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 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
This is a study to determine the optimal treatment for patients with advanced stage or recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates the effectiveness of the combination of hormona...
Endometrial cancer is the most common gynecologic malignancy with 40,100 new cases diagnosed and 6,800 deaths attributable to this malignancy in 2003. Most patients diagnosed with endometrial cancer have early stage disease that is amenable to treatment with hysterectomy and bilateral salpingo-oophorectomy with excelle...
Uterine Cancer
null
1
arm 1: Single
[ 0 ]
1
[ 0 ]
intervention 1: Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megester...
intervention 1: Paclitaxel ,Carboplatin , Megesterol Acetate
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
30
0
0
0
NCT00584857
1COMPLETED
2011-10-01
2004-07-01
University of Alabama at Birmingham
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
This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.
All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression. During the study, all patients will receive 10 mg of RAD001 orall...
Metastatic Melanoma
Metastatic Melanoma Everolimus RAD001 Bevacizumab
null
1
arm 1: All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
[ 0 ]
2
[ 0, 0 ]
intervention 1: 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks. intervention 2: 10 mg by mouth daily
intervention 1: Bevacizumab intervention 2: Everolimus
15
Fort Myers | Florida | United States | -81.84059 | 26.62168 Lakeland | Florida | United States | -81.9498 | 28.03947 Orlando | Florida | United States | -81.37924 | 28.53834 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Gainesville | Georgia | United States | -83.82407 | 34.29788 Evansville | Indiana ...
57
0
0
0
NCT00591734
1COMPLETED
2011-10-01
2008-01-01
SCRI Development Innovations, LLC
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 ]
84
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This randomized phase II trial is studying the side effects and how well giving tipifarnib together with etoposide works in treating older patients with newly diagnosed, previously untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dr...
OBJECTIVES: I. To compare the efficacy and toxicity of two schedules of tipifarnib plus etoposide as induction therapy in older patients with newly diagnosed, previously untreated acute myeloid leukemia. II. To study mechanisms of leukemia cell resistance to tipifarnib in combination with etoposide. OUTLINE: This is...
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) A...
null
2
arm 1: Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10. arm 2: Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Given orally intervention 2: Given orally
intervention 1: tipifarnib intervention 2: etoposide
5
Atlanta | Georgia | United States | -84.38798 | 33.749 Baltimore | Maryland | United States | -76.61219 | 39.29038 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Rochester | Minnesota | United States | -92.4699 | 44.02163 New York | New York | United States | -74.00597 | 40.71427
84
0
0
0
NCT00602771
1COMPLETED
2011-10-01
2008-01-01
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
[ 3 ]
41
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Primary Objectives: * To determine the effect of Avastin on tumor blood flow as determined by functional computed tomography (CT) in patients with low or intermediate grade neuroendocrine carcinoma. * To determine the effect of RAD001 on tumor blood flow as determined by functional CT in patients with low or intermedi...
The Study Drugs: Avastin is designed to prevent the formation of new blood vessels that help cancer cells to grow. RAD001 is designed to block a protein that is important in the growth of cancer cells. Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the ...
Neuroendocrine Carcinoma
Neuroendocrine Carcinoma Avastin Bevacizumab RAD001 Everolimus
null
3
arm 1: Cycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV) arm 2: Cycle 2: Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 3 weeks arm 3: Cycle 1 (First 3 weeks of study)- RAD001 10 mg orally daily for 21 Days
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: 15 mg/kg By Vein Over 90 Minutes Every 21 Days intervention 2: 10 mg By Mouth Daily For 21 Days
intervention 1: Avastin intervention 2: RAD001
1
Houston | Texas | United States | -95.36327 | 29.76328
39
0
0
0
NCT00607113
1COMPLETED
2011-10-01
2008-01-01
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
[ 3 ]
38
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.
The trial consists of two phases, a 48 week treatment period, followed by an individualized treatment period of up to two years. Patients are treated in cohorts of increasing doses (100 mg, 300 mg and 700 mg) with 12 patients in each dose cohort. Within each cohort patients are randomized asymmetrically in a 2:1 ratio...
Multiple Sclerosis
relapsing forms of multiple sclerosis ofatumumab multiple sclerosis
null
6
arm 1: 100mg ofatumumab then placebo arm 2: placebo then 100mg ofatumumab arm 3: 300mg ofatumumab then placebo arm 4: placebo then 300mg ofatumumab arm 5: 700mg ofatumumab then placebo arm 6: placebo then 700mg ofatumumab
[ 0, 0, 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 100mg intervention 2: 300mg intervention 3: 700mg intervention 4: matching placebo
intervention 1: Ofatumumab 100 intervention 2: Ofatumumab 300 intervention 3: Ofatumumab 700 intervention 4: Placebo
0
null
38
0
0
0
NCT00640328
1COMPLETED
2011-10-01
2008-05-01
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 ]
63
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel ...
Lung cancer has become the leading cause of cancer death in both men and women in the US and Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment is available for advanced stages of the disease (stag...
Tumors
non-small cell lung cancer non-small cell lung carcinoma neoplasms, lung lung cancer tumors NSCLC
null
2
arm 1: Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 m...
[ 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. intervention 2: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. intervention 3: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. intervention 4: Bevacizumab (15 mg/kg) on D...
intervention 1: Fosbretabulin intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Bevacizumab
15
Campbell | California | United States | -121.94996 | 37.28717 Fountain Valley | California | United States | -117.95367 | 33.70918 Los Angeles | California | United States | -118.24368 | 34.05223 Pleasant Hill | California | United States | -122.0608 | 37.94798 Boca Raton | Florida | United States | -80.0831 | 26.35869...
60
0
0
0
NCT00653939
1COMPLETED
2011-10-01
2008-03-01
Mateon 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
[ 4 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. These studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intes...
Advanced Parkinson's Disease
levodopa-carbidopa Carbidopa levodopa dyskinesia Duodopa levodopa-carbidopa intestinal gel Severe Motor Fluctuations levodopa/carbidopa suspension DUOPA
null
2
arm 1: Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. arm 2: Participants were randomized to placebo intestinal gel a...
[ 0, 1 ]
7
[ 0, 0, 0, 0, 1, 1, 1 ]
intervention 1: infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour) intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: percutaneous endoscopic gastrostomy tube intervention 7: jejunal tub...
intervention 1: Levodopa carbidopa intestinal gel (LCIG) intervention 2: Placebo Gel intervention 3: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets intervention 4: Placebo (PBO) oral capsules intervention 5: CADD-Legacy® 1400 ambulatory infusion pump intervention 6: PEG tube intervention 7: J-...
14
Birmingham | Alabama | United States | -86.80249 | 33.52066 Fountain Valley | California | United States | -117.95367 | 33.70918 Oceanside | California | United States | -117.37948 | 33.19587 Port Charlotte | Florida | United States | -82.09064 | 26.97617 Chicago | Illinois | United States | -87.65005 | 41.85003 Lexing...
71
0
0
0
NCT00660387
1COMPLETED
2011-10-01
2009-12-01
AbbVie (prior sponsor, Abbott)
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 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life...
The purpose of this study is to assess the efficacy of Lubiprostone (Amitiza) compared to standard care for the treatment of constipation in orthopedic patients receiving opioids for pain control during inpatient rehabilitation. Lubiprostone (Amitiza®) is a locally acting chloride channel activator that increases intes...
Constipation
constipation opioid rehabilitation post-operative orthopedic
null
2
arm 1: Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon arm 2: Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 24 µg po BID given with meals for 6 days intervention 2: 2 tabs daily for 6 days
intervention 1: Lubiprostone intervention 2: Senna
1
Chicago | Illinois | United States | -87.65005 | 41.85003
60
0
0
0
NCT00662363
1COMPLETED
2011-10-01
2008-04-01
Shirley Ryan AbilityLab
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, 4 ]
67
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreati...
Same
Lateral Epicondylitis Tennis Elbow
Lateral epicondylitis Tennis elbow Prolotherapy
null
3
arm 1: Deep injection with 15% dextrose in lidocaine arm 2: Deep injection with saline/lidocaine arm 3: Superficial injection with saline/lidocaine
[ 0, 2, 2 ]
2
[ 0, 3 ]
intervention 1: Injection of 15% dextrose with lidocaine at the lateral epicondyle intervention 2: Saline/lidocaine
intervention 1: Prolotherapy intervention 2: Placebo
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
66
0
0
0
NCT00674622
1COMPLETED
2011-10-01
2007-09-01
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 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if lenalidomide can help to treat uncontrolled pain caused by advanced cancer. Primary Objectives: 1\. Determine efficacy of Lenalidomide for the treatment of refractory cancer pain, as measured by the change on Edmonton symptom assessment scale (ESAS). Secondary ...
The Study Drug: Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. The drug is also designed to decrease the level of certain proteins ...
Advanced Cancer Pain
Advanced Cancer Refractory Cancer Pain Lenalidomide Revlimid CC-5103
null
1
arm 1: 10 mg by mouth daily
[ 0 ]
1
[ 0 ]
intervention 1: 10 mg by mouth daily
intervention 1: Lenalidomide
1
Houston | Texas | United States | -95.36327 | 29.76328
3
0
0
0
NCT00684242
6TERMINATED
2011-10-01
2008-05-01
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
[ 3 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
To evaluate the cognitive enhancing effect of BF2.649 and to evaluate the effect of BF2.649 on symptom severity in persons with schizophrenia or schizoaffective disorder.
We will recruit persons with schizophrenia or schizoaffective disorder who are not currently experiencing an acute exacerbation of psychotic symptoms, but still display cognitive symptoms and have consequent psychosocial dysfunction. The subjects recruited will be taking haloperidol, aripiprazole, risperidone or palipe...
Schizophrenia
schizophrenia cognitive deficients cognitive enhancing antipsychotics
null
2
arm 1: Volunteers are given Placebo, up to 20mg per day arm 2: Volunteers are given BF2.649, up to 20mg per day
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: up to 20mg per day intervention 2: up to 20mg per day
intervention 1: BF2.649 intervention 2: Placebo
2
Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306
38
0
0
0
NCT00690274
1COMPLETED
2011-10-01
2008-06-01
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
[ 3 ]
28
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), the bone trophic fact...
null
Disorder of Bone Density and Structure, Unspecified
Bone density Bone turnover markers rhIGF-1 Bone structure Anorexia nervosa
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Twice daily
intervention 1: Recombinant human insulin like growth factor-1 (rhIGF-1)
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
28
0
0
0
NCT00720122
1COMPLETED
2011-10-01
2008-07-01
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 ]
29
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids as well as measures of safety over the long-term.
