wurttemberg \| Germany \| 9.99155 \| 48.39841 Aschaffenburg \| Bavaria \| Germany \| 9.15214 \| 49.97704 Augsburg \| Bavaria \| Germany \| 10.89851 \| 48.37154 Hof \| Bavaria \| Germany \| 11.91261 \| 50.31297 Munich \| Bavaria \| Germany \| 11.57549 \| 48.13743 Würzburg \| Bavaria \| Germany \| 9.95121 \| 49.79391 Bad Soden \| Hesse \| Germany \| 9.36404 \| 50.28857 Kassel \| Hesse \| Germany \| 9.5 \| 51.31667 Braunschweig \| Lower Saxony \| Germany \| 10.52673 \| 52.26594 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Essen \| North Rhine-Westphalia \| Germany \| 7.01228 \| 51.45657 Recklinghausen \| North Rhine-Westphalia \| Germany \| 7.19738 \| 51.61379 Würselen \| North Rhine-Westphalia \| Germany \| 6.1347 \| 50.81809 Magdeburg \| Saxony-Anhalt \| Germany \| 11.62916 \| 52.12773 Lübeck \| Schleswig-Holstein \| Germany \| 10.68729 \| 53.86893 Pinneberg \| Schleswig-Holstein \| Germany \| 9.79698 \| 53.65887 Jena \| Thuringia \| Germany \| 11.5899 \| 50.92878 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Veszprém \| N/A \| Hungary \| 17.91149 \| 47.09327 Potenza \| Basilicate \| Italy \| 15.80794 \| 40.64175 Rionero in Vulture (PZ) \| Basilicate \| Italy \| 15.6711 \| 40.92328 Reggio Calabria \| Calabria \| Italy \| 15.66129 \| 38.11047 Avellino \| Campania \| Italy \| 14.79103 \| 40.91494 Benevento \| Campania \| Italy \| 14.77816 \| 41.1307 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Genoa \| Liguria \| Italy \| 8.94439 \| 44.40478 Sassari \| Sardinia \| Italy \| 8.55552 \| 40.72586 Catania \| Sicily \| Italy \| 15.07041 \| 37.49223 Florence \| Tuscany \| Italy \| 11.24626 \| 43.77925 Terni \| Umbria \| Italy \| 12.64329 \| 42.56335 Padua \| Veneto \| Italy \| 11.88586 \| 45.40797 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 Region \| N/A \| Russia \| N/A \| N/A Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Banská Bystrica \| N/A \| Slovakia \| 19.15349 \| 48.73946 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Košice \| N/A \| Slovakia \| 21.25808 \| 48.71395 Poprad \| N/A \| Slovakia \| 20.29798 \| 49.06144 Gyeonggi-do \| N/A \| South Korea \| 126.76917 \| 37.58944 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Songpa-gu, Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	707	0	0	0	NCT00601172	1COMPLETED	2009-04-13	2008-03-10	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .	null	Idiopathic Thrombocytopenic Purpura	AMG 531 Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia Japan Placebo controlled Phase 3	null	2	arm 1: Double blinded placebo-controlled study arm 2: None	[ 2, 2 ]	2	[ 0, 0 ]	intervention 1: Subcutaneously administered, once a week, for 12 weeks intervention 2: Subcutaneously administered, once a week, for 12 weeks	intervention 1: Placebo intervention 2: AMG 531	0	null	34	0	0	0	NCT00603642	1COMPLETED	2009-04-13	2007-10-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	65	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.	null	Cystitis, Interstitial	Painful Bladder Syndrome monoclonal antibody	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: PF-04383119 200 mcg/kg IV, single dose intervention 2: placebo IV, single dose	intervention 1: PF-04383119 intervention 2: Placebo	34	Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Fresno \| California \| United States \| -119.77237 \| 36.74773 Glendora \| California \| United States \| -117.86534 \| 34.13612 San Diego \| California \| United States \| -117.16472 \| 32.71571 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 New London \| Connecticut \| United States \| -72.09952 \| 41.35565 New London \| Connecticut \| United States \| -72.09952 \| 41.35565 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Jeffersonville \| Indiana \| United States \| -85.73718 \| 38.27757 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Owings Mills \| Maryland \| United States \| -76.78025 \| 39.41955 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 Utica \| Michigan \| United States \| -83.03354 \| 42.62614 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Mountlake Terrace \| Washington \| United States \| -122.30874 \| 47.78815 Spokane \| Washington \| United States \| -117.42908 \| 47.65966	64	0	0	0	NCT00601484	1COMPLETED	2009-04-15	2008-03-17	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	4	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	false	This study will evaluate acute symptomatic improvements in cognitive performance in healthy elderly participants with mild-to-moderate Alzheimer's disease. A four-week pilot study will first evaluate the CogState computerized cognitive battery in participants who are not receiving treatment. After completion of the pilot study, participants will be randomized to receive Placebo, Donepezil 5 mg, MK-0249 7.5 mg, and MK-0249 25 mg. After each drug administration the participants will be given the CogState computerized cognitive battery to assess cognitive performance. The primary hypotheses are that cognitive performance in participants with Alzheimer's disease, or in healthy participants, is improved by the administration of a single oral 5 mg dose of Donepezil as compared to placebo.	null	Alzheimer's Disease Dementia		null	12	arm 1: Treatment by single oral dose with Placebo (PBO) in the first crossover period; MK-0249 7.5 mg (MK-7.5) in the second crossover period; Donepezil 5 mg (DON) in the third crossover period; and MK-0249 25 mg (MK-25) in the fourth crossover period. arm 2: Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 25 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period. arm 3: Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period. arm 4: Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Placebo in the fourth crossover period. arm 5: Treatment by single oral dose with Placebo in the first crossover period; MK-0249 25 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period. arm 6: Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Donepezil 5 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 25 mg in the fourth crossover period. arm 7: Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and Placebo in the fourth crossover period. arm 8: Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Placebo in the second crossover period; Donepezil 5 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period. arm 9: Treatment by single oral dose with Placebo in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period. arm 10: Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Donepezil 5 mg in the third crossover period; and Placebo in the fourth crossover period. arm 11: Treatment by single oral dose with Donepezil 5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 7.5 mg in the third crossover period; and MK-0249 25 mg in the fourth crossover period. arm 12: Treatment by single oral dose with MK-0249 25 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; Placebo in the third crossover period; and Donepezil 5 mg in the fourth crossover period.	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 4 tablets (1 x 0.5 mg + 2 x 1 mg + 1 x 5 mg) totaling 7.5 mg, single oral dose during each crossover period intervention 2: 5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period intervention 3: One 5 mg tablet, single oral dose during each crossover period intervention 4: Five tablets, single oral dose during each crossover period intervention 5: One over-encapsulated capsule, single oral dose during each crossover period	intervention 1: MK-0249 7.5 mg intervention 2: MK-0249 25 mg intervention 3: Donepezil 5mg intervention 4: Placebo to MK-0249 intervention 5: Placebo to Donepezil	0	null	0	0	0	0	NCT00874939	6TERMINATED	2009-04-20	2009-04-06	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	97	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.	null	Mild to Severe Alzheimer's Disease		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.	intervention 1: Donepezil HCl	36	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Carson \| California \| United States \| -118.28202 \| 33.83141 Fresno \| California \| United States \| -119.77237 \| 36.74773 Hawthorne \| California \| United States \| -118.35257 \| 33.9164 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Danbury \| Connecticut \| United States \| -73.45401 \| 41.39482 Norwalk \| Connecticut \| United States \| -73.4079 \| 41.1176 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami Springs \| Florida \| United States \| -80.2895 \| 25.82232 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Venice \| Florida \| United States \| -82.45426 \| 27.09978 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Elk Grove \| Illinois \| United States \| -87.94034 \| 42.00725 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Mission \| Kansas \| United States \| -94.65579 \| 39.02778 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593 Pittsfield \| Massachusetts \| United States \| -73.24538 \| 42.45008 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Toms River \| New Jersey \| United States \| -74.19792 \| 39.95373 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Albany \| New York \| United States \| -73.75623 \| 42.65258 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Centerville \| Ohio \| United States \| -84.15938 \| 39.62839 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 East Providence \| Rhode Island \| United States \| -71.37005 \| 41.81371 East Providence \| Rhode Island \| United States \| -71.37005 \| 41.81371 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Plano \| Texas \| United States \| -96.69889 \| 33.01984	97	0	0	0	NCT00571064	1COMPLETED	2009-04-22	2008-01-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	2,149	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder	null	Urinary Bladder, Overactive	Frequency YM178 Overactive bladder (OAB) Micturition Urgency Urinary urge incontinence Urinary incontinence	null	3	arm 1: Participants received matching placebo tablets orally once a day for 12 weeks arm 2: Participants received mirabegron 50 mg tablets orally once a day for 12 weeks arm 3: Participants received mirabegron 100 m tablets, orally once a day for 12 weeks	[ 2, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Oral intervention 2: Oral	intervention 1: Mirabegron intervention 2: Placebo	125	Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Atherton \| California \| United States \| -122.19774 \| 37.46133 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Buena Park \| California \| United States \| -117.99812 \| 33.86751 Burbank \| California \| United States \| -118.30897 \| 34.18084 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Fresno \| California \| United States \| -119.77237 \| 36.74773 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Mission Hills \| California \| United States \| -120.43683 \| 34.68609 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Orange \| California \| United States \| -117.85311 \| 33.78779 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Bernardino \| California \| United States \| -117.28977 \| 34.10834 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Tarzana \| California \| United States \| -118.55397 \| 34.17334 Torrance \| California \| United States \| -118.34063 \| 33.83585 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Celebration \| Florida \| United States \| -81.53313 \| 28.32529 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Wellington \| Florida \| United States \| -80.24144 \| 26.65868 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Alpharetta \| Georgia \| United States \| -84.29409 \| 34.07538 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Melrose Park \| Illinois \| United States \| -87.85673 \| 41.90059 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Jeffersonville \| Indiana \| United States \| -85.73718 \| 38.27757 Newburgh \| Indiana \| United States \| -87.40529 \| 37.94449 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Greenbelt \| Maryland \| United States \| -76.87553 \| 39.00455 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Watertown \| Massachusetts \| United States \| -71.18283 \| 42.37093 North Kansas City \| Missouri \| United States \| -94.56218 \| 39.13 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 West Orange \| New Jersey \| United States \| -74.23904 \| 40.79871 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Albany \| New York \| United States \| -73.75623 \| 42.65258 Endwell \| New York \| United States \| -76.02103 \| 42.11285 Garden City \| New York \| United States \| -73.6343 \| 40.72677 Kingston \| New York \| United States \| -73.99736 \| 41.92704 Poughkeepsie \| New York \| United States \| -73.92097 \| 41.70037 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Concord \| North Carolina \| United States \| -80.58158 \| 35.40888 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Lyndhurst \| Ohio \| United States \| -81.48873 \| 41.52005 Wadsworth \| Ohio \| United States \| -81.72985 \| 41.02561 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Edmond \| Oklahoma \| United States \| -97.4781 \| 35.65283 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Reading \| Pennsylvania \| United States \| -75.92687 \| 40.33565 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Arlington \| Texas \| United States \| -97.10807 \| 32.73569 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 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 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Mountlake Terrace \| Washington \| United States \| -122.30874 \| 47.78815 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Surrey \| British Columbia \| Canada \| -122.82509 \| 49.10635 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Saint Johns \| New Brunswick \| Canada \| N/A \| N/A Barrie \| Ontario \| Canada \| -79.66634 \| 44.40011 Brampton \| Ontario \| Canada \| -79.76633 \| 43.68341 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 North Bay \| Ontario \| Canada \| -79.46633 \| 46.3168 Oshawa \| Ontario \| Canada \| -78.84957 \| 43.90012 Owen Sound \| Ontario \| Canada \| -80.94349 \| 44.56717 Thunder Bay \| Ontario \| Canada \| -89.25018 \| 48.38202 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Granby \| Quebec \| Canada \| -72.73243 \| 45.40008 Pointe-Claire \| Quebec \| Canada \| -73.81669 \| 45.44868	1,328	0	0	0	NCT00662909	1COMPLETED	2009-04-22	2008-03-28	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,246	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.	null	Type 2 Diabetes Mellitus		null	2	arm 1: Arm 1: drug arm 2: Arm 2: active comparator	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period. intervention 2: metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period	intervention 1: sitagliptin phosphate (+) metformin hydrochloride intervention 2: metformin	0	null	1,246	0	0	0	NCT00482729	1COMPLETED	2009-04-27	2007-06-19	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	564	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide. Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.	null	Metabolism and Nutrition Disorder Obesity		null	6	arm 1: Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 2: Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 3: Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 4: Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 5: Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 6: Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)	[ 2, 0, 0, 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Injected s.c. (under the skin) once daily intervention 2: 120 mg capsule. Administered thrice daily intervention 3: Injected s.c. (under the skin) once daily	intervention 1: liraglutide intervention 2: orlistat intervention 3: placebo	19	Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Århus C \| N/A \| Denmark \| N/A \| N/A Frederiksberg C \| N/A \| Denmark \| N/A \| N/A Hvidovre \| N/A \| Denmark \| 12.47708 \| 55.64297 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Almere Stad \| N/A \| Netherlands \| 5.21413 \| 52.37025 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Pamplona \| N/A \| Spain \| -1.64323 \| 42.81687 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Luton \| N/A \| United Kingdom \| -0.41748 \| 51.87967 Norwich \| N/A \| United Kingdom \| 1.29834 \| 52.62783	564	0	0	0	NCT00422058	1COMPLETED	2009-04-30	2007-01-10	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	29	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.	