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
[ 4 ]
836
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine. The study enrolled 836 patients that had completed one of two other vortioxetine studies. ...
Major Depressive Disorder
Major Depressive Disorder Depression Melancholia Mood Disorder Dysthymic Disorder Drug Therapy
null
1
arm 1: Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as ju...
[ 0 ]
1
[ 0 ]
intervention 1: Encapsulated vortioxetine immediate-release tablets
intervention 1: Vortioxetine
92
Beverly Hills | California | United States | -118.40036 | 34.07362 Irvine | California | United States | -117.82311 | 33.66946 Santa Ana | California | United States | -117.86783 | 33.74557 Torrance | California | United States | -118.34063 | 33.83585 Upland | California | United States | -117.64839 | 34.09751 Bradento...
834
0
0
0
NCT00707980
1COMPLETED
2010-08-01
2008-06-01
Takeda
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 ]
441
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.
Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and...
Diabetes Mellitus
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks. intervention 2: Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
intervention 1: Alogliptin intervention 2: Glipizide
80
Alexander City | Alabama | United States | -85.95385 | 32.94401 Foothill Ranch | California | United States | -117.66088 | 33.68641 Huntington Park | California | United States | -118.22507 | 33.98168 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 |...
441
0
0
0
NCT00707993
1COMPLETED
2010-08-01
2008-06-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.
Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (DCs), type 1 interferons (IFN) and Th1-ty...
Discoid Lupus Erythematosus
Cutaneous lupus Intervention Discoid lupus Phosphodiesterase 5 inhibitor
null
1
arm 1: CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
[ 0 ]
1
[ 0 ]
intervention 1: 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
intervention 1: CC-10004
1
New York | New York | United States | -74.00597 | 40.71427
8
0
0
0
NCT00708916
1COMPLETED
2010-08-01
2008-06-01
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
[ 5 ]
23
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The consolidation of learning is enhanced by adrenalin and other stress hormones. This memory enhancing effect is opposed by propranolol. In posttraumatic stress disorder (PTSD), a psychologically traumatic event may overstimulate stress hormones such as adrenalin, which in turn overly strengthen consolidation of the m...
Background: Animal evidence indicates that some consolidated memories when reactivated (retrieved) need to be reconsolidated. During this process, memories can be enhanced or weakened. In a preliminary, randomized, double-blind, placebo-controlled study, we tested whether post-reactivation administration of the beta-ad...
Posttraumatic Stress Disorder
stress disorders post-traumatic memory propranolol psychophysiology
null
2
arm 1: 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a "scrip...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 0.67 mg/kg short-acting propranolol combined with 1 mg/kg long-acting propranolol intervention 2: Placebo (matching propranolol) short-acting and long-acting capsules
intervention 1: Propranolol intervention 2: Placebo
3
Bedford | Massachusetts | United States | -71.27617 | 42.49065 Boston | Massachusetts | United States | -71.05977 | 42.35843 Manchester | New Hampshire | United States | -71.45479 | 42.99564
23
0
0
0
NCT00709735
1COMPLETED
2010-08-01
2007-05-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
14
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing endogenous enkephalin levels in subjects with active Crohn's disease. This is especially important in children who often are suffering from nutritional deprivation which retards their growth. The key objectives are to: 1. Eva...
The present proposal is designed as double-blinded placebo controlled study involving 30 children between 6-17 years of age with active Crohn's disease. Children will be treated with either naltrexone or placebo for the first 8 weeks then all subjects will receive active naltrexone drug the last 8 weeks. A one month fo...
Crohn's Disease
children pediatric Crohn's Disease naltrexone LDN IBD Inflammatory bowel disease
null
2
arm 1: Subjects will receive placebo for for the first 8 weeks administered orally one time daily. After 8 weeks placebo treated subjects are then crossed over to active drug naltrexone 0.1 mg/kg not to exceed 4.5 mg PO once daily for an additional 8 weeks. arm 2: Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day o...
[ 2, 0 ]
2
[ 0, 10 ]
intervention 1: Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks intervention 2: Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily
intervention 1: Naltrexone intervention 2: Placebo, sugar pill
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
18
0
0
0
NCT00715117
1COMPLETED
2010-08-01
2008-07-01
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
[ 0 ]
104
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation. This may require inpatient hospitalization several days prior to and after the procedure, potentially increasing medical costs and pat...
null
Bradycardia Tachycardia Atrial Fibrillation Valvular Heart Disease
bleeding anticoagulation pacemaker implantable cardioverter-defibrillator patients undergoing implantation of a pacemaker or defibrillator (ICD)"
null
4
arm 1: Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure. arm 2: Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize). arm 3: High risk patients (mechanical mitral valve...
[ 0, 1, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period. intervention 2: For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure. intervention 3: For high risk patients, warfarin is held for 4-5 days prior to the procedure ...
intervention 1: continue warfarin through the procedure intervention 2: Hold warfarin intervention 3: Warfarin held with heparin transition.
2
Baltimore | Maryland | United States | -76.61219 | 39.29038 Columbia | Maryland | United States | -76.83942 | 39.24038
100
0
0
0
NCT00721136
1COMPLETED
2010-08-01
2007-09-01
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
[ 0 ]
1
NA
SINGLE_GROUP
6HEALTH_SERVICES_RESEARCH
0NONE
false
1FEMALE
false
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. The non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. Meaningful treatm...
Sleep Disorders, Circadian Rhythm Insomnia Psychomotor Agitation
Kabuki Syndrome Actigraphy Treatment Response Measurement
null
1
arm 1: Actigraphic measurements were obtained by attaching an actigraphic watch device to the child's non-dominant wrist. The measurements will include three separate three week periods beginning with a baseline period and the period in which the child's pharmacological treatment was initiated. Two additional three wee...
[ 0 ]
1
[ 0 ]
intervention 1: Five treatment conditions: 1. Baseline no medication 2. Risperidone .25 mg at bedtime (q.h.s.) x 7 days 3. Risperidone .25 mg twice daily (b.i.d.) 4. Risperidone .25 mg three times a day (t.i.d.) and 5. Risperidone .5 mg three times a day (t.i.d.).
intervention 1: risperidone
1
Fargo | North Dakota | United States | -96.7898 | 46.87719
1
0
0
0
NCT00723580
1COMPLETED
2010-08-01
2008-05-01
Child Psychopharmacology Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
Evaluate pleiotropic effects of simvastatin in hypertensive patients.
null
Hypertension
null
4
arm 1: Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) arm 2: Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) arm 3: Participants who were administered Valsartan 80 mg plus simvastatin 40 mg ...
[ 1, 1, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 80 mg valsartan. Duration: 12 months. Tablets intervention 2: 40 mg pravastatin. Duration: 12 months. Tablets intervention 3: 40 mg simvastatin. Duration: 12 months. Tablets intervention 4: ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
intervention 1: valsartan intervention 2: pravastatin intervention 3: simvastatin intervention 4: ezetimibe (+) simvastatin
0
null
11
0
0
0
NCT00738972
6TERMINATED
2010-08-01
2008-01-01
Fundación Lindavista del Corazón AC
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 ]
227
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
null
Diabetes Mellitus, Type 2
null
3
arm 1: 52 week treatment arm 2: First 18 weeks of treatment arm 3: Placebo patients switch to glimepiride week19-52
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 5mg once daily intervention 2: 0 mg placebo comparator for part 1 of study (to 18 weeks) intervention 3: 1-4mg for part 2 of study (weeks 19-52)
intervention 1: Linagliptin intervention 2: Linagliptin Placebo intervention 3: Glimepiride
53
Birmingham | Alabama | United States | -86.80249 | 33.52066 Peoria | Arizona | United States | -112.23738 | 33.5806 Greenbrae | California | United States | -122.5247 | 37.94854 Harbor City | California | United States | -118.29785 | 33.79002 Huntington Park | California | United States | -118.22507 | 33.98168 Los Ange...
227
0
0
0
NCT00740051
1COMPLETED
2010-08-01
2008-08-01
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
[ 0 ]
163
RANDOMIZED
PARALLEL
null
3TRIPLE
true
0ALL
true
The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the resp...
We proposed the following primary hypotheses: 1. Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo. 2. Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices...
Tobacco Dependence
tobacco nicotine smoking reward reinforcement craving cues conditioned stimuli cue reactivity
null
2
arm 1: For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. arm 2: Participants in this group received a placebo instead of medication. ...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Participants in this group received varenicline according to the schedule in the Arm Description. intervention 2: Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.
intervention 1: varenicline intervention 2: placebo
1
Tampa | Florida | United States | -82.45843 | 27.94752
163
0
0
0
NCT00747643
1COMPLETED
2010-08-01
2008-09-01
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
[ 3, 4 ]
23
NON_RANDOMIZED
PARALLEL
9OTHER
0NONE
true
0ALL
false
Previously it was observed that individuals with tetraplegia have reduced baseline airway caliber and exhibit non-specific airway hyperresponsiveness (AHR). In persons with tetraplegia we have suggested that this is due to overriding cholinergic airway tone. In asthma, the mechanisms underlying bronchoconstriction and ...
The study requires a maximum of five study visits in the following order: 1. nebulized normal saline, 2. nebulized 1mg/kg of L-NAME (see below), 3. intravenous normal saline, 4. intravenous 1 mg/kg L-NAME, 5. intravenous 2 mg/kg L-Name.
Tetraplegia Asthma
Tetraplegia Mild asthma Exhaled Nitric Oxide NOS inhibitor Spinal cord injury Pulmonary Function
null
3
arm 1: Individuals with chronic tetraplegia arm 2: Individuals with diagnosed mild asthma arm 3: Neurologically intact, otherwise healthy, age-matched control
[ 0, 1, 2 ]
1
[ 0 ]
intervention 1: A non-specific inhibitor of the nitric oxide synthase enzyme.
intervention 1: N-Nitro L-arginine-methylester (L-NAME)
1
The Bronx | New York | United States | -73.86641 | 40.84985
23
0
0
0
NCT00753948
1COMPLETED
2010-08-01
2006-12-01
VA Office of Research and Development
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
[ 4 ]
241
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
true
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
null
Uterine Myomas
null
3
arm 1: PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ arm 2: PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ arm 3: PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing ...
