FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.
The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the succes...
Methamphetamine Dependence
null
2
arm 1: Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day. arm 2: Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of...
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper. intervention 2: Placebo
intervention 1: Bupropion intervention 2: Placebo
12
Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 Torrance | California | United States | -118.34063 | 33.83585 Woodland Hills | California | United States | -118.60592 | 34.1...
204
0
0
0
NCT00687713
1COMPLETED
2011-05-01
2008-05-01
National Institute on Drug Abuse (NIDA)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
109
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical bene...
Pancreatic Cancer Metastatic Pancreatic Cancer
null
2
arm 1: 400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib arm 2: placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Gemcitabine: per package insert. intervention 2: placebo: 100 mg tablets, 400 mg/day intervention 3: Erlotinib - per package insert. intervention 4: apricoxib: 100mg tablets, given orally
intervention 1: gemcitabine intervention 2: placebo intervention 3: Erlotinib intervention 4: apricoxib
39
Tucson | Arizona | United States | -110.92648 | 32.22174 Bakersfield | California | United States | -119.01871 | 35.37329 Campbell | California | United States | -121.94996 | 37.28717 Concord | California | United States | -122.03107 | 37.97798 Pleasant Hill | California | United States | -122.0608 | 37.94798 San Dimas...
109
0
0
0
NCT00709826
1COMPLETED
2011-05-01
2008-08-01
Tragara 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 ]
105
RANDOMIZED
PARALLEL
2DIAGNOSTIC
1SINGLE
true
0ALL
true
The purpose of this study is: 1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers. 2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.
Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics. LTRAs are felt ...
Asthmatic Smokers Non-asthmatic Smokers
asthmatics smokers inhaled corticosteroids leukotriene receptor antagonists
null
5
arm 1: Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months arm 2: Asthmatic smoker treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months arm 3: Non-smoking asthmatics treated with combin...
[ 0, 0, 1, 1, 4 ]
3
[ 0, 0, 0 ]
intervention 1: DPI 250 mcg BID for 3 weeks intervention 2: PO 10 mg QHS for 3 weeks intervention 3: DPI 50mg BID for 3 weeks
intervention 1: Fluticasone Propionate intervention 2: Montelukast intervention 3: Salmeterol
1
Seoul | N/A | South Korea | 126.9784 | 37.566
75
0
0
0
NCT00712335
1COMPLETED
2011-05-01
2007-02-01
Inje 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 ]
21
null
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer....
null
Lung Adenocarcinoma
MAB C225(CETUXIMAB)(ANTI-EGFR) OSI-774, TARCEVA (ERLOTINIB) Lung Adenocarcinoma Lung cancer
null
1
arm 1: In the phase I portion, patients will be enrolled in cohorts of 3-6 patients;receiving daily erlotinib 100 mg along with cetuximab given every 2 weeks beginning at 250mg/m2 IV. Following the initial dose, for dose levels 1 and 2 (250 mg/m2 and 375 mg/m2) patients will receive treatment every 2 weeks with cetuxim...
[ 0 ]
1
[ 0 ]
intervention 1: The phase I portion will accrue as many as 3 cohorts of 3-6 patients; receiving erlotinib 100 mg daily along with escalating doses of cetuximab administered every 2 weeks beginning at 250mg/m2 IV without a loading dose. Subsequent cetuximab dose levels will be 375 mg/m2, and 500 mg/m2, administered IV e...
intervention 1: erlotinib with cetuximab
5
Basking Ridge | New Jersey | United States | -74.54932 | 40.70621 Commack | New York | United States | -73.29289 | 40.84288 New York | New York | United States | -74.00597 | 40.71427 Rockville Centre | New York | United States | -73.64124 | 40.65871 Sleepy Hollow | New York | United States | -73.85847 | 41.08565
21
0
0
0
NCT00716456
1COMPLETED
2011-05-01
2008-07-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete ...
The primary objective of this proposed clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete...
Bipolar Depression
Bipolar disorder Bipolar depression Natural substances Depression
null
2
arm 1: 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 1000-3000 mg/day of acetyl-l-carnitine in addition to 600-1800 mg/day of alpha-lipoic acid. intervention 2: Placebo
intervention 1: acetyl-l-carnitine PLUS alpha-lipoic acide intervention 2: Placebo
1
Belmont | Massachusetts | United States | -71.17867 | 42.39593
40
0
0
0
NCT00719706
1COMPLETED
2011-05-01
2008-08-01
Mclean 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
[ 5 ]
7
NON_RANDOMIZED
PARALLEL
9OTHER
0NONE
false
0ALL
false
This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with no...
Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects w...
Growth Hormone Deficiency
Growth hormone
null
2
arm 1: Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with gro...
[ 1, 1 ]
5
[ 3, 0, 3, 3, 3 ]
intervention 1: Subjects will have serum cardiovascular markers assessed intervention 2: Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion. intervention 3: Subjects will have an ultrasound of their neck to assess th...
intervention 1: Blood draws intervention 2: growth hormone releasing hormone (GHRH) & arginine intervention 3: Carotid ultrasound intervention 4: MRI intervention 5: Endothelial cell biopsy
1
New York | New York | United States | -74.00597 | 40.71427
7
0
0
0
NCT00720902
6TERMINATED
2011-05-01
2007-02-01
Columbia University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
185
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm will be dosed with 2.60 mg/kg of NA-1 or placeb...
null
Stroke
Stroke Vascular cognitive impairment Coiling Endovascular repair Brain aneurysm NA-1
null
2
arm 1: 20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier. arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion intervention 2: single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
intervention 1: NA-1 intervention 2: Placebo
14
Phoenix | Arizona | United States | -112.07404 | 33.44838 Stanford | California | United States | -122.16608 | 37.42411 Portland | Oregon | United States | -122.67621 | 45.52345 Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Halifax | Nova Scotia | Canada | -63.57...
185
0
0
0
NCT00728182
1COMPLETED
2011-05-01
2008-08-01
NoNO Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
15
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
3TRIPLE
true
0ALL
true
The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunte...
null
Insulin Resistance Diabetes Mellitus
Insulin Resistance Diabetes mellitus Antipsychotic
null
2
arm 1: Placebo arm 2: Olanzapine 10mg po daily x 3 days
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: (1) 10 mg tablets administered orally before bed for three consecutive evenings (Total Dose = 30 mg, 3 tablets) intervention 2: (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
intervention 1: Olanzapine 10 mg po qhs for 3 days intervention 2: Placebo
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
30
0
0
0
NCT00741026
1COMPLETED
2011-05-01
2008-08-01
Milton S. Hershey Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
18
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various ca...
null
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
null
2
arm 1: Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal...
[ 0, 5 ]
2
[ 0, 0 ]
intervention 1: Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol. intervention 2: Inhaled insulin technology to be administered immediately before a meal (p...
intervention 1: TI Inhalation Powder and Humalog (Amendment 1) intervention 2: TI Inhalation Powder (original protocol)
1
Santa Barbara | California | United States | -119.69819 | 34.42083
20
0
0
0
NCT00747006
6TERMINATED
2011-05-01
2008-09-01
Mannkind 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
[ 4 ]
168
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joi...
Rheumatoid Arthritis
Rheumatoid Arthritis Joint Disease Arthritis Certolizumab pegol Cimzia
null
1
arm 1: Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combina...
[ 0 ]
1
[ 0 ]
intervention 1: Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 \& Week 4, followed by 200 mg every 2 weeks).
intervention 1: Certolizumab pegol
40
Huntsville | Alabama | United States | -86.58594 | 34.7304 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Huntington Beach | California | United States | -117.99923 | 33.6603 La Joll...
168
0
0
0
NCT00753454
1COMPLETED
2011-05-01
2008-09-01
UCB 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
[ 0 ]
73
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
true
0ALL
false
The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.
The incidence of atrial arrhythmia after thoracic, non-cardiac procedures is exceedingly common and has been reported to occur in between 10-39% of patients. It has been shown to increase majority morbidity and also delay hospital discharge. Recent studies suggest that one week of pre-operative atorvastatin may reduce ...
Arrhythmia
null
2
arm 1: 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. arm 2: 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 40 mg QD 7 day continue after procedure for 14 days intervention 2: 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
intervention 1: Atorvastatin intervention 2: Placebo
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
55
0
0
0
NCT00756886
1COMPLETED
2011-05-01
2008-09-01
University of Alabama at Birmingham
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
67
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
1SINGLE
true
0ALL
false
People often develop fearful responses to things, but have no conscious control over the fear. This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear m...
People often develop fearful responses to things, but have no conscious control over the fear (e.g. phobias). This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unc...
Phobias
anesthetic drugs, associative memory, fear
null
5
arm 1: Saline Infusion arm 2: Anesthetic Drug Infusion arm 3: Anesthetic Drug Infusion arm 4: Anesthetic Drug Infusion arm 5: Anesthetic Drug Infusion
[ 2, 1, 1, 1, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: IV Saline infusion for 2 hours. intervention 2: IV Propofol infusion for 2 hours. intervention 3: IV Propofol infusion for 2 hours. intervention 4: IV Thiopental 1.5mcg/mL infusion for 2 hours intervention 5: IV Thiopental 3mcg/mL infusion for 2 hours
intervention 1: Placebos intervention 2: Propofol 0.45mcg/mL intervention 3: Propofol 0.90mcg/mL intervention 4: Thiopental 1.5mcg/mL intervention 5: Thiopental 3mcg/mL
1
New York | New York | United States | -74.00597 | 40.71427
67
0
0
0
NCT00767767
1COMPLETED
2011-05-01
2008-10-01
Weill Medical College of Cornell University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
13
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
true
T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.
null
Obesity
Obesity Endothelial Function Fibrinolytic Balance Baseline
null
1
arm 1: Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.
