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 drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
In this study the investigators will be using an AUC of 6 based on creatinine clearance using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols. Given that myelosuppression was significant using the docetaxel dose of 75 mg/m\*2 in the SCOTROC trial, the prophylactic use of pegylated G-CSF in...
null
Ovarian Cancer
null
1
arm 1: * Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles * Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Docetaxel intervention 2: Carboplatin intervention 3: Pegylated G-CSF
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
0
0
0
NCT02469116
6TERMINATED
2010-03-01
2006-01-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
549
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatment...
We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine 0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron \& Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced fibrosis/cirrhosis. The specific aims of this proposal are to ev...
Hepatitis C Virus Advanced Fibrosis Cirrhosis
hepatitis C cirrhosis interferon colchicine
null
2
arm 1: PEG-Intron 0.5mcg/kg once a week SC arm 2: 0.6mg twice a day
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: 0.6mg twice a day
intervention 1: PEG -Intron intervention 2: Colchicine
49
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Bakersfield | California | United States | -119.01871 | 35.37329 Sacramento | California | United States | -121.4944 | 38.58157 Sacramento | California | United States | -121.4944 | 38.58157 San Die...
549
0
0
0
NCT00179413
1COMPLETED
2010-03-03
2000-01-15
Beth Israel Deaconess Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.
null
Breast Cancer
null
1
arm 1: Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
[ 0 ]
2
[ 0, 0 ]
intervention 1: R1507 was administered at a dose 16 mg/kg every 3 weeks. intervention 2: Letrozole was administered orally at a dose 2.5 mg daily.
intervention 1: RG1507 intervention 2: Letrozole
6
Birmingham | Alabama | United States | -86.80249 | 33.52066 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgia | United States | -84.38798 | 33.749 St Louis | Missouri | United States | -90.19789 | 38.62727 Houston | Tex...
6
0
0
0
NCT00796107
6TERMINATED
2010-03-03
2009-01-28
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
576
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.
null
Alzheimer's Disease
Alzheimer's disease Cognition SB-742457
null
4
arm 1: SB-742457 - 15mg arm 2: None arm 3: SB-742457 - 35mg arm 4: None
[ 0, 2, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: investigational drug intervention 2: comparator intervention 3: comparator
intervention 1: SB-742457 intervention 2: Donepezil intervention 3: Placebo
72
Shumen | N/A | Bulgaria | 26.92286 | 43.27064 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Viña del Mar | Región de Valparaíso | Chile | -71.55183 | -33.02457 Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694 San...
574
0
0
0
NCT00708552
1COMPLETED
2010-03-09
2008-07-04
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
null
Lymphoma, B-Cell
B-cell Non-Hodgkin's Lymphoma NHL
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: 1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs. intervention 2: 375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
intervention 1: Inotuzumab Ozogamicin (CMC-544) intervention 2: Rituximab (Rituxan)
4
Aichi | N/A | Japan | 130.62158 | 32.51879 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895
10
0
0
0
NCT00724971
1COMPLETED
2010-03-10
2008-07-04
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
184
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).
null
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic
null
1
arm 1: Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: esmirtazapine
0
null
184
0
0
0
NCT00750919
6TERMINATED
2010-03-10
2008-10-07
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
69
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.
Objectives: The combination of methotrexate-sulfasalazine-hydroxychloroquine has been shown to be more effective than methotrexate alone or the double combination of methotrexate-sulfasalazine or methotrexate-hydroxychloroquine. The objective of this study is to look at the safety and efficacy of a new DMARD, leflunomi...
Rheumatoid Arthritis
null
3
arm 1: Group A: Leflunomide alone arm 2: Methotrexate, Sulfasalazine, Hydroxychloroquine. arm 3: Leflunomide-Sulfasalazine-Hydroxychloroquine
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: A loading dose of 100 mg (or placebo) for three (3) days will be given. Following that three-day period, a dose of 20 mg/day will be maintained throughout the remainder of the study. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor toxicities occur (e.g., diar...
intervention 1: Leflunomide intervention 2: Methotrexate-Sulfasalazine-Hydroxychloroquine intervention 3: Leflunomide-Sulfasalazine-Hydroxychloroquine
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
69
0
0
0
NCT00579878
1COMPLETED
2010-03-11
2001-03-27
University of Nebraska
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
129
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection
This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days. Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 t...
Complicated Urinary Tract Infection
Complicated Urinary Tract Infection Pyelonephritis Antimicrobial Cephalosporin Intravenous
null
2
arm 1: CXA-101 arm 2: Ceftazidime
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: intravenous intervention 2: intravenous
intervention 1: CXA-101 intervention 2: Ceftazidime
21
Los Angeles | California | United States | -118.24368 | 34.05223 Orlando | Florida | United States | -81.37924 | 28.53834 Decatur | Georgia | United States | -84.29631 | 33.77483 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Picayune | Mississippi | United States | -89.67788 | 30.52556 Butte | Montana |...
127
0
0
0
NCT00921024
1COMPLETED
2010-03-11
2009-06-30
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
69
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.
The results of previous trials showed that the safety profile of sugammadex observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. Reoccurrence of neuromuscular blockade was not observed, and sugammadex was safe and generally well tolerated in subjects...
Anesthesia
null
2
arm 1: Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance \<30mL/min. arm 2: Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 s...
[ 0, 1 ]
1
[ 0 ]
intervention 1: Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1 - 0.2 mg.kg-1 rocuronium may be given. In case of maintenance dosing, the target depth of neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC...
intervention 1: sugammadex
0
null
68
0
0
0
NCT00702715
1COMPLETED
2010-03-15
2008-09-24
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
176
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.
This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-l...
Pulmonary Disease, Chronic Obstructive
Dose ranging Chronic Bronchitis Long-acting muscarinic antagonist cross-over COPD Emphysema Chronic Obstructive Pulmonary Disease (COPD) anticholinergic
null
10
arm 1: Placebo arm 2: Tiotropium arm 3: GSK573719 1000mcg once daily arm 4: GSK573719 500mcg once daily arm 5: GSK573719 250mcg once daily arm 6: GSK573719 125mcg once daily arm 7: GSK573719 62.5 mcg once daily arm 8: GSK573719 250mcg twice daily arm 9: GSK573719 125mcg twice daily arm 10: GSK573719 62.5mcg twice daily
[ 2, 1, 0, 0, 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: long-acting muscarinic receptor antagonist; 18mcg once-daily intervention 2: Inactive/ excipients only intervention 3: GSK573179 investigational drug
intervention 1: Tiotropium intervention 2: Placebo intervention 3: GSK573179
19
Phoenix | Arizona | United States | -112.07404 | 33.44838 San Diego | California | United States | -117.16472 | 32.71571 Upland | California | United States | -117.64839 | 34.09751 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Easley | South Carolina | United States | -82.60152 | 34.82984 Gaffney | South Car...
472
0
0
0
NCT00950807
1COMPLETED
2010-03-15
2009-09-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
62
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
null
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Chronic Prostatis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Intravenous, 20 mg, single dose. intervention 2: Intravenous placebo, single dose
intervention 1: Tanezumab intervention 2: Placebo
44
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Goodyear | Arizona | United States | -112.35821 | 33.43532 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Costa Mesa | Ca...
62
0
0
0
NCT00826514
1COMPLETED
2010-03-17
2009-03-25
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
100
RANDOMIZED
CROSSOVER
9OTHER
2DOUBLE
false
0ALL
false
The purpose of this study is to see if GSK1292263 is safe and well-tolerated when administered to type 2 diabetics, and to get preliminary information about whether it may be effective in the treatment of type 2 diabetes.
Data from this study will be used to assess the potential of GSK1292263 as a treatment for T2DM, and will aid the design and dose selection of future studies of longer duration in T2DM subjects that will evaluate GSK1292263 alone or in combination with other anti-diabetic drugs.
Diabetes Mellitus, Type 2
Tolerability Pharmacokinetics Safety Pharmacodynamics Glucose
null
3
arm 1: Part A (Cohort 1) is a single-blind, randomized, placebo-controlled, 5-period crossover in which drug naïve T2DM subjects will receive escalating doses of GSK1292263 in each of 3 periods and placebo and open-label sitagliptin in the other 2 periods. The sequence will be randomized, but will maintain the low, med...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: GSK1292263 is an immediate-release round, white, film-coated tablet provided in 3 strengths, 25mg, 75mg and 200mg being developed for the treatment of type 2 diabetes. intervention 2: Matching placebo to active drug GSK1292263 intervention 3: Sitagliptin (Januvia) 100mg tablets are beige, round, film-co...
intervention 1: GSK1292263 intervention 2: GSK1292263 matching placebo intervention 3: Sitagliptin
7
Phoenix | Arizona | United States | -112.07404 | 33.44838 Chula Vista | California | United States | -117.0842 | 32.64005 Miami | Florida | United States | -80.19366 | 25.77427 Durham | North Carolina | United States | -78.89862 | 35.99403 Columbus | Ohio | United States | -82.99879 | 39.96118 San Antonio | Texas | Uni...
150
0
0
0
NCT01119846
1COMPLETED
2010-03-19
2009-06-05
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability...
It was planned that this Phase 2a, open-label, safety and efficacy study to be performed at 5 sites in the US and 1 site in the United Kingdom. The study was to enroll \~30 boys with nonsense mutation DMD/BMD (nmDBMD) who have been nonambulatory for at least 1 year. Enrollment was to be stratified to ensure evaluation...
Duchenne Muscular Dystrophy Becker Muscular Dystrophy
Duchenne muscular dystrophy Becker muscular dystrophy Nonsense mutation Premature stop codon DMD BMD Ataluren PTC124
null
1
arm 1: Ataluren was provided as a vanilla-flavored powder to be mixed with water, apple juice, or milk. Study drug dosing was based on milligrams of drug per kilogram of body weight. The dose level for ataluren was 20 milligrams/kilograms (mg/kg) in the morning, 20 mg/kg at midday, and 40 mg/kg in the evening. Administ...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Oral powder intervention 2: Enrollment was stratified to ensure evaluation of approximately half of the participants were receiving chronic corticosteroid therapy and approximately half of participants were not receiving chronic corticosteroid therapy. Therefore, 3 out of 6 participants were receiving c...
intervention 1: Ataluren intervention 2: Chronic Corticosteroid Therapy
6
Davis | California | United States | -121.74052 | 38.54491 Boston | Massachusetts | United States | -71.05977 | 42.35843 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 St Louis | Missouri | United States | -90.19789 | 38.62727 Columbus | Ohio | United States | -82.99879 | 39.96118 Newcastle upon Tyne | ...
6
0
0
0
NCT01009294
6TERMINATED
2010-03-23
2010-01-13
PTC Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Participating subjects are those who are referred for electroconvulsive therapy (ECT) for severe depression who have agreed to the protocol. The control group receives ECT as usual. The other group receives propofol to terminate the ECT-induced seizure timed so that the seizure lasts at least 25 seconds. Extensive neur...