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: tablets intervention 2: tablets intervention 3: Tablets
intervention 1: PGL4001 (ulipristal) and iron intervention 2: PGL4001 matching placebo and iron intervention 3: PGL4001 (ulipristal) and iron
38
Brno | N/A | Czechia | 16.60796 | 49.19522 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Békéscsaba | N/A | Hungary | 21.1 | 46.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Sze...
241
0
0
0
NCT00755755
1COMPLETED
2010-08-01
2008-10-01
PregLem SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).
null
Ankylosing Spondylitis
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: capsule, 200 mg QD, 6-12 weeks intervention 2: tablet, 75 mg QD,6-12 weeks
intervention 1: Celecoxib intervention 2: Diclofenac SR
5
Guangzhou | Guangdong | China | 113.25 | 23.11667 Xi’an | Shanxi | China | 113.52486 | 35.99785 Chengdu | Sichuan | China | 104.06667 | 30.66667 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075
456
0
0
0
NCT00762463
1COMPLETED
2010-08-01
2009-07-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
15
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(...
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.
Diabetic Foot Ulcer
Diabetic Ulcer Wound
null
2
arm 1: 1.0% doxycycline gel arm 2: placebo gel
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1.0% doxycycline gel applied topically to the wound once daily for 20 weeks intervention 2: placebo gel applied topically to the wound once daily for 20 weeks
intervention 1: doxycycline intervention 2: placebo gel
1
Gainesville | Florida | United States | -82.32483 | 29.65163
15
0
0
0
NCT00764361
1COMPLETED
2010-08-01
2009-01-01
NanoSHIFT 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
[ 2, 3 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Complications with current HIV antiretroviral therapy have left many children and adolescents with limited therapeutic options due to drug resistance. The purpose of this study is to test the effectiveness and safety of Vicriviroc (VCV), an HIV entry inhibitor and CCR5 co-receptor antagonist.
Highly active antiretroviral therapy (HAART) that includes a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI) has become the standard treatment of HIV-infected adults and children. When effective, HAART decreases the viral population, increases the body's immune responses, and leads t...
HIV Infections
Treatment Experienced
null
1
arm 1: HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus
[ 0 ]
1
[ 0 ]
intervention 1: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
intervention 1: Vicriviroc
9
San Diego | California | United States | -117.16472 | 32.71571 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41.85003 New York | New York | United States | -74.0...
4
0
0
0
NCT00766597
1COMPLETED
2010-08-01
2009-08-01
National Institute of Allergy and Infectious Diseases (NIAID)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
116
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia. The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
null
Chronic Kidney Disease Dialysis Hyperphosphatemia
Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
intervention 1: MCI-196
21
Los Angeles | California | United States | -118.24368 | 34.05223 Orange | California | United States | -117.85311 | 33.78779 Tarzana | California | United States | -118.55397 | 34.17334 Orlando | Florida | United States | -81.37924 | 28.53834 Pembroke Pines | Florida | United States | -80.22394 | 26.00315 Atlanta | Geo...
116
0
0
0
NCT00772382
1COMPLETED
2010-08-01
2008-12-01
Mitsubishi Tanabe Pharma Corporation
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 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them ...
PRIMARY OBJECTIVES: I. To determine the objective response rate of R-(-)-gossypol in patients with recurrent chemotherapy-sensitive extensive stage small cell lung cancer. II. To determine the time to disease progression. III. To determine the overall survival. IV. To assess the toxicities associated with this drug. ...
Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
null
1
arm 1: Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
3
[ 0, 10, 10 ]
intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies
intervention 1: R-(-)-gossypol acetic acid intervention 2: pharmacological study intervention 3: laboratory biomarker analysis
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
15
0
0
0
NCT00773955
1COMPLETED
2010-08-01
2008-11-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
189
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
null
Hepatitis C
Chronic Hepatitis C Protease Inhibitor Telaprevir Peginterferon Alfa-2b Ribavirin
null
2
arm 1: None arm 2: None
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 750 mg every 8 hours for 12 weeks intervention 2: 600 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5 mcg/kg/week for 24 weeks intervention 4: 600 - 1000 mg/day based on body weight for 48 weeks intervention 5: 1.5 mcg/kg/week for 48 weeks
intervention 1: MP-424 intervention 2: Ribavirin intervention 3: Peginterferon Alfa-2b intervention 4: Ribavirin intervention 5: Peginterferon Alfa-2b
1
Kawasaki | Takatsu-ku | Japan | 139.71722 | 35.52056
189
0
0
0
NCT00780416
1COMPLETED
2010-08-01
2008-11-01
Mitsubishi Tanabe Pharma Corporation
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 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overwe...
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks arm 2: Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insu...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Insulin detemir once daily plus insulin aspart at mealtime intervention 2: Insulin NPH once daily plus insulin aspart at mealtime
intervention 1: insulin detemir intervention 2: insulin NPH
1
Málaga | N/A | Spain | -4.42034 | 36.72016
59
0
0
0
NCT00795600
1COMPLETED
2010-08-01
2009-04-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
62
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks aft...
null
Colorectal Cancer
null
1
arm 1: Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
[ 0 ]
2
[ 4, 0 ]
intervention 1: Administered as prescribed according to normal clinical practice. intervention 2: 825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.
intervention 1: Standard radiotherapy intervention 2: Capecitabine [Xeloda]
2
Banská Bystrica | N/A | Slovakia | 19.15349 | 48.73946 Bratislava | N/A | Slovakia | 17.10674 | 48.14816
62
0
0
0
NCT00796718
1COMPLETED
2010-08-01
2008-10-01
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
[ 2, 3 ]
15
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.
null
Advanced Squamous Non-Small Cell Lung Cancer
AMG 479 IGF-1R Apoptosis Monoclonal Antibody Advanced Squamous Non-Small Cell Lung Cancer antibody 1st-line
Prot_SAP_000.pdf: Product: AMG479 Protocol Number: 20080257 Date: 02-September-2008 Page 1 of 114 Title: A Phase 1b/ 2 Study of AMG 479 in Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer AMG 479 Amgen Protocol Number 20080257 Cli...
3
arm 1: AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1 arm 2: AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study ...
[ 0, 0, 0 ]
5
[ 2, 2, 0, 2, 0 ]
intervention 1: AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study ...
intervention 1: AMG 479 intervention 2: AMG 479 intervention 3: Carboplatin intervention 4: AMG 479 intervention 5: Paclitaxel
25
Fayetteville | Arkansas | United States | -94.15743 | 36.06258 Fayetteville | Arkansas | United States | -94.15743 | 36.06258 Fort Wayne | Indiana | United States | -85.12886 | 41.1306 Fort Wayne | Indiana | United States | -85.12886 | 41.1306 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Indianapolis |...
14
0
0
0
NCT00807612
6TERMINATED
2010-08-01
2009-01-01
NantCell, Inc.
4INDUSTRY
true
true
false
https://cdn.clinicaltrials.gov/large-docs/12/NCT00807612/Prot_SAP_000.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
155
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.
null
Irritable Bowel Syndrome
null
3
arm 1: A high dose of LX1031; daily oral intake for 28 days arm 2: A low dose of LX1031; daily oral intake for 28 days arm 3: Matching placebo dosing with daily oral intake
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: A high dose of LX1031; daily oral intake for 28 days intervention 2: A low dose of LX1031; daily oral intake for 28 days. intervention 3: Matching placebo dosing with daily oral intake
intervention 1: LX1031 High Dose intervention 2: LX1031 Low Dose intervention 3: Placebo
36
Tucson | Arizona | United States | -110.92648 | 32.22174 Sherwood | Arkansas | United States | -92.22432 | 34.81509 Anaheim | California | United States | -117.9145 | 33.83529 Fountain Valley | California | United States | -117.95367 | 33.70918 Los Angeles | California | United States | -118.24368 | 34.05223 Orange | C...
155
0
0
0
NCT00813098
1COMPLETED
2010-08-01
2008-12-01
Lexicon 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
[ 0 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.
People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher...
Cancer Cachexia
n-3 fatty acids nutritional treatment molecular pathogenesis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of pr...
intervention 1: Eicosapentaenoic Acid
2
Stuart | Florida | United States | -80.25283 | 27.19755 Tampa | Florida | United States | -82.45843 | 27.94752
36
0
0
0
NCT00815685
1COMPLETED
2010-08-01
2007-07-01
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
[ 3 ]
53
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).
null
Heart Catheterization
null
3
arm 1: experimental drug therapy in this indication arm 2: experimental drug therapy in this indication arm 3: standard therapy in this indication as comparator
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: comparison of different dabigatran dosages with unfractionated heparin intervention 2: comparison of different dabigatran dosages with unfractionated heparin intervention 3: comparison of different dosages dabigatran with unfractionated heparin
intervention 1: dabigatran 110 mg intervention 2: dabigatran 150 mg intervention 3: unfractionated heparin
4
Alkmaar | N/A | Netherlands | 4.74861 | 52.63167 Nieuwegein | N/A | Netherlands | 5.08056 | 52.02917 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225
51
0
0
0
NCT00818753
1COMPLETED
2010-08-01
2009-01-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
432
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extens...
null
Gout
Gout Chronic gout Gouty arthritis Gout flares
null
11
arm 1: Canakinumab 25 mg subcutaneously (sc) once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol w...