null	Psoriasis		null	5	arm 1: INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days arm 2: INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days arm 3: INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days arm 4: INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days arm 5: INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days	[ 0, 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Ruxolitinib phosphate cream 0.5% intervention 2: Cream applied once or twice daily for up to 56 days. intervention 3: Cream applied once or twice daily for up to 56 days intervention 4: Cream applied once or twice daily for 56 days intervention 5: Ruxolitinib phosphate cream 1.0% intervention 6: Ruxolitinib phosphate cream 1.5%	intervention 1: Ruxolitinib phosphate cream intervention 2: Dovonex® calcipotriene 0.005% intervention 3: Diprolene® AF betamethasone dipropionate 0.05% cream. intervention 4: Placebo cream intervention 5: Ruxolitinib phosphate cream intervention 6: Ruxolitinib phosphate cream	6	Vallejo \| California \| United States \| -122.25664 \| 38.10409 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	58	0	0	0	NCT00820950	1COMPLETED	2009-04-30	2007-05-31	Incyte Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	Bipolar disorder (BD) is a common and severe psychiatric illness. Drug and alcohol abuse are very common in people with BD and other mood disorders and are associated with increased rates of hospitalization, violence towards self and others, medication non-adherence and cognitive impairment. However, few studies have investigated the treatment of dual-diagnosis patients as substance use is frequently an exclusion criterion in clinical trials of patients with BD. To address this need, we have developed a research program that explores the pharmacotherapy of people with BD and substance related-disorders. A potentially very interesting treatment for BD is citicoline. Some data suggest that this supplement may stabilize mood, decrease drug use and craving, and improve memory. We found promising results with citicoline in patients with BD and cocaine dependence. In recent years the use of amphetamine and methamphetamine has become an important public health concern. However, virtually no research has been conducted on the treatment of amphetamine abuse. We propose a double-blind placebo controlled prospective trial of citicoline in a group of 60 depressed outpatients with bipolar disorder, depressed phase or major depressive disorder and amphetamine abuse/dependence, to explore the safety and tolerability of citicoline, and its efficacy for mood symptoms, stimulant use and craving and its impact on cognition. Our goal is to determine which symptoms (e.g. mood, cognition, substance use) citicoline appears to be most effective and estimate effect sizes for future work.	Sixty outpatients meeting the inclusion and exclusion criteria will be enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation will include a medical and psychiatric history, structured clinical interview for Diagnostic and Statistical Manual (DSM-IV) (SCID), mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-C), Young Mania Rating Scale (YMRS), and cognitive assessment with the Hopkins Auditory Verbal Learning Test (HVLT) (similar to the Rey Auditory Verbal Learning Test (RAVLT) but more alternative equivalent versions are available), Stroop and computer assessments including Sternberg Memory Task and the Running Memory Continuous Performance Test. Alternate but equivalent versions of all cognitive tests, except the Stroop, will be used to minimize practice effects with repeated administration. Days and amounts of amphetamine and other substance use will be assessed at each visit with urine drug screens, and through self-report using the timeline follow-back method. Amphetamine, and other drug, craving will be assessed with a visual analogue scales. Citicoline or placebo add-on therapy will be given beginning at one tablet (500mg)/day with an increase to two tablets 1000 mg/day at week 2, three tables 1500 mg/day at week 4 and four tablets 2000 mg/day at week 6.	Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder	Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder Citicoline	null	2	arm 1: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. arm 2: Placebo matching active medication.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4 and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects. intervention 2: Placebo matching active medication in all other physical aspects	intervention 1: Citicoline intervention 2: Placebo	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	60	1	0.016667	1	NCT00377299	1COMPLETED	2009-05-01	2006-10-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0	1	0	0.002948
[ 4 ]	224	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension (PH). Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension (PAH), long-term treatment success, and survival.	This study was to enroll up to 200 participants with PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5). Participants with left heart disease or left heart failure were excluded (WHO Group 2). Participants could be receiving prostacyclin or sildenafil therapy at baseline, and participants who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities were eligible.	Pulmonary Hypertension		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Oral tablets taken once daily.	intervention 1: Ambrisentan	39	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Torrance \| California \| United States \| -118.34063 \| 33.83585 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Miami Beach \| Florida \| United States \| -80.13005 \| 25.79065 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 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 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 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 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Lexington \| South Carolina \| United States \| -81.23621 \| 33.98154 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Darlinghurst \| New South Wales \| Australia \| 151.21925 \| -33.87939 Perth \| N/A \| Australia \| 115.8614 \| -31.95224 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	224	2	0.008929	1	NCT00380068	1COMPLETED	2009-05-01	2006-08-01	Gilead Sciences	4INDUSTRY	false	false	false	null	2	0	0	0.002452
[ 4 ]	808	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.	null	Hypertension		null	2	arm 1: Drug Arm arm 2: active comparator	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide intervention 2: Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide	intervention 1: losartan potassium (+) hydrochlorothiazide intervention 2: Comparator: Valsartan (+) Hydrochlorothiazide	0	null	808	1	0.001238	1	NCT00546754	1COMPLETED	2009-05-01	2007-05-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	1	0.000219
[ 3 ]	39	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia.	OBJECTIVES: * Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine, high dose cyclophosphamide, and rituximab. * Survival up to 5 years * Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients. OUTLINE: This is an open label study. Patients receive fludarabine IV once daily for 5 days. Treatment is repeated every 4 weeks for 3 or 6 courses. Three weeks later, cyclophosphamide is administered intravenously every 2-3 weeks for 3 courses. Filgrastim (G-CSF) is administered on days 2-10. Beginning 4 weeks after the last dose of cyclophosphamide, patients receive rituximab by intravenous infusion once weekly for 4 weeks. Patient are followed every 3 months until death. PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.	Leukemia	stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia	null	1	arm 1: This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.	[ 0 ]	4	[ 2, 2, 0, 0 ]	intervention 1: Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses. intervention 2: Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses. intervention 3: Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses. intervention 4: Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.	intervention 1: filgrastim intervention 2: rituximab intervention 3: cyclophosphamide intervention 4: fludarabine phosphate	1	New York \| New York \| United States \| -74.00597 \| 40.71427	36	0	0	0	NCT00003659	1COMPLETED	2009-05-01	1998-09-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	84	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.	PRIMARY OBJECTIVES: I. To evaluate the safety and feasibility of the combination of liposomal doxorubicin (Doxil) and Taxotere (Taxotere) ± trastuzumab (Herceptin), particularly with respect to cardiotoxicity. II. To evaluate the overall objective response rate, response duration, time to treatment failure, and median survival of patients with metastatic breast cancer treated with Doxil and Taxotere ± Herceptin. III. To determine the overall toxicity of Doxil and Taxotere ± Herceptin in patients with advanced breast cancer. IV. To determine whether there is an association between trough plasma levels of cTnT (cardiac troponin T) and NT-proBNP (brain natriuretic peptide) and any cardiac event (CHF or LVEF decrease). V. To determine tissue and plasma levels of HER2 using several assays and explore potential correlation with protocol treatment toxicity and/or response. OUTLINE: Patients are assigned to one of two treatment arms according to HER2 overexpression status. Arm I (HER2 nonoverexpressed): Patients receive doxorubicin hydrochloride liposome IV over 30 minutes followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity. Arm II (HER2 overexpressed): Patients receive trastuzumab IV over 90 minutes on day 1, with subsequent doses over 30 minutes. Patients receive doxorubicin HCl liposome IV over 30 minutes followed by docetaxel IV over 1 hour on day 2 of course 1, followed by subsequent doses on day 1 of each course. Antibody therapy continues weekly and chemotherapy every 3 weeks for 8 courses. Patients may receive maintenance therapy of trastuzumab IV over 30 minutes weekly followed by docetaxel IV over 1 hour weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 89 patients were accrued for this study.	Recurrent Breast Cancer Stage IV Breast Cancer		null	2	arm 1: Patients receive doxorubicin hydrochloride liposome IV over 30 minutes followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive trastuzumab IV over 90 minutes on day 1, with subsequent doses over 30 minutes. Patients receive doxorubicin HCl liposome IV over 30 minutes followed by docetaxel IV over 1 hour on day 2 of course 1, followed by subsequent doses on day 1 of each course. Antibody therapy continues weekly and chemotherapy every 3 weeks for 8 courses. Patients may receive maintenance therapy of trastuzumab IV over 30 minutes weekly followed by docetaxel IV over 1 hour weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity.	[ 0, 0 ]	4	[ 0, 0, 2, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies	intervention 1: pegylated liposomal doxorubicin hydrochloride intervention 2: docetaxel intervention 3: trastuzumab intervention 4: laboratory biomarker analysis	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	89	0	0	0	NCT00004888	1COMPLETED	2009-05-01	2001-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.	OBJECTIVES: * Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide. * Determine the toxicity of this drug in these patients. OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor). Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.	Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	metastatic osteosarcoma recurrent childhood rhabdomyosarcoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma stage III childhood liver cancer stage IV childhood liver cancer recurrent childhood liver cancer childhood hepatoblastoma stage III Wilms tumor stage IV Wilms tumor stage V Wilms tumor recurrent Wilms tumor and other childhood kidney tumors intraocular retinoblastoma extraocular retinoblastoma recurrent retinoblastoma recurrent osteosarcoma childhood germ cell tumor metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma localized unresectable neuroblastoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor untreated childhood medulloblastoma recurrent childhood medulloblastoma previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor childhood teratoma childhood malignant testicular germ cell tumor childhood malignant ovarian germ cell tumor childhood extragonadal germ cell tumor recurrent childhood malignant germ cell tumor	null	1	arm 1: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: arsenic trioxide	1	New York \| New York \| United States \| -74.00597 \| 40.71427	22	0	0	0	NCT00024258	1COMPLETED	2009-05-01	2001-03-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	389	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.	BACKGROUND: Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery. DESIGN NARRATIVE: This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.	Coronary Disease Heart Diseases Cardiovascular Diseases Neurologic Manifestations		null	2	arm 1: 100 mg/kg magnesium arm 2: 100 mg/kg 0.9 % saline	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 100 mg/kg intervention 2: Placebo	intervention 1: Magnesium intervention 2: 0.9% saline	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	389	0	0	0	NCT00041392	1COMPLETED	2009-05-01	2001-12-01	Duke University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	106	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I, stage II, stage III, or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.	PRIMARY OBJECTIVES: I. To determine the complete response rate after treatment with EPOCH given either concurrently or sequentially with rituximab. SECONDARY OBJECTIVES: I. To evaluate the toxicity of EPOCH given either concurrently or sequentially with rituximab. II. To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab on immune function (CD4, CD8 lymphocyte count) after two cycles of EPOCH, and 1 month, 3 months, 6 months, and 12 months after the completion of EPOCH. III. To evaluate the effect of EPOCH given either concurrently or sequentially with rituximab on HIV and EBV viral load after two cycles of EPOCH, and 1 month, 3 months, 6 months, and 12 months after the completion of EPOCH. IV. To evaluate the relationship between EBV viral load and EBV CD8 cytotoxic T cells in the peripheral blood and the presence of EBV in lymphoma tumor cells. V. To determine whether rituximab or the concurrent use of antiretroviral therapy significantly alters the steady state concentration of etoposide, doxorubicin, or vincristine during the first cycle of therapy. VI. To determine whether steady state concentration of etoposide or doxorubicin correlate with nadir neutrophil and platelet count during the first cycle of therapy. VII. To determine time to progression and overall survival in patients treated with EPOCH given either concurrently or sequentially with rituximab. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to CD4 count (less than 100/mm\^3 vs at least 100/mm\^3), age-adjusted International Prognostic Index adverse risk factors (0 or 1 vs 2 or 3), and concurrent antiretroviral therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive rituximab intravenously (IV) over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks. ARM II: Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.	AIDS-related Diffuse Large Cell Lymphoma AIDS-related Immunoblastic Large Cell Lymphoma AIDS-related Peripheral/Systemic Lymphoma AIDS-related Small Noncleaved Cell Lymphoma		null	2	arm 1: Patients receive rituximab intravenously (IV) over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks. arm 2: Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.	[ 0, 0 ]	7	[ 2, 0, 0, 0, 0, 0, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given orally intervention 6: Given IV intervention 7: Correlative studies	intervention 1: rituximab intervention 2: etoposide intervention 3: doxorubicin hydrochloride intervention 4: vincristine sulfate intervention 5: prednisone intervention 6: cyclophosphamide intervention 7: laboratory biomarker analysis	1	Rockville \| Maryland \| United States \| -77.15276 \| 39.084	106	0	0	0	NCT00049036	1COMPLETED	2009-05-01	2003-03-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 4 ]	74	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer. PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.	