ECT Administration All patients will receive ECT administered using a Thymatron-System IV (Somatics, LLC , Lake Bluff, IL) ECT device, the same device used for our usual ECT. All patients will be monitored with continuous electrocardiogram (EKG) monitoring, pulse oximetry, and regular blood pressure readings from an au...
Major Depression
Depression Electroconvulsive therapy
null
2
arm 1: ECT as usual arm 2: ECT-induced seizures terminated with propofol
[ 1, 0 ]
3
[ 3, 3, 0 ]
intervention 1: electroconvulsive therapy as usual intervention 2: electroconvulsive therapy identical to the comparator group except that propofol 0.5 mg/kg is given intravenously 15 seconds after the electrical stimulation at each treatment in order to terminate the ECT-induced seizure intervention 3: Propofol 0.5 mg...
intervention 1: electroconvulsive therapy intervention 2: electroconvulsive therapy plus propofol intervention 3: propofol
1
Loma Linda | California | United States | -117.26115 | 34.04835
0
0
0
0
NCT00616759
1COMPLETED
2010-03-24
2006-09-01
Loma Linda University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
37
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration
null
Glaucoma
null
1
arm 1: Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
[ 0 ]
1
[ 0 ]
intervention 1: Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
intervention 1: timolol/dorzolamide combination
0
null
37
0
0
0
NCT00832377
1COMPLETED
2010-03-26
2009-04-24
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.
null
Metastatic Renal Cell Carcinoma Metastatic Melanoma
Metastatic Renal Cell Carcinoma Metastatic Melanoma Aldesleukin IL-2
null
1
arm 1: All participants were treated with aldesleukin 600,000 international units per kilogram \[IU/kg\] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeate...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Aldesleukin
4
Los Angeles | California | United States | -118.24368 | 34.05223 Aurora | Colorado | United States | -104.83192 | 39.72943 Louisville | Kentucky | United States | -85.75941 | 38.25424 Lebanon | New Hampshire | United States | -72.25176 | 43.64229
26
0
0
0
NCT00414765
1COMPLETED
2010-03-28
2008-09-03
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
18
RANDOMIZED
CROSSOVER
9OTHER
3TRIPLE
false
0ALL
null
To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.
null
Attention-Deficit Hyperactivity Disorder
ADHD
null
3
arm 1: Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo arm 2: Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo arm 3: Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo intervention 2: Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo intervention 3: Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Sa...
intervention 1: Lisdexamfetamine Dimesylate (LDX) intervention 2: Immediate Release Mixed Amphetamine Salts (MAS-IR) intervention 3: LDX Placebo + MAS-IR Placebo
1
Houston | Texas | United States | -95.36327 | 29.76328
52
0
0
0
NCT01010750
1COMPLETED
2010-03-28
2010-01-05
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
159
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
2MALE
false
This multi-center study will evaluate whether thalidomide can improve the effectiveness of the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer. Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone production, which, in most patients, reduces the size of th...
This is a double-blind randomized phase III study designed to determine if thalidomide can improve the efficacy of the luteinizing hormone releasing hormone (LHRH) agonist (leuprolide or goserelin) in hormone-responsive patients with a rising PSA after primary definitive therapy for prostate cancer. Patients with only ...
Prostate Cancer
Angiogenesis Cancer Hormonal Therapy Prostate Thalidomide Prostate Cancer
ICF_001.pdf: Prot_000.pdf:
2
arm 1: Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to ...
[ 0, 0 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Thalidomide 200 mg given orally every evening at 9pm. Treatment may continue indefinitely provided that there are no dose-limiting toxicity. intervention 2: Injections of leuprolide once a month for six months. intervention 3: Injections of Goserelin once a month for six months. intervention 4: Patients...
intervention 1: Thalidomide intervention 2: leuprolide acetate intervention 3: goserelin intervention 4: Placebo
9
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Bethesda | Maryland | United States | -77.10026 | 38.98067 Detroit | Michigan | United States | -83.04575 | 42.33143 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 New York | N...
580
0
0
0
NCT00004635
1COMPLETED
2010-03-30
2000-03-01
National Cancer Institute (NCI)
0NIH
true
false
true
https://cdn.clinicaltrials.gov/large-docs/35/NCT00004635/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/35/NCT00004635/ICF_001.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,640
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
null
Asthma
null
3
arm 1: Arm 1: Montelukast arm 2: Arm 2: Fluticasone arm 3: Arm 3: Placebo
[ 0, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: montelukast 10 mg tablet once daily, 6 month treatment period intervention 2: fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period intervention 3: fluticasone propionate 250 mcg twice daily, 6 month treatment period intervention 4: montelukast 10 mg Pbo tablet once daily, 6...
intervention 1: montelukast sodium intervention 2: Comparator: Placebo intervention 3: Comparator: fluticasone intervention 4: Comparator: Placebo
0
null
1,018
9
0.008841
1
NCT00284856
1COMPLETED
2010-04-01
2006-05-01
Organon and Co
4INDUSTRY
false
false
false
null
0
8
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.004658
[ 2 ]
61
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.
null
Non-Small Cell Lung Cancer
Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days intervention 2: Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle intervention 3: Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cyc...
intervention 1: vorinostat intervention 2: Gemcitabine intervention 3: Platinum-based agent
0
null
62
2
0.032258
1
NCT00423449
1COMPLETED
2010-04-01
2007-03-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.008891
[ 4 ]
3,449
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor. The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not comp...
Venous Thrombosis
null
2
arm 1: Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily arm 2: Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target inter...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food. intervention 2: Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 ...
intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin followed by VKA
324
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Redlands | California | United States | -117.18254 | 34.05557 Bay Pines | Florida | United States | -82.77816 | 27.81419 Miami | Florida | United States | -80.19366 | 25.77427 Miami | Florida | United States | -80.19366 | 25.77427 Idaho Falls | Idaho | Unite...
3,429
2
0.000583
1
NCT00440193
1COMPLETED
2010-04-01
2007-03-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0.00016
[ 3 ]
338
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned t...
null
Kidney Transplantation
Immunosuppression JAK3 inhibitor kidney transplantation.
null
3
arm 1: Treatment Arm 1 will also receive standard of care medications arm 2: Treatment Arm 2 will also receive standard of care medications arm 3: Treatment Arm 3 will also receive standard of care medications
[ 1, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Standard of care intervention 2: CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12 intervention 3: CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
intervention 1: Cyclosporine intervention 2: CP-690,550 intervention 3: CP-690,550
69
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 Sa...
322
1
0.003106
1
NCT00483756
1COMPLETED
2010-04-01
2007-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000548
[ 5 ]
801
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or...
null
Post-Menopausal Osteoporosis
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 3mg intravenous (iv) injection every 3 months intervention 2: 3mg intravenous (iv) infusion every 3 months intervention 3: 70mg per oral (po) weekly
intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: Alendronate
44
Birmingham | Alabama | United States | -86.80249 | 33.52066 Riverside | California | United States | -117.39616 | 33.95335 Lakewood | Colorado | United States | -105.08137 | 39.70471 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Gainesville | Georgia | United States | -83.82407 | 34.29788 Topeka | Ka...
793
1
0.001261
1
NCT00503113
1COMPLETED
2010-04-01
2007-07-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0.000223
[ 4 ]
238
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up...
LGS poses a significant treatment challenge. No single antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Even with combination therapy, many LGS patients show resistance to treatment. Adjunctive therapy with newer anticonvulsant me...
Epilepsy Epilepsy, Generalized Seizures
Epilepsy Lennox-Gastaut Syndrome Drop seizures Clobazam
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 0.25 mg/kg/day; tablets; orally; for 15-18 weeks intervention 2: 0.5 mg/kg/day; tablets; orally; for 15-18 weeks intervention 3: 1.0 mg/kg/day; tablets; orally; for 15-18 weeks intervention 4: tablets; orally; daily for 15-18 weeks
intervention 1: Clobazam Low Dose intervention 2: Clobazam Medium Dose intervention 3: Clobazam High Dose intervention 4: Placebo
53
Huntsville | Alabama | United States | -86.58594 | 34.7304 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Aurora | Colorado | United States | -104.83192 | 39.72943 Washington D.C. | Dist...
238
1
0.004202
1
NCT00518713
1COMPLETED
2010-04-01
2007-08-01
Lundbeck LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000742
[ 5 ]
7,376
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who ...
null
Pulmonary Disease, Chronic Obstructive
null
2
arm 1: patients inhale Tiotropium 18mcg once daily via HandiHaler and Placebo MDI twice daily arm 2: patients inhale Salmeterol 50mcg twice daily via MDI and Placebo HandiHaler once daily
[ 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 18 mcg/daily intervention 2: 100 mcg/daily intervention 3: Placebo identical to Salmeterol device intervention 4: Placebo identical to Tiotropium device
intervention 1: Tiotropium bromide intervention 2: Salmeterol intervention 3: Placebo Salmeterol intervention 4: Placebo Tiotropium
752
Feldbach | N/A | Austria | 15.88833 | 46.95306 Feldkirch | N/A | Austria | 9.6 | 47.23306 Gänserndorf | N/A | Austria | 16.72016 | 48.33925 Grimmenstein/Hochegg | N/A | Austria | N/A | N/A Hallein | N/A | Austria | 13.1 | 47.68333 Linz | N/A | Austria | 14.28611 | 48.30639 Mittersill | N/A | Austria | 12.48333 | 47.283...
7,376
1
0.000136
0
NCT00563381
1COMPLETED
2010-04-01
2008-01-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0.000024
[ 4 ]
404
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA \[HCV-R...
null
Hepatitis C, Chronic
Treatment failure
null
3
arm 1: Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. arm 2: Participants in Arm 2 (experimental) were assigned ei...
[ 2, 0, 0 ]
4
[ 0, 2, 0, 0 ]
intervention 1: Boceprevir, 200 mg capsules, 800 mg TID PO intervention 2: PEG2b 1.5 μg/kg/week subcutaneously (SC) intervention 3: Ribavirin WBD 600 mg/day to 1400 mg/day by mouth (PO) divided twice daily (BID). intervention 4: Boceprevir placebo, 200 mg capsules, 800 mg three times daily (TID) PO.
intervention 1: Boceprevir (SCH 503034) intervention 2: Pegylated interferon alfa-2b (SCH 54031) intervention 3: Ribavirin (SCH 18908) intervention 4: Boceprevir placebo
0
null
403
1
0.002481
1
NCT00708500
1COMPLETED
2010-04-01
2008-08-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000438
[ 4 ]
41
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.
null
Congenital Bleeding Disorder Congenital FXIII Deficiency
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 35 IU/kg body weight, i.v. administration, once every 4 weeks
intervention 1: catridecacog
35
Phoenix | Arizona | United States | -112.07404 | 33.44838 Orange | California | United States | -117.85311 | 33.78779 Tampa | Florida | United States | -82.45843 | 27.94752 Atlanta | Georgia | United States | -84.38798 | 33.749 Boston | Massachusetts | United States | -71.05977 | 42.35843 Detroit | Michigan | United St...