[ 0, 0, 0, 0, 0, 0, 1, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Canakinumab was supplied in glass vials as a lyophilized powder. intervention 2: 0.5 mg capsule orally once daily for 16 weeks. intervention 3: 100-300 mg orally once daily for 24 weeks. intervention 4: Subcutaneous injection. intervention 5: Capsule orally once daily for 16 weeks.
intervention 1: Canakinumab intervention 2: Colchicine intervention 3: Allopurinol intervention 4: Placebo Matching Canakinumab intervention 5: Placebo Matching Colchicine
89
Huntington Beach | California | United States | -117.99923 | 33.6603 San Diego | California | United States | -117.16472 | 32.71571 Jupiter | Florida | United States | -80.09421 | 26.93422 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Overland Park | Kansas | United States | -94.67079 | 38.98223 Topeka | Ka...
772
0
0
0
NCT00819585
1COMPLETED
2010-08-01
2008-12-01
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
[ 4 ]
103
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90 seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local anesthetics.
Patients will be randomized into one of two groups, Group M: Ropivacaine and Mepivacaine - subject will receive two injections before surgery begins. These two injections will consist of the mixture of mepivacaine (15 ml) and ropivacaine (15 ml). Group S: Mepivacaine followed by Ropivacaine. Subjects will receive two ...
Local Anesthetic
surgery for arm hand or elbow mepivacaine ropivacaine hand surgery elbow surgery forearm surgery
null
2
arm 1: combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence; arm 2: sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepiv...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: ropivacaine (15 ml). intervention 2: One syringe will contain mepivacaine (15 ml)
intervention 1: Ropivacaine intervention 2: Mepivacaine
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
103
0
0
0
NCT00825786
1COMPLETED
2010-08-01
2008-09-01
The Cleveland 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 ]
164
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.
null
Anesthesia, General Neuromuscular Blockade
null
2
arm 1: At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe. arm 2: At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
[ 0, 0 ]
1
[ 0 ]
intervention 1: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammad...
intervention 1: Sugammadex
0
null
151
0
0
0
NCT00826176
1COMPLETED
2010-08-01
2010-01-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.
The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compuls...
Compulsive Buying
Buying Shopping Impulse Control
null
1
arm 1: 10-30mg, memantine
[ 0 ]
1
[ 0 ]
intervention 1: 10-30mg, by mouth, daily
intervention 1: Memantine
2
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Minneapolis | Minnesota | United States | -93.26384 | 44.97997
10
0
0
0
NCT00830375
1COMPLETED
2010-08-01
2008-12-01
University of Minnesota
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
116
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
null
Type 2 Diabetes Mellitus
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tablets, Oral, 5 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 0 mg, Once daily, 12 weeks
intervention 1: Dapagliflozin intervention 2: Placebo
3
San Diego | California | United States | -117.16472 | 32.71571 Baton Rouge | Louisiana | United States | -91.18747 | 30.44332 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
44
0
0
0
NCT00831779
1COMPLETED
2010-08-01
2009-04-01
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
[ 2 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
Aims: 1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? 2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? 3. Are there benefits of anti-inflamm...
We set out to pursue the following Aims: 1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? Pilot studies were performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individual...
Pre-diabetes Obesity
Vascular function Glucose tolerance Obesity Pre-diabetes
null
3
arm 1: Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after a single dose of oral salsalate. arm 2: Obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months' treatment with oral salsalate. arm 3: Lean subjects will be ...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses. intervention 2: Subjects will receive a single oral dose of 2 gram of oral salsalate
intervention 1: Chronic salsalate intervention 2: Acute Salsalate
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
16
0
0
0
NCT00837590
6TERMINATED
2010-08-01
2009-03-01
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
[ 5 ]
65
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed. The study will began with a one month run-in phase, where all patients were instructed to take Defer...
Following the run-in phase, patients entered a three month, assessment phase. During the assessment phase, patients were given five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.
Transfusional Hemosiderosis
Exjade deferasirox palatability tolerability food iron overload Serum Iron overload due to transfusions
null
1
arm 1: Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.
[ 0 ]
1
[ 0 ]
intervention 1: Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.
intervention 1: deferasirox:
23
Oakland | California | United States | -122.2708 | 37.80437 Palo Alto | California | United States | -122.14302 | 37.44188 Pleasant Hill | California | United States | -122.0608 | 37.94798 Aurora | Colorado | United States | -104.83192 | 39.72943 New Haven | Connecticut | United States | -72.92816 | 41.30815 Augusta | ...
265
0
0
0
NCT00845871
1COMPLETED
2010-08-01
2009-05-01
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
[ 0 ]
1
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
1FEMALE
true
The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS, particularly ER-negative DCIS.
Ductal carcinoma in situ (DCIS) of the breast is a pre-malignant lesion of the breast, which is associated with a marked increase in the likelihood of developing invasive breast cancer. Since DCIS tends to be associated with microcalcifications, it is detected with an increased frequency in patients being screened with...
Ductal Carcinoma in Situ
DCIS breast
null
0
null
null
1
[ 0 ]
intervention 1: 1500 mg lapatinib for 14-21 days
intervention 1: lapatinib
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
1
0
0
0
NCT00857714
6TERMINATED
2010-08-01
2009-04-01
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
[ 2, 3 ]
17
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
This is a phase I, open-label, controlled drug interaction study to determine the effects of darunavir plus ritonavir on the pharmacokinetics of the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, rosuvastatin, in HIV-1-seronegative subjects.
Twelve HIV-negative healthy volunteers will be randomized to one of two groups. Group 1 would receive rosuvastatin 10mg daily (Treatment A) in interval 1 for 7 days, followed by a washout period of at least 7 days. In interval 2, darunavir/ritonavir 600/100mg bid (Treatment B) would be administered for 7 days, followed...
HIV Infections
HIV dyslipidemia statins protease inhibitors
null
2
arm 1: Darunavir+ritonavir x 7 days; Rosuvastatin x 7 days; Combination x 7 days arm 2: Rosuvastatin x 7 days; darunavir+ritonavir x 7 days; Combination x 7 days
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: darunavir 600 mg twice daily for 7 days ritonavir 100 mg twice daily for 7 days rosuvastatin 10 mg once daily for 7 days Combination of all three drugs for 7 days intervention 2: rosuvastatin 10 mg daily for 7 days; darunavir 600 mg twice daily for 7 days with ritonavir 100 mg twice daily for 7 days; Co...
intervention 1: darunavir, ritonavir, rosuvastatin intervention 2: rosuvastatin, darunavir, ritonavir
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
41
0
0
0
NCT00885495
1COMPLETED
2010-08-01
2009-01-01
University of Cincinnati
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 ]
15
NA
SINGLE_GROUP
4SUPPORTIVE_CARE
0NONE
false
1FEMALE
false
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Patients who have received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), ...
null
Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis
Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis Bone Biopsy Transiliac Crest Bone Histology Histomorphometry
null
1
arm 1: Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.
[ 5 ]
1
[ 0 ]
intervention 1: Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.
intervention 1: Previous denosumab
0
null
15
0
0
0
NCT00887965
1COMPLETED
2010-08-01
2009-06-01
Amgen
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 ]
86
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.
This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy f...
Alzheimer Disease
Alzheimer disease moderate-to-severe memantine safety and efficacy
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks intervention 2: Placebo (matched to Dimebon) po for 26 weeks
intervention 1: Dimebon 20 mg po TID intervention 2: Placebo po TID
47
Phoenix | Arizona | United States | -112.07404 | 33.44838 Costa Mesa | California | United States | -117.91867 | 33.64113 Encino | California | United States | -118.50119 | 34.15917 Los Alamitos | California | United States | -118.07256 | 33.80307 Newport Beach | California | United States | -117.92895 | 33.61891 Newpo...
86
0
0
0
NCT00912288
6TERMINATED
2010-08-01
2009-09-01
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 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
BL22 is a type of protein that scientists have created to interact with certain cancer cells. Experiments have shown that BL22 can bind with cancer cells that have a particular kind of protein (called CD22 ) on their surface, and can kill those cells. CD22 is present on certain types of hairy cell leukemia (HCL) cancer...
Background: BL22, also called CAT-3888 or RFB4(dsFv)-PE38, is a recombinant immunotoxin containing an Fv fragment of an anti-CD22 monoclonal antibody and truncated Pseudomonas exotoxin (PE). In Phase 1 and 2 trials in patients with chemoresistant hairy cell leukemia (HCL), BL22 showed 47-61% complete remission (CR) r...
Hairy Cell Leukemia
BL22 in HCL after Immunotoxin Hairy Cell Leukemia Leukemia
null
1
arm 1: 30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
[ 0 ]
1
[ 0 ]
intervention 1: 30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
intervention 1: BL22 (CAT-3888)
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
1
0
0
0
NCT00924040
6TERMINATED
2010-08-01
2009-02-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
The purpose of the study is to determine whether the addition of the experimental mucinous glycoprotein 1 (MUC1) antigen-specific cancer immunotherapy tecemotide (L-BLP25) to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advan...
Breast Cancer
Phase III trial randomized cancer vaccine MUC1 BLP25 advanced breast cancer postmenopausal breast cancer immunotherapy of breast cancer Inoperable locally advanced, recurrent, or metastatic endocrine-sensitive Breast Cancer
null
2
arm 1: Investigational Arm: * Pretreatment (Single Dose): 300 milligrams per square meter (mg/m\^2) up to a maximum dose of 600 mg of intravenous cyclophosphamide * tecemotide (L-BLP25) plus Hormonal Therapy (Standard Dose) arm 2: Control Arm: * Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/...
[ 0, 1 ]
4
[ 2, 2, 0, 0 ]
intervention 1: Investigational Arm: Pretreatment (Single Dose) 300 mg/m\^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg). Primary treatment phase: Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual del...
intervention 1: Tecemotide (L-BLP25) and Hormonal Treatment intervention 2: Placebo of tecemotide (L-BLP25) and Hormonal Treatment intervention 3: cyclophosphamide intervention 4: sodium chloride (NaCl)
29
Hickory | North Carolina | United States | -81.3412 | 35.73319 Bedford Park, SA | N/A | Australia | 138.56815 | -35.02204 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Salzburg | N/A | Austria | 13.04399 | 47.79941 Leuven | N/A | Belgium | 4.70093 | 50.87959 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/...