OBJECTIVES: * Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy. * Compare the objective response rate in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the quality of life (QOL) of patients treated with these regimens. * Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms. Arm I (Gemcitabine alone): * Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest. * Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Arm II (Gemcitabine with radiotherapy): * Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1. * Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival. ACCRUAL: 74 patients were accrued for this study.	Pancreatic Cancer	stage III pancreatic cancer adenocarcinoma of the pancreas	null	2	arm 1: None arm 2: None	[ 1, 0 ]	2	[ 0, 4 ]	intervention 1: Induction: Patients receive the first cycle of gemcitabine 1000 mg/m\^2 intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m\^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles. intervention 2: Induction: Patients receive gemcitabine 600 mg/m\^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.	intervention 1: Gemcitabine intervention 2: radiation therapy	229	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Fresno \| California \| United States \| -119.77237 \| 36.74773 Modesto \| California \| United States \| -120.99688 \| 37.6391 Modesto \| California \| United States \| -120.99688 \| 37.6391 Greeley \| Colorado \| United States \| -104.70913 \| 40.42331 Loveland \| Colorado \| United States \| -105.07498 \| 40.39776 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Norwich \| Connecticut \| United States \| -72.07591 \| 41.52426 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Valdosta \| Georgia \| United States \| -83.28032 \| 30.83334 Aurora \| Illinois \| United States \| -88.32007 \| 41.76058 Bloomington \| Illinois \| United States \| -88.99369 \| 40.4842 Canton \| Illinois \| United States \| -90.03512 \| 40.55809 Carthage \| Illinois \| United States \| -91.13625 \| 40.41643 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Effingham \| Illinois \| United States \| -88.54338 \| 39.12004 Eureka \| Illinois \| United States \| -89.27286 \| 40.72143 Evanston \| Illinois \| United States \| -87.69006 \| 42.04114 Galesburg \| Illinois \| United States \| -90.37124 \| 40.94782 Galesburg \| Illinois \| United States \| -90.37124 \| 40.94782 Galesburg \| Illinois \| United States \| -90.37124 \| 40.94782 Havana \| Illinois \| United States \| -90.06095 \| 40.30004 Hinsdale \| Illinois \| United States \| -87.93701 \| 41.80086 Hopedale \| Illinois \| United States \| -89.41454 \| 40.42087 Joliet \| Illinois \| United States \| -88.0834 \| 41.52519 Joliet \| Illinois \| United States \| -88.0834 \| 41.52519 Kankakee \| Illinois \| United States \| -87.86115 \| 41.12003 Kewanee \| Illinois \| United States \| -89.92483 \| 41.24559 La Grange \| Illinois \| United States \| -87.86923 \| 41.80503 Lake Forest \| Illinois \| United States \| -87.84063 \| 42.25863 Libertyville \| Illinois \| United States \| -87.95313 \| 42.28308 Macomb \| Illinois \| United States \| -90.6718 \| 40.45921 Niles \| Illinois \| United States \| -87.80284 \| 42.01892 Normal \| Illinois \| United States \| -88.99063 \| 40.5142 Normal \| Illinois \| United States \| -88.99063 \| 40.5142 Ottawa \| Illinois \| United States \| -88.84258 \| 41.34559 Pekin \| Illinois \| United States \| -89.64066 \| 40.56754 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Peru \| Illinois \| United States \| -89.12897 \| 41.32753 Princeton \| Illinois \| United States \| -89.46481 \| 41.36809 Rockford \| Illinois \| United States \| -89.094 \| 42.27113 Skokie \| Illinois \| United States \| -87.73339 \| 42.03336 Skokie \| Illinois \| United States \| -87.73339 \| 42.03336 Skokie \| Illinois \| United States \| -87.73339 \| 42.03336 Spring Valley \| Illinois \| United States \| -89.19981 \| 41.32754 Spring Valley \| Illinois \| United States \| -89.19981 \| 41.32754 Urbana \| Illinois \| United States \| -88.20727 \| 40.11059 Urbana \| Illinois \| United States \| -88.20727 \| 40.11059 Elkhart \| Indiana \| United States \| -85.97667 \| 41.68199 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 La Porte \| Indiana \| United States \| -86.71389 \| 41.60774 Michigan City \| Indiana \| United States \| -86.89503 \| 41.70754 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Ames \| Iowa \| United States \| -93.61994 \| 42.03471 Davenport \| Iowa \| United States \| -90.57764 \| 41.52364 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Mason City \| Iowa \| United States \| -93.20104 \| 43.15357 Onawa \| Iowa \| United States \| -96.09724 \| 42.02665 Ottumwa \| Iowa \| United States \| -92.4113 \| 41.02001 Sioux City \| Iowa \| United States \| -96.40031 \| 42.49999 Sioux City \| Iowa \| United States \| -96.40031 \| 42.49999 Sioux City \| Iowa \| United States \| -96.40031 \| 42.49999 West Des Moines \| Iowa \| United States \| -93.71133 \| 41.57721 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Adrian \| Michigan \| United States \| -84.03717 \| 41.89755 Escanaba \| Michigan \| United States \| -87.06458 \| 45.74525 Iron Mountain \| Michigan \| United States \| -88.06596 \| 45.82023 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Lambertville \| Michigan \| United States \| -83.62799 \| 41.76588 Monroe \| Michigan \| United States \| -83.39771 \| 41.91643 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Saint Joseph \| Michigan \| United States \| -86.48002 \| 42.10976 Burnsville \| Minnesota \| United States \| -93.27772 \| 44.76774 Coon Rapids \| Minnesota \| United States \| -93.28773 \| 45.11997 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 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 Cloud \| Minnesota \| United States \| -94.16249 \| 45.5608 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 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Great Falls \| Montana \| United States \| -111.30081 \| 47.50024 Kearney \| Nebraska \| United States \| -99.08148 \| 40.69946 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Papillion \| Nebraska \| United States \| -96.04224 \| 41.15444 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 East Orange \| New Jersey \| United States \| -74.20487 \| 40.76732 Flemington \| New Jersey \| United States \| -74.85933 \| 40.51233 Marlton \| New Jersey \| United States \| -74.92183 \| 39.89122 Red Bank \| New Jersey \| United States \| -74.06431 \| 40.34705 Somers Point \| New Jersey \| United States \| -74.5946 \| 39.31762 Toms River \| New Jersey \| United States \| -74.19792 \| 39.95373 Cooperstown \| New York \| United States \| -74.92426 \| 42.70048 Goldsboro \| North Carolina \| United States \| -77.99277 \| 35.38488 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Wilson \| North Carolina \| United States \| -77.91554 \| 35.72127 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Minot \| North Dakota \| United States \| -101.29627 \| 48.23251 Boardman \| Ohio \| United States \| -80.66285 \| 41.02423 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Findlay \| Ohio \| United States \| -83.64993 \| 41.04422 Fremont \| Ohio \| United States \| -83.12186 \| 41.35033 Lima \| Ohio \| United States \| -84.10523 \| 40.74255 Lima \| Ohio \| United States \| -84.10523 \| 40.74255 Maumee \| Ohio \| United States \| -83.65382 \| 41.56283 Oregon \| Ohio \| United States \| -83.48688 \| 41.64366 Sandusky \| Ohio \| United States \| -82.70796 \| 41.44894 Sylvania \| Ohio \| United States \| -83.71299 \| 41.71894 Tiffin \| Ohio \| United States \| -83.17797 \| 41.1145 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Warren \| Ohio \| United States \| -80.81842 \| 41.23756 Wauseon \| Ohio \| United States \| -84.14161 \| 41.54922 Youngstown \| Ohio \| United States \| -80.64952 \| 41.09978 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Bryn Mawr \| Pennsylvania \| United States \| -80.08672 \| 40.30396 Drexel Hill \| Pennsylvania \| United States \| -75.29213 \| 39.94706 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Lewistown \| Pennsylvania \| United States \| -77.57138 \| 40.59924 Paoli \| Pennsylvania \| United States \| -75.47631 \| 40.04205 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Phoenixville \| Pennsylvania \| United States \| -75.51491 \| 40.13038 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Reading \| Pennsylvania \| United States \| -75.92687 \| 40.33565 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 West Chester \| Pennsylvania \| United States \| -75.60804 \| 39.96097 West Grove \| Pennsylvania \| United States \| -75.82744 \| 39.82205 West Reading \| Pennsylvania \| United States \| -75.94743 \| 40.3337 Wynnewood \| Pennsylvania \| United States \| -75.27074 \| 40.00289 Wynnewood \| Pennsylvania \| United States \| -75.27074 \| 40.00289 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Laredo \| Texas \| United States \| -99.50754 \| 27.50641 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Murray \| Utah \| United States \| -111.88799 \| 40.66689 Ogden \| Utah \| United States \| -111.97383 \| 41.223 Provo \| Utah \| United States \| -111.65853 \| 40.23384 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 St. George \| Utah \| United States \| -113.58412 \| 37.10415 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Charleston \| West Virginia \| United States \| -81.63262 \| 38.34982 Huntington \| West Virginia \| United States \| -82.44515 \| 38.41925 Fond du Lac \| Wisconsin \| United States \| -88.43883 \| 43.775 Green Bay \| Wisconsin \| United States \| -88.01983 \| 44.51916 Green Bay \| Wisconsin \| United States \| -88.01983 \| 44.51916 Green Bay \| Wisconsin \| United States \| -88.01983 \| 44.51916 Green Bay \| Wisconsin \| United States \| -88.01983 \| 44.51916 La Crosse \| Wisconsin \| United States \| -91.23958 \| 43.80136 Manitowoc \| Wisconsin \| United States \| -87.65758 \| 44.08861 Marinette \| Wisconsin \| United States \| -87.63066 \| 45.09998 Marshfield \| Wisconsin \| United States \| -90.1718 \| 44.66885 Oconto Falls \| Wisconsin \| United States \| -88.14288 \| 44.87388 Sturgeon Bay \| Wisconsin \| United States \| -87.37704 \| 44.83416 Wausau \| Wisconsin \| United States \| -89.63012 \| 44.95914 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486	69	0	0	0	NCT00057876	1COMPLETED	2009-05-01	2003-08-29	Eastern Cooperative Oncology Group	5NETWORK	false	false	false	null	0	0	0	0
[ 3 ]	128	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.	Treatment: Methylation is a change that occurs to Deoxyribonucleic acid (DNA) that has an effect on gene usage in human cells. Abnormal methylation is very common in leukemias. Decitabine is a new drug that blocks DNA methylation. Before treatment starts, a physical exam, blood tests (between 4-6 tablespoons), and a bone marrow study will be done. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women able to have children must have a negative blood or urine pregnancy test. When this study began, participants were randomly assigned (as in the toss of a coin) to one of 3 treatment groups. The assignment to one of the 3 schedules was adjusted according to how well patients respond to treatment. About 17 patients were assigned to each group for the first 50 patients. Participants in the first group received decitabine intravenously (IV--through a needle in their vein) over one hour, once a day, for 10 days. Treatment was given every 4 to 8 weeks depending on how well their blood counts recovered. Participants in the second group received decitabine as an IV infusion over one hour, once a day, for 5 days. Treatment was given every 4 to 8 weeks. Participants who received decitabine by vein got the same total dose per course. Participants in the third group received decitabine by subcutaneous (SQ) injections (injections given under the skin) twice a day for 5 days. As in the first and second group, treatment was given every 4 to 8 weeks. After 65 patients were enrolled on this study, it was decided that the 5-day IV schedule was the best of the 3 schedules. The study will now continue with all new patients receiving the 5 -day IV decitabine treatment. If you are now enrolling on the study, you will be placed in this treatment group, instead of being randomly assigned to a treatment group. Participants who are already on study and who are receiving the 5-day SQ schedule or the 10-day IV schedule, will be given the option to change to the 5-day IV schedule at the start of their next course of study drug treatment, since this is considered the new "standard" schedule on this particular study. If you choose to take part in this study and begin receiving the study treatment described above, your response to treatment will be checked after completing 8 weeks of therapy. If the response to treatment is good, treatment with decitabine will continue. Decitabine treatment may be continued for up to 24 courses, or as long as it is judged best to control the leukemia. During this study, you will need to visit your doctor for a physical exam and vital signs. The frequency of doctor visits will vary depending on your physical condition, but will be required at least once a month. Blood tests (about 2 teaspoons) will be done about every week during the first 6-8 weeks of treatment, then every 1 to 2 weeks for the length of the study. The blood samples will be used for routine lab tests. Periodic bone marrow samples will also be taken to check cells related to the disease before, during, and after completion of this study. Patients will be taken off study if the disease gets worse or intolerable side effects occur. This is an investigational study. Decitabine is not yet Food and Drug Administration (FDA) approved.Up to 133 participants will be treated in this study. All will be enrolled at M. D. Anderson.	Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia	Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia MDS Decitabine Dacogen Methylation	null	3	arm 1: 10 mg/m\^2 intravenous (IV) over 1 hour daily for 10 days arm 2: 20 mg/m2 IV over 1 hour daily for 5 days arm 3: 20 mg/m2 subcutaneous (SQ) daily for 5 days	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg/m\^2 by vein over 1 hour daily for 10 days intervention 2: 20 mg/m2 by vein (IV) over 1 hour daily x 5 days intervention 3: 20 mg/m2 subcutaneous (SQ) daily x 5 days	intervention 1: Decitabine intervention 2: Decitabine intervention 3: Decitabine	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	124	0	0	0	NCT00067808	1COMPLETED	2009-05-01	2003-10-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3, 4 ]	1,354	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	true	0ALL	true	Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children. Children infected with TB have a higher risk of developing severe disease than adults with TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB infection in infants born to HIV-infected mothers.	Tuberculosis (TB) and the Human Immunodeficiency Virus (HIV) are major public health problems in southern Africa, and the incidence of TB in South Africa is among the highest in the world. TB is caused by the highly contagious bacterium Mycobacterium tuberculosis. The use of Isoniazid (INH) prophylaxis in adults has been associated with reduced risk of TB disease in high-risk populations. Delay in initiating INH prophylaxis in children has resulted in more cases of childhood TB infection. This study evaluated the effectiveness of INH prophylaxis in preventing TB infection in infants born to HIV-infected mothers in southern Africa. Infants were randomly assigned to receive either INH or placebo by mouth daily, beginning between the 91st and 120th day of life, and at least 90 days after Bacille Calmette-Guerin (BCG) vaccination. At sites in South Africa, HIV-infected infants received daily trimethoprim/sulfamethoxazole (TMP/SMX) as Pneumocystis jiroveci pneumonia (PCP) prophylaxis until at least 1 year of age; HIV-uninfected infants received TMP/SMX until at least 6 months of age. The study was to follow participants for 192 weeks. Study visits occurred at study entry and every 12 weeks until week 192. A physical exam and blood collection occurred at each study visit. Infants were assessed for peripheral neuropathy every 12 weeks until week 96 and for TB at weeks 96, 144, and 192. The study also assessed medication adherence. As of November 12, 2008, follow-up was revised. All participants were permanently discontinued from study follow-up by February 28, 2009 and no later than May 31, 2009. Only clinical evaluations were performed for all participants. For HIV-infected participants, the study drug was stopped at the next scheduled visit. For HIV-uninfected subjects, the study drug was discontinued immediately.	HIV Infection Tuberculosis Pneumocystis Jiroveci Pneumonia	Treatment Naive INH Prophylaxis HIV Seronegativity	null	4	arm 1: Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding arm 2: Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding arm 3: HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines. arm 4: HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.	[ 0, 2, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Antibiotic for the prevention and treatment of TB intervention 2: Antibiotic for the prevention and treatment of pneumocystis pneumonia (PCP) intervention 3: Isoniazid placebo and TMP/SMX	intervention 1: Isoniazid (INH) intervention 2: Trimethoprim/Sulfamethoxazole (TMP/SMX) intervention 3: Isoniazid Placebo (PL)	6	Gaborone \| N/A \| Botswana \| 25.90859 \| -24.65451 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Durban \| N/A \| South Africa \| 31.0292 \| -29.8579 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227	1,351	0	0	0	NCT00080119	6TERMINATED	2009-05-01	2004-02-01	International Maternal Pediatric Adolescent AIDS Clinical Trials Group	5NETWORK	false	false	false	null	0	0	0	0