[ 0 ]
1
[ 0 ]
intervention 1: Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.
intervention 1: Bradykinin
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
0
0
0
NCT00780481
6TERMINATED
2011-05-01
2007-01-01
Vanderbilt University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
78
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
This study is designed as a randomized, parallel-group, double-blind, placebo-controlled trial. After a 14-day baseline to evaluate ulcer healing to ensure DU are chronic, a 4-week active treatment followed by 8 weeks of observation and assessment of the treatment will compare the effects of two concentrations of DSC12...
Foot Ulcer, Diabetic Diabetic Foot
Diabetes mellitus Diabetic neuropathy Peripheral vascular disease Infection Topical application plantar foot ulcers
null
3
arm 1: control placebo vehicle gel arm 2: 0.03 % DSC127 in Vehicle Control arm 3: 0.01% DSC127 in Vehicle Control
[ 2, 1, 1 ]
1
[ 0 ]
intervention 1: Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.
intervention 1: NorLeu3-A(1-7) in a gel formulation
12
Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Castro Valley | California | United States | -122.08635 | 37.6941 San Diego | California | United States | -117.16472 | 32.71571 Sylmar | California | United States | -118.44925 | 34.30778 Jacksonville | Il...
78
0
0
0
NCT00796744
1COMPLETED
2011-05-01
2008-10-01
US Biotest, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
731
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
null
Idiopathic Restless Legs Syndrome
RLS
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 0, 1, 1, 0, 1, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime. intervention 2: following 3 months placebo treatment, subjects are to be re-distributed to pr...
intervention 1: placebo and pregabalin intervention 2: pramipexol intervention 3: pramipexol intervention 4: Pregabalin intervention 5: pramipexol intervention 6: pramipexol
110
Birmingham | Alabama | United States | -86.80249 | 33.52066 Jasper | Alabama | United States | -87.27751 | 33.83122 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Glendale | Arizona | United States | -112.18599 | 33.53865 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United ...
719
0
0
0
NCT00806026
1COMPLETED
2011-05-01
2008-12-01
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
[ 4 ]
514
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will use an open-label design to evaluate the safety of NP101. Adult subjects who meet the enrollment criteria will be treated with NP101 (sumatriptan succinate iontophoretic transdermal patch) for acute migraine attacks over a 12 month period.
null
Migraine Disorders
null
1
arm 1: sumatriptan iontophoretic transdermal patch
[ 0 ]
1
[ 0 ]
intervention 1: NP101 study patch four hour application
intervention 1: NP101
31
Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Irvine | California | United States | -117.82311 | 33.66946 Newport Beach | California | United States | -117.92895 | 33.61891 San Francisco | California | United States | -122.41942 | 37.77493 Santa M...
479
0
0
0
NCT00806546
1COMPLETED
2011-05-01
2009-02-01
NuPathe 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 ]
60
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
null
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as treatment of moderate to severe ankylosing spondylitis (AS).
null
Ankylosing Spondylitis
ankylosing spondylitis
null
5
arm 1: AIN457A 10.0 mg/kg was administered intravenously as a single dose. arm 2: Placebo to AIN457A was administered intravenously as a single dose arm 3: AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 4: AIN457A 0.1 mg/kg was ...
[ 0, 2, 0, 0, 0 ]
2
[ 2, 0 ]
intervention 1: AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A. intervention 2: Placebo to AIN457
intervention 1: AIN457 intervention 2: Placebo
20
Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Springfield | Illinois | United States | -89.64371 | 39.80172 Springfield | Illinois | United States | -89.64371 | 39.80172 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Duncansville | Pennsylvania | United States | -78.4339 | 40.42341 ...
60
0
0
0
NCT00809159
1COMPLETED
2011-05-01
2009-03-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
94
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus...
null
Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy
tranexamic acid major abdominal surgery blood loss
null
2
arm 1: end of the operation and on the mornings of the first, second, fourth and seventh postoperative days. arm 2: Standard of Care
[ 0, 5 ]
2
[ 0, 3 ]
intervention 1: Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques ...
intervention 1: Tranexamic acid + Standard of Care intervention 2: Standard of Care
2
Surat | Gujarat | India | 72.83023 | 21.19594 Vadodara | Gujarat | India | 73.20812 | 22.29941
94
0
0
0
NCT00827931
1COMPLETED
2011-05-01
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 ]
683
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).
null
In Vitro Fertilization
Luteal Phase Support in IVF patients
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 25 mg, s.c., once à day intervention 2: 90 mg, vaginally, once à day
intervention 1: Progesterone intervention 2: Progesterone
14
Lübeck | N/A | Germany | 10.68729 | 53.86893 Budapest | N/A | Hungary | 19.04045 | 47.49835 Bruneck | Bolzano | Italy | 11.93429 | 46.79942 Milan | Milan | Italy | 9.18951 | 45.46427 Naples | Naples | Italy | 14.26811 | 40.85216 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Pisa |...
682
0
0
0
NCT00827983
1COMPLETED
2011-05-01
2009-01-01
IBSA Institut Biochimique 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 ]
498
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
null
Fibromyalgia
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose) intervention 2: Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
intervention 1: Placebo intervention 2: Pregabalin
35
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Ichihara-shi | Chiba | Japan | N/A | N/A Yotukaidou | Chiba | Japan | N/A | N/A Matuyama-si | Ehime | Japan | N/A | N/A Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Iiduka | Fukuoka | Japan | N/A | N/A Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181 Takasaki | Gunma...
498
0
0
0
NCT00830167
1COMPLETED
2011-05-01
2009-03-01
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
[ 4 ]
85
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
false
The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.
Study Objectives: Primary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy The impact of observation versus ciprofloxacin on...
Elevated Prostate Specific Antigen
Men with Elevated PSA
null
2
arm 1: Observation only for 2 weeks arm 2: Ciprofloxacin 500 mg twice daily for 2 weeks
[ 4, 1 ]
1
[ 0 ]
intervention 1: None
intervention 1: Ciprofloxacin
1
Chicago | Illinois | United States | -87.65005 | 41.85003
77
0
0
0
NCT00840294
6TERMINATED
2011-05-01
2009-01-01
University of Chicago
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 ]
330
RANDOMIZED
PARALLEL
null
0NONE
false
0ALL
false
Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides ...
null
Cancer Pain Breakthrough Pain
Breakthrough Cancer Pain
null
2
arm 1: During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days. Participants who reached an effective dose entered the Open-label Treatment Period, whose length depe...
[ 0, 1 ]
1
[ 0 ]
intervention 1: FBTs were self-administered by participants via the oral mucosa. During the open-label dose titration period, participants used 1 to 4 tablets of the 100 mcg or 200 mcg strength to individually titrate upwards to an effective dose through the range of available strengths (i.e. 100, 200, 400, 600, or 800...
intervention 1: Fentanyl Buccal Tablet (FBT)
123
Bayonne | N/A | France | -1.473 | 43.49316 Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Clichy | N/A | France | 2.30952 | 48.90018 Grenoble | N/A | France | 5.71479 | 45.17869 Le Chesnay | N/A | France | 2.12213 | 48.8222 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 L...
312
0
0
0
NCT00842829
6TERMINATED
2011-05-01
2009-01-01
Cephalon
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
6
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
1SINGLE
true
0ALL
true
The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.
Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.
Obesity Insulin Resistance
obesity
null
2
arm 1: Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling. arm 2: Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: treatment with placebo for 3 months intervention 2: treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months
intervention 1: placebo intervention 2: pioglitazone
1
Portland | Oregon | United States | -122.67621 | 45.52345
6
0
0
0
NCT00843791
6TERMINATED
2011-05-01
2009-02-01
Oregon Health and Science University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and cons...
This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.
Constipation
Constipation small intestinal bacterial overgrowth stool bacteria
null
1
arm 1: Subjects receive lubiprostone and bacteria is measured before and after
[ 0 ]
1
[ 0 ]
intervention 1: 24 mcg bid for 28 days
intervention 1: Lubiprostone
1
Louisville | Kentucky | United States | -85.75941 | 38.25424
25
0
0
0
NCT00844831
1COMPLETED
2011-05-01
2009-05-01
University of Louisville
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 ]
645
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
1FEMALE
true
Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the US. All participants who complete the 12-week randomized t...
null
Urge Urinary Incontinence Overactive Bladder
null
2
arm 1: fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication. arm 2: placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants will be instructed to take one tablet of blinded study medication once a day, orally, for 12 weeks. They will start with a 4 mg dose of study medication and will have the option of doubling that dose after 2 or 4 weeks if they wish. At the end of the 12 week blinded trial, participants will...
intervention 1: Fesoterodine intervention 2: Matching Placebo
13
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 Iowa City | Iowa | United States | -91.53017 | 41.66113 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Albuquerque | ...
645
0
0
0
NCT00862745
1COMPLETED
2011-05-01
2009-01-01
University of California, San Francisco
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 ]
660
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
null
Diabetes Mellitus, Type 2
null
4
arm 1: 100 mg arm 2: 2000 mg arm 3: lower dose arm 4: higher dose
[ 1, 1, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: BI 10773 high dose once daily intervention 2: open label comparator intervention 3: BI 10773 low dose once daily intervention 4: open label comparator
intervention 1: BI 10773 intervention 2: Metformin intervention 3: BI 10773 intervention 4: Sitagliptin
137
Mission Viejo | California | United States | -117.672 | 33.60002 Spring Valley | California | United States | -116.99892 | 32.74477 Walnut Creek | California | United States | -122.06496 | 37.90631 Clearwarter | Florida | United States | N/A | N/A Miami | Florida | United States | -80.19366 | 25.77427 Saint Cloud | Flo...
659
0
0
0
NCT00881530
1COMPLETED
2011-05-01
2009-03-01
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
[ 5 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Objectives of the study: 1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir. 2. To collect relevant information about the safety and the metabolic impact of this strategy in order to ...
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction ...