Homozygous familial hypercholesterolemia (FH) is a serious life-threatening genetic disease. Total plasma cholesterol levels are generally over 500 mg/dl and markedly premature cardiovascular disease is the major consequence. Untreated, most patients develop atherosclerosis before age 20 and generally do not survive pa...
Homozygous Familial Hypercholesterolemia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 5-80 mg daily by mouth for 1.5 yrs
intervention 1: AEGR-733
10
Los Angeles | California | United States | -118.24368 | 34.05223 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 London | Ontario | Canada | -81.23304 | 42.98339 Chicoutimi | Quebec | Canada | -71.06369 | 48.41963 Palermo | Sicily | Italy | 13.3636 | 38.1166 Ferrara | N/A | Italy | 11.62057 | 44.8380...
29
0
0
0
NCT00730236
1COMPLETED
2011-10-01
2007-12-01
Aegerion 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
[ 2, 3 ]
23
NON_RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
4QUADRUPLE
true
0ALL
true
This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More in...
Specific Aims: Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects. Hypotheses related to Aim 1: 1. Subjects wil...
Cocaine Dependence
substance abuse cocaine caffeine impulsivity
null
4
arm 1: Caffeine 150 mg arm 2: Placebo arm 3: Amphetamine arm 4: Caffeine 300 mg
[ 0, 2, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion intervention 2: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300...
intervention 1: Caffeine 150 MG intervention 2: Placebo intervention 3: Amphetamine intervention 4: Caffeine 300 MG
1
Houston | Texas | United States | -95.36327 | 29.76328
69
0
0
0
NCT00733993
1COMPLETED
2011-10-01
2008-04-01
Virginia Commonwealth 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
[ 2 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II t...
This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy. Avastin will be given as an IV dose on days ...
Pancreatic Cancer
Locally advanced Unresectable
null
1
arm 1: Avastin, Tarceva and Radiation Therapy
[ 0 ]
3
[ 0, 0, 4 ]
intervention 1: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy intervention 2: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy intervention 3: Radiation to the pancreas Monday through Friday for 28 treatments
intervention 1: Avastin intervention 2: Tarceva intervention 3: Radiation Therapy
1
Durham | North Carolina | United States | -78.89862 | 35.99403
12
0
0
0
NCT00735306
1COMPLETED
2011-10-01
2008-07-01
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
[ 3 ]
22
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
null
Anxious Major Depressive Disorder
Anxious Major Depressive Disorder
null
2
arm 1: AZD2327 3mg BID arm 2: Placebo BID
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tablet, Oral, Daily intervention 2: Tablet, Oral, Daily
intervention 1: AZD2327 intervention 2: Placebo
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
22
0
0
0
NCT00759395
1COMPLETED
2011-10-01
2009-01-01
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
[ 3 ]
79
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to explore the use of d-cycloserine (DCS) to facilitate extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may lead to the development of new treatment options for cocaine dependence.
Cocaine dependence remains a serious problem in the United States today and in spite of two decades of intense research, efficacious pharmacotherapeutic treatments have not been identified. Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related cues is likely to be involved in rel...
Cocaine Use Disorders
substance-related disorders
null
5
arm 1: Participants were assigned to receive placebo for each of 3 cue exposure sessions and at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footag...
[ 2, 0, 5, 0, 1 ]
2
[ 0, 0 ]
intervention 1: 50 mg d-cycloserine or placebo taken orally intervention 2: None
intervention 1: D-Cycloserine (DCS) intervention 2: Placebo
2
Charleston | South Carolina | United States | -79.93275 | 32.77632 Pickens | South Carolina | United States | -82.70736 | 34.88345
79
0
0
0
NCT00759473
1COMPLETED
2011-10-01
2008-09-01
Medical University of South Carolina
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 ]
104
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
The purpose of the study is to assess early signs of response to abatacept+methotrexate in metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with active rheumatoid arthritis.
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Abatacept, 10 mg/kg, solution given intravenously on Days 1, 15, 29,57, 85, 113, 141, and 169 intervention 2: Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline
intervention 1: Abatacept intervention 2: Methotrexate
21
Glostrup Municipality | N/A | Denmark | 12.40377 | 55.6666 Bois-Guillaume | N/A | France | 1.12219 | 49.4602 Boulogne | N/A | France | -1.3194 | 46.79346 Échirolles | N/A | France | 5.71441 | 45.14603 Nice | N/A | France | 7.26608 | 43.70313 München | N/A | Germany | 13.31243 | 51.60698 Budapest | N/A | Hungary | 19.04...
104
0
0
0
NCT00767325
1COMPLETED
2011-10-01
2008-12-01
Bristol-Myers Squibb
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 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will test the safety and effectiveness CC-4047 (pomalidomide) in patients with advanced, steroid refractory graft-versus-host disease.
Chronic Graft vs. Host Disease is a major complication after allogeneic hematopoietic stem cell transplantation developing in 30 - 70% of patients. It is a multisystem alloimmune and autoimmune disorder with a negative impact on quality of life and functional status, increased need for extended immunosuppression and is...
Graft vs Host Disease
null
1
arm 1: CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: CC-4047
1
St Louis | Missouri | United States | -90.19789 | 38.62727
13
0
0
0
NCT00770757
1COMPLETED
2011-10-01
2009-02-01
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
[ 0 ]
47
NA
SINGLE_GROUP
6HEALTH_SERVICES_RESEARCH
0NONE
true
0ALL
true
This study will evaluate the effects of impaired blood flow regulation on exercise. It will also determine whether the effects are more important in the heart or in the skeletal muscle tissue during exercise. In addition, this study will decide whether temporarily reversing these problems will improve blood flow contro...
The investigators have found that persons with type 2 diabetes have an impaired ability to perform exercise even without clinically apparent complications. The reasons for this marked abnormality are unknown but are important as the decreased ability to exercise could contribute to the decreased expenditure of physical...
Type 2 Diabetes
Type 2 Diabetes Blood Vessel Function Exercise Program Intervention Vitamin C Men Women Blood vessel function
null
1
arm 1: All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
[ 0 ]
2
[ 5, 0 ]
intervention 1: Three month exercise program located at the Anschutz Medical Campus at I-225 and Colfax. The program runs three times per week for about an hour each session. Gym is open Monday - Saturday during specific hours (morning, noon, evening). intervention 2: During one exercise study visit, 0.06 grams of Vita...
intervention 1: Exercise program intervention 2: Ascorbic Acid (Vitamin C)
1
Aurora | Colorado | United States | -104.83192 | 39.72943
47
0
0
0
NCT00786019
1COMPLETED
2011-10-01
2008-05-01
University of Colorado, Denver
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, 4 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha antagonist will provide more effective treatment for acute COPD exacerbation compared to the current standard treatment of antibiotics plus prednisone.
Acute exacerbations of COPD (AECOPD)are usually treated with steroids and antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts,and suppression of the immune system. Studies have suggested that up to 24% of inpatients and 27% of outpatients fail this treatment b...
COPD Exacerbation
COPD Exacerbation Etanercept TNF alpha Randomized
null
2
arm 1: etanercept 50 mg subcutaneous given on the day of randomization and one week later prednisone placebo po daily for 10 days Levofloxacin 750 mg po daily for 10 days. arm 2: prednisone 40 mg daily for 10 days etanercept placebo subcutaneous given on the day of randomization and one week later Levofloxacin 750 mg d...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: prednisone 40 mg daily for 10 days or placebo prednisone intervention 2: etanercept 50 mg subcutaneous given on the day of randomization and one week later or placebo subcutaneous injection intervention 3: Levofloxacin 750 mg daily for 10 days.
intervention 1: Prednisone intervention 2: Etanercept intervention 3: levofloxacin
0
null
81
0
0
0
NCT00789997
1COMPLETED
2011-10-01
2008-11-01
Ottawa Hospital Research 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 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
To determine if peri-operative treatment with omega-3 fatty acids is associated with a decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an improvement in probability of long-term maintenance of sinus rhythm after radiofrequency catheter ablation for Atrial Fibrillation.
AF is the most prevalent arrhythmia, affecting \>2 million Americans. Antiarrhythmic drug therapy often is ineffective to eliminate recurrent episodes of AF. In recent years radiofrequency catheter ablation has emerged as a highly effective treatment strategy in patients with paroxysmal and chronic AF.6, 7 However, AF ...
Atrial Fibrillation
Radiofrequency Ablation atrial fibrillation
null
2
arm 1: Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. arm 2: Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.
[ 0, 2 ]
3
[ 0, 0, 10 ]
intervention 1: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF. intervention 2: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure. intervention 3: Control group will receive placebo before \& after ablation.
intervention 1: LOVAZA Omega 3-acid ethyl esters intervention 2: LOVAZA intervention 3: placebo
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
12
0
0
0
NCT00791089
6TERMINATED
2011-10-01
2008-11-01
University of Michigan
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 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
People infected with HIV have a greater risk of developing cardiovascular disease than people not infected with HIV. This may be due to increased inflammation brought on by either the HIV infection itself or the use of antiretroviral medications to treat HIV infection. This study will evaluate an anti-inflammatory drug...
People infected with HIV have an increased risk for cardiovascular disease, which is a leading cause of death for those with HIV. The increase in cardiovascular disease has been thought to be linked to the use of several types of antiretroviral medications used to treat HIV infection. These medications have been shown ...
HIV Cardiovascular Diseases Atherosclerosis
Endothelial Function Inflammation
null
2
arm 1: Participants will receive pentoxifylline. arm 2: Participants will receive placebo.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 400 mg three times a day for 8 weeks intervention 2: One pill three times a day for 8 weeks
intervention 1: Pentoxifylline intervention 2: Placebo
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
26
0
0
0
NCT00796822
1COMPLETED
2011-10-01
2009-01-01
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
[ 4 ]
21
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
null
Fungemia Neutropenia Candidiasis
Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia
null
2
arm 1: Subjects were randomized 2:1 (anidulafungin:caspofunin). arm 2: Subjects were randomized 2:1 (anidulafungin:caspofunin).