16
0
0
0
NCT00925548
6TERMINATED
2010-08-01
2009-09-01
EMD Serono
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 ]
56
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.
The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and fun...
Pain, Postoperative
null
2
arm 1: 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) arm 2: Normal saline with Epi 1:100,000 (B block)
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Bupivacaine local anesthesia block prior to start of FESS procedure. intervention 2: placebo is identical in appearance in comparison to active drug.
intervention 1: Bupivacaine Block intervention 2: Placebo
1
Stanford | California | United States | -122.16608 | 37.42411
56
0
0
0
NCT00927888
1COMPLETED
2010-08-01
2007-08-01
Stanford University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with ...
This single-center pilot study is designed as a double-blind, randomized, cross-over clinical trial to evaluate the effects of inhaled lucinactant, an investigational peptide-containing synthetic surfactant (6 ml of 20 mg total phospholipid (TPL)/mL solution x 5 doses) in patients with mild to moderate CF lung disease....
Cystic Fibrosis
null
2
arm 1: Active treatment first, then washout period, then placebo treatment arm 2: 0.9% NaCl vehicle treatment first, then washout period, then lucinactant treatment
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours, then washout period x 14 days, then vehicle x 5 doses over 24 hrs intervention 2: 6 mL normal saline x 5 doses over 24 hours, then washout period x 14 days, then lucinactant x 5 doses over 24 hours
intervention 1: Lucinactant first intervention 2: Placebo first
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
31
0
0
0
NCT00934362
1COMPLETED
2010-08-01
2008-10-01
University of North Carolina, Chapel Hill
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 ]
41
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.
null
Diabetes Mellitus, Type 2
null
1
arm 1: Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
[ 0 ]
1
[ 0 ]
intervention 1: dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
intervention 1: linagliptin QD (once daily) for 7 days
6
Cypress | California | United States | -118.03729 | 33.81696 DeLand | Florida | United States | -81.30312 | 29.02832 Miami | Florida | United States | -80.19366 | 25.77427 Baltimore | Maryland | United States | -76.61219 | 39.29038 New York | New York | United States | -74.00597 | 40.71427 Dallas | Texas | United State...
41
0
0
0
NCT00935220
1COMPLETED
2010-08-01
2009-06-01
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
[ 4 ]
326
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.
null
Nocturia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Nasal Spray, once a day intervention 2: Nasal Spray
intervention 1: SER120 intervention 2: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
326
0
0
0
NCT00937378
1COMPLETED
2010-08-01
2009-06-01
Serenity 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
[ 5 ]
862
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare whether Symbicort Maintenance \& Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.
null
Asthma
Symbicort SMART
null
1
arm 1: Symbicort Turbuhaler 160/4.5 µg delivered dose
[ 0 ]
1
[ 0 ]
intervention 1: Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms
intervention 1: Symbicort (Budesonide/Formoterol)
35
Guangzhou | Guangdong | China | 113.25 | 23.11667 Zheng Ahou | Henan | China | N/A | N/A Wuhan | Hubei | China | 114.26667 | 30.58333 Changsha | Hunan | China | 112.97087 | 28.19874 Qingdao | Shandong | China | 120.38042 | 36.06488 Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222 Beijing | N/A | China | ...
862
0
0
0
NCT00939341
1COMPLETED
2010-08-01
2009-07-01
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
[ 4 ]
649
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.
This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy ...
Alzheimer's Disease
null
1
arm 1: 10 mg TID for Week 1, followed by 20 mg TID for remainder of study
[ 0 ]
1
[ 0 ]
intervention 1: Tablet for oral administration
intervention 1: Dimebon
105
Mobile | Alabama | United States | -88.04305 | 30.69436 Northport | Alabama | United States | -87.57723 | 33.22901 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Oceanside | California | United States | -117.37948 | 33.19587 San Diego | California | United States | -117.16472 | 32.71571 Santa Rosa | Cali...
648
0
0
0
NCT00939783
6TERMINATED
2010-08-01
2009-09-01
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
[ 4 ]
803
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spo...
null
Irritable Bowel Syndrome Characterized by Constipation
Irritable Bowel Syndrome Constipation Linaclotide
null
2
arm 1: Linaclotide 290 micrograms arm 2: Matching placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 2: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
intervention 1: Linaclotide 290 micrograms intervention 2: Matching placebo
118
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Hueytown | Alabama | United States | -86.99666 | 33.45122 Huntsville | Alabama | United States | -86.58594 | 34.7304 Chandler | Arizona | United States | -111.84125 | 33.30616 Mesa | Arizona | United ...
1,447
0
0
0
NCT00948818
1COMPLETED
2010-08-01
2009-07-01
Forest Laboratories
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 ]
838
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
4QUADRUPLE
false
0ALL
true
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
null
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Lung Respiratory disease Efficacy Safety and tolerability Placebo-controlled Pharmacokinetics COPD
null
4
arm 1: AZD9668 active treatment arm 2: AZD9668 active treatment arm 3: AZD9668 active treatment arm 4: AZD9668 placebo treatment
[ 1, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 2 x 30 mg oral tablets twice daily (bid) for 12 weeks intervention 2: 2 x 10 mg oral tablets twice daily (bid) for 12 weeks intervention 3: 2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks intervention 4: 2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
intervention 1: AZD9668 intervention 2: AZD9668 intervention 3: AZD9668 intervention 4: AZD9668 Placebo
105
Fullerton | California | United States | -117.92534 | 33.87029 Valparaiso | Indiana | United States | -87.06114 | 41.47309 Council Bluffs | Iowa | United States | -95.86083 | 41.26194 Hickory | North Carolina | United States | -81.3412 | 35.73319 Jefferson Hills | Pennsylvania | United States | -79.93199 | 40.29118 Gaf...
838
0
0
0
NCT00949975
1COMPLETED
2010-08-01
2009-07-01
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 ]
28
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.
null
Major Depressive Disorder
depression
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: 50 mg DVS SR tablet days 1-6, period 2 only. intervention 2: 4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.
intervention 1: Desvenlafaxine Succinate Sustained Release intervention 2: Midazolam
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
84
0
0
0
NCT00952653
1COMPLETED
2010-08-01
2010-06-01
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 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Marijuana is the most commonly used illicit drug in the United States. However, the treatment options for cannabis dependence are limited; notably, no effective pharmacotherapy has been developed. Conceptually, the ideal medication treatment for cannabis dependence would: 1. be safe when administered to patients activ...
Conceptually, the pharmacodynamic and clinical actions of quetiapine suggest that it may be useful for cannabis dependence. By antagonizing dopamine, quetiapine may interfere with the reinforcing effects of cannabis, while serotonin type 2A, histamine type 1, and adrenergic receptor antagonism may reduce cannabis withd...
Cannabis Dependence
Cannabis quetiapine
null
1
arm 1: Open label treatment with quetiapine
[ 0 ]
1
[ 0 ]
intervention 1: Quetiapine treatment from 25 mg daily to 300 mg twice daily
intervention 1: quetiapine
1
New York | New York | United States | -74.00597 | 40.71427
15
0
0
0
NCT00954681
1COMPLETED
2010-08-01
2009-08-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (in...
null
Hypotrichosis
null
2
arm 1: bimatoprost ophthalmic 0.03% solution arm 2: vehicle sterile solution
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Apply one drop of study medication along the upper eyelid margin once daily in the evening intervention 2: Apply one drop of study medication along the upper eyelid margin once daily in the evening
intervention 1: bimatoprost ophthalmic 0.03% solution intervention 2: vehicle sterile solution (placebo)
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
89
0
0
0
NCT00958035
1COMPLETED
2010-08-01
2009-11-01
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 ]
161
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study is a six-month, prospective, randomized, multicenter, single- blind, controlled clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic control and safety in subjects with Type 2 diabetes under diet control and exercise. The subjects were randomized in one of the 3 arms r...
Screening (Visit 1) and Run-in Period This period of the study was designed as an 8-week screening and stabilization period, during which potentially eligible subjects participated in a weight-maintaining diet and a daily exercise program. Subjects who were eligible for screening were diabetic subjects treated solely...
Type 2 Diabetes
null
3
arm 1: 2.5 Active - 2.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months. arm 2: 5.0 mid dose - 5.0 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months. arm 3: 7.5 high dose - 7.5 g D-tagatose given orally, three times daily, immediately prior to me...
[ 0, 1, 1 ]
1
[ 0 ]
intervention 1: powder to be dissolved in water prior to dosage.
intervention 1: D-Tagatose
13
Garden Grove | California | United States | -117.94145 | 33.77391 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgia | United States | -84.38798 | 33.749 Decatur | Georgia | United States | -84.29631 | 33.77483 Houston | Texas | United States | -95.36327 | 29.76328 Patna | Bihar | India | 85.13563...
145
0
0
0
NCT00961662
1COMPLETED
2010-08-01
2008-02-01
Robert Lodder
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 ]
18
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell carcinomas in Gorlin's syndrome patients. Following...
null
Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
Basal Cell Carcinoma Gorlin Syndrome, Gorlin-Goltz Syndrome, Basal Cell Nevus Syndrome, Nevoid Basal Cell Carcinoma Syndrome, Basal Cell Carcinoma Nevus Syndrome
null
4
arm 1: Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant. arm 2: Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice...
[ 1, 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo cream intervention 2: None intervention 3: None
intervention 1: Vehicle intervention 2: LDE225 0.25% intervention 3: LDE225 0.75%
3
Graz | N/A | Austria | 15.45 | 47.06667 Vienna | N/A | Austria | 16.37208 | 48.20849 Zurich | N/A | Switzerland | 8.55 | 47.36667
18
0
0
0
NCT00961896
1COMPLETED
2010-08-01
2009-07-01
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
[ 0 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The objective of this prospective, randomized, double-blind, parallel-group, placebo-controlled study is to determine the effectiveness of intranasal oxytocin in subjects suffering from chronic daily headache.