[ 4 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor. PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.	OBJECTIVES: Primary * Compare event-free survival and overall survival of patients with newly diagnosed primary CNS germ cell tumor treated with conventional radiotherapy alone (regimen A) vs chemotherapy followed by tumor response-based radiotherapy (regimen B). Secondary * Determine the complete response rate in patients treated with regimen B. * Determine the acute and subacute toxicity of regimen B in these patients. * Compare treatment-related morbidity, in terms of verbal learning and memory, executive functioning, and quality of life, in patients treated with these regimens. * Determine the prognostic value of baseline serum, lumbar, and intraventricular levels of human chorionic gonadotropin levels from patients treated with these regimens. * Determine the prognostic value of extent of disease (M+ vs modified M+ vs M0) on event-free survival and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor location (pineal vs suprasellar vs pineal + suprasellar or other), and disease stage (disseminated vs occult multi-focal vs localized). Patients are randomized to 1 of 2 treatment regimens. All patients undergo an operative procedure (endoscopic biopsy, stereotactic biopsy, or open craniotomy) to confirm the diagnosis of pure germ cell germinoma followed by an intraoperative and perioperative staging evaluation. * Regimen A (radiotherapy only): Within 52 days of surgery, patients undergo standard-dose radiotherapy once daily on days 1-5 for approximately 5-6 weeks. * Regimen B (chemotherapy plus radiotherapy): * Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Patients achieving a complete response (CR) proceed to reduced-dose radiotherapy. Patients with minimal residual disease (MRD), a partial response (PR), or stable disease (SD) receive chemotherapy courses 3 and 4 as outlined below. Patients with progressive disease undergo a second surgical procedure for biopsy and are restaged. Patients with a confirmed diagnosis of germ cell tumor with no change in tumor markers and no new lesions after restaging proceed to chemotherapy courses 3 and 4. * Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) subcutaneously or IV beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or progressive disease are restaged. Patients with a confirmed diagnosis of germ cell tumor after restaging undergo standard radiotherapy as in regimen A. * Reduced-dose radiotherapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiotherapy once daily on days 1-5 for 5 weeks. Treatment in both regimens continues in the absence of unacceptable toxicity or in the event that a non-germinomatous germ cell tumor is detected. Quality of life and neuropsychological function within the domains of intelligence, attention-concentration, memory, and executive functioning are assessed at 9, 30, and 60 months after diagnosis. Patients are followed every 4 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 225 patients (approximately 112 per treatment regimen) will be accrued for this study within 5 years.	Brain Tumor Central Nervous System Tumor	childhood central nervous system germ cell tumor	null	2	arm 1: Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks. arm 2: Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below. Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF), subcutaneous (SC) or IV beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A. Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks	[ 0, 0 ]	6	[ 2, 0, 0, 0, 0, 4 ]	intervention 1: Given by infusion or injection intervention 2: Given IV over 1 hour intervention 3: Given IV over 6 hours intervention 4: Given IV over 1 hour intervention 5: Given IV over 2 hours intervention 6: Patients undergo radiotherapy 5 days a week	intervention 1: filgrastim intervention 2: carboplatin intervention 3: cisplatin intervention 4: cyclophosphamide intervention 5: etoposide intervention 6: radiation therapy	107	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Downey \| California \| United States \| -118.13257 \| 33.94001 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Madera \| California \| United States \| -120.06072 \| 36.96134 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Stanford \| California \| United States \| -122.16608 \| 37.42411 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Wilmington \| Delaware \| United States \| -75.54659 \| 39.74595 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Oak Lawn \| Illinois \| United States \| -87.75811 \| 41.71087 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Alexandria \| Louisiana \| United States \| -92.44514 \| 31.31129 Bangor \| Maine \| United States \| -68.77265 \| 44.79884 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 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 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Morristown \| New Jersey \| United States \| -74.48154 \| 40.79677 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Paterson \| New Jersey \| United States \| -74.17181 \| 40.91677 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 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 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 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 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Amarillo \| Texas \| United States \| -101.8313 \| 35.222 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 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 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Charleston \| West Virginia \| United States \| -81.63262 \| 38.34982 Marshfield \| Wisconsin \| United States \| -90.1718 \| 44.66885 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Brisbane \| Queensland \| Australia \| 153.02809 \| -27.46794 Parkville \| Victoria \| Australia \| 144.95 \| -37.78333 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Santurce \| N/A \| Puerto Rico \| -67.14018 \| 18.19523	22	0	0	0	NCT00085098	1COMPLETED	2009-05-01	2007-01-01	Children's Oncology Group	5NETWORK	false	false	false	null	0	0	0	0
[ 3 ]	82	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients. Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance.	CIS is a single clinical event indicating temporary disruption of normal nerve function. CIS patients may have a loss of vision in one eye; trouble with balance; double vision; numbness in the face; and tingling, numbness, or weakness in the arms or legs. Some CIS patients may develop MS, but others may not. Studies have shown that when CIS is accompanied by magnetic resonance imaging (MRI)-detected brain lesions that are consistent with those seen in MS, there is a high risk of a second neurologic event and a diagnosis of MS within several years. This study will evaluate the efficacy of atorvastatin, an antihyperlipidemic, in the prevention of MS in CIS patients. This study will last 18 months. All participants must complete a 3- to 5-day course of corticosteroids at least 28 days before the baseline evaluations. This corticosteroid therapy must be initiated within 60 days of CIS onset. Participants will be randomly assigned to receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months. Study visits will occur at screening and every 3 months thereafter until the end of the 18-month study. Blood collection will occur at selected visits, and other additional evaluations will be performed at Months 1 and 2. Selected participants will undergo MRI brain scans. Participants will be offered interferon beta-1a (Avonex®), free of charge, if they develop disease activity. Participants will be instructed to report any change in their health status to their treating physician within 48 hours of the onset of symptoms.	Multiple Sclerosis	Early Multiple Sclerosis MS Clinically Isolated Syndrome	null	2	arm 1: 80 mg/day arm 2: Once daily.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated intervention 2: tablet form	intervention 1: Atorvastatin intervention 2: Placebo	14	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	83	0	0	0	NCT00094172	1COMPLETED	2009-05-01	2005-05-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	26	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer	PRIMARY OBJECTIVES: I. To evaluate the objective response rate (complete response \[CR\] + partial response \[PR\]) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria in each group of patients. SECONDARY OBJECTIVES: I. To evaluate the progression free survival at 6 months. II. To evaluate the toxicity profile of this treatment in each group of patients. III. To evaluate median overall survival, 6 and 12 months survival rates. IV. To assess target-epidermal growth factor receptor (EGFR)/EGFR-P protein expression and the genes that regulate the cell cycle and apoptosis, which are either downstream of or cross-talk with the EGFR signaling pathway, to explore their association with clinical outcome. V. To measure expression profile and mutations of genes critical for EGFR and (v-erb-b2 erythroblastic leukemia viral oncogene homolog 2 (ERBB2 signaling pathways with particular relevance to GW572016, and to explore new gene-drug relationships as relating to hepatocellular and biliary carcinomas. OUTLINE: This is a multicenter study. Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 1 year.	Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer		null	1	arm 1: Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 10 ]	intervention 1: None intervention 2: Correlative studies	intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	26	0	0	0	NCT00107536	1COMPLETED	2009-05-01	2005-10-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 4 ]	784	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.	null	Menorrhagia Heavy Menstrual Bleeding	Menorrhagia Heavy Menstrual Bleeding	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation	intervention 1: Tranexamic acid tablets (XP12B)	59	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Pinellas Park \| Florida \| United States \| -82.69954 \| 27.8428 Venice \| Florida \| United States \| -82.45426 \| 27.09978 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Alpharetta \| Georgia \| United States \| -84.29409 \| 34.07538 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Champaign \| Illinois \| United States \| -88.24338 \| 40.11642 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Portage \| Michigan \| United States \| -85.58 \| 42.20115 Chaska \| Minnesota \| United States \| -93.60218 \| 44.78941 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Moorestown \| New Jersey \| United States \| -74.94267 \| 39.96706 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Johnson City \| New York \| United States \| -75.95881 \| 42.11563 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 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 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Wexford \| Pennsylvania \| United States \| -80.05589 \| 40.62646 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288	723	0	0	0	NCT00113568	1COMPLETED	2009-05-01	2005-06-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,053	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjects will receive Q2-week oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm subjects will not receive concomitant panitumumab therapy.	null	Colorectal Cancer	Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study) Colorectal, Colon, Rectal Cancer, Metastatic Colorectal Cancer EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Oncology	null	4	arm 1: Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. arm 2: Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W arm 3: Irinotecan-based chemotherapy and Bevacizumab Q2W alone arm 4: Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W	[ 1, 0, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 2: PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. intervention 3: Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 4: Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration .	intervention 1: Oxaliplatin Based Chemotherapy intervention 2: Panitumumab intervention 3: Irinotecan Based Chemotherapy intervention 4: Bevacizumab	0	null	1,028	0	0	0	NCT00115765	1COMPLETED	2009-05-01	2005-06-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.	PRIMARY OBJECTIVES: I. To evaluate the response probability (complete, complete unconfirmed, and partial) in patients with relapsed or refractory Hodgkin's lymphoma. II. To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkin's lymphoma treated with SAHA. III. To assess the toxicity profile of SAHA in this patient population. IV. To perform gene expression profiling on tumor tissue before and after treatment in order to explore in a preliminary manner the association between response and specific gene expression results. OUTLINE: This is a multicenter study. Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.	Adult Favorable Prognosis Hodgkin Lymphoma Adult Lymphocyte Depletion Hodgkin Lymphoma Adult Lymphocyte Predominant Hodgkin Lymphoma Adult Mixed Cellularity Hodgkin Lymphoma Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma Adult Nodular Sclerosis Hodgkin Lymphoma Adult Unfavorable Prognosis Hodgkin Lymphoma Recurrent Adult Hodgkin Lymphoma		null	1	arm 1: Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR.	[ 0 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Correlative studies	intervention 1: vorinostat intervention 2: laboratory biomarker analysis	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	25	0	0	0	NCT00132028	1COMPLETED	2009-05-01	2005-09-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 5 ]	4,484	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.	