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Subjects in this arm will receive active anidulafungin and placebo caspofungin intervention 2: Subjects in this arm will receive active caspofungin and placebo anidulafungin
intervention 1: Active Anidulafungin intervention 2: Active Caspofungin
10
Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864 Grenoble | N/A | France | 5.71479 | 45.17869 Strasbourg | N/A | France | 7.74553 | 48.58392 Bologna | N/A | Italy | 11.33875 | 44.49381 Roma | N/A | Italy | 11.10642 | 44.99364 Gdansk | N/A | Poland | 18.64912 | 54.35227 Warsaw | N/A | Poland | 21.01178 | 52...
21
0
0
0
NCT00806351
6TERMINATED
2011-10-01
2009-08-01
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
0
0
0
0
0
0
0
0
0
[ 3 ]
195
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.
null
HIV-1
HIV-1. Treatment Naive HIV Infections treatment naive
null
3
arm 1: UK 453,061 Dose One plus Truvada arm 2: UK 453,061 Dose Two plus Truvada arm 3: Efavirenz + Truvada
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. intervention 2: UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. intervention 3: Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.
intervention 1: UK-453, 061 intervention 2: UK-453, 061 intervention 3: EFV +TVA
31
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Darlinghurst | New South Wales | Australia | 151.21925 | -33.87939 Melbourne | Victoria | Australia | 144.96332 | -37.814 Toronto | Ontario | Canada | -79.39864 | 43.70643 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45...
193
0
0
0
NCT00824421
1COMPLETED
2011-10-01
2009-02-01
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 ]
22
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
false
The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus placebo in patients suffering from Friedreich Ataxia
null
Friedreich Ataxia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: EGb 761® 120 mg bid, orally for 12 to 14 weeks intervention 2: Placebo 1 tablet BID, orally for 12 to 14 weeks
intervention 1: EGb 761 120 mg intervention 2: Placebo
1
Paris | N/A | France | 2.3488 | 48.85341
22
0
0
0
NCT00824512
1COMPLETED
2011-10-01
2008-06-01
Ipsen
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 ]
28
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
null
Non-small-cell Lung Cancer
Cancer Lung Cancer
null
2
arm 1: This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin. arm 2: Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1). intervention 2: Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel...
intervention 1: E7080 intervention 2: E7080 intervention 3: Paclitaxel intervention 4: Carboplatin
3
Sunto-gun | Shizuoka | Japan | N/A | N/A Chuo-ku | Tokyo | Japan | N/A | N/A Koto-ku | Tokyo | Japan | N/A | N/A
28
0
0
0
NCT00832819
1COMPLETED
2011-10-01
2009-02-01
Eisai Co., Ltd.
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 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study is to determine whether addition of Revlimid to standard therapy will increase overall and complete response rates compared to historical standard frontline therapy and whether this combination treatment has fewer side effects than similar combination induction treatment.
Current multiple myeloma therapies, typically an induction regimen followed by consolidation therapy with high dose chemotherapy and autologous stem cell rescue (autologous transplantation), can induce remission but relapse and death are inevitable. A growing body of literature suggests that consolidation therapy with ...
Multiple Myeloma
multiple myeloma frontline treatment first-line treatment
null
1
arm 1: Treatment phase (28 days/cycle x 6 cycles): Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22. Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Lenalidomide (Revlimid) intervention 2: Melphalan intervention 3: Dexamethasone
3
New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427
7
0
0
0
NCT00843310
6TERMINATED
2011-10-01
2008-11-01
NYU Langone Health
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 ]
46
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study is intended to provide a definitive test of the hypothesis that elevating sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in the CNS will result in measurable improvements in core symptoms of autism in young individuals, under age 6 years. The study will entail a dou...
Over the past 20 years, several studies have suggested that sapropterin (tetrahydrobiopterin) might ameliorate core symptoms of autism at least in young (under age 6) subjects. However, those studies had somewhat questionable methodologies, a major one being that the doses of sapropterin used were roughly one tenth tha...
Autistic Disorder
autism
null
2
arm 1: Sapropterin was supplied as a 100 mg tablet and dosage was based on 20 mg/kg/d, rounding to the nearest 100 mg. Most subjects crushed the tablets and administered it in liquid or a food to mask the taste. Subjects took the same dose daily for 16 weeks. arm 2: The placebo was supplied as a 100 mg tablet, and dosa...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Patients will receive sapropterin 20 mg per kilogram per day for 16 weeks intervention 2: Patients will receive a placebo identical in form and dosage to the active drug daily for 16 weeks.
intervention 1: sapropterin intervention 2: Placebo
1
Palo Alto | California | United States | -122.14302 | 37.44188
46
0
0
0
NCT00850070
1COMPLETED
2011-10-01
2009-03-01
The Children's Health Council
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
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
null
Follicular Lymphoma
null
2
arm 1: VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle arm 2: fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle intervention 2: rituximab 375mg/m2 on Day 1 of every 35-day cycle intervention 3: 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
intervention 1: fludarabine intervention 2: rituximab intervention 3: VELCADE
43
Amiens | N/A | France | 2.3 | 49.9 Bordeaux | N/A | France | -0.5805 | 44.84044 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Le Mans | N/A | France | 0.20251 | 48.0021 Nîmes | N/A | France | 4.35788 | 43.83665 Paris Cedex 10, 75 | N/A | France | 2.3488 | 48.85341 Paris, 75, Cedex 14 | N/A | France | 2.3488 | 48...
12
0
0
0
NCT00850499
6TERMINATED
2011-10-01
2009-09-01
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
[ 4 ]
304
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age, inclusive) and adolescents (12 17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
This is a multi center, open label, long term safety study in pediatric subjects 6 through 17 years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to participate in this long term safety stud...
Insomnia Attention Deficit Hyperactivity Disorder
Hypnotic Eszopiclone Attention Deficit Hyperactivity Disorder Insomnia Children Adolescent
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: One 2 mg tablet per day for 12 months intervention 2: one 3mg tablet per day for 12 months
intervention 1: eszopiclone intervention 2: eszopiclone
89
Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Carson | California | United States | -118.28202 | 33.83141 Costa Mesa | California | United States | -117.91867 | 33.64113 Glendale | California | United States | -118.25508 | 34.14251 Imperial | Cali...
303
0
0
0
NCT00857220
1COMPLETED
2011-10-01
2009-05-01
Sumitomo Pharma America, 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
[ 0 ]
20
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
false
1FEMALE
true
This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.
With varying complications, OHSS is an iatrogenic condition cause by ovarian stimulation. Classified as mild, moderate, or severe, mild OHSS is relatively common as it occurs in up to 1/3 of women undergoing ovarian stimulation. Symptoms include abdominal ascites, nausea, vomiting, increased abdominal girth and weight ...
Ovarian Hyperstimulation Syndrome
ovarian hyperstimulation syndrome cetrotide acetate GnRH antagonist oocyte donors
null
1
arm 1: oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
[ 0 ]
1
[ 0 ]
intervention 1: cetrotide acetate is a GnRH antagonist. The dose is 3 mg once on the day of oocyte retrieval.
intervention 1: Cetrotide acetate
1
Reston | Virginia | United States | -77.3411 | 38.96872
20
0
0
0
NCT00867659
1COMPLETED
2011-10-01
2009-03-01
Virginia Center for Reproductive 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
[ 4 ]
23
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The seconda...
null
Major Depressive Disorder Generalized Anxiety Disorder
null
2
arm 1: Quetiapine XR arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day intervention 2: Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
intervention 1: Quetiapine XR intervention 2: Placebo
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
23
0
0
0
NCT00868374
6TERMINATED
2011-10-01
2008-06-01
Keming Gao
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 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into...
OBJECTIVES: Primary * To determine the rate of neutrophil engraftment and grade III-IV acute graft-versus-host disease (GVHD) following a T cell depleted (TCD) umbilical cord blood (UCB) transplantation without post-transplant immunosuppression followed by administration of interleukin-2 (IL-2, aldesleukin) (every ot...
Leukemia
recurrent adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent child...
null
1
arm 1: Patients receive cyclophosphamide, fludarabine phosphate, total-body irradiation, T cell depleted umbilical cord blood transplantation (UCBT), followed by interleukin-2 (IL-2, aldesleukin) every other day beginning day +3 for a total of 6 doses and again on day +60 every other day for 6 doses.
[ 0 ]
5
[ 2, 0, 0, 3, 4 ]
intervention 1: IL-2 will be administered (9 million units; 5 million units if weight is less than 45 kg) every other day beginning on day +3 for a total of 6 doses and again on day +60 every other day for 6 doses. intervention 2: 60 mg/kg over 1 hour intravenously (IV) on days -7 and -6. intervention 3: 25 mg/m\^2 int...
intervention 1: aldesleukin intervention 2: cyclophosphamide intervention 3: fludarabine phosphate intervention 4: umbilical cord blood transplantation intervention 5: total-body irradiation
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
2
0
0
0
NCT00871689
6TERMINATED
2011-10-01
2009-01-01
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
[ 5 ]
54
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).
Opiate Addiction
Opiate Addiction Narcotic Addiction Drug Addiction Pain
null
2
arm 1: Methadone 10-60 mg per day in 2-4 divided doses for 6 months arm 2: Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Oral, 10-60 mg per day, 2-4 times per day, 6 months intervention 2: Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
intervention 1: Methadone intervention 2: Buprenorphine/naloxone
2
Buffalo | New York | United States | -78.87837 | 42.88645 Buffalo | New York | United States | -78.87837 | 42.88645
54
0
0
0
NCT00879996
1COMPLETED
2011-10-01
2009-04-01
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
[ 2, 3 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
In adults, drug clearance is less than half of the glomerular filtration rate and the drug half-life is 6-8 hours. Renal function in infants at birth is characterized by immature glomerular filtration and is only 20% that of older children. The specific esterase responsible for levetiracetam hydrolysis has not been ide...
Seizures Disorder of Fetus or Newborn
Neonatal seizures
null
1
arm 1: 6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
[ 0 ]
2
[ 0, 0 ]
intervention 1: 20 mg/kg loading dose; 5 mg/kg daily for 7 days. intervention 2: 40 mg/kg IV load; 10 mg/kg/day maintenance
intervention 1: Low dose levetiracetam intervention 2: High dose levetiracetam
1
San Diego | California | United States | -117.16472 | 32.71571
18
0
0
0
NCT00884052
1COMPLETED
2011-10-01
2007-04-01
Richard H. Haas
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 ]
256
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
1FEMALE
false
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.
Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to comple...