The TI004 and TI005 studies both used a randomized, double-blind, placebo-controlled, parallel-group study design. A protocol-specified interim analysis was performed after completion of the first 40 subjects, resulting in termination of the TI004 study and development of the TI005 protocol, which included the followin...
Chronic Daily Headache
intranasal oxytocin acute headache treatment chronic daily headache
null
4
arm 1: Treated group arm 2: Placebo group arm 3: None arm 4: None
[ 0, 2, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 4 actuations in each nostril for a total dose of 32 IU intervention 2: 4 actuations in each nostril intervention 3: 8 actuations in each nostril for a total dose of 64 IU intervention 4: 8 actuations in each nostril
intervention 1: Syntocinon intervention 2: Sterile water intervention 3: Syntocinon intervention 4: Sterile water
1
Wellesley Hills | Massachusetts | United States | -71.27867 | 42.30843
60
0
0
0
NCT00963040
1COMPLETED
2010-08-01
2009-11-01
MedVadis Research Corporation
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 ]
32
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
Osteoarthritis
null
1
arm 1: ACTIVE CONTROL
[ 0 ]
1
[ 0 ]
intervention 1: 2.5 mL of EUFLEXXA (per injection) x 3 injections
intervention 1: EUFLEXXA
1
Marietta | Georgia | United States | -84.54993 | 33.9526
32
0
0
0
NCT00969501
1COMPLETED
2010-08-01
2009-08-01
Georgia Institute for Clinical Research, 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
[ 4 ]
82
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effe...
The trial will last up to 13 weeks for each subject and includes: * One week of observation under previous analgesic treatment. * Twelve weeks of treatment with tapentadol hydrochloride PR.
Chronic Pain Osteoarthritis
Osteoarthritis pain assessment tapentadol centrally acting analgesic
null
1
arm 1: Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol IR tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
[ 0 ]
1
[ 0 ]
intervention 1: Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not per...
intervention 1: Tapentadol PR
24
Melbourne | N/A | Australia | 144.96332 | -37.814 Perth | N/A | Australia | 115.8614 | -31.95224 Aalborg | N/A | Denmark | 9.9187 | 57.048 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Kolding | N/A | Denmark | 9.47216 | 55.4904 Odense | N/A | Denmark | 10.38831 | 55.39594 Vejle | N/A | Denmark | 9.5357 | 55.70927 Ber...
63
0
0
0
NCT00982280
6TERMINATED
2010-08-01
2009-09-01
Grünenthal GmbH
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 ]
196
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as p...
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment. Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only...
Blood Loss
To decrease blood loss during knee surgery
null
2
arm 1: 2 vials of Floseal applied once at the end of surgery arm 2: No intervention.
[ 0, 4 ]
1
[ 0 ]
intervention 1: FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze s...
intervention 1: Hemostatic Matrix
1
New York | New York | United States | -74.00597 | 40.71427
196
0
0
0
NCT00990288
1COMPLETED
2010-08-01
2007-10-01
Hospital for Special Surgery, New York
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 ]
406
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
null
Inflammation Pain
null
2
arm 1: Loteprednol etabonate arm 2: Vehicle of loteprednol etabonate
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days. intervention 2: 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
intervention 1: Vehicle of Loteprednol Etabonate intervention 2: Loteprednol Etabonate
1
Rochester | New York | United States | -77.61556 | 43.15478
406
0
0
0
NCT01010633
1COMPLETED
2010-08-01
2009-11-01
Bausch & Lomb Incorporated
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
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.
null
Psoriasis
Psoriasis
null
7
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
[ 0, 2, 2, 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: administered intravenously at randomization and every 2 weeks for 6 weeks intervention 2: administered subcutaneously at randomization and every 2 weeks for 6 weeks intervention 3: administered intravenously at randomization and every 2 weeks for 6 weeks intervention 4: administered subcutaneously at ra...
intervention 1: LY2525623 Intravenous intervention 2: LY2525623 Subcutaneous intervention 3: Placebo Intravenous intervention 4: Placebo Subcutaneous
28
Mobile | Alabama | United States | -88.04305 | 30.69436 Peoria | Arizona | United States | -112.23738 | 33.5806 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Fremont | California | United States | -121.98857 | 37.54827 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | Californi...
8
0
0
0
NCT01018810
6TERMINATED
2010-08-01
2009-12-01
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 ]
615
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
null
Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary lung respiratory disease efficacy placebo-controlled COPD FEV1 St Georges Respiratory Questionnaire
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 x 30 mg oral tablets bd for 12 weeks intervention 2: 2 x matched placebo to oral tablet bd for 12 weeks
intervention 1: AZD9668 intervention 2: Placebo
66
Lovech | N/A | Bulgaria | 24.71667 | 43.13333 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Stara Zagora | N/A | Bulgaria | 25.64194 | 42.43278 Troyan Municipality | N/A | Bulgaria | 24.715...
615
0
0
0
NCT01023516
1COMPLETED
2010-08-01
2009-11-01
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 ]
401
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
null
Papulopustular Rosacea
rosacea papulopustular azelaic acid foam
null
2
arm 1: Participants received azelaic acid foam, 15% topically twice daily for 12 weeks arm 2: Participants received vehicle foam topically twice daily for 12 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Applied topically twice daily for 12 weeks intervention 2: Applied topically twice daily for 12 weeks
intervention 1: Azelaic acid foam 15% intervention 2: Vehicle foam
20
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Fremont | California | United States | -121.98857 | 37.54827 Santa Monica | California | United States | -118.49138 | 34.01949 Miami | Florida | United States | -80.19366 | 25.77427 Miramar | Florida ...
401
0
0
0
NCT01025635
1COMPLETED
2010-08-01
2009-12-01
LEO Pharma
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 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
false
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks. Thirty subjects will be ...
Stretch Marks Striae Treatment
Stretch marks Striae Tretinoin Superficial dermabrasion
null
2
arm 1: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. arm 2: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
[ 1, 1 ]
2
[ 0, 1 ]
intervention 1: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. intervention 2: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
intervention 1: Tretinoin cream 0.005% intervention 2: Superficial Dermabrasion
1
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
22
0
0
0
NCT01027793
1COMPLETED
2010-08-01
2009-03-01
Brazilan Center for Studies in Dermatology
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 ]
128
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol f...
null
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
null
5
arm 1: Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) arm 2: Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) arm 3: Aclidinium bromide 400 μg administered twice-daily (BID) arm 4: Formoterol fumarate ...
[ 0, 0, 0, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 2: Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day...
intervention 1: Aclidinium 400 μg / Formoterol 12 μg intervention 2: Aclidinium 400 μg / Formoterol 6 μg intervention 3: Aclidinium 400 μg intervention 4: Formoterol 12 μg intervention 5: Placebo
20
Glendale | Arizona | United States | -112.18599 | 33.53865 Pheonix | Arizona | United States | N/A | N/A Rancho Mirage | California | United States | -116.41279 | 33.73974 Stockton | California | United States | -121.29078 | 37.9577 Wheat Ridge | Colorado | United States | -105.07721 | 39.7661 Clearwater | Florida | Un...
456
0
0
0
NCT01049360
1COMPLETED
2010-08-01
2009-12-01
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
[ 4 ]
7
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).
null
Normal Pressure Hydrocephalus
Amyloid NPH Normal pressure hydrocephalus PET Positron Emission Tomography SUVR Standard uptake value ratios
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).
intervention 1: [18F] Flutemetamol
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
7
0
0
0
NCT01053312
1COMPLETED
2010-08-01
2009-12-01
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
[ 3 ]
84
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to...
Chronic Idiopathic Constipation
Chronic Idiopathic Constipation Constipation Irritable Bowel Syndrome
null
5
arm 1: SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days. arm 2: SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days. arm 3: SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days arm 4: SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days. arm 5: Placebo tablet by mout...
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: SP-304 0.3 mg intervention 2: SP-304 1.0 mg intervention 3: SP-304 3.0 mg intervention 4: SP-304 9.0 mg intervention 5: Placebo
intervention 1: SP-304 0.3 mg intervention 2: SP-304 1.0 mg intervention 3: SP-304 3.0 mg intervention 4: SP-304 9.0 mg intervention 5: Placebo
14
Mesa | Arizona | United States | -111.82264 | 33.42227 Tucson | Arizona | United States | -110.92648 | 32.22174 Anaheim | California | United States | -117.9145 | 33.83529 Orange | California | United States | -117.85311 | 33.78779 Hialeah | Florida | United States | -80.27811 | 25.8576 Miami | Florida | United States ...
78
0
0
0
NCT01053962
1COMPLETED
2010-08-01
2010-03-01
Bausch Health Americas, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
255
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.
null
Pain
Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with "moderate pain" or "severe pain"rated as 45.0 mm or more on the VAS intervention 2: Additional dose: Celecoxib 200mg tablet x 1 ...
intervention 1: Celecoxib intervention 2: Celecoxib intervention 3: Placebo
22
Niihama-shi | Ehime | Japan | N/A | N/A Kitakyusyu-shi | Fukuoka | Japan | N/A | N/A Takasaki-shi | Gunma | Japan | N/A | N/A Kure-shi | Hiroshima | Japan | N/A | N/A Kanazawa | Ishikawa-ken | Japan | 136.61667 | 36.6 Kita-gun | Kagawa-ken | Japan | N/A | N/A Isehara-shi | Kanagawa | Japan | N/A | N/A Kumamoto | Kumamo...
255
0
0
0
NCT01062113
1COMPLETED
2010-08-01
2010-04-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
246
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
null
Type 2 Diabetes Mellitus Impaired Glucose Tolerance
Type 2 Diabetes Mellitus canakinumab Pre diabetic glucose intolerant oral anti diabetic medication insulin treatment metabolic syndrome
null
10
arm 1: Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening arm 2: Eligible participants received a s...