41
4
0.097561
1
NCT00713648
1COMPLETED
2010-04-01
2008-08-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.038597
[ 4 ]
178
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.
Gastroesophageal reflux disease is recognized as a common and persistent medical problem in the US adult population. Gastroesophageal reflux disease comprises a spectrum of acid-related disorders including symptomatic nonerosive gastroesophageal reflux disease and erosive esophagitis. It affects men and women in nearly...
Gastroesophageal Reflux
Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD Regurgitation, Gastric Heartburn Drug Therapy
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
intervention 1: Dexlansoprazole MR QD
52
Hueytown | Alabama | United States | -86.99666 | 33.45122 Chandler | Arizona | United States | -111.84125 | 33.30616 Sierra Vista | Arizona | United States | -110.30369 | 31.55454 Tucson | Arizona | United States | -110.92648 | 32.22174 Sherman | Arkansas | United States | N/A | N/A Sherwood | Arkansas | United States ...
178
1
0.005618
1
NCT00847808
1COMPLETED
2010-04-01
2009-02-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000992
[ 4 ]
6,505
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently r...
null
Chronic Heart Failure
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months. intervention 2: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 month...
intervention 1: Ivabradine intervention 2: Placebo
2
Paris | N/A | France | 2.3488 | 48.85341 Gothenburg | N/A | Sweden | 11.96679 | 57.70716
6,492
1
0.000154
0
NCT02441218
1COMPLETED
2010-04-01
2006-09-01
Institut de Recherches Internationales Servier
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0.000027
[ 3 ]
180
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes...
OBJECTIVES: * Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions. OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma \[BCC\] vs nodular BCC vs superficial squamous...
Non-melanomatous Skin Cancer Precancerous Condition
basal cell carcinoma of the skin squamous cell carcinoma of the skin actinic keratosis
null
1
arm 1: 4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: aminolevulinic acid
1
Buffalo | New York | United States | -78.87837 | 42.88645
0
0
0
0
NCT00002975
1COMPLETED
2010-04-01
1997-02-01
Roswell Park Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
118
NON_RANDOMIZED
PARALLEL
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Peripheral stem cell transplantation may be able to replace im...
OBJECTIVES: * Assess the efficacy of a high-dose chemoradiotherapy regimen in patients with refractory or relapsed Hodgkin's lymphoma. OUTLINE: Patients are stratified into 1 of 3 treatment arms (0-1 adverse prognostic factors vs 2 adverse prognostic factors vs 3 adverse prognostic factors). * Arm I (0-1 adverse pro...
Lymphoma
recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma
null
3
arm 1: (0-1 adverse prognostic factors): Patients receive ifosfamide by 24 hour infusion on day 2. Carboplatin is administered on day 2. Etoposide IV is administered once daily on days 1-3. Patients then receive filgrastim (G-CSF) subcutaneously or IV on days 5-12. Patients receive another course of ICE chemotherapy 2-...
[ 0, 0, 0 ]
11
[ 2, 0, 0, 0, 0, 0, 0, 0, 3, 3, 4 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None
intervention 1: filgrastim intervention 2: carboplatin intervention 3: carmustine intervention 4: cyclophosphamide intervention 5: cytarabine intervention 6: etoposide intervention 7: ifosfamide intervention 8: melphalan intervention 9: bone marrow ablation with stem cell support intervention 10: peripheral blood stem ...
1
New York | New York | United States | -74.00597 | 40.71427
118
0
0
0
NCT00003631
1COMPLETED
2010-04-01
1998-08-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel ki...
PRIMARY OBJECTIVES: I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer. II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics. OUTLINE: Th...
Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
null
1
arm 1: Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Given IV intervention 2: Given IV
intervention 1: paclitaxel intervention 2: bryostatin 1
1
The Bronx | New York | United States | -73.86641 | 40.84985
19
0
0
0
NCT00031694
1COMPLETED
2010-04-01
2002-03-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
43
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, ey...
This study uses the IL-1 receptor antagonist anakinra to treat children and adults with Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. NOMID/CINCA syndrome is a rare genetic systemic auto-inflammatory disease that is cha...
Nervous System Malformations Arthropathy, Neurogenic Urticaria Papilledema
Central Nervous System Abnormalities Arthropathy Urticaria Papilledema Auto-Inflammation Inflammatory Disease Neonatal Onset Multisystem Inflammatory Disease NOMID CINCA Syndrome
null
1
arm 1: All patients enrolled received daily doses of subcutaneous injection of increased doses of anakinra starting at 0.5mg/kg/day up to a maximum 10mg/kg/day to achieve disease remission.
[ 0 ]
1
[ 0 ]
intervention 1: daily injection of subcutaneous injection
intervention 1: anakinra
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
43
0
0
0
NCT00069329
6TERMINATED
2010-04-01
2003-09-01
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
903
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
Overall Survival (OS), Patient-reported outcome (PRO)
Carcinoma, Renal Cell
Renal Cell Cancer (RCC) Cancer
null
2
arm 1: Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted. arm 2: Placebo tablets matching in appearance were to be orally administered twice a day.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Multi Kinase Inhibitor intervention 2: Placebo
intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
121
Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 Aurora | Colorado | United States | -104.83192 | 39.72943 Hamden | Con...
1,570
0
0
0
NCT00073307
1COMPLETED
2010-04-01
2003-11-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Background: Neurofibromatosis Type 1 (NF1) is an autosomal dominant, progressive genetic disorder characterized by diverse clinical manifestations. Patients with NF1 have an increased risk of developing tumors of the central and peripheral nervous system including plexiform neurofibromas, which are benign nerve sheath...
Background: Neurofibromatosis Type 1 (NF1) is an autosomal dominant, progressive genetic disorder characterized by diverse clinical manifestations. Patients with NF1 have an increased risk of developing tumors of the central and peripheral nervous system including plexiform neurofibromas, which are benign nerve sheath...
Neurofibromatosis 1 Neurofibroma, Plexiform
Side Effect Oral Administration Nerve Sheath Tumor Antifibrotic Agent Volumetric Tumor Measurement Plexiform Neurofibroma Neurofibromatosis Type 1 Volumetric MRI Analysis Time to Progression NF1
Prot_SAP_ICF_000.pdf: PROTOCOL NO. 04c0080-c PROTOCOL SUBMISSION FORM Amendment Form PRINCIPAL INVESTIGATOR (NlH Employee Name, InsUBr, Telephone and e-mail): Brigitte Widemann NCI POB 301.496 .4256 widemanb@mait.nih.1 PROTOCOL TITLE: "Phase ll Trial of Pirfenidone in Children, Adolescents, and Young Aclults with N...
1
arm 1: Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m\^2 every 8 hours (1500 mg/m2/day).
[ 0 ]
1
[ 0 ]
intervention 1: Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m\^2 every 8 hours (1500 mg/m2/day).
intervention 1: Pirfenidone
15
Birmingham | Alabama | United States | -86.80249 | 33.52066 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41.85003 Baltimore | Maryland | United States | -76.61219 | 39.29038 Bethesda | Maryland | United States | -77.10026 | 38.98067 Bosto...
36
0
0
0
NCT00076102
1COMPLETED
2010-04-01
2004-07-21
National Cancer Institute (NCI)
0NIH
true
true
true
https://cdn.clinicaltrials.gov/large-docs/02/NCT00076102/Prot_SAP_ICF_000.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well bortezomib works as first-line systemic therapy in treating patients with unresectable locally advanced or metastatic adenocarcinoma (cancer) of the bile duct or gallbladder. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the bile duct or gallbladder treated with bortezomib. SECONDARY OBJECTIVES: I. Determine the time to disease progression in patients treated with this drug. II. Determine the o...
Adenocarcinoma of the Extrahepatic Bile Duct Adenocarcinoma of the Gallbladder Advanced Adult Primary Liver Cancer Gastrointestinal Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic...
null
1
arm 1: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
[ 0 ]
1
[ 0 ]
intervention 1: Given IV
intervention 1: bortezomib
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
20
0
0
0
NCT00085410
6TERMINATED
2010-04-01
2004-01-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
731
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
null
Diabetic Retinopathy
null
2
arm 1: 32 milligrams (mg) once daily (QD) oral for up to 36 months arm 2: QD oral for up to 36 months
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 32 mg once daily (QD) oral for up to 36 months intervention 2: QD oral for up to 36 months
intervention 1: ruboxistaurin intervention 2: placebo
84
Artesia | California | United States | -118.08312 | 33.86585 Palm Springs | California | United States | -116.54529 | 33.8303 Poway | California | United States | -117.03586 | 32.96282 Walnut Creek | California | United States | -122.06496 | 37.90631 Denver | Colorado | United States | -104.9847 | 39.73915 New London |...
731
0
0
0
NCT00090519
1COMPLETED
2010-04-01
2004-02-01
Chromaderm, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
173
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of placebo-controlled, double-blind treatment and following an additional 192 weeks of open-label adefovir dipiv...
Weeks 1 through 48 (Study Year 1): The first 48 weeks of the study were a randomized, double-blind, placebo-controlled, parallel-group treatment period. Participants were randomly assigned to treatment in a 2:1 fashion to ADV or PLB. Prior to randomization, eligible participants were classified into 1 of 6 strata based...
Chronic Hepatitis B
Hepatitis B Children Pediatric Adefovir Dipivoxil
null
2
arm 1: Participants randomized to receive placebo received placebo during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study. arm 2: Participants randomized to receive ADV received ADV during the first 48 weeks of treat...
[ 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Matching placebo intervention 2: 10-mg tablet or 2-mg/mL oral suspension intervention 3: 100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration \>= 1000 copies/mL at 2 consecutive study visits at o...
intervention 1: Placebo (PLB) intervention 2: Adefovir Dipivoxil (ADV) intervention 3: Lamivudine
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
335
0
0
0
NCT00095121
1COMPLETED
2010-04-01
2004-06-01
Gilead Sciences
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by sto...
PRIMARY OBJECTIVE: I. Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). SECONDARY OBJECTIVES: I. ...
Anaplastic Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Mantle Cell Lymphoma
null
1
arm 1: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 addit...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: tanespimycin
1
Houston | Texas | United States | -95.36327 | 29.76328
22
0
0
0
NCT00117988
1COMPLETED
2010-04-01
2005-02-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been approved to treat ot...
This research study is a Phase ll clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as...
Nonmalignant Neoplasm Tuberous Sclerosis Lymphangioleimyomatosis Kidney Angiomyolipoma
angiomyolipoma
Prot_SAP_000.pdf: Protocol # 04-298 Principal Investigator: Sandra L. Dabora Rapamycin for treating kidney angiomyolipomas (1/30/09 version) 1 SECTION 1 – Protocol Summary PRINCIPAL/OVERALL INVESTIGATOR: Sandra L. Dabora, M.D., Ph.D. Brigham and Women’s Hospital CO-INVESTI...