Postoperative Nausea and Vomiting
Elective hysterectomy
null
2
arm 1: 40 mg aprepitant arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 40 mg administered orally with a sip of water prior to anesthesia induction. intervention 2: Placebo
intervention 1: Aprepitant intervention 2: Placebo
1
Phoenix | Arizona | United States | -112.07404 | 33.44838
71
0
0
0
NCT00888329
6TERMINATED
2011-10-01
2007-07-01
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
[ 2, 3 ]
24
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can...
null
Marijuana Abuse
withdrawal acute effects cognitive performance Marijuana Use Marijuana Abstinence
null
1
arm 1: 0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
[ 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 10mg dronabinol administered 3x/day for 5 days intervention 2: 20mg dronabinol administered 3x/day for 5 days intervention 3: 40mg dronabinol administered 3x/day for 5 days intervention 4: placebo dronabinol administered 3x/day for 5 days
intervention 1: Dronabinol 30mg/day intervention 2: Dronabinol 60mg/day intervention 3: Dronabinol 120mg/day intervention 4: Placebo
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
96
0
0
0
NCT00893074
1COMPLETED
2011-10-01
2009-04-01
Johns Hopkins 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 ]
606
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit from prescription treatment alternatives, including Zyban or Chantix. In this study, the investigators propose to develop and evaluate a step...
null
Smoking Cessation
Smoking Cessation Chantix varenicline Nicotine Replacement Therapy Nicotine Patches Zyban bupropion Quit Smoking
null
7
arm 1: Nicotine Responders arm 2: Participants not responsive to nicotine patches who are randomly assigned at week 2 to use of Zyban (bupropion) in combination with nicotine patches arm 3: Participants not responsive to nicotine patches who are randomly assigned at week 2 to use of Chantix (varenicline) arm 4: Partici...
[ 1, 1, 1, 1, 1, 1, 1 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks. intervention 2: 21mg (1 patch) or 42mg (2 patches) nicotine patches f...
intervention 1: Nicotine Patches intervention 2: Nicotine patches, then bupropion & nicotine patches (Pre-Quit) intervention 3: Nicotine patches, then varenicline (Pre-Quit) intervention 4: Nicotine patches, then nicotine patches (Pre-Quit) intervention 5: Nicotine patches, then bupropion & nicotine patches (Post-Quit)...
1
Charlotte, Durham, Raleigh, Winston-Salem | North Carolina | United States | N/A | N/A
572
0
0
0
NCT00894166
1COMPLETED
2011-10-01
2009-05-01
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 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients
null
Ankylosing Spondylitis
IMT evaluation in AS patients treated with etanercept
null
1
arm 1: etanercept 50 mg/week
[ 0 ]
1
[ 0 ]
intervention 1: etanercept 50 mg/week
intervention 1: etanercept
4
Bologna | N/A | Italy | 11.33875 | 44.49381 Prato | N/A | Italy | 11.09699 | 43.8805 Reggio Emilia | N/A | Italy | 10.63125 | 44.69825 Roma | N/A | Italy | 11.10642 | 44.99364
34
0
0
0
NCT00910273
6TERMINATED
2011-10-01
2009-07-01
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
[ 5 ]
22
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
1FEMALE
false
The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome. This study will have 2...
Patients will be recruited up to 21 days prior to the day of surgery. The consent form will be reviewed with the patient, and the patient will be allowed to take a copy home. If the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will be obtained at the time of recruitment. At the tim...
Pain
Lidocaine Mastectomy Pain
null
2
arm 1: Group B using saline as a placebo. arm 2: Group A lidocaine infusion and bolus.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW) intervention 2: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug
intervention 1: Lidocaine intervention 2: Placebo
0
null
22
0
0
0
NCT00913003
6TERMINATED
2011-10-01
2009-05-01
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 ]
70
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.
null
Solid Tumors High Grade Gliomas Lung Cancer Head and Neck Cancer Sarcoma Renal Cell Carcinoma Breast Cancer
null
1
arm 1: Fluciclatide Injection
[ 0 ]
1
[ 0 ]
intervention 1: Fluciclatide Injection (AH111585 (18F) Injection)
intervention 1: Fluciclatide Injection
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
49
0
0
0
NCT00918281
1COMPLETED
2011-10-01
2009-06-01
GE Healthcare
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 ]
1,143
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.
When protocol Amendment 2 was released, there were patients who had already been randomized into the study. These patients were included in the trial prior to making changes to the eligibility criteria. Thus, the study contains 2 distinct cohorts. Cohort 1 contains those patients who had already been randomized, and ha...
Hypertension
Hypertension, Type II Diabetes, Aliskiren, Valsartan, Systolic blood pressure, Diastolic blood pressure, Stage II, Combination
null
2
arm 1: To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 we...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Aliskiren 150 mg tablet intervention 2: Valsartan 160 mg capsules intervention 3: Placebo for Aliskiren 150 mg tablets intervention 4: Placebo for Valsartan 160 mg capsules
intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo for Aliskiren intervention 4: Placebo for Valsartan
4
Newark | Delaware | United States | -75.74966 | 39.68372 Kansas City | Missouri | United States | -94.57857 | 39.09973 Camden | New Jersey | United States | -75.11962 | 39.92595 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
1,139
0
0
0
NCT00927394
1COMPLETED
2011-10-01
2009-05-01
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
[ 3 ]
45
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective of the study was to evaluate the efficacy of Givinostat in combination with hydroxyurea in patients with JAK2V617F-positive Polycythemia Vera (PV) non-responders to the maximum tolerated dose of hydroxyurea monotherapy. The secondary objectives of this study were: * To evaluate the safety and to...
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months. Recruited patients will be rand...
Polycythemia Vera
Polycythemia Vera GIVINOSTAT ITF2357
null
2
arm 1: 50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy arm 2: 50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy intervention 2: 50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy
intervention 1: GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea intervention 2: GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
22
Bari | BA | Italy | 16.86982 | 41.12066 Cuneo | CN | Italy | 7.54828 | 44.39071 Catania | CT | Italy | 15.07041 | 37.49223 San Giovanni Rotondo | FG | Italy | 15.7277 | 41.70643 Florence | FI | Italy | 11.24626 | 43.77925 Monza | MB | Italy | 9.27246 | 45.58005 Messina | ME | Italy | 15.55256 | 38.19394 Palermo | PA | ...
44
0
0
0
NCT00928707
1COMPLETED
2011-10-01
2009-06-01
Italfarmaco
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 ]
91
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
No suitable treatment has been identified to reverse and ideally prevent, the cardiovascular disease risk associated with depression and anxiety. The purpose of this study is to determine if quetiapine treatment of depression can reverse the signs of arterial stiffening that often occurs in depression and anxiety, and ...
The evidence that depressive and anxiety disorders confer a high relative risk (RR) for cardiovascular disease (CVD) development is clear and compelling. A cadre of inflammation, platelet activation and other biomarkers of endothelial dysfunction strongly suggest multiple and possibly interrelated mechanisms underlying...
Depression Anxiety
Cardiovascular Biomarkers Depression Quetiapine
null
2
arm 1: Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks. arm 2...
[ 0, 4 ]
1
[ 0 ]
intervention 1: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.
intervention 1: Quetiapine-XR
1
Maywood | Illinois | United States | -87.84312 | 41.8792
91
0
0
0
NCT00951483
1COMPLETED
2011-10-01
2009-07-01
Loyola 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 ]
20
NA
SINGLE_GROUP
2DIAGNOSTIC
1SINGLE
true
0ALL
false
The purpose of this study is to learn if breathing nitrous oxide (also known as "laughing gas") changes the pressure in a person's eyes. Some patients who need regular eye exams to measure their eye pressure often need to be put to sleep with medicine in order to complete the eye exam. Some of these medicines are known...
An initial pre-anesthetic evaluation and physical examination will be performed by an attending anesthesiologist, and an eye exam will be performed by an attending ophthalmologist to determine suitability for inclusion according to the above criteria. Ideally the eye exam will take place immediately prior to conduction...
Glaucoma Sedation
Glaucoma Nitrous oxide
null
1
arm 1: All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baselin...
[ 0 ]
1
[ 0 ]
intervention 1: Nitrous oxide sedation by inhalation
intervention 1: Nitrous oxide
1
Portland | Oregon | United States | -122.67621 | 45.52345
26
0
0
0
NCT00967694
1COMPLETED
2011-10-01
2009-08-01
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
[ 2, 3 ]
16
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.
null
Renal Cell Carcinoma
null
2
arm 1: Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle arm 2: Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination intervention 2: Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G
intervention 1: Lenalidomide intervention 2: Sunitinib
3
Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Cleveland | Ohio | United States | -81.69541 | 41.4995 Nashville | Tennessee | United States | -86.78444 | 36.16589
16
0
0
0
NCT00975806
6TERMINATED
2011-10-01
2009-09-01
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 ]
103
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8m...
null
Rheumatoid Arthritis
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: single iv infusion 8 mg/kg intervention 2: single iv infusion intervention 3: iv infusion 8mg/kg every 4 weeks for 11 months
intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: placebo intervention 3: tocilizumab [RoActemra/Actemra]
22
Amiens | N/A | France | 2.3 | 49.9 Amiens | N/A | France | 2.3 | 49.9 Bayonne | N/A | France | -1.473 | 43.49316 Bois-Guillaume | N/A | France | 1.12219 | 49.4602 Bordeaux | N/A | France | -0.5805 | 44.84044 Brest | N/A | France | -4.48628 | 48.39029 Cahors | N/A | France | 1.43663 | 44.4491 Chambray-lès-Tours | N/A | ...
103
0
0
0
NCT00977106
1COMPLETED
2011-10-01
2009-06-01
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
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not precisely understood, a dysfunction of the autonomic nervous system is thought to play a role in this subset of patients. In several sma...
This is a phase II, single-center, open-label study to evaluate the efficacy and safety of droxidopa in subjects with chronic fatigue syndrome. The study will enroll enough subjects to allow 10 to be placed in the 12 week open label treatment period. The study will consist of an initial screening period (up to 7 days)...
Chronic Fatigue Syndrome Orthostatic Hypotension Neurally Mediated Hypotension Neurogenic Orthostatic Hypotension
chronic fatigue syndrome CFS neurally mediated hypotension NMH neurogenic orthostatic hypotension NOH orthostatic hypotension droxidopa
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
intervention 1: Droxidopa
1
Charlotte | North Carolina | United States | -80.84313 | 35.22709
3
0
0
0
NCT00977171
6TERMINATED
2011-10-01
2010-07-01
Chelsea 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
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.