null	Osteoarthritis Arthritis, Rheumatoid	GI events in high risk GI arthritis patients	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Participants are assigned to one of two groups in parallel for the duration of the study intervention 2: Participants are assigned to one of two groups in parallel for the duration of the study	intervention 1: Celecoxib intervention 2: Diclofenac + Omeprazole	194	Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Hasselt \| N/A \| Belgium \| 5.33781 \| 50.93106 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 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 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Pointe-Claire \| Quebec \| Canada \| -73.81669 \| 45.44868 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Ste Foy \| Quebec \| Canada \| N/A \| N/A Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Chengdu \| Sichuan \| China \| 104.06667 \| 30.66667 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Tianjin \| N/A \| China \| 117.17667 \| 39.14222 Tianjin \| N/A \| China \| 117.17667 \| 39.14222 Medellín \| Antioquia \| Colombia \| -75.57151 \| 6.245 Barranquilla \| Atlántico \| Colombia \| -74.78132 \| 10.96854 Barranquilla \| Atlántico \| Colombia \| -74.78132 \| 10.96854 Bogota \| Cundinamarca \| Colombia \| N/A \| N/A Floridablanca \| Santander Department \| Colombia \| -73.08644 \| 7.06222 Cartago \| N/A \| Costa Rica \| -83.9195 \| 9.86371 Heredia \| N/A \| Costa Rica \| -84.11587 \| 9.99872 San José \| N/A \| Costa Rica \| -84.08489 \| 9.93388 San José \| N/A \| Costa Rica \| -84.08489 \| 9.93388 Opatija \| N/A \| Croatia \| 14.30782 \| 45.33658 Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Pilsen \| Bory \| Czechia \| 13.37759 \| 49.74747 Ostrava \| Trebovice \| Czechia \| 18.28204 \| 49.83465 České Budějovice \| N/A \| Czechia \| 14.47434 \| 48.97447 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Cuenca \| Azuay \| Ecuador \| -78.9963 \| -2.8953 Guayaquil \| Guayas \| Ecuador \| -79.88621 \| -2.19616 Quito \| Pichincha \| Ecuador \| -78.52495 \| -0.22985 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Amiens \| N/A \| France \| 2.3 \| 49.9 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Deggingen \| N/A \| Germany \| 9.71891 \| 48.5971 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hoyerswerda \| N/A \| Germany \| 14.23549 \| 51.43787 Künzing \| N/A \| Germany \| 13.08333 \| 48.66667 München \| N/A \| Germany \| 13.31243 \| 51.60698 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Guatemala City \| N/A \| Guatemala \| -90.51327 \| 14.64072 Lai Chi Kok \| N/A \| Hong Kong \| 114.14031 \| 22.3369 Shatin \| N/A \| Hong Kong \| 114.18333 \| 22.38333 Hyderabad \| Andhra Pradesh \| India \| N/A \| N/A Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Ludhiana \| Punjab \| India \| 75.85379 \| 30.91204 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Alytus \| N/A \| Lithuania \| 24.04142 \| 54.39635 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Klaipėda \| N/A \| Lithuania \| 21.13912 \| 55.7068 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Vlaardingen \| South Holland \| Netherlands \| 4.34167 \| 51.9125 Alkmaar \| N/A \| Netherlands \| 4.74861 \| 52.63167 Leidschendam \| N/A \| Netherlands \| 4.39281 \| 52.08167 Panama City \| N/A \| Panama \| -79.51973 \| 8.9936 Surco \| Lima region \| Peru \| -76.44002 \| -11.88401 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Ponta Delgada \| N/A \| Portugal \| -25.66874 \| 37.73952 Ponte de Lima \| N/A \| Portugal \| -8.58393 \| 41.76719 Ponte de Lima \| N/A \| Portugal \| -8.58393 \| 41.76719 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 Petrozavodsk \| N/A \| Russia \| 34.34691 \| 61.78491 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Smolensk \| N/A \| Russia \| 32.04371 \| 54.77944 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Belgrade \| N/A \| Serbia \| 20.46513 \| 44.80401 Niška Banja \| N/A \| Serbia \| 22.0057 \| 43.29507 Novi Sad \| N/A \| Serbia \| 19.83694 \| 45.25167 Sinapore \| N/A \| Singapore \| N/A \| N/A Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Bloemfontein \| Free State \| South Africa \| 26.214 \| -29.12107 Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Durban \| KZN \| South Africa \| 31.0292 \| -29.8579 Parow \| Western Cape \| South Africa \| 18.59992 \| -33.89723 Bellville \| N/A \| South Africa \| 18.62847 \| -33.90022 Cape Town \| N/A \| South Africa \| 18.42322 \| -33.92584 Kempton Park \| N/A \| South Africa \| 28.2377 \| -26.10859 Observatory Cape Town \| N/A \| South Africa \| 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 Partida de Bacarot \| Alicante \| Spain \| N/A \| N/A Sabadell \| Barcelona \| Spain \| 2.10942 \| 41.54329 Oviedo \| Principality of Asturias \| Spain \| -5.84476 \| 43.36029 Barakaldo \| Vizcaya \| Spain \| -2.98813 \| 43.29639 Ávila \| N/A \| Spain \| -4.69951 \| 40.65724 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Zaragoza \| N/A \| Spain \| -0.87734 \| 41.65606 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Luleå \| N/A \| Sweden \| 22.15465 \| 65.58415 Norrköping \| N/A \| Sweden \| 16.1826 \| 58.59419 Kaohsiung Hsien \| N/A \| Taiwan \| N/A \| N/A 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 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Ivano-Frankivsk \| N/A \| Ukraine \| 24.71248 \| 48.92312 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Lutsk \| N/A \| Ukraine \| 25.35024 \| 50.75784 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Simferopol \| N/A \| Ukraine \| 34.11079 \| 44.95719 Zaporizhzhia \| N/A \| Ukraine \| 36.76605 \| 48.03327 Helensburgh \| Argyle & Clyde \| United Kingdom \| -4.72648 \| 56.00614 Maidenhead \| Berks \| United Kingdom \| -0.71986 \| 51.52279 Aston Clinton \| Buckinghamshire \| United Kingdom \| -0.7254 \| 51.8002 St Austell \| Cornwall \| United Kingdom \| -4.77442 \| 50.3425 Bexhill-on-Sea \| East Sussex \| United Kingdom \| 0.47095 \| 50.85023 Aldershot \| Hampshire \| United Kingdom \| -0.76389 \| 51.24827 Basingstoke \| Hampshire \| United Kingdom \| -1.08708 \| 51.26249 Odiham \| Hampshire \| United Kingdom \| -0.93933 \| 51.25407 Ashford \| Middlesex \| United Kingdom \| 0.87376 \| 51.14648 Harrow \| Middlesex \| United Kingdom \| -0.33208 \| 51.57835 Camberley \| Surrey \| United Kingdom \| -0.74261 \| 51.33705 East Horsley, Leatherhead \| Surrey \| United Kingdom \| N/A \| N/A Pound Hill, Crawley \| WEST Sussex \| United Kingdom \| N/A \| N/A Bradford-on-Avon \| Wiltshire \| United Kingdom \| -2.25065 \| 51.34772 Chippenham \| Wiltshire \| United Kingdom \| -2.12472 \| 51.46 Upton \| Wirral \| United Kingdom \| -1.28677 \| 53.61466 Bexhill-on-Sea \| N/A \| United Kingdom \| 0.47095 \| 50.85023 Canterbury \| N/A \| United Kingdom \| 1.07992 \| 51.27904 Chesterfield \| N/A \| United Kingdom \| -1.41667 \| 53.25 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Peterborough \| N/A \| United Kingdom \| -0.24777 \| 52.57364 Peterborough \| N/A \| United Kingdom \| -0.24777 \| 52.57364 Saint Leonards-on-Sea \| N/A \| United Kingdom \| 0.5452 \| 50.85565 Swindon \| N/A \| United Kingdom \| -1.78116 \| 51.55797 Vale of Glamorgan \| N/A \| United Kingdom \| N/A \| N/A Wansford \| N/A \| United Kingdom \| -0.42001 \| 52.57851	4,460	0	0	0	NCT00141102	1COMPLETED	2009-05-01	2005-10-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	190	RANDOMIZED	SEQUENTIAL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance.	Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain has been linked to some symptoms of depression. Repetitive transcranial magnetic stimulation (rTMS) can be used to influence the brain's electrical activity. This procedure entails attaching electrodes to the head and using a device to pass magnetic energy through coils and into the brain. rTMS has been shown to have antidepressant effects in depressed individuals. However, optimal levels of intensity and treatment duration have yet to be determined. This study will assess the safety and effectiveness of rTMS on the prefrontal region of the brain in depressed adults with moderate treatment resistance. The treatment phase of this double-blind study will last a minimum of 32 weeks and will consist of 3 phases. In Phase I, participants will be randomly assigned to receive either rTMS or sham stimulation. The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. In Phase II, participants who were unresponsive to Phase I treatment will receive daily rTMS at a lower dose for 3 weeks. Participants who show signs of improvement, but have not achieved remission, may continue Phase II for 4 additional weeks. Baseline magnetic resonance images will be used to determine the optimal stimulus intensity by adjusting for individual differences in cortical to skull distances. Phase III participants will be only those who achieved remission in the first 2 phases. These participants will receive antidepressant medication treatment daily for six months. Participants' functional status and symptoms of depression will be measured using self-report scales and video-recorded interviews at study start date and at the end of each treatment phase.	Depression	Electric Stimulation Magnetic Stimulation Prefrontal Cortex Brain	null	4	arm 1: Phase I participants receiving rTMS arm 2: Phase I participants receiving sham stimulation arm 3: rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS arm 4: All patients who met remission who were then transitioned to medications after the TMS trial was completed.	[ 0, 2, 0, 0 ]	3	[ 3, 0, 3 ]	intervention 1: Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. intervention 2: Particpants who acheive remission with rTMS may start antidepressant medication in phase III. intervention 3: The sham stimulation will mimic the sensation of rTMS but will not induce an intracerebral current. Treatments will be administered daily for 3 weeks.	intervention 1: Prefrontal rTMS intervention 2: Antidepressant Regimen intervention 3: Sham Stimulation	4	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 New York \| New York \| United States \| -74.00597 \| 40.71427 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	395	0	0	0	NCT00149838	1COMPLETED	2009-05-01	2005-02-01	Medical University of South Carolina	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	196	NON_RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is an extension study of A7501013 (P05771/NCT00145496) to further test the efficacy and safety of Asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.	null	Schizophrenia		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 5-10 mg sublingually twice daily for 26 weeks intervention 2: 5-20 mg by mouth once daily for 26 weeks	intervention 1: asenapine intervention 2: olanzapine	0	null	195	0	0	0	NCT00174265	1COMPLETED	2009-05-01	2005-07-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2, 3 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.	Pulmonary arterial hypertension (PAH) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. This results in a pressure load on the heart and heart failure. The narrowing is in part due to constriction but mostly due to structural changes in affected vessels. The structural changes affect all cell components of the vessel wall (the endothelial lining, the muscle layer and fibrous tissue) and can lead to local clot formation. In addition there is evidence of inflammation of the vessels and what is known as oxidative stress. The disease may occur with no obvious cause, when it is known as idiopathic, but it can also be associated with a variety of other diseases, including congenital heart disease, collagen vascular disease and HIV infection. Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above. Alternative or additional treatments are therefore required and an attrative approach is to use a statin (a 3-hydroxy-3-methylglutaryl-coenzymeA, or HMG-CoA, reductase inhibitor). Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation, clot formation and oxidative stress - that might be beneficial in pulmonary hypertension.	Pulmonary Hypertension	Pulmonary hypertension Simvastatin Statins	null	2	arm 1: Placebo tablet once daily arm 2: Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Simvastatin 40mg od for 1 month, then 80mg od for 11 months intervention 2: Placebo tablet once daily.	intervention 1: Simvastatin intervention 2: Placebo	3	Giessen \| N/A \| Germany \| 8.67554 \| 50.58727 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	42	0	0	0	NCT00180713	1COMPLETED	2009-05-01	2005-10-01	Imperial College London	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.	null	Uterine Cervical Cancer	Cervical Carcinoma	null	1	arm 1: Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation	[ 0 ]	1	[ 0 ]	intervention 1: Gemcitabine weekly x 6 wks with concurrent external radiation	intervention 1: Gemcitabine	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	35	0	0	0	NCT00184093	1COMPLETED	2009-05-01	1999-06-01	University of Southern California	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	123	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.	Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen: Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.	Breast Cancer	Locally Advanced Breast Cancer Inflammatory Breast Cancer Breast Cancer Abraxane nab Paclitaxel Epirubicin Gemcitabine Gemzar	null	1	arm 1: Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles intervention 2: Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles intervention 3: ABI-007 175 mg/m2 D1 q 14 days x 6 cycles	intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Albumin-bound Paclitaxel	13	Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Lakeland \| Florida \| United States \| -81.9498 \| 28.03947 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Alexandria \| Louisiana \| United States \| -92.44514 \| 31.31129 Portland \| Maine \| United States \| -70.2589 \| 43.65737 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Newport News \| Virginia \| United States \| -76.42975 \| 36.98038	123	0	0	0	NCT00193206	1COMPLETED	2009-05-01	2005-09-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	414	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.	One interim analysis was planned for possible early termination due to proven efficacy when 75% of the preplanned 500 (approx. 375 patients) recruited patients completed the entire study duration or early discontinued. In addition to the stopping rule already given for proven efficacy, the sponsor was also interested in examining the data for futility (i.e., absence of the desired treatment effect) with the view to terminating the trial if an "insufficient" effect of the treatment is seen. The reasons why the need for futility arose were: 1. Recruitment difficulties 2. Increasing dropout rate 3. Budgetary constraints The primary efficacy measure is defined as the percent change from baseline to termination (Month 36 or Early Termination) in normalized brain volume (Brain Atrophy) measured according to the SIENA (Structural Imaging Evaluation using Normalization of Atrophy) method. However, since not many patients had completed the entire study at the time of futility analysis, it was the sponsor's decision that the futility analysis be performed on patients with MRI scans at months 24 or 36 or at early termination visits - the latest available. Based on the recalculation of study power (probability is unconditioned on the interim result and provide the real power of the study if designed anew), conditional power (based on the interim results) and risk assessment of a false negative, the Data Monitoring Committee agreed that the study should be terminated early.	Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis brain atrophy Glatiramer Acetate Copaxone Steroids Prednisone	null	2	arm 1: Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily. arm 2: Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.	[ 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 20mg glatiramer acetate (GA) administered by daily subcutaneous injections intervention 2: Placebo for prednisone given daily intervention 3: Prednisone 1250 mg taken daily	intervention 1: Glatiramer Acetate intervention 2: Placebo intervention 3: Prednisone	0	null	408	0	0	0	NCT00203047	6TERMINATED	2009-05-01	2005-01-01	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.	null	Primary Renal Transplant		null	2	arm 1: Standard of Care CNI immunosuppression arm 2: Calcineurin inhibitor withdrawal	[ 4, 0 ]	1	[ 0 ]	intervention 1: stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy	intervention 1: Calcineurin inhibitor withdrawal	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	40	0	0	0	NCT00214201	1COMPLETED	2009-05-01	2003-05-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	60	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.	Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids (GC). This is an investigator-initiated study funded by Aventis Pharmaceuticals. The study will be divided into 2 phases. All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study. In year one subjects will be randomly assigned to receive PTH (subcutaneously daily) or placebo and risedronate tablets or placebo. In year two, PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo. Subjects in group 2 and 3 will continue on risedronate tablets. In year one of the study, subjects were randomly assigned to one of the following treatment groups. 