1
arm 1: Rapamycin treatment was initiated with a loading dose of 6 mg by mouth on day 1 followed by 2 mg by mouth daily. The dose was then adjusted to maintain a target blood level of 3-9 ng/ml for the first 16 weeks. After week 16, the dose of Rapamycin was increased to a target level of 9-15 ng/ml unless there was evi...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Rapamycin
7
Loma Linda | California | United States | -117.26115 | 34.04835 Hartford | Connecticut | United States | -72.68509 | 41.76371 Boston | Massachusetts | United States | -71.05977 | 42.35843 New York | New York | United States | -74.00597 | 40.71427 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Philadelphia | P...
36
0
0
0
NCT00126672
1COMPLETED
2010-04-01
2005-12-20
Dana-Farber Cancer Institute
7OTHER
true
true
false
https://cdn.clinicaltrials.gov/large-docs/72/NCT00126672/Prot_SAP_000.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 1 ]
28
null
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiother...
Pre Radiation Period: * Bevacizumab (10 mg/kg) on days -14 and 0, or * Tarceva (100 mg) daily from -14-0, or * Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0 Chemoradiation Period: * Radiotherapy may be delivered via conventional 2-D, conformal 3-D, or intensity modulated (IMRT) techniqu...
Head and Neck Cancer Pharynx Cancer
head and neck cancer targeted therapy bevacizumab erlotinib Tarceva radiotherapy concurrent chemotherapy pharynx cancer tonsil cancer hyperfractionation angiogenesis epidermal growth factor vascular endothelial growth factor magnetic resonance spectroscopy cancer of the head and neck upper aerodigestive tract neoplasms...
null
1
arm 1: Radiation Therapy concurrent with cisplatin chemotherapy, Avastin and Tarceva
[ 0 ]
4
[ 4, 0, 0, 0 ]
intervention 1: External beam radiation daily (M-F) intervention 2: Cisplatin week 1 and 5 of radiation intervention 3: Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation intervention 4: Erlotinib daily during radiation
intervention 1: Chemoradiotherapy intervention 2: Cisplatin intervention 3: Bevacizumab intervention 4: Erlotinib
1
Durham | North Carolina | United States | -78.89862 | 35.99403
28
0
0
0
NCT00140556
1COMPLETED
2010-04-01
2005-08-01
David M. Brizel, MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
33
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This research is being done to develop new treatment for non-hodgkin's lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy. The investigational drug clofarabine is being used in this study. An investigational drug is one that has not been approved by the United States Food and Drug Ad...
The safety profile of clofarabine appears acceptable within the target populations studied to date in the clinical studies, with numerous responses observed in heavily pre-treated patients with relapsed/refractory ALL or AML. Dose escalation of clofarabine in patients with solid tumors and lymphoproliferative disorders...
Lymphoma, B-Cell Lymphoma, Non-Hodgkin
B-Cell NHL
null
1
arm 1: Clofarabine 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles.
[ 0 ]
1
[ 0 ]
intervention 1: 4 mg/m\^2 days 1-5 of every cycle for a maximum of 6 cycles
intervention 1: CLOFARABINE
1
Park Ridge | Illinois | United States | -87.84062 | 42.01114
33
0
0
0
NCT00156013
1COMPLETED
2010-04-01
2005-09-01
Oncology Specialists, S.C.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
72
NON_RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
1FEMALE
false
Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian can...
This is an open labeled, single arm phase II study of GM-CSF, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determin...
Ovarian Cancer Fallopian Tube Cancer
Asymptomatic Clinical trial Phase II GM-CSF Immunotherapy
null
2
arm 1: GM-CSF, Sargramostim 250 μg/m\^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. arm 2: GM-CSF, sargramostim 150 μg/m\^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable...
[ 0, 0 ]
1
[ 0 ]
intervention 1: GM-CSF subcutaneous injection
intervention 1: GM-CSF, sargramostim
0
null
72
0
0
0
NCT00157573
1COMPLETED
2010-04-01
2004-12-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together ...
The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma. The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study ...
Asthma
Asthma Ciclesonide Exacerbation
null
3
arm 1: None arm 2: Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months. arm 3: Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
[ 2, 1, 1 ]
2
[ 0, 0 ]
intervention 1: Ciclesonide metered-dose inhaler intervention 2: Ciclesonide placebo-matching metered-dose inhaler
intervention 1: Ciclesonide intervention 2: Placebo
7
Calgary | N/A | Canada | -114.08529 | 51.05011 Fleurimont | N/A | Canada | -71.83796 | 45.40842 London | N/A | Canada | -81.23304 | 42.98339 London,ON | N/A | Canada | -81.23304 | 42.98339 Winnipeg | N/A | Canada | -97.14704 | 49.8844 Budapest | N/A | Hungary | 19.04045 | 47.49835 Cape Town | N/A | South Africa | 18.42...
239
0
0
0
NCT00163293
1COMPLETED
2010-04-01
2005-01-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to alemtuzumab administra...
null
Kidney Transplant Failure and Rejection
Kidney Transplant Living Donor Kidney Transplant Recipients
null
2
arm 1: Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in as...
[ 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Tacrolimus (TAC) will be given standard of care by prescription twice a day (2.0 mg), orally. Doses will be adjusted by serum levels. The dose will be modified to achieve 12 hour trough concentrations of 5-8 ng/mL. intervention 2: Sirolimus will be given standard of care by prescription, dosed at 5mg da...
intervention 1: Tacrolimus (TAC) intervention 2: Sirolimus intervention 3: Alemtuzumab intervention 4: Mycophenolate mofetil (MMF)
1
Chicago | Illinois | United States | -87.65005 | 41.85003
43
0
0
0
NCT00166712
6TERMINATED
2010-04-01
2005-04-01
Northwestern University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
63
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress...
Participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (auto-HCT)\]. P...
Blood Cancer Multiple Myeloma
null
1
arm 1: Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Pos...
[ 0 ]
8
[ 3, 3, 0, 0, 0, 4, 3, 0 ]
intervention 1: The target cell dose is 2.6 x 10e6 CD34+ cells/kg intervention 2: The target cell dose is 5 x 10e6 CD34 cells/kg intervention 3: Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion intervention 4: * Filgrastim 10 µg/kg...
intervention 1: Autologous hematopoietic cell transplant (Auto-HCT) intervention 2: Allogeneic hematopoietic cell transplant (Allo-HCT) intervention 3: Cyclophosphamide intervention 4: Filgrastim intervention 5: Melphalan intervention 6: Total body irradiation (TBI) intervention 7: Cyclosporine (CSP) intervention 8: My...
1
Stanford | California | United States | -122.16608 | 37.42411
63
0
0
0
NCT00185614
1COMPLETED
2010-04-01
2000-08-01
Wen-Kai Weng
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
602
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
null
The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus
IGT is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, the hyperglycemia-related complications of this devastating disease can be prevented. Subjects with IGT will be identified with an oral glucose tolerance test (OGTT). Eligible subjects also will have a measurement of first phase ins...
Impaired Glucose Tolerance Type 2 Diabetes
Impaired Glucose Tolerance Type 2 Diabetes Prevention Pioglitazone
null
2
arm 1: Placebo tablet similar to pioglitazone tablet arm 2: Pioglitazone tablet similar to placebo tablet
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Pioglitazone tablets - 45 mg/day intervention 2: Placebo tablets similar to pioglitazone tablets - 1 tablet/day
intervention 1: Pioglitazone intervention 2: Placebo
8
Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Baton Rouge | Louisiana | United States | -91.18747 | 30...
602
0
0
0
NCT00220961
1COMPLETED
2010-04-01
2004-01-01
The University of Texas Health Science Center at San Antonio
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
141
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
Anemia Chronic Kidney Disease
Iron Anemia CKD
null
3
arm 1: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously arm 2: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously arm 3: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously intervention 2: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously intervention 3: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
intervention 1: Venofer (iron sucrose injection) intervention 2: Venofer (iron sucrose injection) intervention 3: Venofer (iron sucrose injection)
1
Norristown | Pennsylvania | United States | -75.3399 | 40.1215
141
0
0
0
NCT00239642
1COMPLETED
2010-04-01
2005-07-01
American Regent, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
97
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as poly ICLC, may stimulate the immune system in...
OBJECTIVES: Primary * Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme. Secondary * Estimate the frequency of toxicity associated with this treatment regimen. OUTLIN...
Glioblastoma Multiforme
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
null
1
arm 1: RT + TMZ 6wks, followed by poly ICLC, temozolomide, radiation: radiation therapy
[ 0 ]
3
[ 0, 0, 4 ]
intervention 1: 20 mcg/kg 3x each week (Maintenance cycles) intervention 2: daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) intervention 3: RT: 60 Gy (6 weeks) concomitant therapy
intervention 1: poly ICLC intervention 2: temozolomide intervention 3: radiation therapy
9
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tampa | Florida | United States | -82.45843 | 27.94752 Atlanta | Georgia | United States | -84.38798 | 33.749 Baltimore | Maryland | United States | -76.61219 | 39.29038 Boston | Massachusetts | United States | -71.05977 | 42.35843 Detroit | Michigan | United ...
97
0
0
0
NCT00262730
1COMPLETED
2010-04-01
2006-01-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
42
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.
OBJECTIVES: Primary * Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-dose therapy with autologous stem cell rescue). * Determine the response rate in patients treated with this regi...
Lymphoma
recurrent adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma
null
2
arm 1: Primary progressive, recurrent, or resistant relapse patients arm 2: First recurrence patients
[ 0, 0 ]
7
[ 2, 0, 0, 0, 0, 3, 4 ]
intervention 1: 480 mcg beginning day +5 intervention 2: 11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses intervention 3: 60 mg/kg IV over 2 hours x 2 days intervention 4: 60 mg/kg, IV intervention 5: 150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes. intervention 6: autologous-autologous tandem hematopoieti...
intervention 1: filgrastim intervention 2: busulfan intervention 3: cyclophosphamide intervention 4: etoposide intervention 5: melphalan intervention 6: autologous-autologous tandem hematopoietic stem cell transplantation intervention 7: radiation therapy
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
37
0
0
0
NCT00265889
1COMPLETED
2010-04-01
2002-02-01
Case Comprehensive Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
42
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
0ALL
false
This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficult...
This was a double-blind randomized placebo controlled trial to evaluate the effect of aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in adults newly diagnosed with eosinophilic esophagitis (EoE). Participants were randomized to receive aerosolized swallowed fluticasone 880 mcg bid ...
Eosinophilic Esophagitis
Eosinophilic Esophagitis Fluticasone Dysphagia
null
2
arm 1: Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks arm 2: Placebo inhaler swallowed bid for 6 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Aerosolized swallowed fluticasone 880 mg twice a day intervention 2: Placebo inhaler swallowed twice a day for 6 weeks
intervention 1: Fluticasone intervention 2: Placebo
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
34
0
0
0
NCT00275561
1COMPLETED
2010-04-01
2005-11-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
249
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Treating tumor tissue in the laboratory with different drugs may help doctors find the best drug for treating individual patients with pancreatic cancer. PURPOSE: This phase II trial is studying an individualized drug treatment selection process, based on laboratory results, for treating patients with pancr...