[ 0, 2, 0, 2, 0, 2, 0, 2, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Single subcutaneous injection of Canakinumab 150 mg. intervention 2: Single subcutaneous injection of Placebo to Canakinumab.
intervention 1: Canakinumab 150 mg intervention 2: Placebo to Canakinumab
52
Los Angeles | California | United States | -118.24368 | 34.05223 Santa Ana | California | United States | -117.86783 | 33.74557 Spring Valley | California | United States | -116.99892 | 32.74477 Madisonville | Kentucky | United States | -87.49889 | 37.3281 Omaha | Nebraska | United States | -95.94043 | 41.25626 Omaha |...
244
0
0
0
NCT01068860
1COMPLETED
2010-08-01
2010-02-01
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
[ 4 ]
99
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.
null
Type 2 Diabetes Mellitus
insulin resistance
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: MP-513 10 mg, once a day, for 4 weeks intervention 2: MP-513 20 mg, once a day, for 4 weeks intervention 3: MP-513 placebo, once a day, for 4 weeks
intervention 1: MP-513 intervention 2: MP-513 intervention 3: Placebo of MP-513
1
Suita | Osaka | Japan | 135.51567 | 34.76143
99
0
0
0
NCT01072331
1COMPLETED
2010-08-01
2010-02-01
Mitsubishi Tanabe Pharma Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
7
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.
Dry eye disease affects millions of people world-wide, and presents with symptoms of blurred vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling in the eyes, and sensitivity to light. Topical eye drops for eye lubrication (i.e., artificial tear solutions) and controlling ocular i...
Dry Eye Syndromes
Dry Eye Syndromes Lacrimal Apparatus Diseases
null
2
arm 1: Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . arm 2: Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: ophthalmic solution; 1 drop both eyes twice daily intervention 2: Cyclosporin solution; 1 drop both eyes twice daily
intervention 1: Euphrasia-based homeopathic therapy intervention 2: Cyclosporin solution
1
Columbia | Missouri | United States | -92.33407 | 38.95171
6
0
0
0
NCT01072526
6TERMINATED
2010-08-01
2007-12-01
University of Missouri-Columbia
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 ]
10
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
Previous studies have shown that the beta-adrenergic system plays a role in processing pain and the expression of hyperalgesia. Recent studies have investigated the analgesic effects, and potential anti-hyperalgesic effects (using a model of opioid induced (OIH) hyperalgesia) of propranolol, a beta adrenergic antagonis...
This study is a double blind-placebo controlled study in which subjects will be exposed to propranolol infusion during one study day, the opioid alfentanil on another day, and placebo infusion during a third study day. The infusion order will be randomized, and the participant and individual conducting the pain testing...
Pain Measurement
null
3
arm 1: Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally. arm 2: Experimental inflammation and tissue injury sit...
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: An infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump. intervention 2: An infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump. intervention 3: An infusion of normal saline was administered over 3 hours using a pro...
intervention 1: Alfentanil intervention 2: Propranolol intervention 3: Placebo
1
Stanford | California | United States | -122.16608 | 37.42411
10
0
0
0
NCT01094574
1COMPLETED
2010-08-01
2010-01-01
Martin Angst
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 ]
335
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
null
Pain
Pain following third molar extraction
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) intervention 2: Single-dose of standard ibuprofen (400mg) intervention 3: Single-dose of standard ibuprofen (400mg) intervention 4: Single-dose of placebo
intervention 1: Novel Ibuprofen intervention 2: Standard Ibuprofen intervention 3: Standard Ibuprofen intervention 4: Placebo
0
null
316
0
0
0
NCT01098747
1COMPLETED
2010-08-01
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
[ 4 ]
61
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study \[NCT00679432\]).
Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.
Colitis, Ulcerative
ulcerative colitis Budesonide
null
1
arm 1: Budesonide-MMX 9 mg tablet
[ 0 ]
1
[ 0 ]
intervention 1: One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
intervention 1: Budesonide
15
Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Assam | N/A | India | N/A | N/A Gujarat | N/A | India | N/A | N/A Karnataka | N/A | India | N/A | N/A Karnataka | N/A | India | N/A | N/A Kerala | N/A | Ind...
60
0
0
0
NCT01100112
1COMPLETED
2010-08-01
2010-02-01
Bausch Health Americas, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
101
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model du...
null
Allergic Conjunctivitis
null
5
arm 1: Loteprednol etabonate ophthalmic base dosed once/day. arm 2: Loteprednol etabonate ophthalmic base dosed two times/day arm 3: Loteprednol etabonate ophthalmic base dosed four times/day. arm 4: Loteprednol etabonate ophthalmic suspension dosed four times/day arm 5: Vehicle of loteprednol etabonate, dosed either Q...
[ 1, 1, 1, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks intervention 2: Loteprednol etabonate ophthalmic base BID dosing for 2 weeks intervention 3: Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week intervention 4: Loteprednol etabonate ophthalmic suspension dosed four t...
intervention 1: Loteprednol etabonate base (QD) intervention 2: Loteprednol etabonate base (BID) intervention 3: Loteprednol etabonate base (QID) intervention 4: Loteprednol etabonate suspension intervention 5: Vehicle of loteprednol etabonate
1
Rochester | New York | United States | -77.61556 | 43.15478
101
0
0
0
NCT01107405
1COMPLETED
2010-08-01
2010-04-01
Bausch & Lomb Incorporated
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 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to compare the efficacy of these currently used capsules wi...
Bile acids are end products of cholesterol metabolism. Individuals with inborn errors of bile acid synthesis lack the enzymes needed to synthesize the primary bile acids cholic acid and chenodeoxycholic acid (CDCA). These conditions are serious and account for approximately 1% of cases presenting as idiopathic cholesta...
Inborn Errors of Bile Acid Synthesis
Inborn Errors Bile Acid Pediatrics Liver Disease
null
1
arm 1: Manufactured cholic acid capsules
[ 0 ]
1
[ 0 ]
intervention 1: The IUPAC name for cholic acid is 3 alpha,7alpha,12 alpha-trihydroxy-5 beta-cholanoic acid. The international nonproprietary name (INN) is cholic acid. Each patient will be given a box containing a 1 month supply of study drug. Each bottle will contain 90 capsules; each capsule will contain either 50 o...
intervention 1: Cholic acid
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
16
0
0
0
NCT01115582
1COMPLETED
2010-08-01
2010-04-01
Mirum 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 ]
79
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary dis...
null
Chronic Obstructive Pulmonary Disease (COPD)
COPD
null
5
arm 1: Aclidininum bromide 100 μg twice daily by inhalation arm 2: Aclidininum bromide 200 μg twice daily by inhalation arm 3: Aclidininum bromide 400 μg twice daily by inhalation arm 4: Placebo twice-daily by inhalation arm 5: Formoterol 12 μg twice daily by inhalation
[ 0, 0, 0, 2, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 2: Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 3: Aclidinium bromide 4...
intervention 1: Aclidinium bromide 100 μg bid intervention 2: Aclidinium bromide 200 μg bid intervention 3: Aclidininum bromide 400 μg bid intervention 4: Placebo intervention 5: Formoterol 12 μg bid
11
Ghent | N/A | Belgium | 3.71667 | 51.05 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Groβhansdorf | N/A | Germany | N/A | N/A Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N...
370
0
0
0
NCT01120093
1COMPLETED
2010-08-01
2010-05-01
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
[ 2 ]
41
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
The 2 formulations of insulin lispro will be referred to here as: Lispro A Lispro B
Healthy Volunteers
insulin lispro
null
2
arm 1: 20 units (U) subcutaneously (SC) arm 2: 20 units (U) subcutaneously (SC)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 20 units (U) subcutaneously (SC). intervention 2: 20 U subcutaneously (SC).
intervention 1: Insulin lispro A intervention 2: Insulin lispro B
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
75
0
0
0
NCT01133392
1COMPLETED
2010-08-01
2010-05-01
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 ]
11
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The proposed study will evaluate the potential benefit of a tapered course of hydrocortisone compared to abrupt cessation in patients initiated on hydrocortisone for septic shock. The study will include adult patients in the medical intensive care unit (MICU) who meet criteria for corticosteroid therapy for septic shoc...
Current therapy for septic shock includes antimicrobials, fluid resuscitation, catecholamines, and measures to improve tissue oxygen delivery. The use of corticosteroids as an adjunctive treatment in septic shock has been an area of intensive research over the past decade. A handful of studies suggest that patients in ...