1. Group 1: rhPTH (1-34) (20ug subcutaneously daily) + riesdronate placebo tablets 2. Group 2: rhPTh (1-34) (20ug subcutaneously daily) + risedronate tablets (35mg/wk) 3. Group 3: rhPTh placebo (subcutaneous injections of normal saline) + risedronate tablets (35mg/wk) In year two of the study, beginning at the 12 month timepoint 1. Group 1 subjects were re-randomized to either: Group 1a: risedronate (35mg/wk) or Group 1b: risedronate placebo 2. Group 2 subjects continued risedronate (35mg/wk) 3. Group 3 subjects continued risedronate (35mg/wk) Potential study subjects will have dual x-ray absorptiometry measurements (DEXA) of the spine and hip at the screening visit. Those study subjects who meet the inclusion criteria will be invited back for a baseline visit. DEXA scans of the spine, hip, and forearm will be done at Baseline visit, 6-month, 12-month, 18-month, and 24-month follow-up visits. DEXA scan of the spine, hip, and forearm takes approximately 20 minutes to complete. To assess incident vertebral and non-vertebral fractures, lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment \[IVA\] will be done at Baseline, 12-month, and 24-month follow-up visits. The specific aims of the study are as follows: 1. To determine if changes in bone mineral density in the spine and hip caused by 1 year of treatment with rhPTH (1-34) alone then followed by risedronate or rhPTH (1-34) with risedronate are greater than PTH placebo and risedronate in patients with GIO who are taking calcium, MVIs and chronic low doses of glucocorticoids. 2. To determine if risedronate will preserve the high bone mass state created by 1 year of rhPTH (1-34) treatment. 3. To determine the association of biochemical markers of bone turnover with rhPTH (1-34) and risedronate both during and after treatment. 4. To compare, as possible, the fracture incidence between the rhPTH (1-34) alone followed by risedronate, and rhPTH (1-34) with risedronate compared to risedronate + placebo groups.	Osteoporosis	Osteoporosis Steroids Prednisone	null	4	arm 1: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year. arm 2: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year. arm 3: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year. arm 4: First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.	[ 1, 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: One 35mg tab of risedronate/placebo taken once a week for one year. intervention 2: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.	intervention 1: Risedronate intervention 2: Parathyroid Hormone	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	49	0	0	0	NCT00221299	1COMPLETED	2009-05-01	2005-09-01	University of California, Davis	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	129	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.	null	Atrial Fibrillation		null	2	arm 1: Catheter ablation arm 2: Antiarrhythmic drugs	[ 0, 1 ]	2	[ 1, 0 ]	intervention 1: Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System intervention 2: Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study	intervention 1: RF ablation intervention 2: Antiarrhythmic drugs	0	null	129	0	0	0	NCT00227344	6TERMINATED	2009-05-01	2004-12-01	Biosense Webster EMEA	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study will assess the efficacy of topiramate in the treatment of pathological gambling. Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal, familial, financial, social, and occupational impairments. In PG, the patient experiences a progressive inability to resist impulses to gamble, and gambling significantly disrupt the patient's functioning in the personal, familial, and/or vocational spheres. Topiramate has shown preliminary evidence of efficacy in some impulse control disorders.	This is a 14-week, outpatient, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of topiramate in subjects with pathological gambling. After giving informed consent, subjects who meet all the inclusion and exclusion criteria may be enrolled. The study will consist of three phases: * Washout/Screening Phase (up to 28 days prior to randomization or longer for those medications requiring a longer washout period; * Double-Blind Phase (Titration: up to 6 weeks; Maintenance: 8 weeks); and * Taper Phase (approximately 1 week). The study medication will be titrated to 300 mg/day or the subject's maximum tolerated dose (MTD). Subjects must reach a minimum dose of 50 mg/day by Week 2. The taper phase will last approximately one week where subjects gradually reduce their medication until they are no longer taking study medication. Patient may also give an optional blood sample for pharmacogenomic testing	Pathological Gambling	Pathological Gambling Compulsive Gambling Gambling topiramate	null	2	arm 1: 25mg to 300mg daily dose arm 2: placebo equivalent tablets	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: minimum does of 50mg/day intervention 2: matching tablet	intervention 1: Topiramate intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	42	0	0	0	NCT00245583	6TERMINATED	2009-05-01	2005-10-01	Icahn School of Medicine at Mount Sinai	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	56	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	false	The purpose of this study is to determine whether doxycycline (Periostat) at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass (CPB).	This proposal is for a randomized, placebo-controlled, double-blinded study of the use of doxycycline in patients requiring CABG surgery. Patients will be randomized 1:1 to receive either doxycycline or placebo. This study will be conducted in a blinded manner. The pharmacy will randomize patients and will have the randomization code. The code will only be broken in the case of an emergency and the event will be fully documented. In addition to standard care, patients will receive oral administration of 20 mg of doxycycline or placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3. Myocardial atrial biopsies will be taken at 2 time points during the CABG procedure: during cannulation of the right atrium and 10 minutes after cross-clamp release. Tissue will be analyzed for MMP-2 and -9 activity and TnI and MLC-1 levels. A Swan-Ganz-Catheter will be placed in the pulmonary artery over 24 hours to measure hemodynamics (LVSWI). A coronary sinus catheter will be placed under echocardiographic guidance prior to initiation of CPB (will be removed 20 minutes after cross-clamp release). Patients will have an additional ECG on post-operative days 1 and 3. Additional blood will be drawn to determine doxycycline plasma levels, MMP-2 and -9 activity, total gelatinolytic activity, and levels of troponin I and T products at the following time points: pre-induction, prior to initiation of CPB, 10 and 20 minutes following the release of the aortic cross clamp (arterial and venous) and 3, 6, 24 and 72 hours post aortic cross clamp removal (venous). Each of the above samples will require 6 mL of blood for a study total of 72 mL. At the time of each blood draw we will measure and record the hematocrit value.	Coronary Artery Bypass Grafting Cardiopulmonary Bypass Reperfusion Injury	Doxycycline coronary artery bypass grafting	null	2	arm 1: Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it). arm 2: Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3. intervention 2: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.	intervention 1: Periostat intervention 2: Placebo Oral Tablet	1	Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014	42	0	0	0	NCT00246740	1COMPLETED	2009-05-01	2005-10-01	University of Alberta	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	139	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC \[Study BMAC\]) will be examined.	null	Manic or Mixed Episode Associated With Bipolar I Disorder		null	2	arm 1: Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks. arm 2: Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: oral, daily intervention 2: Dose adjusted according to local package insert intervention 3: Dose adjusted according to local package insert intervention 4: Dose adjusted according to local package insert	intervention 1: olanzapine intervention 2: lithium intervention 3: valproate intervention 4: carbamazepine	11	Akita \| N/A \| Japan \| 140.11667 \| 39.71667 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Gunma \| N/A \| Japan \| N/A \| N/A Hokkaido \| N/A \| Japan \| N/A \| N/A Hyōgo \| N/A \| Japan \| 144.43333 \| 43.36667 Nara \| N/A \| Japan \| 135.80485 \| 34.68505 Okayama \| N/A \| Japan \| 133.93333 \| 34.65 Okinawa \| N/A \| Japan \| 127.80139 \| 26.33583 Saitama \| N/A \| Japan \| 139.65657 \| 35.90807 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	139	0	0	0	NCT00266630	1COMPLETED	2009-05-01	2005-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	25	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	1FEMALE	false	The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.	A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.	Breast Pain Non-cyclical Mastalgia Surgical Scar-Related Breast Pain		null	2	arm 1: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. arm 2: Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks intervention 2: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks	intervention 1: Diclofenac intervention 2: Placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	36	0	0	0	NCT00276419	6TERMINATED	2009-05-01	2005-06-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	86	RANDOMIZED	null	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when given together with paclitaxel and carboplatin to compare how well they work in treating patients with stage III, stage IV, or recurrent non-small cell lung cancer.	OBJECTIVES: * Compare the major objective response (complete and partial response) rates in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin. * Compare the duration of response, time to progression, and survival of patients treated with these regimens. * Characterize and compare the toxicities of these regimens. * Determine the recommended phase III dose of erlotinib hydrochloride. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 3. * Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and carboplatin as in arm I. In both arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.	Lung Cancer	recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer	null	3	arm 1: Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2 arm 2: Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2 arm 3: Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.	[ 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: None intervention 2: 150mg intervention 3: 200mg/m2 intervention 4: 1500mg	intervention 1: Carboplatin intervention 2: erlotinib hydrochloride intervention 3: Paclitaxel intervention 4: erlotinib hydrochloride	2	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 New York \| New York \| United States \| -74.00597 \| 40.71427	86	0	0	0	NCT00287989	1COMPLETED	2009-05-01	2004-11-01	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	50	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.	null	Melanoma	gene transfer gene therapy oncolytic virus GM-CSF melanoma	null	1	arm 1: Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.	[ 0 ]	1	[ 0 ]	intervention 1: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection	intervention 1: Talimogene Laherparepvec	8	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Robbinsdale \| Minnesota \| United States \| -93.33856 \| 45.03219 Montclair \| New Jersey \| United States \| -74.20903 \| 40.82593 New York \| New York \| United States \| -74.00597 \| 40.71427 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	50	0	0	0	NCT00289016	1COMPLETED	2009-05-01	2005-12-01	BioVex Limited	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	2,564	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.	null	Thromboembolism		null	2	arm 1: twice daily arm 2: prn to maintain INR (2-3)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: twice daily intervention 2: prn to maintain INR (2-3)	intervention 1: dabigatran etexilate 150 mg intervention 2: warfarin (INR 2-3)	250	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Pontiac \| Michigan \| United States \| -83.29105 \| 42.63892 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Valhalla \| New York \| United States \| -73.77513 \| 41.07482 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Grand Forks \| North Dakota \| United States \| -97.03285 \| 47.92526 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Altoona \| Pennsylvania \| United States \| -78.39474 \| 40.51868 Summerville \| South Carolina \| United States \| -80.17565 \| 33.0185 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Adrogué \| N/A \| Argentina \| -58.38384 \| -34.80041 Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Capital Federal \| N/A \| Argentina \| N/A \| N/A Woolloongabba \| Queensland \| Australia \| 153.03655 \| -27.48855 Bedford Park \| South Australia \| Australia \| 138.56815 \| -35.02204 Box Hill \| Victoria \| Australia \| 145.12545 \| -37.81887 Clayton \| Victoria \| Australia \| 145.11667 \| -37.91667 Windsor \| Victoria \| Australia \| 144.99241 \| -37.85344 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Campinas \| N/A \| Brazil \| -47.06083 \| -22.90556 Cerqueira César - Sao Paulo \| N/A \| Brazil \| N/A \| N/A Cerqueira César - São Paulo \| N/A \| Brazil \| N/A \| N/A Cristo Rei - Curitiba \| N/A \| Brazil \| N/A \| N/A Goiânia \| N/A \| Brazil \| -49.25389 \| -16.67861 Paraná \| N/A \| Brazil \| -38.31306 \| -6.48639 Porto Alegre \| N/A \| Brazil \| -51.23019 \| -30.03283 Rio de Janeiro - RJ \| N/A \| Brazil \| N/A \| N/A Santo André \| N/A \| Brazil \| -46.53833 \| -23.66389 São José do Rio Preto \| N/A \| Brazil \| -49.37944 \| -20.81972 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Saint Johns \| New Brunswick \| Canada \| N/A \| N/A Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Sainte-Foy \| Quebec \| Canada \| -71.29217 \| 46.78139 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Hranice \| N/A \| Czechia \| 17.73469 \| 49.54796 Jihlava \| N/A \| Czechia \| 15.59124 \| 49.3961 Liberec \| N/A \| Czechia \| 15.05619 \| 50.76711 Nový Jičín \| N/A \| Czechia \| 18.01028 \| 49.59438 Ostrava-Vitkovice \| N/A \| Czechia \| N/A \| N/A Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Tábor \| N/A \| Czechia \| 14.6578 \| 49.41441 Teplice \| N/A \| Czechia \| 13.82451 \| 50.6404 Ústí nad Labem \| N/A \| Czechia \| 14.03227 \| 50.6607 Zlín \| N/A \| Czechia \| 17.67065 \| 49.22645 Esbjerg \| N/A \| Denmark \| 8.45187 \| 55.47028 Holbæk \| N/A \| Denmark \| 11.71279 \| 55.7175 Kolding \| N/A \| Denmark \| 9.47216 \| 55.4904 København NV \| N/A \| Denmark \| 12.52343 \| 55.71258 København S \| N/A \| Denmark \| 12.5978 \| 55.65059 Slagelse \| N/A \| Denmark \| 11.35459 \| 55.40276 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Brest \| N/A \| France \| -4.48628 \| 48.39029 Lorient \| N/A \| France \| -3.37177 \| 47.74817 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nancy \| N/A \| France \| 6.18496 \| 48.68439 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Saint-Priest-en-Jarez \| N/A \| France \| 4.37678 \| 45.4739 Toulon Naval \| N/A \| France \| N/A \| N/A Toulon Naval \| N/A \| France \| N/A \| N/A Toulon Naval \| N/A \| France \| N/A \| N/A Toulon Naval \| N/A \| France \| N/A \| N/A Toulon Naval \| N/A \| France \| N/A \| N/A Vandœuvre-lès-Nancy \| N/A \| France \| 6.17114 \| 48.66115 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 München \| N/A \| Germany \| 13.31243 \| 51.60698 Püttlingen \| N/A \| Germany \| 6.88723 \| 49.2855 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 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 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Pécs \| N/A \| Hungary \| 18.23083 \| 46.0725 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Chennai \| N/A \| India \| 80.27847 \| 13.08784 Indore \| N/A \| India \| 75.8333 \| 22.71792 Karna \| N/A \| India \| 77.47331 \| 18.70866 Kerala \| N/A \| India \| N/A \| N/A Ludhiana \| N/A \| India \| 75.85379 \| 30.91204 Mysore \| N/A \| India \| 76.63925 \| 12.29791 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 Vadodara \| N/A \| India \| 73.20812 \| 22.29941 Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Ashkelon \| N/A \| Israel \| 34.57149 \| 31.66926 