The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Small Cell Lung Carcinoma
Small Cell Lung Cancer Extensive stage disease SCLC IGF-1R inhibitor
null
2
arm 1: Figitumumab (CP-751,871) Plus Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle arm 2: Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Figitumumab (20 mg/kg) intervention 2: Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 intervention 3: Etoposide (100 mg/m2 IV on Days 1, 2 and 3) intervention 4: Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 intervention 5: Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
intervention 1: figitumumab intervention 2: Cisplatin (Or Carboplatin) intervention 3: Etoposide intervention 4: Cisplatin (Or Carboplatin) intervention 5: Etoposide
51
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Marrero | Louisiana | United States | -90.10035 | 29.89937 Metairie | Louisiana | United States | -90.15285 | 29.98409 City of Saint Peters | Missouri | United Stat...
9
0
0
0
NCT00977561
6TERMINATED
2011-10-01
2010-04-01
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 ]
174
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
null
Multiple System Atrophy
null
2
arm 1: rasagiline tablet, 1 mg/day for up to 48 weeks. arm 2: placebo tablet for up to 48 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: rasagiline 1 mg tablet/day for 48 weeks intervention 2: placebo tablet for 48 weeks
intervention 1: rasagiline mesylate intervention 2: placebo
47
Irvine | California | United States | -117.82311 | 33.66946 La Jolla | California | United States | -117.2742 | 32.84727 Sunnyvale | California | United States | -122.03635 | 37.36883 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Boca Raton | Florida | United States | -80.0831 | 26.35869...
174
0
0
0
NCT00977665
1COMPLETED
2011-10-01
2009-12-01
Teva Branded Pharmaceutical Products R&D, 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 ]
76
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
Effects of; Anesthesia, in Pregnancy
cesarean delivery blood pressure cardiac output
null
3
arm 1: Carbetocin injection, 100µg, single injection arm 2: Oxytocin 5U, injection, single injection arm 3: Saline single injection
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Hemodynamic effect of intervention 2: Hemodynamic effect of intervention 3: Hemodynamic effect of
intervention 1: carbetocin 100 µg intervention 2: oxytocin 5 u intervention 3: placebo (NaCl)
2
Oslo | N/A | Norway | 10.74609 | 59.91273 Oslo | N/A | Norway | 10.74609 | 59.91273
76
0
0
0
NCT00977769
1COMPLETED
2011-10-01
2009-11-01
Oslo University 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 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy with one or more chemotherapeutic agents. More recently, novel new agents targeting specific enzymes or pathways responsible for cell division have been developed and clinicians have begun to utilize various combinations of these...
The majority of patients with NSCLC present with inoperable locally advanced or metastatic disease for which no curative therapy is available. For these patients, platinum based doublet combination regimens have become standard of care due to increased survival rates over platinum therapy alone. In order to try to imp...
Non-Small Cell Lung Cancer
NSCLC
null
1
arm 1: Chemotherapy infusion on Day 1 of a 3-week cycle
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour intervention 2: 4\. Cisplatin 75mg/m2 IV over 60-120 minutes intervention 3: 5\. Bevacizumab 15mg/kg IV over 90 minutes
intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Bevacizumab
2
Lake Success | New York | United States | -73.71763 | 40.77066 New York | New York | United States | -74.00597 | 40.71427
8
0
0
0
NCT00998166
6TERMINATED
2011-10-01
2009-06-01
Columbia 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
[ 2, 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objectives: * Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with gemcitabine, every 3 weeks in patients with advanced solid malignancies. * Study part 2: To determine the antitumor activity of ...
The study consisted of a screening phase (maximum length of 21-day), a treatment phase with 21-day treatment cycles and a 30-day follow-up visit after the last dose of study medication. The cut-off date for study part 1 was when last participant completed the first treatment cycle and the subsequent 30 days follow-up....
Neoplasms, Malignant
null
1
arm 1: Cabazitaxel and gemcitabine on Day 1 then gemcitabine alone on Day 8 every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision. On Day 1, cabazitaxel was given either first followed by gemcitabine (part 1a) or after gemcitabine with 1 hour gap between t...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Pharmaceutical form: 60 mg/1.5 ml concentrate solution for infusion Route of administration: Intravenous infusion over 60 minutes Dosage: * Study part 1: 15, 20 or 25 mg/m\^2 according to pre-defined dose escalation schedule * Study part 2: MTD as determined in Study part 1 intervention 2: Pharmaceut...
intervention 1: cabazitaxel intervention 2: gemcitabine
4
Detroit | Michigan | United States | -83.04575 | 42.33143 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Nashville | Tennessee | United States | -86.78444 | 36.16589
18
0
0
0
NCT01001221
6TERMINATED
2011-10-01
2009-11-01
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 ]
55
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
null
Hepatitis C Infection
null
5
arm 1: Treatment Naive arm 2: Treatment Naive arm 3: Treatment Naive arm 4: Non-Responder arm 5: Non-Responder
[ 0, 0, 2, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Tablets, Oral, 10 mg, daily, 24-48 weeks intervention 2: Tablets, Oral, 60 mg, daily, 24-48 weeks intervention 3: Tablets, Oral, 0 mg, daily, 48 weeks intervention 4: Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks intervention 5: Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Placebo intervention 4: Peginterferon alfa-2a intervention 5: Ribavirin
6
Chiba | Chiba | Japan | 140.11667 | 35.6 Kurume-Shi | Fukuoka | Japan | N/A | N/A Okayama | Okayama-ken | Japan | 133.93333 | 34.65 Osaka | Osaka | Japan | 135.50107 | 34.69379 Osaka | Osaka | Japan | 135.50107 | 34.69379 Musashino-Shi | Tokyo | Japan | N/A | N/A
42
0
0
0
NCT01017575
1COMPLETED
2011-10-01
2009-12-01
Bristol-Myers Squibb
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 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a phase II study of the combination of panitumumab with irinotecan in malignant glioma patients. The primary objective of the study is to determine the activity of the combination of panitumumab with irinotecan as measured by 6-month progression-free survival. Secondary objectives include the following- to dete...
null
Malignant Glioma of Brain
Panitumumab Vectibix Irinotecan CPT-11 Camptosar Malignant glioma Glioblastoma multiforme Gliosarcoma Duke Vredenburgh Pro00015447
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Irinotecan: for those patients on an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. For those not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment on both drugs will continue until tumor progression or unacceptable toxicity. intervention...
intervention 1: Irinotecan intervention 2: Panitumumab
1
Durham | North Carolina | United States | -78.89862 | 35.99403
16
0
0
0
NCT01017653
6TERMINATED
2011-10-01
2010-02-01
Annick Desjardins
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
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.
null
Multiple Myeloma Non-Hodgkin Lymphoma Hodgkin Disease
null
2
arm 1: TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) arm 2: TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) intervention 2: TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
intervention 1: TG-0054 (2.24 mg/kg) intervention 2: TG-0054 (3.14 mg/kg)
6
Chiayi City | N/A | Taiwan | 120.44889 | 23.47917 Hualien City | N/A | Taiwan | 121.60444 | 23.97694 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Linkou District | N/A | Taiwan | 121.39348 | 25.07777 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306
19
0
0
0
NCT01018979
1COMPLETED
2011-10-01
2010-02-01
GPCR Therapeutics, 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 ]
42
NA
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.
Rationale: Heterotopic ossification is a frequent complication after total hip replacement. Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to effectively prevent heterotopic ossification, but gastrointestinal complaints are reported frequently. Selective cyclooxygenase-2 (COX-2) inhibiting NSAID produce less g...
Ossification, Heterotopic
Arthroplasty Hip Cemented Heterotopic ossification Selective Cyclooxygenase-2 Inhibitors Arthroplasty, Replacement Hip Prosthesis Cyclooxygenase Inhibitors
null
1
arm 1: Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.
[ 0 ]
1
[ 0 ]
intervention 1: Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
intervention 1: Etoricoxib (Arcoxia)
1
Nijmegen | N/A | Netherlands | 5.85278 | 51.8425
42
0
0
0
NCT01022190
1COMPLETED
2011-10-01
2009-12-01
Radboud 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
[ 0 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
Many women with breast cancer who are treated with aromatase inhibitor medications develop aches and pains during treatment, and some develop numbness and tingling in their hands and feet. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Fre...
Aromatase inhibitor (AI) therapy is commonly used for treatment of postmenopausal women with hormone receptor-positive breast cancer. The most common toxicities are arthralgias and myalgias, which can be difficult to manage and necessitate discontinuation of therapy in up to 10% of patients. One potential interventiona...
Breast Cancer
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: Patients will be treated with open-label duloxetine: * 30 mg daily x 7 days, then * 60 mg daily x 3 weeks, then * If a patient believes she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will continue taking 60 mg daily for weeks 5-8 * If a patient does not believe she has...
intervention 1: Duloxetine
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
29
0
0
0
NCT01028352
1COMPLETED
2011-10-01
2008-10-01
University of Michigan Rogel 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 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma. The patient's physical state, their symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is saf...
A single-arm, open label, proof of principle phase II study exploring the efficacy of RAD001 in resectable soft tissue sarcomas either in the extremities, trunk or retroperitoneum. Patients with resectable sarcomas as detailed below were to have a core biopsy for molecular markers prior to therapy with RAD001 10mg PO d...
Sarcoma
Soft Tissue Retroperitoneal resectable
null
1
arm 1: RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: Patients were instructed to take RAD001 in the morning, at the same time each day.
intervention 1: RAD001
1
Tampa | Florida | United States | -82.45843 | 27.94752
2
0
0
0
NCT01048723
6TERMINATED
2011-10-01
2010-01-01
H. Lee Moffitt Cancer Center and Research 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 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Pulmonary hypertension is common in patients with aortic stenosis and is associated with worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery pressure and improve exercise performance in patients with left-sided heart failure, but this has not been tested in patients with aortic ...
Patients with severe aortic stenosis referred for a clinically ordered right and left heart catheterization will be eligible. Twenty subjects will be enrolled: 10 patients will receive 40mg and 10 patients will receive 80mg; each dose will be equally distributed among those with preserved (≥50%) and reduced (\<50%) EF....
Aortic Stenosis
Aortic valve stenosis Sildenafil Phosphodiesterase inhibitors Hypertension, Pulmonary
null
1
arm 1: A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (\<50%) EF.