Septic Shock
Sepsis hydrocortisone
null
2
arm 1: Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) arm 2: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1\) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) intervention 2: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortison...
intervention 1: hydrocortisone intervention 2: Normal Saline
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
11
0
0
0
NCT01150409
6TERMINATED
2010-08-01
2008-05-01
The Cleveland 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 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
null
This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
null
Healthy Pulmonary Disease, Chronic Obstructive
null
2
arm 1: solution for oral inhalation arm 2: tablet
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 10 mcg solution for oral inhalation intervention 2: 10 mcg solution for oral inhalation intervention 3: 400 mg tablet intervention 4: 400 mg tablet
intervention 1: BI 1744 intervention 2: BI 1744 intervention 3: Ketoconazole intervention 4: Ketoconazole
1
Ingelheim | N/A | Germany | 8.05883 | 49.97078
64
0
0
0
NCT01153711
1COMPLETED
2010-08-01
2010-05-01
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
[ 2 ]
40
NON_RANDOMIZED
PARALLEL
1PREVENTION
0NONE
true
0ALL
false
The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine will be safe, tolerable, and have the effect of suppressing appetite, when taken in combination daily by mouth by healthy, overweight, adult men and women. In this study, up to 12 people will be assigned to one of 4 groups: A...
null
Obesity
Obesity Overweight Sertraline Telenzepine Decrease appetite Reduce appetite Lose weight
null
4
arm 1: Group A: No Sertraline; 0, 1, 2, 3 mg/day Telenzepine arm 2: Sertraline 50 mg/day; 0, 1, 2, 3 mg/day Telenzepine arm 3: Sertraline 50, 100 mg/day; 0, 1, 2, 3 mg/day Telenzepine arm 4: Sertraline 50, 100, 150 mg/day; 0, 1, 2, 3 mg/day Telenzepine
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: oral sertraline tablets at 0, 50, 100, or 150/day plus oral telenzepine capsules at 0, 1, 2, or 3 mg/day for 7 days in each combination
intervention 1: Sertraline plus Telenzepine
0
null
40
0
0
0
NCT01155531
1COMPLETED
2010-08-01
2010-05-01
Theracos
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 ]
215
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.
null
Allergic Conjunctivitis
Allergic conjunctivitis
null
1
arm 1: 1 drop self-administered in each eye once daily in the morning for 7 days
[ 0 ]
1
[ 0 ]
intervention 1: Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
intervention 1: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
0
null
215
0
0
0
NCT01159769
1COMPLETED
2010-08-01
2010-06-01
Alcon Research
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 ]
20
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
true
Clopidogrel, in combination with aspirin, is currently the recommended treatment for secondary prevention of ischemic events in high-risk patients and for prevention of coronary artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated with proton pump inhibitors, such as omeprazole or ...
Clopidogrel, in combination with aspirin, is currently the recommended treatment for secondary prevention of ischemic events in high-risk patients and for prevention of coronary artery stent thrombosis. Patients receiving aspirin and clopidogrel are frequently treated with proton pump inhibitors, such as omeprazole or ...
Drug Interaction
proton pump inhibitor clopidogrel platelet function
null
2
arm 1: prospective, open-label, two-sequence, three-period, randomized crossover study arm 2: prospective, open-label, two-sequence, three-period, randomized crossover study
[ 1, 1 ]
1
[ 0 ]
intervention 1: The clopidogrel dose will be a 600mg loading dose followed by a 75mg daily maintenance dose, starting the next day for 7 days. Omeprazole will be used at a daily dose of 40mg and pantoprazole at 80mg.
intervention 1: omeprazole and pantoprazole
1
Jacksonville | Florida | United States | -81.65565 | 30.33218
40
0
0
0
NCT01170533
1COMPLETED
2010-08-01
2009-03-01
University of Florida
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 ]
89
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
true
0ALL
true
This is a research study on Altitude Illness. From the information collected and studied in this project we hope to learn more about Altitude Illness, including factors that may affect and prevent the development and progression of this condition. We hope to learn if the commonly used non-steroidal anti-inflammatory me...
This study was designed to bring together elements of prior studies and go one step further for definitive data on several points. The trial will employ two pharmaceutical intervention arms, which will compare placebo (the standard of care - information on prevention of altitude sickness) with the widely used NSAID ibu...
Altitude Sickness
null
2
arm 1: 600mg ibu TID arm 2: visually identical
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total) intervention 2: identical number of visually identical tasteless pills as ibuprofen arm
intervention 1: Ibuprofen intervention 2: Placebo
1
Stanford | California | United States | -122.16608 | 37.42411
89
0
0
0
NCT01171794
1COMPLETED
2010-08-01
2010-07-01
Stanford University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will...
null
Acne Vulgaris
Acne Acne vulgaris Adherence Compliance MEMS Benzoyl peroxide
null
2
arm 1: Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. arm 2: Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
[ 0, 2 ]
2
[ 5, 0 ]
intervention 1: A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication. intervention 2: Topical benzoyl peroxide 5% gel, to be used once daily to the face.
intervention 1: Internet survey intervention 2: Benzoyl peroxide 5% gel
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
20
0
0
0
NCT01176955
1COMPLETED
2010-08-01
2009-05-01
Wake Forest 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 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.
null
Acne Vulgaris
P. acnes, Acne vulgaris
null
2
arm 1: * Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:Topical to the face, once daily application in the evening. * Duration of Treatment:12 weeks arm 2: * Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel. * Mode and Frequency of Administration:T...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Once daily application on the face in the evening for 12 weeks intervention 2: Once daily application on the face in the evening for 12 weeks
intervention 1: Epiduo gel intervention 2: BPO
1
Iwonicz-Zdrój | N/A | Poland | 21.78992 | 49.56319
40
0
0
0
NCT01188538
1COMPLETED
2010-08-01
2010-03-01
Galderma R&D
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 ]
27
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (A...
This is a pilot open-label, national, multi-centre, Phase IV trial. This trial will be conducted with outpatients. Once subject has met all eligibility criteria, she will be treated with Gonal-f® prefilled pen and will receive on a randomization basis the GnRH agonist or antagonist. The follicle stimulating hormone (FS...
In Vitro Fertilization
Infertility Gonal-f gene expression Assisted Reproductive Technologies Follitropin alfa endometrium
null
2
arm 1: None arm 2: None
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed. intervention 2: Ovulation triggering will be performed using a single injection o...
intervention 1: Gonal -f® [r-hFSH] intervention 2: Ovitrelle® [r-hCG alfa] intervention 3: Gonadotropin-releasing hormone (GnRH) Agonist intervention 4: Gonadotropin-releasing hormone (GnRH) Antagonist
1
Paris | N/A | France | 2.3488 | 48.85341
24
0
0
0
NCT01210144
6TERMINATED
2010-08-01
2008-08-01
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
[ 2, 3 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
null
Seasonal Allergic Rhinitis
null
4
arm 1: bepotastine besilate nasal product - low dose arm 2: bepotastine besilate nasal product - medium dose arm 3: bepotastine besilate nasal product - high dose arm 4: placebo comparator nasal product
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: sterile nasal product intervention 2: sterile nasal product intervention 3: sterile nasal product intervention 4: sterile nasal product
intervention 1: bepotastine besilate nasal product - low dose intervention 2: bepotastine besilate nasal product - medium dose intervention 3: bepotastine besilate nasal product - high dose intervention 4: placebo comparator nasal product
1
Irvine | California | United States | -117.82311 | 33.66946
89
0
0
0
NCT01222299
1COMPLETED
2010-08-01
2010-05-01
Bausch & Lomb Incorporated
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 ]
43
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose...
null
Colorectal Cancer
null
1
arm 1: None
[ 0 ]
7
[ 0, 0, 4, 3, 0, 0, 0 ]
intervention 1: 5 mg/kg intravenously every 2 weeks, 4 cycles intervention 2: 825 mg/m2 twice daily orally, 38 days intervention 3: Total dose of 45 Gy over 38 days intervention 4: 6-8 weeks after completion of neoadjuvant treatment intervention 5: Post-surgery adjuvant treatment at the discretion of the investigator: ...
intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] intervention 3: Radiation therapy intervention 4: Mesorectal excision intervention 5: bevacizumab [Avastin] intervention 6: 5-fluorouracil intervention 7: leucovorin
9
Ancona | N/A | Italy | 13.5103 | 43.60717 Bologna | N/A | Italy | 11.33875 | 44.49381 Cuneo | N/A | Italy | 7.54828 | 44.39071 Genova | N/A | Italy | 11.87211 | 45.21604 Napoli | N/A | Italy | 14.5195 | 40.87618 Paola | N/A | Italy | 16.03691 | 39.36313 Pisa | N/A | Italy | 10.4036 | 43.70853 Roma | N/A | Italy | 11.10...
42
0
0
0
NCT01227707
1COMPLETED
2010-08-01
2005-11-01
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 ]
14
RANDOMIZED
CROSSOVER
null
2DOUBLE
false
0ALL
false
The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. This observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. Currently, salmeterol/f...
Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue medication. Inclusion criteria: 1. Males and females, 18 to 65 years of age. 2. FEV1 60-85% of predicted on the screening day. Exclusi...
Asthma
asthma, corticosteroids, bronchodilator, airway blood flow
null
4
arm 1: participants were treated fluticasone/salmeterol, arm 2: participants were treated with salmeterol arm 3: participants were treated with fluticasone arm 4: participants were treated with placebo
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 220- mcg once intervention 2: placebo inhalation once intervention 3: 50 mcg salmeterol once intervention 4: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
intervention 1: fluticasone intervention 2: placebo inhalation intervention 3: Salmeterol intervention 4: fluticasone/salmeterol
0
null
56
0
0
0
NCT01231230
1COMPLETED
2010-08-01
2007-05-01
University of Miami
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy) Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoc...
null
Healthy
Drug Drug Interaction Study in Normal Healthy Volunteers
null
1
arm 1: Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).
[ 5 ]
3
[ 0, 0, 0 ]
intervention 1: MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2 intervention 2: IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3 intervention 3: Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
intervention 1: MAP0004 intervention 2: IV DHE intervention 3: Ketoconazole
1
Merthyr Tydfil | Merthyr Tydfil | United Kingdom | -3.37779 | 51.74794
70
0
0
0
NCT01468558
1COMPLETED
2010-08-01
2010-07-01
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
[ 2 ]
25
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more
Parkinson Disease
Parkinson Disease BIA 9-1067
null
3
arm 1: Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg arm 2: Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA ...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: 50 mg BIA 9-1067 (single-dose) intervention 2: 1 mg rasagiline (single-dose)
intervention 1: BIA 9-1067 intervention 2: Rasagiline
1
Rennes | N/A | France | -1.67429 | 48.11198
98
0
0
0
NCT01532141
1COMPLETED
2010-08-01
2009-11-01
Bial - Portela C S.A.
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 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED) with intravenous opiates. However, this class of medications may cause deleterious side effects. An alternative analgesic approach involves regional anesthesia. The investigators attempted to determine (1) whether ultrasound g...