HIV Infections
HIV/AIDS HAART Simplification Atazanavir Lamivudine treatment experienced
null
1
arm 1: Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Epivir 300 mg intervention 2: Reyataz 300 mg intervention 3: Norvir 100 mg
intervention 1: Lamiduvine (Epivir) intervention 2: Atazanavir (Reyataz) intervention 3: Ritonavir (Norvir)
1
Rome | N/A | Italy | 12.51133 | 41.89193
40
0
0
0
NCT00885482
1COMPLETED
2011-05-01
2009-05-01
Catholic University of the Sacred Heart
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 ]
526
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive...
The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.
Alzheimer Disease
null
5
arm 1: Placebo arm 2: SAM-531 1.5 mg arm 3: SAM-531 3.0 mg arm 4: SAM-531 5.0 mg arm 5: Donepezil
[ 2, 0, 0, 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks. intervention 2: Capsules SAM-531 1.5 mg, once a day during 52 weeks. intervention 3: Capsules SAM-531 3.0 mg, once a day during 52 weeks. intervention 4: Capsules SAM-531 5.0 mg, once a day duri...
intervention 1: Placebo intervention 2: SAM-531 1.5 mg intervention 3: SAM-531 3.0 mg intervention 4: SAM-531 5.0 mg intervention 5: Donepezil
96
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Costa Mesa | California | United States | -117.91867 | 33.64113 Fresno | California | United States | -119.77237 | 36.74773 Garden Grove | California | United States | -117.94145 | 33.77391 Long Beach | C...
1,036
0
0
0
NCT00895895
6TERMINATED
2011-05-01
2009-05-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea). Because this nutriceutical is now patented by the Univ. of Mass., other trials at that institution may be considered a conflict of interes...
This IRB-approved study is a randomized double blind study of patients diagnosed with Mild Cognitive Impairment (MCI) in the Center for Alzheimer's and Neurodegenerative Disorders (CANDO) at VAMC in Oklahoma City. Dr. Shea provided the pills (nutriceutical and placebos) from the same batches he used in former studies o...
Mild Cognitive Impairment
Memory XL Mild Cognitive Impairment cognitive status
null
2
arm 1: Subjects will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D.). Mild Cognitive Impairment (MCI) patients, who met inclusion/exclusion criteria, were assessed initially using 3 cognitive tests and 4 behavioral questionnaires, before they began ingesting pills a...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: An over-the-counter vitamin nutriceutical patented by Univ. of Mass. that contains folic acid 400 mg, Vit. B12 6 ug, alpha-tocopherol 30 IU, S-adenosyl methionine (SAM) 400 mg, N-acetyl cysteine (NAC) 600 mg, \& acetyl-L-carnitine (ALCAR) 500 mg; 2 pills per day for 12 months intervention 2: placebo com...
intervention 1: Memory XL intervention 2: placebo
2
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
10
0
0
0
NCT00903695
6TERMINATED
2011-05-01
2009-06-01
University of Oklahoma
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 ]
368
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those...
null
Hypotrichosis
eyelashes
null
3
arm 1: Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use...
[ 0, 5, 5 ]
2
[ 0, 0 ]
intervention 1: Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). intervention 2: Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid marg...
intervention 1: Bimatoprost 0.03% solution intervention 2: Vehicle solution
2
San Diego | California | United States | -117.16472 | 32.71571 London | England | United Kingdom | -0.12574 | 51.50853
366
0
0
0
NCT00907426
1COMPLETED
2011-05-01
2009-08-01
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
[ 4 ]
62
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
null
Cystic Fibrosis
Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents Treatment of infections with P. aeruginosa in cystic fibrosis subjects
null
2
arm 1: Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. arm 2: Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b....
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler. intervention 2: Placebo inhalation powder consisting of...
intervention 1: Tobramycin Inhalation Powder intervention 2: Placebo
24
Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Alexandria | N/A | Egypt | 29.91582 | 31.20176 Giza | N/A | Egypt | 31.20861 | 30.00944 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | N...
62
0
0
0
NCT00918957
1COMPLETED
2011-05-01
2009-06-01
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
[ 5 ]
61
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
null
Anesthesia
Pediatric patients undergoing surgery
null
4
arm 1: Methadone 0.1mg/kg arm 2: Methadone 0.2mg/kg arm 3: Methadone 0.3mg/kg arm 4: No methadone
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Subjects will receive methadone as their intraoperative opioid. intervention 2: Subjects will receive methadone as their intraoperative opioid. intervention 3: Subjects will receive methadone as their intraoperative opioid. intervention 4: Subjects will not receive methadone as their intraoperative opio...
intervention 1: Methadone 0.1mg/kg intervention 2: Methadone 0.2mg/kg intervention 3: Methadone 0.3mg/kg intervention 4: Control
1
St Louis | Missouri | United States | -90.19789 | 38.62727
61
0
0
0
NCT00921843
1COMPLETED
2011-05-01
2009-05-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
2,283
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effe...
null
Asthma
Asthma LABA Safety
null
2
arm 1: QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) arm 2: Mometasone Twisthaler®, 400 µg QD
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Once daily via multi-dose dry-powder inhaler intervention 2: Once daily via multi-dose dry-powder inhaler
intervention 1: QMF149 Twisthaler® intervention 2: Mometasone Twisthaler®
146
Birmingham | Alabama | United States | -86.80249 | 33.52066 Buena Park | California | United States | -117.99812 | 33.86751 Encinitas | California | United States | -117.29198 | 33.03699 Fullerton | California | United States | -117.92534 | 33.87029 Long Beach | California | United States | -118.18923 | 33.76696 Los An...
1,508
0
0
0
NCT00941798
1COMPLETED
2011-05-01
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
[ 5 ]
104
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
true
0ALL
true
This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compar...
In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking...
Recurrence Smoking Cessation Substance-Related Disorders
Relapse Smoking Cessation Substance Abuse
null
2
arm 1: Group given placebo. arm 2: Experimental group given varenicline dosing.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Varenicline given twice a day or five weeks. intervention 2: Placebo given twice a day or five weeks.
intervention 1: Varenicline intervention 2: Placebo
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
104
0
0
0
NCT00944554
1COMPLETED
2011-05-01
2008-10-01
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 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antim...
Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimic...
Atopic Dermatitis
atopic dermatitis elidel pimecrolimus CASM981 immunity cathelicidin antimicrobial peptide eczema
null
2
arm 1: None arm 2: None
[ 1, 3 ]
2
[ 0, 10 ]
intervention 1: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2...
intervention 1: Pimecrolimus intervention 2: Vehicle cream
1
La Jolla | California | United States | -117.2742 | 32.84727
40
0
0
0
NCT00946478
1COMPLETED
2011-05-01
2009-10-01
University of California, San Diego
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 ]
28
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
null
Glioblastoma
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity intervention 2: Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity
intervention 1: Dasatinib intervention 2: Lomustine
5
Paris | N/A | France | 2.3488 | 48.85341 Bologna | N/A | Italy | 11.33875 | 44.49381 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Lausanne | N/A | Switzerland | 6.63282 | 46.516
26
0
0
0
NCT00948389
6TERMINATED
2011-05-01
2009-10-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
true
2MALE
false
This is a two-arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth.
This is a phase II randomized, placebo controlled double blind, dose-ranging clinical trial of topical cidofovir for the prevention of hair growth. This proof of concept study will evaluate 1% and 3% cidofovir in petrolatum topically applied once a day to the target treatment area on the hair bearing area of the face k...
Prevention of Hair Growth
null
2
arm 1: 1% topical cidofovir to one side of the face and placebo to the other side of the face arm 2: 3% topical cidofovir to one side of the face and placebo to the other side of the face
[ 2, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 1% topical cidofovir intervention 2: 3% topical cidofovir intervention 3: topical placebo
intervention 1: 1% topical cidofovir intervention 2: 3% topical cidofovir intervention 3: Placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
20
0
0
0
NCT00948506
1COMPLETED
2011-05-01
2009-07-01
University of Pennsylvania
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 ]
19
NON_RANDOMIZED
PARALLEL
2DIAGNOSTIC
0NONE
true
0ALL
false
This study will estimate the radiochemical and radiation safety and assess the efficacy of \[18F\]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses will test whether \[18F\]MK-3328 is sufficiently safe and well-tolerated, based on an assessment of clinical and laboratory evaluation...
null
Alzheimer's Disease
null
3
arm 1: Healthy participants will receive a single intravenous (IV) dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part I of the study arm 2: HE and AD participants will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part II of the study arm 3: HE and AD participants will receive two separa...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328
intervention 1: [18F]MK-3328
0
null
19
0
0
0
NCT00954538
1COMPLETED
2011-05-01
2009-08-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
376
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetre...
null
Non-Squamous Non-Small Cell Lung Cancer
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 7.5mg/kg iv on day 1 of each 3-week cycle intervention 2: 75mg/m2 iv on day 1 of each 3-week cycle intervention 3: 500mg/m2 iv on day 1 of each 3-week cycle
intervention 1: bevacizumab [Avastin] intervention 2: cisplatin intervention 3: pemetrexed
91
Béziers | N/A | France | 3.21402 | 43.34122 Bordeaux | N/A | France | -0.5805 | 44.84044 Bron | N/A | France | 4.91303 | 45.73865 Caen | N/A | France | -0.35912 | 49.18585 Caen | N/A | France | -0.35912 | 49.18585 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Créteil | N/A | France | 2.46569 | 48.79266 Gap | N/A...
373
0
0
0
NCT00961415
1COMPLETED
2011-05-01
2009-08-01
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
[ 4 ]
925
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.
null
Severe Nodular Acne
isotretinoin dermatology skin
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily. intervention 2: 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
intervention 1: CIP-Isotretinoin intervention 2: Isotretinoin
49
Birmingham | Alabama | United States | -86.80249 | 33.52066 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 Oceanside | California | United States | -117.37948 | 33.19587 San Diego ...
924
0
0
0
NCT00975143
1COMPLETED
2011-05-01
2009-09-01
Cipher 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 ]
272
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet...