[ 0 ]
1
[ 0 ]
intervention 1: Single oral dose of 40mg or 80mg of Sildenafil
intervention 1: Sildenafil
1
St Louis | Missouri | United States | -90.19789 | 38.62727
20
0
0
0
NCT01060020
1COMPLETED
2011-10-01
2010-01-01
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
[ 4 ]
328
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.
null
Chronic Obstructive Pulmonary Disease
Symbicort Safety Efficacy COPD Japanese
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 2 x 160/4.5 microgram, inhalation, bid, 52 weeks intervention 2: According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
intervention 1: Symbicort Turbuhaler (Budesonide/formoterol) intervention 2: Drug: any available COPD treatment; investigator to decide
17
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Toyota | Aichi-ken | Japan | 137.15 | 35.08333 Yanagawa | Fukuoka | Japan | 130.4 | 33.16667 Hiroshima | Hiroshima | Japan | 132.45 | 34.4 Asahikawa | Hokkaido | Japan | 142.36489 | 43.77063 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Itami | Hyōgo | Japan | 135.4012...
260
0
0
0
NCT01070784
1COMPLETED
2011-10-01
2010-01-01
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 ]
209
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or by decreasing the cardiac output through reduction of the stroke volume or heart rate or both. On the other hand, all antihypertensi...
Central pulse pressure is a better predictor of left ventricular mass and carotid intima thickness, and the conventional peripheral BP does not seem to be an accurate reflection of central arterial BP. The pulse pressure amplification between peripheral and central arteries reflects the left ventricular afterload, sube...
Hypertension
Bisoprolol Atenolol Hypertension Blood pressure
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Bisoprolol tablet will be administered orally at a dose of 5 milligram (mg) once daily in the morning for 12 weeks. intervention 2: Atenolol tablet will be administered orally at a dose of 50 mg once daily in the morning for 12 weeks.
intervention 1: Bisoprolol intervention 2: Atenolol
1
Seoul | N/A | South Korea | 126.9784 | 37.566
209
0
0
0
NCT01079962
1COMPLETED
2011-10-01
2009-12-01
Merck KGaA, Darmstadt, Germany
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 ]
226
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ine...
null
Acute Gout
Frequent flares Gout Anti-interleukin-1β monoclonal antibody
null
2
arm 1: Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed afte...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill). intervention 2: Triamcinolone acetonide 40 mg was supplied as a suspension. intervention 3: Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophil...
intervention 1: Canakinumab 150 mg intervention 2: Triamcinolone acetonide 40 mg intervention 3: Placebo to canakinumab intervention 4: Placebo to triamcinolone acetonide
108
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Foley | Alabama | United States | -87.6836 | 30.40659 Mobile | Alabama | United States | -88.04305 | 30.69436 Peoria | Arizona | United States | -112.23738 | 33.5806 Tucson | Arizona | United States | -...
432
0
0
0
NCT01080131
1COMPLETED
2011-10-01
2010-03-01
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 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the response rate and survival of gemcitabine and pazopanib in patients with metastatic pancreatic cancer.
To determine the response rate by RECIST criteria. To determine the progression free survival. To determine the median survival and overall survival at one year.
Pancreatic Cancer
Pancreas
null
1
arm 1: Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle. Pazopanib 800 mg PO daily of each 28 day cycle.
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Gemcitabine intervention 2: Pazopanib
1
St Louis | Missouri | United States | -90.19789 | 38.62727
2
0
0
0
NCT01080248
6TERMINATED
2011-10-01
2010-08-01
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
[ 0 ]
96
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
false
Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is ...
null
Hypotension After Reperfusion in Liver Transplantation
postreperfusion syndrome phenylephrine epinephrine liver transplantation
null
3
arm 1: 100 mcg of phenylephrine is administered at the time of reperfusion arm 2: 10 mcg of epinephrine is administered iv at the time of reperfusion arm 3: 10 ml of normal saline is administered at the time of reperfusion
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion intervention 2: 10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion intervention 3: 10ml of normal saline is administered at the time of reperfusion
intervention 1: phenylephrine intervention 2: epinephrine intervention 3: placebo control
1
Seoul | N/A | South Korea | 126.9784 | 37.566
96
0
0
0
NCT01080625
1COMPLETED
2011-10-01
2010-04-01
Seoul National University 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 ]
510
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatmen...
Back Pain Lower Back Chronic
chronic pain back pain
null
2
arm 1: Hydrocodone Bitartrate Controlled-Release Capsules arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Capsules, no active substance, shells identical to active comparator capsules intervention 2: dosage form: capsule Strengths 10mg, 20mg, 30mg, 40mg, 50mg
intervention 1: Placebo intervention 2: Hydrocodone bitartrate
51
Phoenix | Arizona | United States | -112.07404 | 33.44838 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Anaheim | California | United States | -117.9145 | 33.83529 Fresno | California | United States | -119.77237 | 36.74773 Laguna Hills | California | United States | -117.71283 | 33.61252 Colorado Springs ...
812
0
0
0
NCT01081912
1COMPLETED
2011-10-01
2010-03-01
Zogenix, 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 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
0ALL
false
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
null
Retinal Vein Occlusions
null
2
arm 1: Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema arm 2: Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
[ 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 1.25mg intravitreally intervention 2: 0.7mg intravitreally intervention 3: 1.25mg intravitreally
intervention 1: Avastin intervention 2: Osurdex intervention 3: Avastin
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
30
0
0
0
NCT01085734
1COMPLETED
2011-10-01
2010-03-01
Maturi, Raj K., M.D., P.C.
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
[ 0 ]
40
RANDOMIZED
PARALLEL
1PREVENTION
1SINGLE
false
0ALL
false
The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but chronic pain has been reported in 10-39%. Catheters implanted at the time of surgery have been used to provide local anesthetic at the h...
The use of local anesthetic at the donor site has been investigated to decrease the morbidity of iliac crest bone harvesting. Along with a decrease in early post-operative pain that may be expected a decrease in chronic pain and improved long-term results have also been demonstrated. Local anesthetics may cause such lo...
Pain
Local anesthetic Iliac crest bone harvest Patients undergoing spine surgery that require use of iliac crest bone autograft
null
2
arm 1: This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site. arm 2: This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site. intervention 2: Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.
intervention 1: Bupivacaine intervention 2: Normal Saline
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
40
0
0
0
NCT01087931
1COMPLETED
2011-10-01
2010-04-01
Vanderbilt 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 ]
70
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump ...
null
Pain, Postoperative Caesarean Section
postoperative pain infiltration analgesia ropivacaine Caesarean Section
null
2
arm 1: Postoperative wound infusion 15 mg /h / 48h arm 2: Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Postoperative wound infusion 2 ml/ h/ 48h intervention 2: Postoperative wound infusion 2 ml/h/48h
intervention 1: Ropivacaine 0,75% intervention 2: NaCl 0,9%
1
Joensuu | N/A | Finland | 29.76316 | 62.60118
67
0
0
0
NCT01094106
1COMPLETED
2011-10-01
2010-04-01
North Karelia Central 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
[ 0 ]
13
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis. The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized...
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone. The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treat...
Psoriasis
psoriasis excimer acitretin tazarotene
null
4
arm 1: patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions. arm 2: Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of...
[ 0, 0, 0, 0 ]
4
[ 0, 1, 0, 1 ]
intervention 1: Acitretin 25 mg oral daily for 12 weeks intervention 2: Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser. intervention 3: Topical tazarotene 0.1% gel was applied daily to active lesions. intervention 4: Lesions on randomly assigned left or right side of body ...
intervention 1: Acitretin 25Mg Oral Capsule intervention 2: Excimer laser intervention 3: Tazarotene 0.1% Gel,Top intervention 4: Sham excimer laser
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
13
0
0
0
NCT01094717
6TERMINATED
2011-10-01
2010-01-01
University of Utah
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 ]
617
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066: * IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disea...
Parkinson's Disease
motor Symptoms efficacy IPX066 Parkinson's Disease
null
1
arm 1: Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
[ 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 23.75 - 95 mg CD-LD capsules intervention 2: 36.25 - 145 mg CD-LD capsules intervention 3: 48.75 - 195 mg CD-LD capsules intervention 4: 61.25 - 245 mg CD-LD capsules
intervention 1: IPX066 95 mg intervention 2: IPX066 145 mg intervention 3: IPX066 195 mg intervention 4: IPX066 245 mg
81
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Jolla | California | United States | -117.2742 | 32.84727 La Jolla | California...
617
0
0
0
NCT01096186
1COMPLETED
2011-10-01
2010-03-01
Impax Laboratories, 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 ]
414
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
2MALE
true
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)
null
Benign Prostatic Hyperplasia
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Administered orally, daily for 24 weeks intervention 2: Administered orally, daily for 24 weeks
intervention 1: LY500307 intervention 2: Placebo
70
Huntsville | Alabama | United States | -86.58594 | 34.7304 Anchorage | Alaska | United States | -149.90028 | 61.21806 Glendora | California | United States | -117.86534 | 34.13612 Newport Beach | California | United States | -117.92895 | 33.61891 San Bernardino | California | United States | -117.28977 | 34.10834 San D...
414
0
0
0
NCT01097707
6TERMINATED
2011-10-01
2010-04-01
Eli Lilly and 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
[ 2 ]
155
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg MD in non-elderly patients.
null
Coronary Artery Disease
Platelet function
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 1, 1 ]
2
[ 0, 0 ]
intervention 1: administered orally, daily for 12 days intervention 2: Administered orally, daily for 12 days
intervention 1: prasugrel intervention 2: clopidogrel
7
Jacksonville | Florida | United States | -81.65565 | 30.33218 Baltimore | Maryland | United States | -76.61219 | 39.29038 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Dublin | N/A | Ireland | -6.24889 | 53.33306 Nieuwegein | N/A | Netherlands | 5.08056 | 52.02917 Lund | N/A | Sweden | 13.19321 | 55.70584 Ma...
456
0
0
0
NCT01107912
1COMPLETED
2011-10-01
2010-03-01
Eli Lilly and 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
[ 3 ]
50
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).
null
Non-Hodgkin's Lymphoma (NHL)
null
1
arm 1: There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m\^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofat...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle. intervention 2: Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
intervention 1: Bendamustine hydrochloride intervention 2: Ofatumumab
39
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Beverly Hills | California | United States | -118.40036 | 34.07362 Stamford | Connecticut | United States | -73.53873 | 41.05343 Boynton Beach | Florida | United States | -80.06643 | 26.52535 New Port...
49
0
0
0
NCT01108341
1COMPLETED
2011-10-01
2010-05-01
Cephalon
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 ]
63
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse la...