OBJECTIVES: * Establish tumor xenografts from patients with resectable adenocarcinoma of the pancreas who undergo surgical resection at Johns Hopkins Hospital. * Determine the activity of a series of 10 anticancer drugs against these tumors in ex vivo studies. * Determine the response rate, time to treatment failure, ...
Pancreatic Cancer
recurrent pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage I pancreatic cancer stage II pancreatic cancer
null
1
arm 1: PART A: Participants will have their tumors collected at the time of conventional surgery. Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Patients will then proceed to receive adjuv...
[ 0 ]
9
[ 2, 0, 0, 0, 0, 0, 0, 0, 3 ]
intervention 1: Tumors will be implanted in nude mice and treated with a set of 8 commercially available anticancer drugs. Drugs will be ranked based in their activity from most to least active. Biological studies will be conducted in tumor tissues to better understand the response to tested drugs. intervention 2: Tumo...
intervention 1: cetuximab intervention 2: capecitabine intervention 3: docetaxel intervention 4: Erlotinib intervention 5: Gemcitabine intervention 6: Irinotecan intervention 7: mitomycin C intervention 8: rapamycin intervention 9: conventional surgery
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
0
0
0
NCT00276744
6TERMINATED
2010-04-01
2005-10-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
660
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
null
Epilepsy, Partial
Epilepsy partial seizures pregabalin monotherapy lamotrigine comparator double-blind and randomized trial
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: dose 150-600 mg/day given BID intervention 2: dose 100-500 mg/day given BID
intervention 1: Pregabalin intervention 2: Lamotrigine
102
Bruges | N/A | Belgium | 3.22424 | 51.20892 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/...
660
0
0
0
NCT00280059
1COMPLETED
2010-04-01
2006-08-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
89
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
PRIMARY OBJECTIVES: I. Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779. II. Determine the toxicity and safety of this drug in these patients. III. Correlate the degree of activation of P13/AKT/...
B-cell Chronic Lymphocytic Leukemia Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Malignant Neoplasm Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small ...
null
1
arm 1: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: temsirolimus
13
Chicago | Illinois | United States | -87.65005 | 41.85003 Decatur | Illinois | United States | -88.9548 | 39.84031 Evanston | Illinois | United States | -87.69006 | 42.04114 Harvey | Illinois | United States | -87.64671 | 41.61003 La Grange | Illinois | United States | -87.86923 | 41.80503 Maywood | Illinois | United S...
89
0
0
0
NCT00290472
1COMPLETED
2010-04-01
2004-03-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
24
RANDOMIZED
PARALLEL
9OTHER
4QUADRUPLE
false
0ALL
true
The overall goal of this double-blind Phase II study is to evaluate the safety, efficacy and biological mechanisms of action of Intravenous Immunoglobulin (IVIg) in the treatment of mild to moderate stage Alzheimer's disease (AD). IVIg contains antibodies against the amyloid beta protein that is the central component o...
Abnormal processing of the beta-amyloid protein is thought to be an early and causative event in the pathogenesis of Alzheimer's disease (AD). Immunotherapy targeting beta amyloid (Aβ) has demonstrated a remarkable capacity to arrest and even reverse elements of AD brain pathology. Intravenous Immunoglobulin (IVIg) is ...
Alzheimer's Disease
Immunotherapy Amyloid beta protein Antibodies Alzheimer's Dementia
null
2
arm 1: ivig arm 2: None
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: None intervention 2: None
intervention 1: Intravenous Immunoglobulin intervention 2: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
24
0
0
0
NCT00299988
6TERMINATED
2010-04-01
2006-02-01
Weill Medical College of Cornell University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel ...
OBJECTIVES: Primary •To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities. Secondary * Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients * Assess significant toxicities in this group of patients and ...
Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Mixed Tumor, Mesodermal
carboplatin paclitaxel elderly women
null
1
arm 1: Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Paclitaxel intervention 2: Carboplatin
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
12
0
0
0
NCT00322881
6TERMINATED
2010-04-01
2006-04-01
Dana-Farber Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation.
Hypertriglyceridemia is common among HIV-infected patients receiving Highly Active Antiretroviral Therapy (HAART). Although fibrates, statins, and niacin have all been used in the management of hypertriglyceridemia in HIV-infected patients, optimal control is difficult to achieve and other agents are needed. Omega-3 fa...
HIV Infections AIDS Dyslipidemia Hypertriglyceridemia
AIDS HIV HAART Lipids Triglycerides Cholesterol omega-3 fatty acids bone turnover inflammation insulin resistance
null
2
arm 1: 4 g/d of omega-3 fatty acid esters, plus dietary counseling arm 2: Corn oil placebo, plus dietary counselling
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: LOVAZA 1 gram capsules, 4 capsules daily intervention 2: Corn-oil placebo
intervention 1: Omega-3 fatty acid administration intervention 2: Placebo
3
Los Angeles | California | United States | -118.24368 | 34.05223 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Baltimore | Maryland | United States | -76.61219 | 39.29038
48
0
0
0
NCT00346697
1COMPLETED
2010-04-01
2006-10-01
Brown, Todd, M.D., Ph.D.
3INDIV
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
102
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.
Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmu...
Multiple Myeloma
null
1
arm 1: Cyclophosphamide + Etoposide + Melphalan + Carmustine with Filgrastim
[ 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in \~250 mL of saline or D5W and infused IV over 2 hours intervention 2: 100 mg etoposide as 5 mL solution in clear ampules for injection. intervention 3: Melphalan as single-use glass vials of freeze-dried melphalan ...
intervention 1: Cyclophosphamide intervention 2: Etoposide intervention 3: Melphalan intervention 4: Carmustine intervention 5: Filgrastim
1
Stanford | California | United States | -122.16608 | 37.42411
102
0
0
0
NCT00349778
1COMPLETED
2010-04-01
2006-08-01
Stanford University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
275
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the...
The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The estimated duration of treatment was to be 6 months. Treatment was to be administered up to progression, unacceptable toxi...
Stomach Neoplasms
null
3
arm 1: Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study. arm 2: Do...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Dose level 1 (non-optimal dose): Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1 Dose level 2 (optimal dose): Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two ...
intervention 1: Docetaxel + Oxaliplatin intervention 2: Docetaxel + Oxaliplatin + 5-FU intervention 3: Docetaxel + Oxaliplatin + Capecitabine
12
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Diegem | N/A | Belgium | 4.43354 | 50.89727 Paris | N/A | France | 2.3488 | 48.85341 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Milan | N/A | Italy | 9.18951 | 45.46427 Porto Salvo | N/A | Portugal | -9.3...
248
0
0
0
NCT00382720
1COMPLETED
2010-04-01
2006-09-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
64
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving ...
PRIMARY OBJECTIVES: I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma). SECONDARY OBJECTIVES: I. Evaluate the effect of combining motexafin gadolinium with daily fractionat...
Untreated Childhood Brain Stem Glioma
null
1
arm 1: Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 4 ]
intervention 1: Given IV intervention 2: Undergo focal cranial radiotherapy
intervention 1: motexafin gadolinium intervention 2: 3-dimensional conformal radiation therapy
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
62
0
0
0
NCT00387790
1COMPLETED
2010-04-01
2007-06-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
87
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza. Researchers want to learn more about the activity of Tamiflu® in the body to determine a dose of that is safe...
Oseltamivir is approved for prophylaxis and treatment of children 1 year of age and older with influenza. Influenza treatments for children under the age of 1 year are needed because mortality from influenza is high among this age group, even when there are no underlying medical conditions. Oseltamivir is frequently us...
Influenza
influenza, oseltamivir, Tamiflu®, antiviral, children, infants
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Oseltamivir is supplied as a white powder blend for constitution to a suspension. It is supplied in 100 ml amber glass bottles with 30 grams of powder for oral suspension, a plastic adapter, a plastic oral dispenser and a plastic measuring cup. Initially subjects in Cohort I received oseltamivir 30 mg o...
intervention 1: oseltamivir (Tamiflu®)
32
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Long Beach | California | United States | -118.18923 | 33.76696 Orange | California | United States | -117.85311 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 Aurora | Co...
87
0
0
0
NCT00391768
1COMPLETED
2010-04-01
2007-01-01
National Institute of Allergy and Infectious Diseases (NIAID)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
859
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study was to investigate the 5cm\^2 and 10cm\^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE \[Mini Mental State Examination\] 10-20). A 52-week extension phase evaluated the safety and tolerability of long-term treatment...
Patients were randomly assigned in a double-blind manner to one of the 3 treatment arms (placebo, rivastigmine 5 cm\^2 and rivastigmine 10 cm\^2) in a ratio of 1:1:1. During the Double-blind treatment phase, patients entered a 16-week Titration Period followed by an 8-week Maintenance Period. During the open-label exte...
Alzheimer's Disease
rivastigmine,Alzheimer's Disease, transdermal patch
null
3
arm 1: Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study. arm 2: During the 16-week titration period patients received daily rivastigmine 2.5 cm\^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm\^2 patch. For patients who exp...
[ 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Rivastigmine transdermal patch was provided in the following sizes and doses: 2.5 cm\^2 (4.5 mg), 5 cm\^2 (9 mg), 7.5 cm\^2 (13.5 mg), and 10 cm\^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each d...
intervention 1: Rivastigmine transdermal patch intervention 2: Placebo
1
Hokkaido Region | Hokkaido | Japan | N/A | N/A
1,492
0
0
0
NCT00423085
1COMPLETED
2010-04-01
2007-01-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
60
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.
Esophageal Cancer Gastric Cancer
esophageal cancer gastroesophageal cancer gastric cancer
Prot_SAP_ICF_000.pdf:
1
arm 1: Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
[ 0 ]
1
[ 0 ]
intervention 1: IV treatment for 6 weeks
intervention 1: Cetuximab,Paclitaxel, Carboplatin
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
60
0
0
0
NCT00439608
1COMPLETED
2010-04-01
2004-10-01
Brown University
7OTHER
true
true
true
https://cdn.clinicaltrials.gov/large-docs/08/NCT00439608/Prot_SAP_ICF_000.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
29
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy...
OBJECTIVES: Primary * Determine whether neoadjuvant chemotherapy comprising oxaliplatin, floxuridine, docetaxel, and leucovorin calcium improves the rate of pathologic complete response in patients with previously untreated, resectable stage II or III adenocarcinoma of the esophagus. Secondary * Determine the progr...