Chronic Kidney Disease Secondary Hyperparathyroidism Hemodialysis
Zemplar paricalcitol IMPACT SHPT Hemodialysis Chronic Kidney Disease Stage 5
null
4
arm 1: Participants in the IV stratum received intravenous (IV) paricalcitol and, if hypercalcemia (calcium \>= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at 0.07 mcg/kg with titration every 2 weeks. arm 2: Participants in the IV stratum received 30 mg of oral cinacalcet daily with a low-dos...
[ 1, 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia) intervention 2: On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)
intervention 1: Paricalcitol intervention 2: Cinacalcet
83
Tempe | Arizona | United States | -111.90931 | 33.41477 Chula Vista | California | United States | -117.0842 | 32.64005 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Riverside | California | United States | -117.39616 | 33.95335 San Die...
268
0
0
0
NCT00977080
1COMPLETED
2011-05-01
2009-11-01
Abbott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
40
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
This is a 90 day study, with patients receiving either oral Rosuvastatin or placebo for up to 28 days. The study will assess the affect of statins administered soon after burn injury on C-reactive protein (CRP) levels, patient mortality and the incidence of septic shock. The investigators also seek to describe the corr...
Infection and sepsis are the major causes of morbidity and mortality in burn patients. Several observational studies have shown that HMG-CoA reductase inhibitors, known as statins, before or after illness or injury results in decreased mortality and incidence of sepsis. We performed a pilot retrospective chart review ...
Burns
Statins Burns Sedatives Neurocognitive Septic Mortality C Reactive Protein Septic shock Sedation Neurocognitive function
null
2
arm 1: Rosuvastatin arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days intervention 2: Placebo administered every day for up to 28 days
intervention 1: Rosuvastatin intervention 2: Placebo
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
0
0
0
NCT00978419
1COMPLETED
2011-05-01
2010-03-01
Vanderbilt University Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
74
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market. The purpose of this study is to look at whether afamelanotide can reduce the n...
PURPOSE: To determine whether afamelanotide can reduce the severity of phototoxic reactions in patients with EPP. THEORETICAL FRAMEWORK: EPP is a genetic photosensitivity disorder where the mainstays of management are covering up from sunlight, systemic beta carotene and the use of controlled courses of UVR treatmen...
Erythropoietic Protoporphyria
Erythropoietic Protoporphyria EPP Afamelanotide
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: One 16mg subcutaneous implant every 2 months for 9 months. intervention 2: One 16mg subcutaneous implant every 2 months for 9 months.
intervention 1: Afamelanotide intervention 2: Placebo
8
Helsinki | N/A | Finland | 24.93545 | 60.16952 Colombes | Cedex | France | 2.25404 | 48.91882 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Dublin | N/A | Ireland | -6.24889 | 53.33306 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Newport | Wales | United Kingdo...
74
0
0
0
NCT00979745
1COMPLETED
2011-05-01
2009-09-01
Clinuvel Pharmaceuticals Limited
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
380
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure to PA32540.
PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers. This study is designed to provide long-term safety data for PA32540 in order to gain regulatory approval to make PA32540 available for clinical use in this subject...
Aspirin-Associated Gastric Ulcers
Subjects Who are at Risk for Developing Aspirin-ASA Subject must have a pre-existing condition for which aspirin is already indicated Gastric Ulcers
null
1
arm 1: 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
[ 0 ]
1
[ 0 ]
intervention 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily
intervention 1: PA32540
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
379
0
0
0
NCT00995410
1COMPLETED
2011-05-01
2009-10-01
POZEN
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as lintuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and s...
OBJECTIVES: Primary * To determine the complete response rate of the combination of lintuzumab and azacitidine in patients with myelodysplastic syndromes. Secondary * To define the specific toxicities of this regimen. * To determine the overall response rate. * To determine the relationship between pretreatment exp...
Leukemia Myelodysplastic Syndromes
de novo myelodysplastic syndromes secondary myelodysplastic syndromes chronic myelomonocytic leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia refractory cytopenia with multilineage dysplasia
null
1
arm 1: Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC(subcutaneous)daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
[ 0 ]
2
[ 2, 0 ]
intervention 1: Cycle 1 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22. Subsequent Cycles (cycles to be repeated every 28 days) 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy. Doses should be given at least 12 days apart...
intervention 1: lintuzumab intervention 2: 5-azacytidine
1
Columbus | Ohio | United States | -82.99879 | 39.96118
7
0
0
0
NCT00997243
6TERMINATED
2011-05-01
2009-11-01
Alison Walker
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
10
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.
Vitamin D deficiency is common and has been associated with an increased risk of heart disease. In patients with the combination of kidney disease and heart disease, inflammation is thought to contribute to a high rate of cardiac events. Less is known about the effects of vitamin D supplementation on certain tests asso...
Coronary Artery Disease Chronic Kidney Disease Hypovitaminosis D Secondary Hyperparathyroidism
Vitamin D Coronary Artery Disease (CAD) Chronic Kidney Disease (CKD)
null
2
arm 1: oral paricalcitol 2 mcg daily arm 2: one oral placebo drug daily
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 mcg oral paricalcitol daily intervention 2: placebo
intervention 1: paricalcitol intervention 2: placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
10
0
0
0
NCT01012414
6TERMINATED
2011-05-01
2010-01-01
Thomas Jefferson 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 ]
62
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Brain injured patients are at high risk for forming blood clots in the legs and lungs. For non-brain injured trauma patients, we decrease the chances of these blood clots forming by placing the patients on a low dose of the blood thinner enoxaparin. Starting patients with a brain injury on the blood thinner is problema...
We propose to conduct a placebo-controlled non-inferiority pilot study to evaluate the rate of worsening of intracranial injury patterns after initiation of enoxaparin in TBI patients. Patient enrollment will occur at ETMC, blinded re-reading of CTs will occur at PMH, and administrative/analytical support will occur at...
Venous Thromboembolism Traumatic Brain Injury
venous thromboembolism enoxaparin traumatic brain injury Venous thromboembolism prophylaxis traumatic brain injury
null
2
arm 1: Enoxaparin started at 24 hours post-injury and continued until 96 hours post-injury. arm 2: vehicle administered sq q 12 hours
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Enoxaparin 30 mg sq q 12 hours intervention 2: vehicle
intervention 1: enoxaparin intervention 2: placebo
2
Dallas | Texas | United States | -96.80667 | 32.78306 Tyler | Texas | United States | -95.30106 | 32.35126
62
0
0
0
NCT01014403
1COMPLETED
2011-05-01
2009-11-01
University of Texas Southwestern Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
2
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
This is a prospective pharmacokinetic study in patients having external ventricular drains with suspected external ventricular drain related bacterial meningitis. A single dose of daptomycin will be administered for the purposes of the study and PK samples will be obtained around this dosing.
information related to the subject's demographics, past medical history and current medical history will be collected from the medical record. This will be collected by the research coordinator. The following samples will be obtained by the research coordinator or bedside RN and sent to UPMC laboratory for evaluation....
Meningitis
meningitis
null
1
arm 1: patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
[ 5 ]
1
[ 0 ]
intervention 1: one dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight
intervention 1: Daptomycin
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
2
0
0
0
NCT01025271
6TERMINATED
2011-05-01
2010-05-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.
null
Infection
Fever antipyretic uncomplicated acute viral infection uncomplicated acute bacterial infections
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen) intervention 2: Single dose of a placebo
intervention 1: Ibuprofen intervention 2: Placebo
5
Cypress | California | United States | -118.03729 | 33.81696 Westlake Village | California | United States | -118.80565 | 34.14584 Omaha | Nebraska | United States | -95.94043 | 41.25626 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Salt Lake City | Utah | United States | -111.89105 | 40.76078
16
0
0
0
NCT01035346
6TERMINATED
2011-05-01
2010-01-01
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
[ 0 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this 13-week clinical trial is to test the hypothesis that treatment with Memantine will significantly improve the symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.
The primary objective of this clinical trial is to test the hypothesis that treatment with Memantine, an anti-glutamatergic drug, will significantly improve the core symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder. We will test this hypothesis by perform...
Bulimia Nervosa Body Dysmorphic Disorder
Bulimia nervosa Bulimia Body dysmorphic disorder Eating disorders Body image Binge eating purging
null
1
arm 1: Memantine, 10-40 mg daily
[ 0 ]
1
[ 0 ]
intervention 1: Drug: Memantine, 10-40 mg daily
intervention 1: Memantine
1
Belmont | Massachusetts | United States | -71.17867 | 42.39593
3
0
0
0
NCT01038128
1COMPLETED
2011-05-01
2009-12-01
Mclean Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
100
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
3TRIPLE
true
0ALL
true
The purpose of this study is to better understand the anti-inflammatory benefits of two prescription medicines that are currently used to help people with cholesterol problems. Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help control cholesterol and reduce inflammation (the ...
null
Cardiovascular Disease
healthy volunteer
null
4
arm 1: Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks. arm 2: Participants will be given 5 placebo pills (4 fish oil placebo and 1 fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks. arm 3: Participant...
[ 0, 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks intervention 2: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks intervention 3: 900 mg/day: One 900 mg capsule ...
intervention 1: Fenofibrate (Tricor) tablets intervention 2: Placebo intervention 3: Lovaza
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
100
0
0
0
NCT01048502
1COMPLETED
2011-05-01
2010-01-01
University of Pennsylvania
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
0NONE
false
0ALL
null
Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene, increasing the maintenance clopidogrel dose ...
The first phase of the clinical trial will involve subject recruitment and informed consent for genetic testing. Because the target population is patients with stable coronary artery disease, patients will be recruited from the outpatient setting during clinic visits or at the time of outpatient cardiac catheterization...