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Holon \| N/A \| Israel \| 34.77918 \| 32.01034 KfarSaba \| N/A \| Israel \| N/A \| N/A Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Tel Litwinsky \| N/A \| Israel \| 34.84588 \| 32.05096 Ẕerifin \| N/A \| Israel \| 34.84852 \| 31.95731 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Perugia \| N/A \| Italy \| 12.38878 \| 43.1122 Reggio Emilia \| N/A \| Italy \| 10.63125 \| 44.69825 Vimercate \| N/A \| Italy \| 9.36801 \| 45.61545 Vittorio Veneto (tv) \| N/A \| Italy \| 12.30065 \| 45.98026 Chihuahua City \| N/A \| Mexico \| -106.08889 \| 28.63528 Culiacán \| N/A \| Mexico \| -107.39421 \| 24.80209 San Luis Potosí City \| N/A \| Mexico \| -100.97135 \| 22.15234 's-Hertogenbosch \| N/A \| Netherlands \| 5.30417 \| 51.69917 Amersfoort \| N/A \| Netherlands \| 5.3875 \| 52.155 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Eindhoven \| N/A \| Netherlands \| 5.47778 \| 51.44083 Maastricht \| N/A \| Netherlands \| 5.68889 \| 50.84833 Nieuwegein \| N/A \| Netherlands \| 5.08056 \| 52.02917 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Auckland \| N/A \| New Zealand \| 174.76349 \| -36.84853 Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Otahuhu Auckland \| N/A \| New Zealand \| N/A \| N/A Takapuna Auckland \| N/A \| New Zealand \| N/A \| N/A Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Rud \| N/A \| Norway \| 11.63333 \| 60.43333 Trondheim \| N/A \| Norway \| 10.39506 \| 63.43049 Almada \| N/A \| Portugal \| -9.1569 \| 38.67902 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 Chelyabinsk \| N/A \| Russia \| 61.42915 \| 55.15402 Chelyabinsk \| N/A \| Russia \| 61.42915 \| 55.15402 Krasnodar \| N/A \| Russia \| 38.97603 \| 45.04484 Kursk \| N/A \| Russia \| 36.18712 \| 51.73758 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Novosibirsk \| N/A \| Russia \| 82.94339 \| 55.03442 Omsk \| N/A \| Russia \| 73.36859 \| 54.99244 Pskov \| N/A \| Russia \| 28.34493 \| 57.81404 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Ufa \| N/A \| Russia \| 55.96779 \| 54.74306 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Banská Bystrica \| N/A \| Slovakia \| 19.15349 \| 48.73946 Lučenec \| N/A \| Slovakia \| 19.66708 \| 48.33249 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Nové Zámky \| N/A \| Slovakia \| 18.16195 \| 47.98544 Žilina \| N/A \| Slovakia \| 18.73941 \| 49.22315 Centurion \| N/A \| South Africa \| 28.18577 \| -25.85891 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Randburg \| N/A \| South Africa \| 28.00123 \| -26.0941 Richards Bay \| N/A \| South Africa \| 32.03768 \| -28.78301 Roodepoort \| N/A \| South Africa \| 27.8725 \| -26.1625 Badalona (Barcelona) \| N/A \| Spain \| 2.24741 \| 41.45004 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Cartagena. Murcia \| N/A \| Spain \| N/A \| N/A Cuenca \| N/A \| Spain \| -2.13333 \| 40.06667 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Santander \| N/A \| Spain \| -3.80444 \| 43.46472 Torrelavega.Santander \| N/A \| Spain \| N/A \| N/A Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Jönköping \| N/A \| Sweden \| 14.15618 \| 57.78145 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Sundsvall \| N/A \| Sweden \| 17.3063 \| 62.39129 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Vinnitsa \| N/A \| Ukraine \| 37.71861 \| 49.84639 Zaporizhzhya \| N/A \| Ukraine \| 35.11714 \| 47.85167 Aberdeen \| N/A \| United Kingdom \| -2.09814 \| 57.14369 Headington, Oxford \| N/A \| United Kingdom \| N/A \| N/A 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 Newcastle upon Tyne \| N/A \| United Kingdom \| -1.61396 \| 54.97328 Sheffield \| N/A \| United Kingdom \| -1.4659 \| 53.38297	2,539	0	0	0	NCT00291330	1COMPLETED	2009-05-01	2006-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	124	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.	This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment. In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.	Combat Disorders Stress Disorders, Post-Traumatic	Atypical Antipsychotics Controlled Trial Paroxetine Quetiapine Stress Disorders, Post-Traumatic Treatment refractory Treatment resistant	null	3	arm 1: Open-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II. arm 2: In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion. arm 3: In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.	[ 5, 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Open-label Paroxetine intervention 2: Double-blind placebo taken with OL paroxetine intervention 3: Double-blind quetiapine taken with OL paroxetine	intervention 1: Open Label (OL) Paroxetine intervention 2: Placebo intervention 3: Quetiapine	3	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	174	0	0	0	NCT00292370	1COMPLETED	2009-05-01	2006-01-01	VA Office of Research and Development	1FED	false	false	false	null	0	0	0	0
[ 5 ]	127	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the safety of long-term administration of ARALAST. Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every 6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to ARALAST, and chemistry panel. Subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the ARALAST package insert.	null	Alpha1-antitrypsin Deficiency		null	0	null	null	1	[ 0 ]	intervention 1: Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician	intervention 1: ARALAST Alpha1-Proteinase Inhibitor	1	San Marino \| California \| United States \| -118.10646 \| 34.1214	127	0	0	0	NCT00313144	6TERMINATED	2009-05-01	2006-06-09	Baxalta now part of Shire	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	33	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer.	null	Lung Cancer, Small Cell	chemonaive small cell lung cancer untreated Lung cancer HYCAMTIN first-line extensive disease	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC. intervention 2: Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.	intervention 1: topotecan intervention 2: carboplatin	13	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Concord \| California \| United States \| -122.03107 \| 37.97798 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Munster \| Indiana \| United States \| -87.51254 \| 41.56448 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Amarillo \| Texas \| United States \| -101.8313 \| 35.222 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692	33	0	0	0	NCT00316186	1COMPLETED	2009-05-01	2005-06-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	242	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery. The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.	This is a randomized, prospective controlled trial in both diabetic and non diabetic patients undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass procedures and amputations, comparing tight versus standard blood glucose control regimens in the operating room, post anesthesia care unit and in the postoperative vascular intensive care unit up to 48 hours and its impact on the cardiovascular, infectious and other morbidity and mortality during the hospital admission and up to 30 days from surgery. After obtaining informed consent, the study subjects will be randomized to tight versus standard blood glucose control regimens. These regimens will be started in the operating room and continued for the first 48 hours or until their discharge, whichever is earlier. All the patients will be inpatients. Day surgery patients will be excluded. The anesthesiologist providing patient care will be given either the tight glucose control protocol or the standard sliding scale insulin protocol. In the tight control regimen, target blood glucose is 100-150 mg/dl. If 3 consecutive blood glucose (BG) level \>150 mg/dL or 1 BG level \>200 mg/dL, then the insulin infusion will be initiated in the tight control group. The insulin infusion rate adjustments will be made based on the blood sugar results. In post anesthetic care unit (PACU) and vascular intensive care unit (VICU), these protocols will be nurse driven. The adjustments will be made based on the current blood sugar levels as well as the insulin infusion rates. They are adjusted in such a way to account for the rate of change of blood sugars and the presence of steroid therapy in the patients. The frequency of blood glucose testing in this group will be every 1-hour until stable (when frequent changes in insulin dosage are no longer necessary, and glucose is in the range of 100 to 150 for 3 consecutive blood sugar checks); then test every 2 hours for 3 consecutive target values and then every 4 hours thereafter. If there is a change in the infusion rates, then blood sugar checks will be done every hour and the cycle followed thereafter. In the standard sliding scale insulin group, blood sugars will be treated with insulin boluses if the blood sugars go more than 150 mg/dL and blood glucose will be monitored every 4 hours. These regimens will be initiated after 2 weeks of in-service training for anesthesiologists, post anesthetic care unit (PACU) and vascular intensive care unit (VICU) nurses. The study investigators will provide this training. Insulin infusion in the tight control regimen will be started through pump piggyback to maintenance intravenous infusion as follows. Insulin infusion bags will be made by the pharmacy (100 units in a 100 ml bag). The anesthesiologists in the operating room and PACU, and VICU nurses will perform blood glucose monitoring, bolus insulin administration, and infusion initiation and rate adjustments as specified by the protocol. Blood glucose levels will be tested by finger stick method or arterial line drop sample.	Peripheral Vascular Disease Abdominal Aortic Aneurysm	Tight Glycemic control outcomes peripheral vascular disease infection cardiovascular morbidity mortality	null	2	arm 1: Continuous intravenous insulin infusion to control glucose to \<150 mg/dL in patients undergoing open peripheral vascular bypass surgery arm 2: Intermittent intravenous insulin insulin boluses to a blood glucose target of \<150mg/dL in patients undergoing peripheral vascular bypass surgery	[ 0, 1 ]	1	[ 0 ]	intervention 1: Tight glucose control versus standard of care	intervention 1: continuous intravenous insulin infusion	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	236	0	0	0	NCT00328094	6TERMINATED	2009-05-01	2006-03-01	Beth Israel Deaconess Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	61	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.	null	Human Immunodeficiency Virus (HIV) Infections	HIV-Infected Patients Evidencing Virologic Suppression	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks	intervention 1: Atazanavir + Ritonavir	7	Córdoba \| N/A \| Spain \| -4.77275 \| 37.89155 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016	61	0	0	0	NCT00337467	1COMPLETED	2009-05-01	2006-06-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	44	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated or treated with chemotherapy. Participants will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum. The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population. Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of participants treated with this combination.	Oxaliplatin causes death of cancer cells and other actively dividing cells by interfering with DNA function. Capecitabine causes death of cancer cells by interfering with certain molecules that are important in cell division. After the screening portion of the study, if you are eligible to continue, you will begin treatment with oxaliplatin and capecitabine. Once treatment begins, you will come to M. D. Anderson at least every three weeks (21 days) for treatment. Each 21-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy unless side effects are severe or the cancer grows very quickly. You will need to have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm to receive oxaliplatin. The central venous line will remain in place the entire time you are taking part in this study. Oxaliplatin must be given at M. D. Anderson. On Day 1 of each cycle, you will receive oxaliplatin injected into a vein over 2 hours. You will take capecitabine tablets by mouth 2 times a day for the first 2 weeks (Days 1-14) of each 3-week cycle. No treatment will be given for the last 7 days of each cycle (except if your first dose of capecitabine for a new cycle is taken in the evening, your last dose will be taken in the morning of Day 15.) You must take capecitabine within 30 minutes after breakfast and dinner. The morning and evening doses should be about 12 hours apart. You should take capecitabine with water, and not with fruit juices. At the first treatment visit and every 3 weeks, you will receive enough capecitabine to last until the next visit. At each visit, you must return any capecitabine you have not used as well as all empty bottles. Before each new cycle of therapy, you will have a complete physical exam and blood (about 2 ½ teaspoons) will be collected for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. During the first cycle, you will have a blood (about 2 teaspoons) sample collected each week for routine tests. You will also have either CT scans or a MRI of the tumor(s) every 9 weeks and at the end of the study. Additional tests may be done during the study if your doctor feels it is necessary for your care. If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study until the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you. When you stop taking part in the study, you will have blood (about 3 teaspoons) collected for routine tests. You will have a physical exam and either a CT scan or a MRI to check on the status of the disease. You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing. All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson. This is an investigational study. The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum. However, the drugs are not approved for gallbladder or biliary tract cancer. Up to 50 participants will take part in this study. All will be enrolled at M. D. Anderson.	Cancer of the Gallbladder Cancer of the Biliary Tract	Gastrointestinal Capecitabine Oxaliplatin Carcinoma of the Gallbladder Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract Xeloda Eloxatin	null	1	arm 1: Combination of intravenous (IV) oxaliplatin 100 mg/m\^2 Day 1 and oral (PO) capecitabine 750 mg/m\^2 twice daily (total daily dose 1500 mg/m2) on Days 1-14.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 1500 mg/m\^2 PO twice daily x 14 days. intervention 2: 130 mg/m\^2 IV over 2 hours on day 1 of cycle.	intervention 1: Capecitabine intervention 2: Oxaliplatin	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	44	0	0	0	NCT00338988	1COMPLETED	2009-05-01	2003-08-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of moderate-to-severe keratoconjunctivitis sicca (KCS). Patients will be randomized to receive either CF101 1 mg or matching placebo, given orally every 12 hours (q12h) for 12 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 12-week treatment period, followed by a 2-week follow-up period.	At a Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, sitting blood pressure, pulse rate and temperature, and clinical laboratory tests. Disease activity will be assessed using tear meniscus (TM) height, tear break-up time (BUT), fluorescein staining (FS), Schirmer test, and the Dry Eye Symptom Score (DESS). Doses of artificial tears must be stable for \>2 weeks prior to the Screening Visit. Eligible patients will begin a 2-week run-in period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for lubricant eye drops. Patients who successfully complete the 2-week run-in period will be randomized to their assigned medication (CF101 1 mg or matching placebo) to be taken orally every q12h for 12 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8 and 12, and at Week 14 for a final follow-up assessment.	Keratoconjunctivitis Sicca	Keratoconjunctivitis Sicca KCS Dry Eye	null	2	arm 1: CF101 1 mg given orally every 12 hours for 12 weeks arm 2: Placebo given orally every 12 hours for 12 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Orally CF101 1mg intervention 2: Orally matching Placebo	intervention 1: CF101 intervention 2: Placebo	3	Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Tel Litwinsky \| N/A \| Israel \| 34.84588 \| 32.05096 Ẕerifin \| N/A \| Israel \| 34.84852 \| 31.95731	76	0	0	0	NCT00349466	1COMPLETED	2009-05-01	2007-01-01	Can-Fite BioPharma	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	83	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.	