Non-Hodgkin's Lymphoma Lymphoma, Large Cell Diffuse, Mantle Cell Lymphoma, Lymphoma Follicular Lymphoma Large B-Cell, Diffuse
Non-Hodgkin's lymphoma Lymphoma, Large B-Cell Diffuse, Mantle cell lymphoma, Lymphoma Follicular, Lymphoma Large B-Cell, Diffuse
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be foll...
intervention 1: SyB L-0501 intervention 2: Rituximab
25
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Akita | Akita | Japan | 140.11667 | 39.71667 Matsuyama | Ehime | Japan | 132.76574 | 33.83916 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Kurume | Fukuoka | Japan | 130.51667 | 33.31667 Maebashi | Gunma | Japan | 139.08333 | 36.4 Sapporo | Hokkaido | Japan | 141.35 | 4...
59
0
0
0
NCT01118845
1COMPLETED
2011-10-01
2010-04-01
SymBio 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, 3 ]
22
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Hypothesis: Oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) will degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. In addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion from blood to the intestinal tract may be in...
Oxazyme is an oxalate degrading compound that can potentially degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. We propose a 20-patient open-label trial pilot study of one month of Oxazyme twice daily (1gm Oxazyme sachet dissolved in 150 ml water) among adult subjects with a ...
Hyperoxaluria
Hyperoxaluria Oxazyme oxalate enteric hyperoxaluria
null
2
arm 1: Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB). Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or frui...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Oxazyme (registered trademark) is a non-systemic orally delivered drug composed of recombinant oxalate decarboxylase (OxDC). It is formulated to enzymatically degrade available dietary oxalate prior to its absorption. Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered...
intervention 1: Oxazyme
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
10
0
0
0
NCT01127087
1COMPLETED
2011-10-01
2010-05-01
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
[ 4 ]
587
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persist...
null
Asthma
Fluticasone propionate asthma vilanterol GW642444 Fluticasone furoate
null
3
arm 1: Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks arm 2: Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks arm 3: Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder onc...
[ 0, 1, 1 ]
5
[ 0, 0, 0, 10, 10 ]
intervention 1: Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks intervention 2: Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks intervention 3: Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks intervention 4: Placebo in...
intervention 1: Fluticasone Furoate/Vilanterol Inhalation Powder intervention 2: Fluticasone Furoate Inhalation Powder intervention 3: Fluticasone Propionate Inhalation Powder intervention 4: Placebo Inhalation Powder 1 intervention 5: Placebo Inhalation Powder 2
71
Bell Gardens | California | United States | -118.15146 | 33.96529 Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Riverside | California | United States | -117.39616 | 33...
586
0
0
0
NCT01134042
1COMPLETED
2011-10-01
2010-06-01
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
[ 1 ]
35
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This single-center, investigator-masked, crossover study is designed to investigate the circadian rhythms of aqueous humor dynamics in human subjects with ocular hypertension (OHT) before and after intervention with a commonly used ocular hypotensive medication, brimonidine for six weeks.
Currently, the only effective treatment to prevent disease progression is lowering of the intraocular pressure (IOP).2 Usually, clinical IOP measurements are performed during the day with little information collected on nocturnal IOP. A recent surge of interest in nocturnal IOPs stems from the hypothesis that significa...
Intraocular Pressure
Aqueous Humor Dynamics Aqueous Humor Dynamics and Circadian Rhythms
null
2
arm 1: Eyedrops for lowering intraocular pressure arm 2: Lubricated eye drops
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: One drop of brimonidine in each eye three times a day for six weeks. intervention 2: Lubricating drops added three times a day for six weeks
intervention 1: Brimonidine intervention 2: Artificial tears
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
66
0
0
0
NCT01144494
1COMPLETED
2011-10-01
2010-08-01
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 ]
162
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks tr...
null
Asthma
asthma GSK2190915
null
5
arm 1: FP 100mcg BID plus GSK2190915 100mg QD (AM) arm 2: FP 100mcg BID plus GSK2190915 300mg QD (AM) arm 3: FP 100mcg BID plus montelukast 10mg QD (PM) arm 4: FP 100mcg BID plus placebo BID arm 5: FP/SAL 100/50mcg BID plus placebo BID
[ 0, 0, 1, 1, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: FP 100mcg BID intervention 2: GSK2190915 100mg QD (AM) intervention 3: GSK2190915 300mg QD (AM) intervention 4: montelukast 10mg QD (PM) intervention 5: placebo BID intervention 6: FP/SAL 100/50mcg BID
intervention 1: FP 100 intervention 2: GSK2190915 100 intervention 3: GSK2190915 300 intervention 4: montelukast intervention 5: placebo intervention 6: FP/SAL 100/50
32
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Huntington Beach | California | United States | -117.99923 | 33.6603 Los Angeles | California | United States | -118.24368 | 34.05223 Vista | California | United States | -117.24254 | 33.20004 Coral...
506
0
0
0
NCT01156792
1COMPLETED
2011-10-01
2010-09-01
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
[ 4 ]
5
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide information on the use...
The objective is to evaluate the efficacy and safety of treatment with chemoradiation (CRT) plus talimogene laherparepvec compared to CRT alone in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) for which surgical resection is not clinical indicated. The efficacy...
Squamous Cell Carcinoma Head and Neck Cancer
squamous cell OncoVEX^GM-CSF Oncovex chemoradiation Cisplatin
null
2
arm 1: Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period. arm 2: The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming un...
[ 1, 0 ]
3
[ 2, 4, 0 ]
intervention 1: Administered by intratumoral injection intervention 2: 70 grays of radiation administered in 35 fractions over 7 weeks intervention 3: Administered by intravenous infusion
intervention 1: Talimogene Laherparepvec intervention 2: Radiation intervention 3: Cisplatin
6
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Louisville | Kentucky | United States | -85.75941 | 38.25424 Canton | Ohio | United States | -81.37845 | 40.79895 Charleston | South Carolina | United States | -79.93275 | 32.77632 Richmond | Virginia | United States | -77.46026 | 37.55376 London | London | ...
5
0
0
0
NCT01161498
6TERMINATED
2011-10-01
2011-02-01
BioVex Limited
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 ]
47
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and hist...
null
Head and Neck Cancer Liver Cancer Breast Cancer Gastric Cancer Non-Small Cell Lung Cancer
Head and Neck Cancer Liver Cancer Breast Cancer Gastric Cancer Non-Small Cell Lung Cancer EGFR HDAC Her2 CUDC-101
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle. intervention 2: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consec...
intervention 1: CUDC-101 intervention 2: CUDC-101
7
Encinitas | California | United States | -117.29198 | 33.03699 Los Angeles | California | United States | -118.24368 | 34.05223 Wheat Ridge | Colorado | United States | -105.07721 | 39.7661 Albuquerque | New Mexico | United States | -106.65114 | 35.08449 Buffalo | New York | United States | -78.87837 | 42.88645 Dallas ...
46
0
0
0
NCT01171924
1COMPLETED
2011-10-01
2010-07-01
Curis, 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 ]
14
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The anaesthetic management of patients undergoing total knee replacement is still not standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good pain relief, but only for 12 to 16 hours, and is ...
Primary objective The primary aim of this study is to measure the molar of levobupivacaine and the molar median effective dose of ropivacaine when administered as a femoral perineural infusion to prevent pain 30 hours after total knee replacement Secondary objectives To assess the: Degree of postoperative pain, need ...
Pain Arthroplasty, Replacement, Knee
local anesthetic levobupivacaine ropivacaine femoral perineural block
null
2
arm 1: Local anaesthetic bolus and infusion arm 2: Local anaesthetic bolus and infusion
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Femoral bolus 150μM followed by femoral infusion 400μM intervention 2: Bolus and infusion
intervention 1: Levobupivacaine intervention 2: Ropivacaine
0
null
14
0
0
0
NCT01172197
6TERMINATED
2011-10-01
2009-01-01
NHS Tayside
2OTHER_GOV
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 ]
49
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximatel...
Bipolar Disorder Panic Disorder Generalized Anxiety Disorder
Bipolar disorder Anxiety Panic GAD Generalized Anxiety Disorder
null
2
arm 1: Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. arm 2: Administered in capsules identical to the ziprasidone capsules.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day. intervention 2: Inactive control
intervention 1: Ziprasidone intervention 2: Placebo
3
Palo Alto | California | United States | -122.14302 | 37.44188 Tampa | Florida | United States | -82.45843 | 27.94752 Mason | Ohio | United States | -84.30994 | 39.36006
49
0
0
0
NCT01172652
1COMPLETED
2011-10-01
2010-04-01
VA Palo Alto Health Care System
1FED
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
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Background: * Chronic hepatitis C (CHC) is a major health problem that particularly affects individuals with human immunodeficiency virus (HIV) infection, and can lead to cirrhosis and liver failure. Standard treatment for people with HIV and CHC is a 48-week course of pegylated-interferon alfa 2a (peg-IFN) and ribavi...
Chronic hepatitis C (CHC) viral infection is a major health problem affecting 130-170 million worldwide, and 2.7-3.9 million in the US, more than 3 times those with HIV infection. One-third of persons with HIV have CHC, a more rapid progression to cirrhosis and liver failure, with liver disease as one of the leading ca...
Hepatitis C Infection HIV Infection
Chronic HCV HCV Treatment Nonresponders HCV Treatment Relapsers HIV-HCV Co-Infection Nitazoxanide Hepatitis C
null
1
arm 1: Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
[ 0 ]
1
[ 0 ]
intervention 1: Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
intervention 1: Nitazoxanide With Pegylated Interferon And Ribavirin
4
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Bethesda | Maryland | United States | -77.10026 | 38.98067
8
0
0
0
NCT01185028
1COMPLETED
2011-10-01
2010-08-01
National Institutes of Health Clinical Center (CC)
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 ]
234
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study
null
Diabetes Mellitus, Type 2
null
2
arm 1: 1 Tablet PO QD arm 2: 1 Tablet PO QD
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Active drug 1 tablet PO QD intervention 2: 1 Tablet PO QD
intervention 1: Linagliptin intervention 2: Placebo
93
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Toney | Alabama | United States | -86.73361 | 34.89814 Little Rock | Alaska | United States | N/A | N/A Pell City | Alaska | United States | N/A ...
226
0
0
0
NCT01194830
1COMPLETED
2011-10-01
2010-09-01
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
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3, 4 ]
56
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in Venezuela. Accidents and violence at Hospital "Miguel Perez Carreño" along april 2009 were represented by gunshots and stabbing wounds which 8th. and 18th cause for medical attention respectively within a total of 76 cases. Like...