Hip fracture (HFx) is a painful orthopedic emergency that commonly presents to the Emergency Department (ED). There are approximately 320,000 HFx diagnosed annually in the United States, with this number expected to increase as the population ages. It has previously been shown that patients with pain from HFx are under...
Hip Fracture
Hip Fracture Ultrasound Nerve Block
null
3
arm 1: Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. arm 2: Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, ...
[ 0, 0, 1 ]
3
[ 3, 3, 0 ]
intervention 1: Ultrasound Guided Femoral Nerve Block intervention 2: None intervention 3: Intravenous Morphine
intervention 1: UFNB (Ultrasound guided femoral nerve block) intervention 2: UFIB (Ultrasound Guided Fascia Iliaca Compartment Block) intervention 3: IVMS (IV Morphine)
1
Brooklyn | New York | United States | -73.94958 | 40.6501
64
0
0
0
NCT01904071
1COMPLETED
2010-08-01
2008-10-01
Antonios Likourezos
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 ]
181
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
null
Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-...
null
Plaque Gingivitis
null
2
arm 1: 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. arm 2: 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control). Return to pre-study hygiene...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 20% sodium bicarbonate intervention 2: Negative control
intervention 1: Arm & Hammer Advance White Brilliant Sparkle (Test product) intervention 2: Crest Cavity Protection Regular Toothpaste (Negative Control)
1
Mississauga | Ontario | Canada | -79.6583 | 43.5789
181
0
0
0
NCT03214406
1COMPLETED
2010-08-03
2010-02-08
Church & Dwight Company, 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 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.
null
Advanced Solid Cancers Metastatic Cancer
Advanced and/or Metastatic solid cancers
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months
intervention 1: Cdc7-inhibitor
6
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 Detroit | Michigan | United States | -83.04575 | 42.33143 Toronto | Ontario | Canada | -79.39864 | 43.70643 Toronto | Ontario | Canada | -79.39864 | 43.70643 Villejuif | N/A | France | 2.35992 | 4...
11
0
0
0
NCT00886782
6TERMINATED
2010-08-04
2009-05-31
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 ]
246
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
null
Major Depressive Disorder
null
2
arm 1: Antidepressant + SPD489 arm 2: Antidepressant + placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks intervention 2: Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
intervention 1: Antidepressant + SPD489 (lisdexamfetamine dimesylate) intervention 2: Antidepressant + placebo
15
Newport Beach | California | United States | -117.92895 | 33.61891 San Diego | California | United States | -117.16472 | 32.71571 Bradenton | Florida | United States | -82.57482 | 27.49893 Fort Myers | Florida | United States | -81.84059 | 26.62168 Orlando | Florida | United States | -81.37924 | 28.53834 Atlanta | Geor...
173
0
0
0
NCT00905424
1COMPLETED
2010-08-04
2009-07-30
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
341
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will b...
null
Gouty Arthritis
Gouty Gouty arthritis Gout flares Anti-interleukin-1β monoclonal antibody
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Canakinumab
45
Seattle | Washington | United States | -122.33207 | 47.60621 Capital Federal Buenos Aires | N/A | Argentina | N/A | N/A Jette | N/A | Belgium | 4.33419 | 50.87309 Barranquilla | N/A | Colombia | -74.78132 | 10.96854 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Bucaramanga | N/A | Colombia | -73.11895 | 7.125 Floridabl...
772
0
0
0
NCT00927810
1COMPLETED
2010-08-04
2009-06-05
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
[ 1 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib ...
OBJECTIVES: Primary * Determine the clinical response rate, as measured by clinical exam and imaging studies, in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combination with lapatinib. Secondary * Determine the pathologic complete response rate in patients treated with this regimen....
Breast Cancer
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
null
1
arm 1: 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. intervention 2: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats ...
intervention 1: lapatinib ditosylate intervention 2: paclitaxel albumin-stabilized nanoparticle formulation
5
Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | United States | -87.65005 | 41.85003 Joliet | Illinois | United States | -88.0834 | 41.52519 Olympia Fields | Illinois | United States | -87.67421 | 41.51337 Lubbock | Texas | United States | -101.85517 | 33.57786
30
0
0
0
NCT00331630
1COMPLETED
2010-08-05
2006-05-04
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
[ 4 ]
2,340
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density l...
null
Mixed Hyperlipidemia
null
6
arm 1: Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks arm 2: Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin...
[ 0, 0, 1, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: MK-0524A intervention 2: Atorvastatin intervention 3: Simvastatin
0
null
2,339
0
0
0
NCT00289900
1COMPLETED
2010-08-06
2006-01-24
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
65
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemotherapy. The original en...
The secondary objectives of this study were to evaluate: * Duration of CR plus CRi * Overall survival * Safety and tolerability
Acute Lymphoblastic Leukemia (ALL)
acute lymphoblastic lymphocytic leukemia leukaemia lukemia leukimia ALL Marqibo Hana Biosciences vincristine liposomal liposome optisome hematology malignancy hematological relapsed anti-leukemia adult chemotherapy
null
1
arm 1: Eligible subjects received study drug at 2.25 mg/m\^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
[ 0 ]
1
[ 0 ]
intervention 1: Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.
intervention 1: Marqibo® (vincristine sulfate liposomes injection)
33
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Stanford | California | United States | -122.16608 | 37.42411 Denver | Colorado | United States | -104.9847 | 39.73915 Atla...
65
0
0
0
NCT00495079
1COMPLETED
2010-08-08
2007-05-01
Spectrum 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 ]
399
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
Multiple agents have been studied to prevent radiocontrast nephropathy. One of these agents is N-Acetylcysteine. Previous trials to assess N-Acetylcysteine's efficacy in the prevention of contrast nephropathy have been promising. However, previous studies have limited applicability to the Emergency Department (ED) pati...
Out of the approximately 110 million Emergency Department (ED) visits in the United States each year approximately 8.8 million people undergo Contrast-Enhanced Computerized Tomography (CT) studies in United States EDs each year (based on the investigators experience). Radiocontrast nephropathy is a serious potential c...
Radiocontrast Nephropathy
NAC Radiocontrast Nephropathy N-Acetylcysteine RCN RCIN Creatinine Computerized Tomography CT Emergency Department ED
null
2
arm 1: Subjects in this group will receive 3 grams of N-acetylcysteine in 500 cc normal saline (0.9% Sodium Chloride) over 30 minutes prior to contrast administration. After contrast administration, they will receive a continuous infusion of 200 mg N-acetylcysteine per hour. This dose will be administered as an infusio...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Experimental: * Before CT: 3 g NAC IV in 500 cc of 0.9% Sodium-chloride * After CT: 200 mg NAC/hour in 0.9% Sodium-chloride at 67 cc/hour for up to 24 hours. intervention 2: Placebo: * Before CT: 500 cc 0.9% Sodium-chloride * After CT: NS at 67 cc/hour for up to 24 hours.
intervention 1: N-Acetylcysteine (NAC) intervention 2: 0.9% Sodium-chloride
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
399
0
0
0
NCT00780962
1COMPLETED
2010-08-09
2007-10-16
Beth Israel Deaconess Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
395
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
null
Type 2 Diabetes Mellitus
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks. intervention 2: All participants...
intervention 1: Comparator: Sitagliptin phosphate intervention 2: Comparator: Placebo
0
null
395
0
0
0
NCT00813995
1COMPLETED
2010-08-09
2008-12-09
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
133
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy
null
Diabetes Mellitus, Non-Insulin-Dependent
null
2
arm 1: None arm 2: None
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo to sitagliptin once daily for 12 weeks (double-blind period) intervention 2: Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period...
intervention 1: Comparator: Placebo intervention 2: Sitagliptin intervention 3: Voglibose
0
null
266
0
0
0
NCT00837577
1COMPLETED
2010-08-11
2009-02-05
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how genistein or placebo works in patients with bladder cancer. This randomized phase II tria...
PRIMARY OBJECTIVES: I. To measure the effect of G-2535 on EGF-R phosphorylation. Two EGF-R phosphorylation sites with functional significance are phosphotyrosine 992, which is a direct binding site for the PLC-gamma SH2 domain, and phosphotyrosine 1068, a binding site for the Grb2/SH2 domain. The expression of EGF-R a...
Recurrent Bladder Carcinoma Stage I Bladder Cancer AJCC v6 and v7 Stage II Bladder Cancer AJCC v6 and v7 Stage III Bladder Cancer AJCC v6 and v7
null
3
arm 1: Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy. arm 2: Patients receive oral genistein as in arm I but at a higher dose. One day afte...
[ 0, 0, 2 ]
5
[ 0, 10, 10, 10, 3 ]
intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Given orally intervention 5: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
intervention 1: Genistein intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study intervention 4: Placebo Administration intervention 5: Therapeutic Conventional Surgery
10
Birmingham | Alabama | United States | -86.80249 | 33.52066 Laguna Hills | California | United States | -117.71283 | 33.61252 Iowa City | Iowa | United States | -91.53017 | 41.66113 Garden City | New York | United States | -73.6343 | 40.72677 Rochester | New York | United States | -77.61556 | 43.15478 San Antonio | Tex...
60
0
0
0
NCT00118040
1COMPLETED
2010-08-15
2005-06-24
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
849
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis
null
Osteoarthritis
monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 1, 2 ]
4
[ 2, 2, 0, 10 ]
intervention 1: tanezumab 10 mg one dose at weeks 0 and 8 intervention 2: tanezumab 5 mg one dose at weeks 0 and 8 intervention 3: naproxen 1000 mg daily for 16 weeks intervention 4: placebo to match tanezumab and naproxen dosing
intervention 1: tanezumab 10 mg intervention 2: tanezumab 5 mg intervention 3: naproxen intervention 4: placebo
95
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Mesa | Arizona | United States | -111.82264 | 33.42227 Mesa | Arizona | United States | -111.82264 | 33.42227 Mesa | Arizona | United States | -1...
840
0
0
0
NCT00863304
1COMPLETED
2010-08-16
2009-06-09
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