Disease Susceptibility
Clopidogrel pharmacogenomics study Performing genetic study looking at clopidogrel resistance
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 75 mg once daily intervention 2: clopidogrel 150 mg
intervention 1: clopidogrel 75 mg intervention 2: Clopidogrel 150 mg
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
50
0
0
0
NCT01097343
1COMPLETED
2011-05-01
2010-03-01
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
[ 0 ]
109
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to study the remission rates in patients with cancer w...
Epoetin alfa is a medication that helps the body make more red blood cells. Before treatment you will have a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of your standard of care). Women who are ab...
Leukemia
Procrit Acute Lymphocytic Leukemia Lymphoblastic Lymphoma Burkitt's Chemotherapy Hyper-CVAD augmented BFM Epoetin alfa Epogen Erythropoietin
null
2
arm 1: Starting dose 40,000 units subcutaneously once a week with chemotherapy. arm 2: No intervention.
[ 0, 4 ]
1
[ 0 ]
intervention 1: Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).
intervention 1: Procrit (epoetin alfa)
1
Houston | Texas | United States | -95.36327 | 29.76328
109
0
0
0
NCT01099202
1COMPLETED
2011-05-01
2003-03-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
2,120
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
null
Cataract
null
4
arm 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery. arm 2: Nepafenac Ophthalmic Suspension, 0.1...
[ 0, 1, 2, 2 ]
4
[ 0, 0, 10, 10 ]
intervention 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery. intervention 2: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days intervention 3: Nepafenac 0...
intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Nepafenac Ophthalmic Suspension, 0.1% intervention 3: Nepafenac Ophthalmic Suspension 0.3% Vehicle intervention 4: NEVANAC Vehicle
1
Fort Worth | Texas | United States | -97.32085 | 32.72541
2,042
0
0
0
NCT01109173
1COMPLETED
2011-05-01
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
[ 3 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
null
Subfoveal Choroidal Neovascularization Age-Related Maculopathy
null
2
arm 1: Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye arm 2: Intravitreal injection of ranibizumab and Sham into study eye
[ 0, 1 ]
3
[ 0, 2, 10 ]
intervention 1: Intravitreal injection of 700 ug dexamethasone into study eye intervention 2: Intravitreal injection of ranibizumab into study eye intervention 3: Sham needle-less injection administered in the study eye
intervention 1: 700 ug dexamethasone intervention 2: ranibizumab intervention 3: sham
2
Fort Myers | Florida | United States | -81.84059 | 26.62168 Abilene | Texas | United States | -99.73314 | 32.44874
4
0
0
0
NCT01122511
6TERMINATED
2011-05-01
2010-08-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will d...
null
Subacromial Impingement Syndrome Partial Thickness Rotator Cuff Tear
subacromial impingement partial thickness rotator cuff PRP platelet rich plasma
null
2
arm 1: corticosteroid injection into subacromial space arm 2: patients will receive an injection of platelet rich plasma into the subacromial space
[ 1, 0 ]
2
[ 2, 0 ]
intervention 1: 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of thei...
intervention 1: platelet rich plasma injection intervention 2: corticosteroid injection
1
Loma Linda | California | United States | -117.26115 | 34.04835
12
0
0
0
NCT01123889
1COMPLETED
2011-05-01
2010-05-01
Loma Linda University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
23
NON_RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study tr...
The present study is designed to assess the effect of missed doses of daily medication (off-days). On the off-days the patient will take a placebo (sugar pill). Over the 4 weeks of the actual study there will be 6 random off-days of study medicine and neither the caregiver, patient nor study doctor will know which days...
Attention Deficit Hyperactivity Disorder
null
2
arm 1: Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants re...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 25-80 milligrams (mg) administered orally, once daily. intervention 2: 18-54 mg administered orally, once daily. intervention 3: Administered orally, once daily for random nonconsecutive 6 days during 4-week treatment period.
intervention 1: Atomoxetine intervention 2: Osmotic-release oral system methylphenidate intervention 3: Placebo
14
Arnhem | N/A | Netherlands | 5.91111 | 51.98 Capelle aan den IJssel | N/A | Netherlands | 4.57778 | 51.92917 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Barcelona | N/A | Spain | 2.15899 | 41.38879 Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283 Esp...
23
0
0
0
NCT01127646
6TERMINATED
2011-05-01
2010-06-01
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 ]
27
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination product and its components on protection from allergic triggers in asthma
Asthma is an increasingly common disease and is essentially caused by an allergic type of reaction of the immune system. Airways of the lungs become inflamed and narrow as a result of a reaction to triggers like chemicals (house-hold cleaning products, pollution) and allergens (house dust mite and cat or dog fur). The ...
Asthma
allergen challenge early asthmatic response mild asthma late asthmatic response
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: FF/GW642444M intervention 2: GW642444M intervention 3: Fluticasone Furoate intervention 4: Placebo
4
Randwick | New South Wales | Australia | 151.24895 | -33.91439 Wellington | N/A | New Zealand | 174.77557 | -41.28664 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Lund | N/A | Sweden | 13.19321 | 55.70584
107
0
0
0
NCT01128595
1COMPLETED
2011-05-01
2010-05-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
502
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
Study Design:
Hypertension
null
1
arm 1: start low dose and uptitrate to high dose on the basis of blood pressure goal
[ 0 ]
1
[ 0 ]
intervention 1: start low dose and uptitrate to high dose on the basis of BP goal
intervention 1: telmisartan/amlodipine
47
Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Haag | N/A | Germany | 12.07614 | 50.30379 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Künzing | N/A | Germany | 13.08333 | 48.66667 Nuremberg | N/A | Germany | 11.07752 | 49.45421 Rednitzhembach | N/A | Germany | 11.07997 ...
733
0
0
0
NCT01134393
1COMPLETED
2011-05-01
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
[ 5 ]
33
RANDOMIZED
PARALLEL
null
1SINGLE
false
0ALL
false
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet...
Colonoscopy Preparation
Preparation Pediatric Colonoscopy
null
2
arm 1: Miralax colonoscopy preparation arm 2: Senna colonoscopy preparation
[ 1, 1 ]
1
[ 0 ]
intervention 1: Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age \>12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure. Miral...
intervention 1: polyethylene glycol, senna
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
33
0
0
0
NCT01140295
6TERMINATED
2011-05-01
2010-09-01
Children's Hospital of Philadelphia
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 ]
244
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and ...
null
Schizophrenia Schizoaffective Disorder
Lurasidone Schizophrenia Latuda
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
intervention 1: Lurasidone HCl
27
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Escondido | California | United States | -117.08642 | 33.11921 Garden Grove | California | United States | -117.94145 | 33.77391 Oakland | California | United States | -122.2708 | 37.80437 Paramount | California | United States | -118.15979 | 33.88946 Pasade...
240
0
0
0
NCT01143077
1COMPLETED
2011-05-01
2010-06-01
Sumitomo Pharma America, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will explore the safety and effectiveness of adding Lovaza® to the therapeutic program utilized internationally for the treatment of individuals with acute coronary syndromes.
Atherosclerotic cardiovascular disease is the cause for over 19 million deaths in the US annually with coronary artery disease accounting for most of this mortality burden.1 Despite major advances in the treatment of coronary heart disease patients, a large number of victims of the disease who are apparently healthy di...
Myocardial Infarction
Acute Coronary Syndrome Fish Oils Platelet Function Tests Cardiac Electrophysiology
null
2
arm 1: Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment. arm 2: The placebo contained 1 gram of corn oil in e...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Lovaza® is prescription grade EPA+DHA fish oil supplement. intervention 2: Placebo Pill
intervention 1: Lovaza® intervention 2: The placebo contained 1 gram of corn oil in each capsule.
1
Rochester | New York | United States | -77.61556 | 43.15478
4
0
0
0
NCT01155336
6TERMINATED
2011-05-01
2010-06-01
University of Rochester
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 ]
336
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion \[TCI\]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted a...
Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.
Elective Laparoscopic Surgery
Sevoflurane Propofol Economics Pharmaceutical Chinese
null
3
arm 1: Subjects received sevoflurane, a inhalational (volatile) anesthetic, which was administered for induction and maintenance of general anesthesia. Inhalational induction was induced via vital capacity induction at 8% and maintained at 0.8-1.5 minimum alveolar concentration (MAC). arm 2: Subjects received propofol,...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance. intervention 2: Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction ...
intervention 1: Sevoflurane Inhalational Induction and Maintenance intervention 2: Propofol Target Controlled Infusion for Induction and Maintenance intervention 3: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
4
Beijing | N/A | China | 116.39723 | 39.9075 Chengdu | N/A | China | 104.06667 | 30.66667 Guangzhou | N/A | China | 113.25 | 23.11667 Shanghai | N/A | China | 121.45806 | 31.22222
334
0
0
0
NCT01191476
1COMPLETED
2011-05-01
2010-11-01
Abbott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
11
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to evaluate the relationship between upper and lower airway allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2) cytokines (interleukins 5 and 13) in sputum and nasal ...
null
Asthma
Nasal Allergen Challenge, Inhaled Allergen Challenge, Asthma
null
2
arm 1: Prednisone in the first crossover treatment period and placebo in the second crossover treatment period arm 2: Placebo in the first crossover treatment period and prednisone in the second crossover treatment period
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period intervention 2: Matching placebo tablets as a single oral dose on Day 1 of each study period
intervention 1: Prednisone intervention 2: Placebo
0
null
22
0
0
0
NCT01193049
1COMPLETED
2011-05-01
2010-08-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
2MALE
false
Volume kinetics is a method mostly used, so far, to study the distribution and elimination of crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected volume kinetics for a crystalloid solution ...
We will study ten volunteers, each one on three occasions. Each volunteer will receive only crystalloid one time, only colloid another time, and on the third occasion first a colloid and then a crystalloid one hour later. The different protocols will be in random order in the different volunteers. During all these test...
Blood Volume Blood Coagulation
Blood volume blood coagulation volume kinetics
null
5
arm 1: First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected. Washout \>7 days Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and bl...