Esophageal Cancer
stage II esophageal cancer stage III esophageal cancer adenocarcinoma of the esophagus
null
1
arm 1: None
[ 0 ]
7
[ 0, 0, 0, 0, 6, 6, 3 ]
intervention 1: Intravenously, 25 mg/m2, over 30 minutes, 2 cycles intervention 2: Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles intervention 3: Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles intervention 4: Intravenously, 85 mg/m2, over 2 hours, 2 cycles intervention 5: Ana...
intervention 1: Docetaxel intervention 2: Floxuridine intervention 3: Leucovorin intervention 4: Oxaliplatin intervention 5: Microarray analysis intervention 6: reverse transcriptase-polymerase chain reaction intervention 7: Conventional surgery
1
Miami | Florida | United States | -80.19366 | 25.77427
29
0
0
0
NCT00448760
1COMPLETED
2010-04-01
2004-10-01
University of Miami
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
11
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid arthritis, in recipients of solid-organ transp...
* Since we are looking for the dose of RAD001 that can be given safely in combination with trastuzumab, not everyone will receive the same amount of RAD001. Small groups of participants will be enrolled at a certain dose of RAD001 and if they tolerate the medications well, the next small group will receive a higher dos...
Breast Cancer
HER2 positive metastatic breast cancer RAD001 Herceptin
null
3
arm 1: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg \[8 mg/kg loading dose\] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity. arm 2: Cycle duration is 21 days. Participants receive trastuzu...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Everolimus is being administered orally 7 days per week. intervention 2: Trastuzumab is being administered at a dose of 6 mg/kg intravenously once every 21 days.
intervention 1: Everolimus intervention 2: Trastuzumab
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
11
0
0
0
NCT00458237
1COMPLETED
2010-04-01
2007-04-01
Beth Israel Deaconess Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
116
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days...
Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for ...
Postoperative Pain
Postoperative pain Hydromorphone oral solution opioid pharmacokinetics pharmacodynamics
null
4
arm 1: infant and toddler arm 2: young child arm 3: older child arm 4: adolescent
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
intervention 1: Hydromorphone
14
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Orange | California | United States | -117.85311 | 33.78779 Stanford | California | United States | -122.16608 | 37.42411 Aurora | Colorado | United States | -104.83192 | 39.72943 New Haven | Connecticut | United States | -72.92816 | 41.30815 Miami | Florida...
232
0
0
0
NCT00465647
1COMPLETED
2010-04-01
2007-04-01
Purdue Pharma LP
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive stu...
null
Age-Related Maculopathy Choroidal Neovascularization
Ranibizumab Lucentis Verteporfin Visudyne Photodynamic therapy
null
3
arm 1: Standard Fluence Photodynamic Therapy combined with ranibizumab arm 2: Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab arm 3: Ranibizumab monotherapy
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: intravitreal administered ranibizumab 0.5 mg in 0.05 mL intervention 2: Verteporfin with 50% fluence photodynamic therapy (25 J/cm2) intervention 3: Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
intervention 1: Ranibizumab intervention 2: Verteporfin intervention 3: Verteporfin
1
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
31
0
0
0
NCT00473642
1COMPLETED
2010-04-01
2007-05-01
Oklahoma State University Center for Health Sciences
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML) or chron...
Leukemias and the related disorders myelodysplastic syndrome and myeloproliferative diseases represent a wide group of bone marrow stem cell malignancies. Some patients can be cured with chemotherapy or by allogeneic stem cell transplantation. However standard treatment approaches are not effective for patients who bec...
Myelodysplastic Syndrome (MDS) Acute Myeloid Leukemia (AML) Chronic Myeloid Leukemia (CML)
Myelodysplastic Syndrome (MDS) Acute Myeloid Leukemia (AML) Chronic Myeloid Leukemia (CML) Wilm's Tumor-1 Proteinase-3 Myelodysplastic Syndrome MDS Acute Myeloid Leukemia AML Chronic Myeloid Leukemia CML
null
1
arm 1: Subjects were given 6 subcutaneous injects of PR1:169-177 in "Montanide" adjuvant and 6 subcutaneous injections of WT1:126-134 in "Montanide" adjuvant at 2 weekly intervals. GM-CSF (Sargramostim) was co administered with each vaccine dose. Subjects with immunological response to one or both peptide vaccines had ...
[ 0 ]
4
[ 2, 2, 0, 2 ]
intervention 1: Subjects were given 6 doses of PR1:169-177 in "Montanide" adjuvant and 6 doses of WT1:126-134 in "Montanide" adjuvant at 2 weekly intervals. The peptides were injected in the deep subcutaneous tissue of the anterior abdominal wall, the thighs or the upper arms near the deltoid region. The sites of injec...
intervention 1: WT1:126-134 intervention 2: PR1:169-177 Peptide intervention 3: GM-CSF (Sargramostim) intervention 4: Montanide adjuvant
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
10
0
0
0
NCT00488592
1COMPLETED
2010-04-01
2007-06-01
National Heart, Lung, and Blood Institute (NHLBI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
768
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olan...
This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken), active- and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy (effectiveness) and safety of paliperidone ER r...
Bipolar Disorder
Bipolar Disorder Mania Depression Manic-Depressive Disorder
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence intervention 2: Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence intervention 3: Once daily until recurrence (only after initial 15 weeks on paliperidone ER)
intervention 1: Olanzapine intervention 2: Paliperidone ER intervention 3: Placebo
78
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Riverside | California | United States | -117.39616 | 33.95335 San Diego | California | United States | -117.16472 | 32.71571 Jacksonville | Florida | United States | -81.65565 | 30.33218 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Chicago | Ill...
1,141
0
0
0
NCT00490971
1COMPLETED
2010-04-01
2006-05-01
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studi...
Some of the drugs in this study have been used with DTIC (Dacarbazine) in the past to control Melanoma that has spread to other parts of the body. However, in most of those cases, the duration of these results are limited and ineffective to control or prevent spread of the disease into the brain, the membranes that cov...
Melanoma
advanced stage IV melanoma unresectable stage III melanoma Melanoma Temozolomide Velban Vinblastine Cisplatin Interleukin-2 Intron-A Interferon Alpha-2b Thalidomide Thalomid Temodar Proleukin
null
1
arm 1: Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
[ 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: 250 mg/m\^2 By Mouth Every 4 Hours x 3 Doses On Day 1 intervention 2: 1.5 mg/m\^2 By Vein Over 15-30 Minutes On Days 1-4 intervention 3: 20 mg/m\^2 By Vein Over 45-120 Minutes On Days 1-4 intervention 4: 9 MIU/m\^2 By Vein Over 24 Hours x 4 Doses On Days 1-4 intervention 5: 5 mu/m\^2 Subcutaneously (Und...
intervention 1: Temozolomide intervention 2: Velban intervention 3: Cisplatin intervention 4: Interleukin-2 intervention 5: Intron-A intervention 6: Thalidomide
1
Houston | Texas | United States | -95.36327 | 29.76328
5
0
0
0
NCT00505635
6TERMINATED
2010-04-01
2007-03-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
21
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
3TRIPLE
false
0ALL
false
To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
Plasminogen activator inhibitor-1, a member of the serine protease inhibitor (serpin) superfamily, is the principal inhibitor to tissue-type plasminogen activator and urokinase-type plasminogen activator. Elevated plasma PAI-1 levels, an independent cardiovascular risk factor, has been shown to be a predictor of recurr...
Metabolic Syndrome X
Metabolic syndrome Aldosterone inhibitor Diurnal drug regimen PAI-1 levels
null
2
arm 1: Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 50mg, by mouth, daily, in the evening x 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks. arm 2: Eplerenone - 50mg, by mouth, daily, in the eve...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg. 100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks. intervention 2: Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks f...
intervention 1: Eplerenone (Morning) intervention 2: Eplerenone (Night-time)
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
20
0
0
0
NCT00515021
1COMPLETED
2010-04-01
2007-04-01
Vanderbilt University Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.
Esophageal Cancer
Esophageal Cancer
null
1
arm 1: PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation
[ 0 ]
1
[ 0 ]
intervention 1: weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks
intervention 1: PPX with cisplatin and radiation
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
40
0
0
0
NCT00522795
1COMPLETED
2010-04-01
2007-08-01
Brown University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and patients. The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha and ribavirin. Treatment duration and rib...
This is a multicentre, open-label, randomized, 5 arm parallel-group, multiple dose study in 50 chronic hepatitis C virus (HCV) genotype 1 non-responders to standard treatment with peg-IFN alpha (2a or 2b) and ribavirin. The entire study lasts a maximum of 96 weeks and consists of a 48- or 72-week treatment period (acco...
Chronic Hepatitis C
Hepatitis Hepatitis C
null
5
arm 1: Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response arm 2: Debio 025 (ali...
[ 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Debio 025 supplied as a 100 mg/mL oral solution intervention 2: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes intervention 3: Ribavirin supplied as 200 mg tablets
intervention 1: Debio 025 intervention 2: Peg-IFNα2a intervention 3: Ribavirin
7
La Jolla | California | United States | -117.2742 | 32.84727 Gainesville | Florida | United States | -82.32483 | 29.65163 Miami | Florida | United States | -80.19366 | 25.77427 Baltimore | Maryland | United States | -76.61219 | 39.29038 Dallas | Texas | United States | -96.80667 | 32.78306 Fairfax | Virginia | United S...
50
0
0
0
NCT00537407
1COMPLETED
2010-04-01
2007-09-01
Debiopharm International SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
8
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be s...
Brain Injury Intracranial Pressure
Brain Injury
null
2
arm 1: Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours. arm 2: Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover) intervention 2: in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
intervention 1: Dexmedetomidine intervention 2: Propofol
1
Durham | North Carolina | United States | -78.89862 | 35.99403
8
0
0
0
NCT00538616
1COMPLETED
2010-04-01
2008-01-01
Carmelo Graffagnino
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
923
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.
Postmenopausal Osteoporosis
null
3
arm 1: 5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast) arm 2: 35 mg / Delayed-release Risedronate (Immediately Following Breakfast) arm 3: 35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)
[ 1, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily intervention 2: 35 mg Delayed-release Risedronate Administered Immediately Following Breakfast Weekly intervention 3: 35 mg Delayed-release Risedronate Administered At Least 30 Minutes Before Breakfast Weekly
intervention 1: risedronate intervention 2: risedronate intervention 3: risedronate
45
Birmingham | Alabama | United States | -86.80249 | 33.52066 Oakland | California | United States | -122.2708 | 37.80437 San Diego | California | United States | -117.16472 | 32.71571 Walnut Creek | California | United States | -122.06496 | 37.90631 Walnut Creek | California | United States | -122.06496 | 37.90631 Lakew...
922
0
0
0
NCT00541658
1COMPLETED
2010-04-01
2007-10-01
Warner Chilcott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
915
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and n...
null
Alzheimer's Disease
Moderate-to-severe Alzheimer's Disease
null
2
arm 1: Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205). arm 2: Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg immediate release (IR) in the preceding doubl...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Donepezil SR 23 mg once daily orally.
intervention 1: Donepezil
1
Santa Ana | California | United States | -117.86783 | 33.74557
902
0
0
0
NCT00566501
1COMPLETED
2010-04-01
2007-12-14
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
116
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study investigated asthma-related quality of life in Brazilian patients using omalizumab.
null
Asthma
Asthma, anti-immunoglobulin E, omalizumab
null
2
arm 1: Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their cu...