The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects. The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period. The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function. The study is including patients undergoing hemorrhoidectomy.	Hemorrhoids Pain	hemorrhoids hemorrhoidectomy S (+) ketamine pain	null	2	arm 1: Saline 0,9% arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery intervention 2: isotonic saline	intervention 1: S (+) Ketamine intervention 2: Placebo	1	Rud \| N/A \| Norway \| 11.63333 \| 60.43333	83	0	0	0	NCT00354029	1COMPLETED	2009-05-01	2006-08-01	Asker & Baerum Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	7	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.	This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness \<225 microns).	Choroidal Neovascularization	Hemorrhagic Choroidal Neovascularization	null	2	arm 1: 0.3 mg/0.05 ml dose of ranibizumab arm 2: 0.5 mg/0.05 ml dose of ranibizumab	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 0.3 mg/0.05 ml dose intervention 2: 0.5 mg/0.05 ml dose	intervention 1: Ranibizumab intervention 2: Ranibizumab	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	7	0	0	0	NCT00363168	1COMPLETED	2009-05-01	2006-08-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	3	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	true	During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with supportive care. During follow-up, patients will be monitored out to 730 days.	1. Pre- Transplantation Phase - 1. Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously. Alternatively, patients may receive G-CSF alone (same dose) as mobilization therapy. 2. Leukapheresis will begin day 4 of G-CSF administration and proceed according to institutional guidelines. Leukapheresis will continue until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. A minimum recipient body weight is required to proceed to transplantation. 2. Transplantation Phase a. Conditioning/Preparative therapy - up to 30 days following PBSC collection, patients will begin conditioning therapy with Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2; subsequent doses will be adjusted based on pharmacokinetic monitoring. * Busulfan plasma level monitoring, collected around the first dose of busulfan b. Stem cell reinfusion - following 1 day of rest, previously collected autologous peripheral blood stem cells will be infused. * The administration of supportive measures (e.g. intravenous fluids, antihistamines) during stem cell reinfusion will be performed according to institutional guidelines. 3. Supportive care 1. Antibiotic prophylaxis- according to hospital/institutional guidelines, and at the discretion of the treating physician. 2. Growth factor support 3. Transfusion support 4. Prophylaxis for busulfan-induced seizures 4. During follow-up, patients will be seen at least weekly for the first month and there after periodically out to 730 days posttransplant. The following medical procedures will be done: * Medical history and physical exam (including concurrent meds, vital signs, performance status and weight) * Standard labs * Bone marrow aspirate and biopsy	Acute Myeloid Leukemia (AML)	Busulfan Acute myeloid leukemia (AML) Hematopoietic Stem Cell Transplantation (HSCT) Dendritic cells Bone marrow transplantation PBSC mobilization Autologous stem cells	null	1	arm 1: G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion	[ 5 ]	4	[ 0, 0, 0, 3 ]	intervention 1: Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously. Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10 mcg/kg twice daily subcutaneously. intervention 2: leukapheresis intervention 3: Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2 intervention 4: autologous stem cell transplant	intervention 1: G-CSF intervention 2: Leukapheresis intervention 3: Busulfan intervention 4: Stem cell reinfusion	1	Tampa \| Florida \| United States \| -82.45843 \| 27.94752	2	0	0	0	NCT00363467	6TERMINATED	2009-05-01	2006-05-01	H. Lee Moffitt Cancer Center and Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	92	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer	null	Breast Cancer Metastasis	Recurrent, locally-advanced, or metastatic breast cancer	null	1	arm 1: Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).	[ 0 ]	2	[ 0, 0 ]	intervention 1: Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average \<6 months) intervention 2: Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average \<6 months)	intervention 1: Dasatinib intervention 2: Dasatinib 100 mg	23	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Haedo \| Buenos Aires \| Argentina \| -58.59212 \| -34.64239 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Paris \| N/A \| France \| 2.3488 \| 48.85341 Saint-Herblain \| N/A \| France \| -1.651 \| 47.21154 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Modena \| N/A \| Italy \| 10.92539 \| 44.64783 Arequipa \| Arequipa \| Peru \| -71.53747 \| -16.39899 Lima \| Lima Province \| Peru \| -77.02824 \| -12.04318 Lima \| Lima Province \| Peru \| -77.02824 \| -12.04318 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Lleida \| N/A \| Spain \| 0.62218 \| 41.61674 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165	70	0	0	0	NCT00371345	1COMPLETED	2009-05-01	2006-12-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	133	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.	null	Non-Small-Cell Lung Cancer		null	2	arm 1: None arm 2: None	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 3: Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles	intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Carboplatin	12	Coswig \| N/A \| Germany \| 13.58312 \| 51.13204 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Großhansdorf \| N/A \| Germany \| 10.28333 \| 53.66667 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hofheim \| N/A \| Germany \| 8.41385 \| 49.65749 Homburg/Saar \| N/A \| Germany \| N/A \| N/A Immenhausen \| N/A \| Germany \| 9.48017 \| 51.42763 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Lübeck \| N/A \| Germany \| 10.68729 \| 53.86893 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 München \| N/A \| Germany \| 13.31243 \| 51.60698	130	0	0	0	NCT00402051	1COMPLETED	2009-05-01	2006-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	128	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP). Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP. The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience. This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.	Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP. The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience. This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.	Familial Amyloid Polyneuropathy	FAP Fx-1006A transthyretin TTR amyloid polyneuropathy V30M familial hereditary amyloidosis FoldRx	null	2	arm 1: Fx-1006A arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months intervention 2: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months	intervention 1: Fx-1006A intervention 2: Placebo	10	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ciudad de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Rio de Janeiro \| Southeast \| Brazil \| -43.18223 \| -22.90642 Le Kremlin-Bicêtre \| Île-de-France Region \| France \| 2.36073 \| 48.81471 Münster \| North Rhine-Westphalia \| Germany \| 7.62571 \| 51.96236 Lisbon \| Lisbon District \| Portugal \| -9.1498 \| 38.72509 Porto \| Norte \| Portugal \| -8.61099 \| 41.14961 Barcelona \| Catalonia \| Spain \| 2.15899 \| 41.38879 Umeå \| Västerbotten County \| Sweden \| 20.25972 \| 63.82842 London \| London \| United Kingdom \| -0.12574 \| 51.50853	128	0	0	0	NCT00409175	1COMPLETED	2009-05-01	2007-01-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	33	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.	* Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day. * Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor. * Participants will remain on the study as long as they continue to benefit from the study medication.	Pancreatic Cancer	RAD001 metastatic pancreatic cancer	null	1	arm 1: RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent. Four weeks of study drug was considered to be one cycle of treatment.	[ 0 ]	1	[ 0 ]	intervention 1: Taken orally daily for as long as the participant continues to receive a benefit.	intervention 1: RAD001	3	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	33	0	0	0	NCT00409292	1COMPLETED	2009-05-01	2007-01-01	Dana-Farber Cancer Institute	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Primary Objectives: * Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy. * To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron premedication using two schedules of palonosetron administration.	Palonosetron is designed to work by blocking the substance serotonin from binding to the brain and gastrointestinal tract, which may help to decrease nausea and vomiting. Participants in this study will be receiving biochemotherapy treatment as part of their routine care. This treatment will include 3 chemotherapy drugs (cisplatin, vinblastine, and DTIC) and 2 drugs that stimulate the immune system (interferon and interleukin-2 (IL-2)). Biochemotherapy often causes nausea, vomiting, loss of appetite, and weight loss. Palonosetron will be given on this study to try to treat the side effects of biochemotherapy. If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. You have an equal chance of being assigned to either group. Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30 minutes before receiving chemotherapy on Days 1 and 4 of therapy. Participants in Group 2 will receive palonosetron by vein over a few minutes on Days 1, 3, and 5. All participants on this study will also receive Ativan by vein every 8 hours for 5 days. Ativan is given for additional control of nausea and it will also help to sedate you. In addition to palonosetron, you may be given standard anti-nausea medications such as lorazepam or compazine if you experience intolerable nausea and vomiting while on study. You will also be asked to fill out a Functional Living Index-Emesis (FLIE) questionnaire every day for 7 days in a row. The questionnaire will ask about any nausea and/or vomiting you are experiencing and the effect of the therapy on your quality of life. You will stay in the hospital for at least 7 days while you receive treatment. After the first course of palonosetron given with biochemotherapy, your doctor will decide if you will receive additional courses of palonosetron or if you will be given another anti-nausea drug. If your doctor does decide to have you continue on palonosetron, it will be given off study. Your participation in this study will be over after 1 course. This is an investigational study. Palonosetron has been approved by FDA for control of nausea and vomiting caused by chemotherapy. However, it has not been adequately evaluated for safety and effectiveness in patients receiving high dose interleukin-2 alone or in combination with chemotherapy. About 30 patients will take part in this study. All patients will enrolled at M. D. Anderson.	Melanoma	Melanoma Nausea Vomiting Palonosetron Cisplatin Vinblastine Loss of Appetite Weight loss	null	2	arm 1: 2 Days Palonosetron 0.25 mg intravenous (IV) arm 2: 3 Days Palonosetron 0.25 mg IV	[ 1, 1 ]	1	[ 0 ]	intervention 1: 0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.	intervention 1: Palonosetron	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	30	0	0	0	NCT00412425	1COMPLETED	2009-05-01	2006-11-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	82	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.	null	Ankylosing Spondylitis	Axial Ankylosing Spondylitis Adult	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 50 mg injection once weekly intervention 2: placebo	intervention 1: Etanercept (Enbrel) intervention 2: Placebo	21	Amiens \| N/A \| France \| 2.3 \| 49.9 Arles \| N/A \| France \| 4.63031 \| 43.67681 Avignon \| N/A \| France \| 4.80892 \| 43.94834 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Cabestany \| N/A \| France \| 2.9409 \| 42.68141 Corbeil-Essonnes \| N/A \| France \| 2.48757 \| 48.60603 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nice \| N/A \| France \| 7.26608 \| 43.70313 Orléans \| N/A \| France \| 1.90389 \| 47.90289 Paris (Ambroise Pare) \| N/A \| France \| 2.3488 \| 48.85341 Paris (Bichat) \| N/A \| France \| 2.3488 \| 48.85341 Paris (cochin) \| N/A \| France \| 2.3488 \| 48.85341 Paris (Pitie Salpetriere) \| N/A \| France \| 2.3488 \| 48.85341 Paris (Saint Antoine) \| N/A \| France \| 2.3488 \| 48.85341 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Herne \| N/A \| Germany \| 7.22572 \| 51.5388 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Maastricht \| N/A \| Netherlands \| 5.68889 \| 50.84833	159	0	0	0	NCT00420238	1COMPLETED	2009-05-01	2007-01-01	Wyeth is now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI) Schizophrenia Research Unit (SRU) inpatient facility.	This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS\], major depressive disorder with psychotic features, and bipolar disorder with psychotic features) in an inpatient and day hospital setting with ziprasidone (Geodon). Ziprasidone is a second-generation antipsychotic (SGA) that is FDA-approved for the treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in adults. It is also used clinically in the treatment of psychotic disorders in children, adolescents and adults. This protocol will help to elucidate the feasibility of studying the treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help facilitate the further study of the treatment of psychosis with novel agents that have a favorable side effect and weight gain profile. The duration of the study can be up to 7 weeks. Depending on the level of symptom severity patients will be managed on either the Schizophrenia Research Unit (SRU) (GAS\<35, CGI-S\>5), or the Children's Day Unit (CDU) of the NYSPI. The seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results. Over a period of one to two weeks patients will be titrated up to 120 mg/day (80 mg for patients under 45kg), and, if necessary, cross tapered off of another SGA that had not been working successfully. Subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study.	Schizophreniform Disorder Schizoaffective Disorder Psychosis Depressive Disorder, Major Bipolar Disorder	psychosis NOS MDD w/ psychotic features bipolar disorder w. psychotic features	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: subjects will use ziprasidone	intervention 1: Ziprasidone	1	New York \| New York \| United States \| -74.00597 \| 40.71427	0	0	0	0	NCT00421954	1COMPLETED	2009-05-01	2006-05-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	16	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.	null	Coccidioidomycosis		null	2	arm 1: Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. arm 2: Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months intervention 2: Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months	intervention 1: Posaconazole intervention 2: Fluconazole	0	null	28	0	0	0	NCT00423267	1COMPLETED	2009-05-01	2007-05-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	181	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.	null	Amyotrophic Lateral Sclerosis (ALS)	Amyotrophic lateral sclerosis (ALS)	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times. intervention 2: Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.	intervention 1: MCI-186 intervention 2: Placebo of MCI-186	1	Watari-gun \| Miyagi \| Japan \| N/A \| N/A	181	0	0	0	NCT00424463	1COMPLETED	2009-05-01	2007-01-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	null	0ALL	null	Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).	null	Renal Transplantation	Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy	null	2	arm 1: Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids arm 2: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Everolimus + Cyclosporine intervention 2: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) intervention 3: Steroids	1	Paris \| N/A \| France \| 2.3488 \| 48.85341	30	0	0	0	NCT00425308	1COMPLETED	2009-05-01	2006-10-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0

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