[ 5, 5, 5, 5, 5 ]
4
[ 0, 0, 0, 1 ]
intervention 1: Infusion of Ringer acetate 20 ml/kg over 30 min intervention 2: Infusion of starch 10 ml/kg over 30 min intervention 3: Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min. intervention 4: Non-...
intervention 1: acetated Ringers intervention 2: colloid intervention 3: colloid+acetated Ringer intervention 4: Non-invasive hemoglobin with pulse-oximeter (SpHb)
1
Linköping | Linköping | Sweden | 15.62157 | 58.41086
10
0
0
0
NCT01195025
1COMPLETED
2011-05-01
2010-08-01
University Hospital, Linkoeping
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 ]
138
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.
null
Relapsing Multiple Sclerosis
Relapsing multiple sclerosis MS Immune response
null
2
arm 1: Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. arm 2: Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment partici...
[ 0, 2 ]
4
[ 0, 0, 2, 2 ]
intervention 1: Fingolimod 0.5 mg capsules for oral administration. intervention 2: Matching placebo capsules for oral administration. intervention 3: Commercially available injectable influenza vaccine for the 2010/11 influenza season. intervention 4: Commercially available tetanus toxoid vaccine booster injection.
intervention 1: Fingolimod intervention 2: Placebo intervention 3: Seasonal influenza vaccine intervention 4: Tetanus toxoid vaccine
25
Aalst | N/A | Belgium | 4.0355 | 50.93604 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Liège | N/A | Belgium | 5.56749 | 50.63373 Wilrijk | N/A | Belgium | 4.39513 | 51.16734 Nepean | Ontario | Canada | -75.7225 | 45.33619 Montreal | Quebec | Canada | -73.58781 | 45.50884 Sh...
138
0
0
0
NCT01199861
1COMPLETED
2011-05-01
2010-08-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
132
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
null
Bacterial Vaginosis
SPL7013 VivaGel bacterial vaginosis BV
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Vaginal gel intervention 2: Vaginal gel intervention 3: Vaginal gel intervention 4: Vaginal gel
intervention 1: 0.5% SPL7013 Gel intervention 2: 1.0% SPL7013 Gel intervention 3: 3.0% SPL7013 Gel intervention 4: Placebo Gel
5
Phoenix | Arizona | United States | -112.07404 | 33.44838 Denver | Colorado | United States | -104.9847 | 39.73915 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Irving | Texas | United States | -96.94889 | 32.81402 Virginia Beach | Virginia | United States | -75.97799 | 36.85293
125
0
0
0
NCT01201057
1COMPLETED
2011-05-01
2010-08-01
Starpharma Pty Ltd
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
624
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in...
A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or 600 mg two times per day for 5 days in reducing the ...
Influenza
influenza
null
3
arm 1: 300 mg nitazoxanide tablet and 1 placebo tablet twice daily for 5 days arm 2: Two 300 mg nitazoxanide tablets(600mg) twice daily for 5 days arm 3: 2 placebo tablets twice daily for 5 days
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days intervention 2: Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days intervention 3: Tablets, (2 tablets) twice daily with food for 5 days
intervention 1: Nitazoxanide intervention 2: Nitazoxanide intervention 3: Placebo
1
Elmira | New York | United States | -76.80773 | 42.0898
624
0
0
0
NCT01227421
1COMPLETED
2011-05-01
2010-12-01
Romark Laboratories L.C.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
34
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application
Male Hypogonadism
testosterone deficiency hypogonadism
null
1
arm 1: testosterone gel 2%
[ 0 ]
1
[ 0 ]
intervention 1: 40 mg testosterone gel 2%
intervention 1: testosterone gel 2%
8
Tucson | Arizona | United States | -110.92648 | 32.22174 Middlebury | Connecticut | United States | -73.12761 | 41.52787 Oviedo | Florida | United States | -81.20812 | 28.67 Tallahassee | Florida | United States | -84.28073 | 30.43826 Brookline | Massachusetts | United States | -71.12116 | 42.33176 Troy | Michigan | Un...
34
0
0
0
NCT01228071
1COMPLETED
2011-05-01
2010-11-01
Endo Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
null
Anemia Kidney Disease
anemia chronic kidney disease CKD chronic renal insufficiency renal impairment erythropoietin safety efficacy tolerability pharmacokinetics
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Different dose levels
intervention 1: AKB-6548
2
Augusta | Georgia | United States | -81.97484 | 33.47097 San Antonio | Texas | United States | -98.49363 | 29.42412
10
0
0
0
NCT01235936
1COMPLETED
2011-05-01
2010-10-21
Akebia Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,342
RANDOMIZED
FACTORIAL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[m...
null
Essential Hypertension
Aliskiren Amlodipine Essential hypertension
null
6
arm 1: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, alisk...
[ 2, 1, 1, 1, 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Aliskiren/amlodipine 150/2.5 mg tablet intervention 2: Aliskiren/amlodipine 150/5 mg tablet intervention 3: Aliskiren 150 mg tablet intervention 4: Amlodipine 2.5 mg capsule intervention 5: Aliskiren placebo tablet intervention 6: Amlodipine placebo capsule intervention 7: Aliskiren/amlodipine 150/2.5 m...
intervention 1: Aliskiren/Amlodipine 150/2.5 mg intervention 2: Aliskiren/amlodipine 150/5 mg intervention 3: Aliskiren 150 mg intervention 4: Amlodipine 2.5 mg intervention 5: Placebo of Aliskiren intervention 6: Placebo of Amlodipine intervention 7: Placebo of Aliskiren/amlodipine 150/2.5 mg intervention 8: Placebo o...
11
Aichi | N/A | Japan | 130.62158 | 32.51879 Ehime | N/A | Japan | N/A | N/A Fukuoka | N/A | Japan | 130.41667 | 33.6 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kyoto | N/A | Japan | 135.75385 | 35.02107 Okayama | N/A | Japan | 133.93333 | 3...
2,286
0
0
0
NCT01237223
1COMPLETED
2011-05-01
2010-10-01
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
[ 2 ]
7
NON_RANDOMIZED
SINGLE_GROUP
null
0NONE
false
0ALL
null
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
null
Cardiovascular Diseases Kidney Failure, Chronic
null
3
arm 1: Capsule, oral arm 2: Capsule, oral arm 3: Capsule, oral
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 150 mg capsule intervention 2: 75 mg capsule intervention 3: 110 mg capsule
intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate
1
Berlin | N/A | Germany | 13.41053 | 52.52437
7
0
0
0
NCT01241539
1COMPLETED
2011-05-01
2010-11-01
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 ]
6
NON_RANDOMIZED
PARALLEL
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the...
null
Obesity
null
2
arm 1: "Lean" defined as (BMI ≥18 and ≤25) arm 2: Obese grade I-II defined as (BMI\>30 and ≤35)
[ 5, 5 ]
1
[ 0 ]
intervention 1: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
intervention 1: Perflutren Lipid Microsphere Injectable Suspension
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
6
0
0
0
NCT01242020
6TERMINATED
2011-05-01
2011-01-01
University of Pennsylvania
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 ]
171
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the difference in effect of three clinically common methods of providing pain medication during surgery for ventilating tubes placed for recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a muscle, and morphine injected in a vein.
Preoperative anxiety will be assessed by the modified Yale Preoperative Anxiety Scale (mYPAS) at two points - (1) prior to separating the patient from the caretaker and bringing the patient to the operating room and (2) on application of the facemask. In keeping with our current standard practice, the child will be bro...
Otitis Media
otitis media recurrent ear infections (otitis media)
null
3
arm 1: 0.1 mg/kg morphine IM arm 2: 0.1 mg/kg morphine IV arm 3: Intranasal fentanyl 2 mcg/kg IN
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 2mcg/kg fentanyl IN intervention 2: 0.1 mg/kg morphine IM for postop pain intervention 3: 0.1 mg/kg morphine IV
intervention 1: Intranasal fentanyl intervention 2: morphine IM intervention 3: IV morphine
1
Houston | Texas | United States | -95.36327 | 29.76328
164
0
0
0
NCT01244126
1COMPLETED
2011-05-01
2008-05-01
Baylor College of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
1FEMALE
false
The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers. Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.
null
Healthy
NPC-01 Pharmacokinetics Healthy female volunteer Norethisterone Ethinyl Estradiol
null
1
arm 1: Single oral administration of NPC-01
[ 0 ]
1
[ 0 ]
intervention 1: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
intervention 1: NPC-01
0
null
12
0
0
0
NCT01246791
1COMPLETED
2011-05-01
2010-11-01
Nobelpharma
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 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administ...
null
Adult Growth Hormone Deficiency
null
4
arm 1: Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks arm 2: Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks arm 3: Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks arm 4: Once daily subcu...
[ 0, 0, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: s.c., weekly injection intervention 2: s.c., weekly injection intervention 3: s.c., weekly injection intervention 4: s.c., daily injection
intervention 1: ACP-001 (TransCon hGH) intervention 2: ACP-001 (TransCon hGH) intervention 3: ACP-001 (TransCon hGH) intervention 4: Omnitrope
4
Aarhus | N/A | Denmark | 10.21076 | 56.15674 Berlin | N/A | Germany | 13.41053 | 52.52437 Genova | N/A | Italy | 11.87211 | 45.21604 Stockholm | N/A | Sweden | 18.06871 | 59.32938
37
0
0
0
NCT01247675
1COMPLETED
2011-05-01
2010-11-01
Ascendis Pharma 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
[ 2 ]
251
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
true
1FEMALE
false
This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized, placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in healthy postmenopausal women. Part A will examine the cumulative irritation and adherence of the transdermal patch, and Part B will examine skin...
null
Osteoporosis, Postmenopausal
null
1
arm 1: Part A: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days Part B: Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms wil...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Transdermal patch intervention 2: Transdermal patch
intervention 1: LY333334 intervention 2: Placebo
5
Daytona Beach | Florida | United States | -81.02283 | 29.21081 Honolulu | Hawaii | United States | -157.85833 | 21.30694 München | N/A | Germany | 13.31243 | 51.60698 Schenefeld | N/A | Germany | 9.48146 | 54.04644 Plymouth | Devon | United Kingdom | -4.14305 | 50.37153
251
0
0
0
NCT01250145
1COMPLETED
2011-05-01
2010-11-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
28
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but s...
* Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also ...
Prostate Cancer
prostatectomy docetaxel
null
1
arm 1: Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy
[ 0 ]
6
[ 0, 0, 0, 0, 0, 3 ]
intervention 1: Given by an IV infusion over 1 hour on day 2 of a three-week cycle intervention 2: Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel intervention 3: Taken orally three times a day for 5 days for the first part of every three week cycle intervention 4: Given subcutaneously fo...
intervention 1: Docetaxel intervention 2: Dexamethasone intervention 3: Estramustine intervention 4: Zoladex intervention 5: Casodex intervention 6: Radical Prostatectomy
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
28
0
0
0
NCT01250717
1COMPLETED
2011-05-01
2001-01-01
Beth Israel Deaconess Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
22
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
4QUADRUPLE
true
0ALL
false
This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer activity in total plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is that niacin augments reverse cholesterol transp...
The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the ability of high density lipoprotein (HDL) to transport cholesterol to the liver to be eliminated. This process is called Reverse Cholesterol transport and is one of the main mechanisms by which HDL protect against atherosclerotic...
Dyslipidemias
Niacin HDL Reverse cholesterol transport
null
2
arm 1: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. arm 2: Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding o...
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated. intervention 2: Placebo
intervention 1: Niacin intervention 2: Placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
22
0
0
0
NCT01250990
1COMPLETED
2011-05-01
2010-11-01
University of Pennsylvania
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 ]
71
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.
null
Renal Transplant
Renal transplant kidney transplant immunosuppressive therapy anti-rejection medication pharmacokinetics tacrolimus
null
2
arm 1: In Period 1 (Days 1-14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram fo...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths. intervention 2: Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.
intervention 1: Generic Tacrolimus intervention 2: Branded Tacrolimus
2
Cincinnati | Ohio | United States | -84.51439 | 39.12711 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
142
0
0
0
NCT01256294
1COMPLETED
2011-05-01
2010-10-01
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
[ 2 ]
64
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
null
Healthy
null
4
arm 1: Fixed-Dose-Combination-Tablet, oral administration with 240 mL water arm 2: Tablets, oral administration with 240 mL water for each treatment arm 3: Fixed-Dose-Combination-Tablet, oral administration with 240 mL water arm 4: Tablets, oral administration with 240 mL water for each treatment
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Medium doses, oral administration intervention 2: Medium doses, oral administration intervention 3: Medium dose oral administration intervention 4: Medium dose oral administration
intervention 1: Linagliptin + Pioglitazone intervention 2: Linagliptin + Pioglitazone intervention 3: Linagliptin/Pioglitazone intervention 4: Linagliptin/Pioglitazone
1
Biberach | N/A | Germany | 8.03333 | 48.33333
125
0
0
0
NCT01276327
1COMPLETED
2011-05-01
2011-01-01
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 ]
601
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
null
Seasonal Allergic Rhinitis
null
4
arm 1: Bepotastine Besilate Nasal Spray 2% Twice a day arm 2: Bepotastine Besilate Nasal Spray 3% Twice a day arm 3: Bepotastine Besilate Nasal Spray 4% Twice a day arm 4: Placebo nasal spray
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: nasal spray intervention 2: nasal spray intervention 3: nasal spray intervention 4: nasal spray
intervention 1: Bepotastine Besilate Nasal Spray 2% Twice a day intervention 2: Bepotastine Besilate Nasal Spray 3% Twice a day intervention 3: Bepotastine Besilate Nasal Spray 4% Twice a day intervention 4: Placebo Nasal Spray
1
Irvine | California | United States | -117.82311 | 33.66946
601
0
0
0
NCT01277341
1COMPLETED
2011-05-01
2010-12-01
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
[ 0 ]
1
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from b...
This study is the first to assess the perioperative time course of systemic inflammation and immunity in colon cancer patients and evaluate the effect of anti-inflammatory treatment with celecoxib on this response. In addition, evaluation of the effect of short-term preoperative administration of celecoxib on tumor imm...
Colorectal Cancer Colon Cancer
null
2
arm 1: Celecoxib, 200 mg tab arm 2: placebo, tab
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 200 mg tablet oral intervention 2: Placebo, tab
intervention 1: Celecoxib intervention 2: placebo
1
Stanford | California | United States | -122.16608 | 37.42411
0
0
0
0
NCT01284504
6TERMINATED
2011-05-01
2011-01-01
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
CROSSOVER
null
2DOUBLE
true
1FEMALE
true
Clomiphene citrate is commonly used for ovulation induction in women with anovulation, correction of luteal phase deficiency or for superovulation as empiric therapy for unexplained infertility. Superovulation using clomiphene, usually with intrauterine insemination, is usually regarded as first line therapy for unexpl...
The aim of this study is to identify psychological and physical symptoms experienced by women taking clomiphene citrate for superovulation in a prospective setting. Clomiphene citrate is commonly used for ovulation induction in women with anovulation, correction of luteal phase deficiency or for superovulation as empi...
Mood
Clomiphene citrate Mood symptoms Infertility Superovulation Effects of clomiphene on mood
null
2
arm 1: Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. arm 2: Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
[ 1, 2 ]
2
[ 10, 0 ]
intervention 1: Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle. intervention 2: Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
intervention 1: Placebo intervention 2: Clomiphene
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
20
0
0
0
NCT01291056
1COMPLETED
2011-05-01
2010-01-01
University of Utah
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
94
RANDOMIZED
CROSSOVER
null
3TRIPLE
true
0ALL
false
Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.
null
Healthy Subjects
Diabetes exenatide Amylin Lilly QT interval
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: IV Exenatide (therapeutic and supratherapeutic concentrations) intervention 2: Oral Moxifloxacin (400 mg) intervention 3: IV Placebo (matching volume of placebo)
intervention 1: Exenatide intervention 2: Moxifloxacin intervention 3: Placebo comparator
2
Daytona Beach | Florida | United States | -81.02283 | 29.21081 Evansville | Indiana | United States | -87.55585 | 37.97476
244
0
0
0
NCT01297062
1COMPLETED
2011-05-01
2011-02-01
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 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
null
Type 2 Diabetes Patients
multiple dose study in type 2 diabetes patients
null
2
arm 1: None arm 2: None
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 5 mg of PF-04620110 given once daily intervention 2: 2.5 mg of PF-04620110 given twice daily intervention 3: Matching placebo giving for 4 weeks
intervention 1: PF-04620110 intervention 2: PF-04620110 intervention 3: Placebo
3
Chula Vista | California | United States | -117.0842 | 32.64005 DeLand | Florida | United States | -81.30312 | 29.02832 Miami Gardens | Florida | United States | -80.2456 | 25.94204
48
0
0
0
NCT01298518
1COMPLETED
2011-05-01
2011-02-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.
null
Healthy
null
2
arm 1: Subject to receive one single dose BI 10773 arm 2: Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days
[ 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1 tablet single dose BI 10773 in the morning intervention 2: Gemfibrozil 600 mg bid for 5 days intervention 3: 1 tablet single dose BI 10773 in the morning
intervention 1: BI 10773 intervention 2: Gemfibrozil intervention 3: BI 10773
1
Biberach | N/A | Germany | 8.03333 | 48.33333
54
0
0
0
NCT01301742
1COMPLETED
2011-05-01
2011-02-01
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 ]
36
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to he...
null
Healthy
null
5
arm 1: Capsule, oral administration with 240 mL water arm 2: Capsule and Tablets, oral administration with 240 mL water arm 3: Capsule and Tablets, oral administration with 240 mL water arm 4: Capsule and Tablets, oral administration with 240 mL water arm 5: Capsule and Tablets, oral administration with 240 mL water
[ 0, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose intervention 2: 150 mg as single dose intervention 3: dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration) intervention 4: dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid inter...
intervention 1: Dabigatran etexilate plus dronedarone intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate plus dronedarone intervention 4: Dabigatran etexilate plus dronedarone intervention 5: Dabigatran etexilate plus dronedarone
1
Ulm | N/A | Germany | 9.99155 | 48.39841
138
0
0
0
NCT01306162
1COMPLETED
2011-05-01
2011-02-01
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
[ 5 ]
23
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This is a single-center, randomized, investigator-masked, parallel group, and active-comparator controlled study investigating the clinical outcomes for visual acuity and macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subj...
Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be...
Inflammation Pseudophakia
NSAID Ocular Inflammation bromfenac
null
2
arm 1: Patients receiving Bromday self-administered one drop of bromfenac 0.09% daily as a topical ophthalmic drop three days prior to cataract surgery, on the day of cataract surgery and 21 days post operatively. arm 2: Patients in this arm self-administered nepafenac topical ophthalmic drops three times daily beginni...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery intervention 2: nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
intervention 1: Bromfenac intervention 2: Nepafenac
0
null
23
0
0
0
NCT01310127
1COMPLETED
2011-05-01
2010-11-01
Toyos 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 ]
21
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
2MALE
false
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg rifampicin, Novartis Sandoz) in healthy Filipino male subjec...
null
Tuberculosis
bioequivalence; rifampicin
null
2
arm 1: Test arm 2: Reference
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg intervention 2: One (1) capsule of Rifampicin 300 mg
intervention 1: Myrin© 2 (Rifampicin + Isoniazid) intervention 2: Rimactane® (Rifampicin)
1
Dasmariñas | N/A | Philippines | 120.93667 | 14.32944
41
0
0
0
NCT01311505
1COMPLETED
2011-05-01
2011-04-01
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
[ 0 ]
18
NON_RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
true
Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and conditions caused by blood clots. Although clopidogrel works in many individuals, some people do not respond as well to this drug. The variation in treatment response may be linked to genetics. This study will examine the effec...