[ 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE. intervention 2: Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent intervention 3: Fixed dose of LABA as prescribed prior to study entry i...
intervention 1: Omalizumab intervention 2: Inhaled corticosteroids (ICS) intervention 3: Long-acting beta 2-adrenergic agonist (LABA) intervention 4: Short-acting beta 2-adrenergic agonist (SABA)
1
São Paulo | N/A | Brazil | -46.63611 | -23.5475
116
0
0
0
NCT00567476
1COMPLETED
2010-04-01
2007-11-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
8
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The core of the proposal is a prospective, randomized, double-blinded, controlled study which will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA approved for plasma volume expansion, is signif...
All patients admitted to the University of Virginia Health system who have clinically or pathologically defined cirrhosis, laboratory evidence consistent with spontaneous bacterial peritonitis and clinically or radiologically accessible ascites will be screened for participation in this prospective,randomized, double-b...
Spontaneous Bacterial Peritonitis
Peritonitis
null
2
arm 1: antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three arm 2: antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
[ 0, 1 ]
2
[ 0, 2 ]
intervention 1: dextran 70, 1.0 g/kg on days one, two and three intervention 2: human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
intervention 1: Dextran 70 intervention 2: human albumin
1
Charlottesville | Virginia | United States | -78.47668 | 38.02931
8
0
0
0
NCT00570960
6TERMINATED
2010-04-01
2007-06-01
University of Virginia
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.
The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial with sorafenib to assess the effects of this novel therapy on HRQL. Understanding the effe...
Carcinoma, Hepatocellular
Hepatocellular Carcinoma TACE Sorafenib Transcatheter Arterial Chemoembolization Nexavar Unresectable
null
1
arm 1: Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination. intervention 2: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.
intervention 1: Sorafenib intervention 2: TACE
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
19
0
0
0
NCT00576056
6TERMINATED
2010-04-01
2008-01-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
165
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilati...
Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.
Acute Hypoxemic Respiratory Failure
null
2
arm 1: SURFAXIN® (lucinactant) for intratracheal instillation arm 2: Sham air (placebo) instillation
[ 0, 3 ]
2
[ 0, 10 ]
intervention 1: Slow intra-tracheal instillation intervention 2: Slow intra-tracheal instillation
intervention 1: Lucinactant intervention 2: Sham Comparator
3
Warrington | Pennsylvania | United States | -75.13406 | 40.24927 Concepción | N/A | Chile | -73.04977 | -36.82699 Santiago | N/A | Chile | -70.64827 | -33.45694
165
0
0
0
NCT00578734
1COMPLETED
2010-04-01
2007-06-01
Windtree Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is: evaluate the safety and activity of administering arsenic trioxide (Trisenox) in the treatment of unresectable or metastatic primary liver cancer, to evaluate the qualitative and quantitative toxicities of this treatment, and to measure the response to treatment and the patterns of failure...
Hepatocellular carcinoma (HCC) is one of the most frequently diagnosed malignancies in some regions of the world, particularly Africa and the Asian portion of the Pacific rim. However, it is an uncommon malignancy in the United States, with less than 14,000 cases diagnosed annually. Malignancies of the gallbladder and ...
Carcinoma, Hepatocellular
livers, hepatocellular carcinoma (HCC)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox i...
intervention 1: arsenic trioxide
1
Galveston | Texas | United States | -94.7977 | 29.30135
9
0
0
0
NCT00582400
6TERMINATED
2010-04-01
2004-09-01
The University of Texas Medical Branch, Galveston
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
20
RANDOMIZED
SINGLE_GROUP
0TREATMENT
3TRIPLE
false
0ALL
false
This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows: Hypothesis 1: Omega-3 fatty acids wil...
Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a component of the human diet if fish is consumed. Aripipr...
Pediatric Bipolar Disorder
bipolar disorder fish oil aripiprazole children
null
2
arm 1: Subjects administered aripiprazole and randomized to receive fish oil arm 2: Subjects administered aripiprazole and randomized to receive placebo
[ 1, 2 ]
3
[ 0, 7, 0 ]
intervention 1: tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks intervention 2: 1600mg (4 capsules) daily for 12 weeks intervention 3: Placebo
intervention 1: Aripiprazole intervention 2: fish oil intervention 3: Placebo
1
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
20
0
0
0
NCT00592683
6TERMINATED
2010-04-01
2007-12-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
11
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
2MALE
false
To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but th...
Prostate Cancer
null
2
arm 1: Subjects receive supplement arm 2: Subjects will receive placebo
[ 0, 2 ]
2
[ 7, 0 ]
intervention 1: Soy/isoflavone supplementation intervention 2: Placebo
intervention 1: Flav-ein capsules intervention 2: Placebo
1
Kansas City | Kansas | United States | -94.62746 | 39.11417
22
0
0
0
NCT00594620
6TERMINATED
2010-04-01
2004-08-01
University of Kansas Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria Cutanea Tarda. Primary objective - the elimination of all blistering within 6 months of treatment. Secondary objective - decrease in total body iron levels.
Phlebotomy is the standard therapy for Porphyria Cutanea Tarda (PCT), but it can be inconvenient and cause anemia in some patients. Deferasirox is a new class of tridentate iron chelators with high affinity and selectivity for iron. The medication is administered orally, which if effective for PCT would make it a more...
Porphyria Cutanea Tarda
Exjade PCT Study PCT Study Porphyria Cutanea Tarda
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 250 mg of deferasirox once daily for 6 months
intervention 1: Deferasirox
1
Dallas | Texas | United States | -96.80667 | 32.78306
10
0
0
0
NCT00599326
1COMPLETED
2010-04-01
2008-01-01
University of Texas Southwestern Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
61
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The primary purpose of this Phase I study is to evaluate the effect of the co-administration of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the effect of a relatively weak inducer. This study...
null
Multiple Myeloma Non-Hodgkin's Lymphoma
null
3
arm 1: Control arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle. arm 2: Treatment Arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3. arm 3: Treatment arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-d...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1.3 mg/m\^3 on days 1, 4, 8, 11 over a 21-day treatment cycle intervention 2: bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3 intervention 3: bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexametha...
intervention 1: bortezomib intervention 2: bortezomib, rifampicin intervention 3: bortezomib, dexamethasone
9
Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Rome | N/A | Italy | 12.51133 | 41.89193 Gdansk | N/A | Poland | 18.64912 | 54.35227 Warsaw | N/A | Poland | 21.01178 | 52.22977 Parow | Cape Town | South Africa | 18.59992 | -33.89723 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Pretoria | N/A | South Africa |...
61
0
0
0
NCT00608907
1COMPLETED
2010-04-01
2007-09-01
Millennium Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This will be an open-label, non-randomized trial pilot phase II trial open to patients with myelodysplastic syndrome. The purpose of the study is to find out if the combination of decitabine, arsenic trioxide and ascorbic acid is safe.
Conventional therapy for MDS has been poor at best. Supportive care with transfusion therapy and antibiotics have remained an option for all patients with myelodysplastic syndrome (MDS). The only known curative therapy is an allogeneic bone marrow transplant. However due to its high morbidity in this elderly populatio...
Myelodysplastic Syndrome
Myelodysplastic syndrome MDS
null
1
arm 1: Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS
[ 0 ]
1
[ 0 ]
intervention 1: Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per...
intervention 1: Decitabine, Arsenic Trioxide and Ascorbic Acid
1
Durham | North Carolina | United States | -78.89862 | 35.99403
6
0
0
0
NCT00621023
1COMPLETED
2010-04-01
2007-11-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
28
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to find out how exenatide causes weight loss. Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).
The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories. Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible. Women who could get pregnant must be on birth ...
Healthy
Exenatide Byetta weight loss energy expenditure normal volunteers
null
1
arm 1: Exenatide. Dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks Each subject serves as their own control for outcome measures taken before and during drug treatment.
[ 0 ]
1
[ 0 ]
intervention 1: Exenatide dose was 5 microgram for 2 weeks that was increased to 10 microgram for 10 weeks of treatment.
intervention 1: Exenatide
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
28
0
0
0
NCT00623545
1COMPLETED
2010-04-01
2008-01-01
University of Wisconsin, Madison
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemotherapy drugs, such as f...
OBJECTIVES: Primary * To determine if allogeneic natural killer (NK) cells infused following chemoimmunotherapy can be safely expanded in vivo with aldesleukin. Secondary * To determine if interleukin-15 production at day 0 correlates with NK cells expansion. * To determine overall response rate at 3 months. * To d...
Leukemia Lymphoma
recurrent adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult ...
null
1
arm 1: Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy.
[ 0 ]
5
[ 2, 2, 2, 0, 0 ]
intervention 1: Day 0-14, 10 million international units, 3 times per week for 6 doses intervention 2: Day 0 infusion of cells (1.5-8 x 10\^7 cells/kg). intervention 3: Administered Day -8, day -1, day +6 and day +13, intravenously (IV) 357 mg/m\^2 intervention 4: 60 mg/kg intravenous (IV) on Day -5. intervention 5: Da...
intervention 1: aldesleukin intervention 2: allogeneic natural killer cells intervention 3: rituximab intervention 4: cyclophosphamide intervention 5: fludarabine phosphate
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
6
0
0
0
NCT00625729
6TERMINATED
2010-04-01
2008-01-01
Masonic Cancer Center, University of Minnesota
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
112
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.
null
Chronic Hepatitis C
Hepatitis C, Chronic
null
2
arm 1: One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. arm 2: One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placeb...
[ 0, 2 ]
4
[ 0, 0, 2, 0 ]
intervention 1: One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks. intervention 2: One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks ...
intervention 1: Nitazoxanide intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
10
Palo Alto | California | United States | -122.14302 | 37.44188 New Haven | Connecticut | United States | -72.92816 | 41.30815 Bay Pines | Florida | United States | -82.77816 | 27.81419 Largo | Florida | United States | -82.78842 | 27.90979 Atlanta | Georgia | United States | -84.38798 | 33.749 Boston | Massachusetts | ...
112
0
0
0
NCT00637923
1COMPLETED
2010-04-01
2008-03-01
Romark Laboratories L.C.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
128
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
true
Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.
This is a safety study.
Smoking Cessation
null
2
arm 1: Randomization 2:1 treatment to placebo arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Randomization 2:1 treatment to placebo intervention 2: One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
intervention 1: placebo intervention 2: varenicline (CP-526,555)
14
Aurora | Colorado | United States | -104.83192 | 39.72943 Farmington | Connecticut | United States | -72.83204 | 41.71982 New Haven | Connecticut | United States | -72.92816 | 41.30815 Worcester | Massachusetts | United States | -71.80229 | 42.26259 New Brunswick | New Jersey | United States | -74.45182 | 40.48622 Durh...
127
0
0
0
NCT00644969
1COMPLETED
2010-04-01
2008-05-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
69
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects ages ≥2 through \<17 years old.