General objectives The object of this research is to evaluated the impact of Early short-term antibiotic therapy with Ertapenem, 3 vs 7 days, upon clinical postoperatory evolution in patients with penetrating abdominal trauma at emergency room of "Miguel Perez Carreño" Hospital Specific objectives 1. To determine the...
SURGICAL SITE INFECTION
DURATION OF THERAPY PENETRATING ABDOMINAL TRAUMA
null
2
arm 1: Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the during the next 7 days after surgery. arm 2: Ertapenem will be administrated within the first 2 hours of Hospital´s admission and during the next 3 days after surgery.
[ 1, 0 ]
1
[ 0 ]
intervention 1: Ertapenem 1 gr endovenous 3 or 7 days
intervention 1: Ertapenem
0
null
56
0
0
0
NCT01203046
1COMPLETED
2011-10-01
2010-12-01
Silvia M. Pinango L.
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
[ 2 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients with these diseases who have \> 1 gram of proteinuria or a decreased glomerular filtration rate (GFR), both predictors of a poor long-term...
Dense deposit disease (DDD), also called membranoproliferative glomerulonephritis (MPGN) type II, is a rare form of glomerulonephritis named because of the characteristic appearance of electron-dense material in the glomerular basement membrane observed on kidney biopsy. The principle immune defect in DDD is excessive ...
Dense Deposit Disease Membranoproliferative Glomerulonephritis
Dense deposit disease C3 nephropathy Eculizumab
null
1
arm 1: Patients will receive Eculizumab and be observed for 60 minutes after the first 5 infusions, then 30 minutes after all subsequent infusions. Patients will not be allowed to take other immunomodulatory therapies during the study period but will continue on their other non-immunomodulatory therapies (e.g. ACE inhi...
[ 0 ]
1
[ 0 ]
intervention 1: Dosage/Frequency: 900 mg IV once a week for 4 weeks, 1200 mg IV week 5, then 1200 mg IV every 2 weeks through week 53.
intervention 1: Eculizumab
2
New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427
6
0
0
0
NCT01221181
1COMPLETED
2011-10-01
2010-07-01
Columbia 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 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to determine if Radiesse injections to the cheeks result in an altered and improved first impression and self esteem.
null
Malar Deficiency
Cheek Cheek flattening Malar deficiency Filler
null
1
arm 1: Subject will be treated at baseline and, if needed, at 2 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
intervention 1: Calcium hydroxylapatite
1
Chicago | Illinois | United States | -87.65005 | 41.85003
20
0
0
0
NCT01225354
1COMPLETED
2011-10-01
2010-08-01
DeNova Research
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 ]
24
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.
null
Vitrectomy
null
2
arm 1: 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). arm 2: 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). intervention 2: 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
intervention 1: 400 µg Brimonidine Tartrate Implant intervention 2: 200 µg Brimonidine Tartrate Implant
2
Salt Lake City | Utah | United States | -111.89105 | 40.76078 Prague | N/A | Czechia | 14.42076 | 50.08804
24
0
0
0
NCT01229410
1COMPLETED
2011-10-01
2010-12-01
Allergan
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 ]
66
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.
There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in r...
Acne Vulgaris
null
2
arm 1: Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or ta...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks intervention 2: Topical, Bid, 12 weeks
intervention 1: BenzaClin intervention 2: Effaclar
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
60
0
0
0
NCT01237821
1COMPLETED
2011-10-01
2010-10-01
Milton S. Hershey 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 ]
374
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.
null
Malignant Melanoma
null
1
arm 1: Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: RO5185426
28
Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 | 37.77493 Santa Monica | California | United States | -118.49138 | 34.0194...
371
0
0
0
NCT01248936
1COMPLETED
2011-10-01
2010-12-01
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
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
70
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
Although ambulatory gynecological laparoscopy is considered to be a minimally invasive surgical procedure, only 60% of patients undergoing this procedure are satisfied with postoperative pain control. Postoperative pain can lead to physiological, immunological and psychological derangements in patients.It also has been...
70 subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers. Group A (study group) will receive lidocaine. Group B (control group) will receive the same volume of saline infusion. The study drugs will be prepared by one of the investigators in the study. Subjects will be rec...
Pain
Pain MQOR 40 Lidocaine Gynecologic Surgery Laparoscopic
null
2
arm 1: Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter arm 2: Placebo will receive the same volume of saline infusion.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Placebo will receive the same volume of saline infusion. intervention 2: Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter
intervention 1: Placebo intervention 2: Lidocaine
1
Chicago | Illinois | United States | -87.65005 | 41.85003
70
0
0
0
NCT01250002
1COMPLETED
2011-10-01
2010-11-01
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
[ 2 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.
null
Advanced Solid Tumours
PG545 Phase I Progen antimetastatic antiangiogenic advanced cancer patients solid tumors solid tumours
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.
intervention 1: PG545
1
Nedlands | Western Australia | Australia | 115.8073 | -31.98184
4
0
0
0
NCT01252095
6TERMINATED
2011-10-01
2011-01-01
Zucero Pty Ltd
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 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.
null
Adenocarcinoma
Adenocarcinoma Gastroesophageal Junction
null
1
arm 1: Each treatment cycle is 4 weeks (28 days)
[ 0 ]
2
[ 2, 0 ]
intervention 1: 8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle intervention 2: 80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
intervention 1: Ramucirumab (IMC-1121B ) intervention 2: Paclitaxel
3
Chiba | N/A | Japan | 140.11667 | 35.6 Osaka | N/A | Japan | 135.50107 | 34.69379 Osaka | N/A | Japan | 135.50107 | 34.69379
6
0
0
0
NCT01253525
1COMPLETED
2011-10-01
2010-11-01
Eli Lilly and 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 ]
164
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma ...
null
Glaucoma, Open-Angle Ocular Hypertension
null
3
arm 1: One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks. arm 2: One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks. arm 3: One drop of latanoprost opht...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks. intervention 2: One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks. intervention 3: One drop of latanoprost op...
intervention 1: bimatoprost ophthalmic solution 0.01% intervention 2: travoprost ophthalmic solution 0.004% intervention 3: latanoprost ophthalmic solution 0.005%
2
Rogers | Arkansas | United States | -94.11854 | 36.33202 Calgary | Alberta | Canada | -114.08529 | 51.05011
164
0
0
0
NCT01253902
1COMPLETED
2011-10-01
2010-12-01
Allergan
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 ]
92
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus Placebo MDI (combined with and without spacer) and formo...
null
Asthma
asthma children persistent
null
6
arm 1: Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI arm 2: Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI wi...
[ 0, 0, 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose intervention 2: Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer) intervention 3: Two inhal...
intervention 1: Formoterol Fumarate DPI intervention 2: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer intervention 3: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer intervention 4: Placebo MDI with spacer intervention 5: Placebo MDI without spacer intervention 6: Mometaso...
0
null
359
0
0
0
NCT01258803
1COMPLETED
2011-10-01
2010-12-01
Organon and Co
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 ]
10
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. The Week 24 visit will be ...
Objectives: The primary objective of this Phase 2a study was to assess the effect of treatment with SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive subjects with chronic genotype 1...
Hepatitis C Infection
Hepatitis C SCY-635 Ribavirin Interferon
null
2
arm 1: Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks arm 2: SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
[ 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Oral tablets given bid for 28 days intervention 2: SCY-635 tablets, 300 mg bid for 28 days intervention 3: 180 ug prefilled syringe given once per week for up to 48 weeks intervention 4: tablets given bid for up to 48 weeks
intervention 1: Placebo intervention 2: SCY-635 intervention 3: Pegasys intervention 4: Copegus
4
San Francisco | California | United States | -122.41942 | 37.77493 Durham | North Carolina | United States | -78.89862 | 35.99403 San Antonio | Texas | United States | -98.49363 | 29.42412 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
10
0
0
0
NCT01265511
1COMPLETED
2011-10-01
2010-11-01
Scynexis, 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 ]
114
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as patients who failed to...
Placebo controlled, double-blind, multicenter study utilizing Standard of Care (SOC) in combination with CTS-1027 in genotype 1 chronic hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA le...
Hepatitis C
HCV Null Responders
null
4
arm 1: Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027, 60 mg (supplied in a blinded kit containing two bottles of 30 mg tablets). One tablet from each of the CTS bottles is taken twice daily, for a total daily dose of 120 mg. arm 2: Standard of Care (ribavirin plus pegylated interferon) plus CTS-1...
[ 0, 0, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Supplied in 30mg, 10mg, or 5mg tablets (depending on dose arm) taken twice daily for up to 48 weeks. intervention 2: 180 micrograms in 0.5 ml of solution subcutaneously (SQ), delivered in single use syringes administered once per week, for up to 48 weeks. intervention 3: 200 mg capsules of ribavirn take...
intervention 1: CTS-1027 intervention 2: pegylated interferon intervention 3: Ribavirin intervention 4: Placebo
45
Birmingham | Alabama | United States | -86.80249 | 33.52066 Coronado | California | United States | -117.18309 | 32.68589 La Jolla | California | United States | -117.2742 | 32.84727 Loma Linda | California | United States | -117.26115 | 34.04835 Pasadena | California | United States | -118.14452 | 34.14778 San Diego |...
114
0
0
0
NCT01273064
6TERMINATED
2011-10-01
2011-01-01
Conatus 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 ]
4
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
0NONE
false
1FEMALE
true
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with ...
PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who deve...
Lymphedema Recurrent Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer
null
2
arm 1: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. arm 2: Patients undergo SNB ...
[ 0, 1 ]
8
[ 4, 0, 0, 3, 3, 3, 3, 10 ]
intervention 1: Given intradermally and periareolarly intervention 2: Given subcutaneously intervention 3: Given subcutaneously intervention 4: Undergo sentinel lymph node biopsy intervention 5: Undergo axillary lymph node biopsy intervention 6: Correlative studies intervention 7: Ancillary studies intervention 8: Unde...
intervention 1: technetium Tc 99m sulfur colloid intervention 2: methylene blue intervention 3: indocyanine green solution intervention 4: sentinel lymph node biopsy intervention 5: axillary lymph node biopsy intervention 6: bioimpedance spectroscopy intervention 7: quality-of-life assessment intervention 8: lymphedema...
1
Los Angeles | California | United States | -118.24368 | 34.05223
4
0
0
0
NCT01276054
6TERMINATED
2011-10-01
2010-12-01
University of Southern California
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