Clopidogrel is a prodrug with high inter-individual response variability. Clopidogrel is converted to an active drug in part through an enzyme encoded by the gene named CYP2C19. Individuals with genetically-impaired CYP2C19 metabolism have lower capacity to convert the prodrug to its active form. Consequently, these in...
Metabolism of Clopidogrel
Clopidogrel Pharmacogenetics Platelets Healthy Subjects
null
6
arm 1: Healthy subjects who have been genotyped for CYP2C19\*2 and received clopidogrel as part of a prior study (PAPI) will be recruited. We will select 6 poor metabolizers (PM) to clopidogrel 75 mg from participants who previously received 75 mg clopidogrel as part of another NIH sponsored clinical trial entitled, "P...
[ 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Over a 6 week period participants will be given: 75 mg of clopidogrel for 8 days, at least 1 week washout, 150 mg of clopidogrel for eight days, at least 1 week washout, 300 mg of clopidogrel for eight days. intervention 2: After a washout of at least 1 week, participants will have the option to partici...
intervention 1: Clopidogrel intervention 2: Omeprazole/Clopidogrel
1
Lancaster | Pennsylvania | United States | -76.30551 | 40.03788
18
0
0
0
NCT01341600
1COMPLETED
2011-05-01
2010-07-01
University of Maryland, Baltimore
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 ]
226
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided. Then you will be assigned to a group if you qualify to continue in the study. All groups will get a...
This is an observer-blind, randomized, parallel-group, single-center, controlled clinical trial. Approximately 246 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 210 subjects (70 per group) would reasonably be expected to complete the study. Subjects will have their...
Dentin Sensitivity
null
3
arm 1: Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste arm 2: Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste arm...
[ 0, 1, 2 ]
3
[ 1, 0, 0 ]
intervention 1: Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste intervention 2: Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assig...
intervention 1: Mouthwash intervention 2: Potassium nitrate toothpaste intervention 3: Sodium fluoride toothpaste
1
Las Vegas | Nevada | United States | -115.13722 | 36.17497
226
0
0
0
NCT01345292
1COMPLETED
2011-05-01
2011-04-01
Johnson & Johnson Consumer and Personal Products Worldwide
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 ]
80
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharm...
null
Nondependent Opioid Abuse, Episodic
abuse potential abuse liability recreational opioid use morphine
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage intervention 2: Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificiall...
intervention 1: Placebo intervention 2: MS Contin (morphine sulfate, controlled release) intervention 3: EMBEDA (morphine sulfate / naltrexone hydrochloride)
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
280
0
0
0
NCT01380093
1COMPLETED
2011-05-01
2011-02-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
null
Seasonal Allergic Conjunctivitis
ocular allergy
null
2
arm 1: Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% arm 2: Ophthalmic solution containing olopatadine, 0.1%
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks. intervention 2: 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
intervention 1: Loteprednol etabonate 0.2% intervention 2: Olopatadine 0.1%
1
Singapore | Singapore | Singapore | 103.85007 | 1.28967
300
0
0
0
NCT01435460
1COMPLETED
2011-05-01
2010-08-01
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
[ 0 ]
35
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
true
The purpose of this study is to determine the importance of genetic differences on individuals' response to warfarin in a group of healthy subjects. Warfarin is also known by the "trade name" Coumadin and is in a class of medications called anticoagulants or "blood thinners." Warfarin works by reducing the blood's abil...
Warfarin is a highly effective oral anticoagulant that is increasingly prescribed in the United States. It has a narrow therapeutic window, however, that represents an inherent limitation, such that insufficient and excessive levels of anticoagulation are associated with elevated risks of thrombosis and bleeding partic...
Healthy
Genetic Determinants of Warfarin Dose Variability
null
1
arm 1: Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.
[ 0 ]
1
[ 0 ]
intervention 1: Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study ent...
intervention 1: Warfarin
1
New York | New York | United States | -74.00597 | 40.71427
30
0
0
0
NCT01520402
1COMPLETED
2011-05-01
2009-06-01
Icahn School of Medicine at Mount Sinai
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 ]
420
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. * To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. * To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.
null
Parkinson's Disease
null
3
arm 1: SPM 962 transdermal patch arm 2: Ropinirole tablet arm 3: SPM962 placebo patch and Ropinirole placebo tab
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Ropinirole oral administration TID up to 15.0 mg/day intervention 3: SPM962-placebo patch and Ropinirole-placebo tab
intervention 1: SPM 962 intervention 2: Ropinirole intervention 3: Placebo
8
Chubu Region | N/A | Japan | N/A | N/A Chugoku Region | N/A | Japan | N/A | N/A Hokkaido Region | N/A | Japan | N/A | N/A Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A Shikoku Region | N/A | Japan | N/A | N/A Tohoku Region | N/A | Japan | N/A | N/A
420
0
0
0
NCT01628926
1COMPLETED
2011-05-01
2009-06-01
Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
121
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. We also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness.
OBJECTIVES: Determine if simvastatin impairs exercise training adaptations. BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle changes, including exercise, to reduce cardiovascular disease risk in patients with the metabolic syndrome. Statin use has been linked to skeletal muscle myo...
Metabolic Syndrome Obese Sedentary
mitochondria fitness statins cholesterol metabolic syndrome
null
3
arm 1: Statins (40mg/day)for an average of 12 weeks arm 2: 12 weeks of exercise training (5 days a week for 45-50 min a session) arm 3: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
[ 0, 0, 1 ]
3
[ 0, 10, 10 ]
intervention 1: Statins (40mg/day)for 12 weeks intervention 2: 12 weeks of exercise training (5 days a week for 45-50 min a session) intervention 3: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
intervention 1: Statin intervention 2: Exercise only intervention 3: Statins + Exercise
1
Columbia | Missouri | United States | -92.33407 | 38.95171
50
0
0
0
NCT01700530
1COMPLETED
2011-05-01
2007-05-01
University of Kansas Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
13
RANDOMIZED
CROSSOVER
null
3TRIPLE
false
0ALL
true
Approximately 25% of people with schizophrenia abuse marijuana. These people may be using marijuana to self-medicate symptoms such as hallucinations (hearing or seeing things that are not heard or seen by others) or delusions (false beliefs i.e. people are harassing or persecuting them) or the depressed and anxious fee...
The trial will be a double two period (visit) blind cross-over trial with one arm dronabinol 10 mg one arm a placebo control. The order of doses and placebo will be randomized with the restriction that half of the subjects will receive each order. This counterbalances possible visit effects or learning effects associat...
Schizophrenia
schizophrenia dronabinol P50 cannabis memory symptoms
null
2
arm 1: dronabinol 10 mg one capsule by mouth at 8:00 a.m. arm 2: one capsule given by mouth at 8:00 a.m.
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: dronabinol 10 mg one capsule by mouth at 8:00 a.m. intervention 2: one capsule given by mouth at 8:00 a.m.
intervention 1: Dronabinol intervention 2: Placebo Comparator
1
Aurora | Colorado | United States | -104.83192 | 39.72943
26
0
0
0
NCT01832766
6TERMINATED
2011-05-01
2005-06-01
University of Colorado, Denver
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
255
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The objective of this study is to demonstrate that, when added to tiotropium (TIO), fluticasone propionate/salmeterol combination (FSC) DISKUS 250/50 significantly increases exercise endurance time (EET) in the endurance shuttle walk test (ESWT), compared to TIO alone. Male and female subjects at least 40 years of age ...
We postulate that adding fluticasone propionate/salmeterol combination DISKUS 250/50 (FSC) to tiotropium (TIO) will improve exercise endurance time (EET) and its clinical and physiologic correlates, based on the combination of the three different mechanisms of action represented. We propose to test this hypothesis by c...
Pulmonary Disease, Chronic Obstructive
endurance shuttle walk test chronic obstructive pulmonary disease fluticasone propionate dyspnea exercise endurance time tiotropium salmeterol exercise inspiratory capacity quality of life
null
2
arm 1: This is the active DISKUS (that is, containing fluticasone propionate/salmeterol combination) + open-label tiotropium arm 2: This is the DISKUS and excipient minus the active ingredient (which is fluticasone propionate/salmeterol combination) + open-label tiotropium
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Experimental comparator consisting of inhaled corticosteroid plus long-acting beta agonist combination also known as ADVAIR DISKUS intervention 2: Open-label drug also known as Spiriva HandiHaler
intervention 1: fluticasone propionate/salmeterol inhalation powder DISKUS 250/50 intervention 2: tiotropium bromide inhalation powder HandiHaler
27
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Torrance | California | United States | -118.34063 | 33.83585 Fort Collins | Colorado | United States | -105.08442 | 40.58526 Hartford | Connecticut | United States | -72.68509 | 41.76371 Saint Charles ...
255
0
0
0
NCT01124422
1COMPLETED
2011-05-02
2010-07-19
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
297
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study. Study Design Rat...
null
Relapsing-remitting Multiple Sclerosis
Multiple Sclerosis (MS) Relapsing-Remitting Demyelinating Autoimmune Diseases Disseminated sclerosis Encephalomyelitis disseminate Inflammatory disease Demyelination Auto-inflammatory disease Devic's disease Balo concentric sclerosis Schilder's diffuse sclerosis
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 0, 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: BAF312 intervention 2: Placebo
72
Cullman | Alabama | United States | -86.84361 | 34.17482 San Francisco | California | United States | -122.41942 | 37.77493 Centennial | Colorado | United States | -104.87692 | 39.57916 Miami | Florida | United States | -80.19366 | 25.77427 Pompano Beach | Florida | United States | -80.12477 | 26.23786 Tallahassee | Fl...
296
1
0.003378
1
NCT00879658
1COMPLETED
2011-05-04
2009-03-30
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000597