This is a phase II, open-label, multicenter, escalating dose study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects. The study population consists of initially intubated and mechanically ventilated pediatric subjects, ages ≥2 through \<17 years old, that require sedation in ...
Intubated and Mechanically Ventilated Pediatric Subjects
Pharmacokinetics Pharmacodynamics Escalating dose Dexmedotimidine Intubated Mechanically ventilated Pediatrics
null
4
arm 1: Dose level 1 arm 2: Dose level 2 arm 3: Dose level 3 arm 4: Dose level 4
[ 5, 5, 5, 5 ]
1
[ 0 ]
intervention 1: Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
intervention 1: Dexmedetomidine, midazolam; fentanyl
9
Miami | Florida | United States | -80.19366 | 25.77427 Louisville | Kentucky | United States | -85.75941 | 38.25424 Buffalo | New York | United States | -78.87837 | 42.88645 Durham | North Carolina | United States | -78.89862 | 35.99403 Cleveland | Ohio | United States | -81.69541 | 41.4995 Philadelphia | Pennsylvania ...
59
0
0
0
NCT00652028
1COMPLETED
2010-04-01
2008-11-01
Hospira, now a wholly owned subsidiary of Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
54
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase. Subjects who qualify for enrollment into the study will enter the Tre...
Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.
T-cell Non-Hodgkin's Lymphoma
NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
null
1
arm 1: Open-label, oral lenalidomide monotherapy
[ 0 ]
1
[ 0 ]
intervention 1: Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
intervention 1: Lenalidomide
45
Beverly Hills | California | United States | -118.40036 | 34.07362 Wichita | Kansas | United States | -97.33754 | 37.69224 Hackensack | New Jersey | United States | -74.04347 | 40.88593 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Garran | Australian Capital Territory | Australia | 149.10846 | -35.3...
54
0
0
0
NCT00655668
6TERMINATED
2010-04-01
2008-03-01
Celgene
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
true
14-week single blind, double baseline, forced-titration, cross-over comparison of the cardiac benefits of Coreg CR compared to valsartan added to existing ACE inhibition
Combination drug therapy is necessary for optimal blood pressure reduction and current guidelines mandate the concomitant use of ACE inhibitors and β-blockers in most patients at significant risk for cardiovascular disease (CVD) events. There is also continuing interest in combining angiotensin receptor blockers (ARBs)...
Hypertension
cardiac work carvedilol CR valsartan tonometry
null
2
arm 1: Valsartan 160 mg daily (one week) and valsartan 320 mg daily (3 weeks) followed by carvedilol CR 20 mg daily (one week) and carvedilol CR 40 mg daily (3 weeks) arm 2: carvedilol CR 20 mg daily (one week) and carvedilol CR 40 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week) and valsartan 320 mg dail...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Carvedilol CR intervention 2: Valsartan
1
Buffalo | New York | United States | -78.87837 | 42.88645
60
0
0
0
NCT00657241
1COMPLETED
2010-04-01
2008-04-01
State University of New York at Buffalo
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
37
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to determine the efficacy and safety of clevidipine for treating acute hypertension (high blood pressure, defined as systolic blood pressure \>160 mmHg) in patients with intracerebral hemorrhage (i.e., bleeding in the brain; stroke).
This was a multicenter, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly control acute hypertension in patients with intracerebral hemorrhage. Informed consent was obtained from patients meeting the...
Hypertension Hemorrhage
Hypertension Hemorrhage Intracranial Pressure Antihypertensive Agent Calcium Channel Blocker
null
1
arm 1: This will be a single-arm study with no reference therapy.
[ 0 ]
1
[ 0 ]
intervention 1: Clevidipine injectable emulsion (0.5 mg/mL) in 20% lipid emulsion in 100 mL bottles was administered intravenously to all patients via a single dedicated line. Clevidipine was infused at an initial rate of 2.0 mg/h for the first 1.5 minutes. Thereafter, titration to higher infusion rates were to be att...
intervention 1: clevidipine
17
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Baltimore | Maryland | United States | -76.61219 | 39.29038 Portland | Massachusetts | United States | N/A | N/A Detroit | Michigan | United States | -83.04575 | 42.33143 New York | Ne...
35
0
0
0
NCT00666328
1COMPLETED
2010-04-01
2008-06-01
The Medicines Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
41
RANDOMIZED
SINGLE_GROUP
0TREATMENT
3TRIPLE
true
0ALL
true
This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics. The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taki...
null
Type 2 Diabetes
diabetes insulin byetta glucose blood sugar metformin A1c
null
2
arm 1: Participants will receive exenatide as part of their diabetes treatment arm 2: Participants will receive placebo rather than exenatide as part of their diabetes treatment
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks intervention 2: 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
intervention 1: exenatide intervention 2: placebo
3
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Rochester | Minnesota | United States | -92.4699 | 44.02163 Portland | Oregon | United States | -122.67621 | 45.52345
103
0
0
0
NCT00667732
1COMPLETED
2010-04-01
2007-03-01
Oregon Health and Science University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
73
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
true
1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your liver and thus speed up your liver's ability to get rid of efavirenz from your body. This may render efavirenz and other medications ineffective....
The human hepatic cytochrome P450 2B6 (CYP2B6) is a key enzyme in the metabolism of a growing list of clinically important drugs, environmental chemicals (e.g. toxicants and carcinogens) and endogenous substances. The expression and activity of this enzyme varies widely among individuals, probably due to genetic polymo...
HIV
CYP2B6 Efavirenz Pharmacokinetics Pharmacogenetics Drug-Interactions
null
3
arm 1: Efavirenz clearance in this genotype was compared with the other genotypes arm 2: Efavirenz clearance in this genotype was compared with the other genotypes arm 3: Efavirenz clearance in this genotype was compared with the other genotypes
[ 5, 5, 5 ]
1
[ 0 ]
intervention 1: The metabolism and pharmacokinetics of efavirenz were assessed at a single 600 mg oral dose of efavirenz and after subjects took multiple doses of efavirenz (600 mg/day orally for 17 days).
intervention 1: Efavirenz
2
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Indianapolis | Indiana | United States | -86.15804 | 39.76838
73
0
0
0
NCT00668395
1COMPLETED
2010-04-01
2007-05-01
Indiana University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
57
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary objective: To estimate 6-month progression free survival probability of pts w recurrent malignant gliomas treated w erlotinib + bevacizumab. Secondary Objectives: To evaluate safety \& tolerability of erlotinib + bevacizumab among pts w recurrent malignant gliomas To evaluate radiographic response of pts w r...
Exploratory, Phase II study designed to assess anti-tumor activity of combinatorial regimen consisting of erlotinib + bevacizumab among pts w recurrent malignant glioma. Signal transduction inhibitors, such as erlotinib, as well as anti-angiogenic agents, such as bevacizumab, are expected to exert a cytostatic anti-tum...
Glioblastoma Gliosarcoma
Glioblastoma Gliosarcoma Recurrent MG Malignant glioma Glioma Glioblastoma multiforme (GBM) GBM Brain tumor Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic oligoastrocytoma Bevacizumab Avastin Erlotinib Tarceva
null
1
arm 1: Bevacizumab + Erlotinib
[ 0 ]
1
[ 0 ]
intervention 1: Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. Dose of erlotinib is based on prior erlotinib monotherapy trial in RMG. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-en...
intervention 1: Bevacizumab and Erlotinib
1
Durham | North Carolina | United States | -78.89862 | 35.99403
57
0
0
0
NCT00671970
1COMPLETED
2010-04-01
2007-02-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
514
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patien...
Each patient will receive one of the following regimens in the morning after breakfast: 1. One budesonide MMX® 6 mg tablet plus three placebo Entocort enteric-coated (EC®) overencapsulated capsules, or 2. One budesonide MMX® 9 mg tablet plus three placebo Entocort EC® overencapsulated capsules, or 3. Three placebo Ent...
Ulcerative Colitis
Ulcerative colitis
null
4
arm 1: One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. arm 2: One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. arm 3: Three Entocort EC® 3 mg overencapsulated capsules plus on...
[ 0, 0, 1, 2 ]
5
[ 3, 0, 0, 0, 0 ]
intervention 1: Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores intervention 2: 6 mg/day, 6 mg tablets intervention 3: 9 mg/day, 9 mg tablets intervention 4: 9 mg/day, 3 mg tablets intervention 5: Placebo
intervention 1: Blood sampling, endoscopy intervention 2: Budesonide MMX® 6 mg intervention 3: Budesonide MMX® 9 mg intervention 4: Entocort EC® 3 mg intervention 5: Placebo
71
Sydney | New South Wales | Australia | 151.20732 | -33.86785 Adelaide | N/A | Australia | 138.59863 | -34.92866 Box Hill | N/A | Australia | 145.12545 | -37.81887 Melbourne | N/A | Australia | 144.96332 | -37.814 Melbourne | N/A | Australia | 144.96332 | -37.814 Bonheiden | N/A | Belgium | 4.54714 | 51.02261 Kohtla-Jär...
511
0
0
0
NCT00679380
1COMPLETED
2010-04-01
2008-06-01
Bausch Health Americas, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.
Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guide...
Opioid-Related Disorders Heroin Dependence
Heroin Dependence Opioid Dependence Primary Care Buprenorphine
null
2
arm 1: Buprenorphine Unobserved at home induction arm 2: Buprenorphine Observed in office induction
[ 1, 1 ]
1
[ 0 ]
intervention 1: Dose is determined according to the participants' individual need.
intervention 1: Buprenorphine
1
New York | New York | United States | -74.00597 | 40.71427
20
0
0
0
NCT00684554
1COMPLETED
2010-04-01
2007-12-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
166
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β \[anti-IL-1β\] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified...
null
Cryopyrin-Associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle Wells Syndrome Neonatal Onset Multisystem Inflammatory Disease
Cryopyrin-associated periodic syndromes (CAPS): Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), MWS with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease (NOMID) or Neonatal Onset Multisystem Inflammatory Disease (NOMID), children, systemic autoinflammatory disease, C...
null
1
arm 1: Subcutaneous injection every 8 weeks based on participant's body weight. Body weight \>40 kilogram (kg): 150 milligrams (mg) per injection and body weight \<= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent dose...
[ 0 ]
1
[ 0 ]
intervention 1: 6 mL glass vial containing 150 mg lyophilized Canakinumab reconstituted with water for a subcutaneous injection every 8 weeks. Dosage based on body weight.
intervention 1: Canakinumab (ACZ885)
28
Little Rock | Arkansas | United States | -92.28959 | 34.74648 San Francisco | California | United States | -122.41942 | 37.77493 Columbus | Georgia | United States | -84.98771 | 32.46098 Chicago | Illinois | United States | -87.65005 | 41.85003 Cleveland | Ohio | United States | -81.69541 | 41.4995 Madison | Wisconsin ...
166
0
0
0
NCT00685373
1COMPLETED
2010-04-01
2008-05-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0