FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 4 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While recei...
null
Psoriasis
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks intervention 2: Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
intervention 1: Infliximab intervention 2: Infliximab and methotrexate
0
null
37
0
0
0
NCT00833053
6TERMINATED
2011-04-01
2009-10-01
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
[ 5 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience ...
null
Postpartum Depression
women postpartum depression anxiety
null
1
arm 1: Flexible dose escitalopram 10mg
[ 0 ]
1
[ 0 ]
intervention 1: Once daily by mouth
intervention 1: Escitalopram
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
3
0
0
0
NCT00833469
1COMPLETED
2011-04-01
2009-01-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
16
RANDOMIZED
PARALLEL
2DIAGNOSTIC
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine efficacy of MR imaging with hyperpolarized helium-3 gas in COPD patients both before and after treatment.
Hyperpolarized Helium Lung imaging has already been tested and proven to be scientifically possible in patients with a number of pulmonary disorders. However there is limited data on the sensitivity of this imaging technique, which would be essential for clinical use. This study is a double blinded study with two cohor...
Chronic Obstructive Pulmonary Disease
COPD aformoterol Helium Hyperpolarized helium Hyperpolarized Noble Gas MRI
null
2
arm 1: Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol wi...
[ 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the interventi...
intervention 1: Hyperpolarized Helium-3 intervention 2: Placebo intervention 3: Aformoterol
1
Worcester | Massachusetts | United States | -71.80229 | 42.26259
31
0
0
0
NCT00846287
1COMPLETED
2011-04-01
2008-11-01
University of Massachusetts, Worcester
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 ]
14
NON_RANDOMIZED
PARALLEL
2DIAGNOSTIC
0NONE
true
0ALL
false
The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.
Current pulmonary imaging techniques are clinically regulated to machines that produce radiation. MR which does not produce radiation was not possible due to the low concentration of fluids in the open spaces of the lungs. With hyperpolarized noble gases we can now use the safe techniques of MR imaging to view the airw...
COPD Cystic Fibrosis Asthma Healthy
Helium MRI Hyperpolarized Helium Hyperpolarized Noble Gas
null
4
arm 1: This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bag...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
intervention 1: Hyperpolarized Helium-3
1
Worcester | Massachusetts | United States | -71.80229 | 42.26259
14
0
0
0
NCT00846573
6TERMINATED
2011-04-01
2008-11-01
University of Massachusetts, Worcester
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 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.
OUTLINE: This is a multi-center study. * Gemcitabine ( 1000 mg/m2) IV days 1 and 8 * Cisplatin (70 mg/m2) IV day 1 and * Sunitinib malate (37.5 mg) oral daily for days 1-14 The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 w...
Transitional Cell Carcinoma of the Bladder
TCC
null
1
arm 1: Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
[ 0 ]
4
[ 0, 0, 0, 3 ]
intervention 1: Gemcitabine ( 1000 mg/m2) IV days 1 and 8 intervention 2: Cisplatin (70 mg/m2) IV day 1 intervention 3: Sunitinib malate (37.5 mg) oral daily for days 1-14 intervention 4: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Sunitinib Malate intervention 4: Radical Cystectomy
5
Gainesville | Florida | United States | -82.32483 | 29.65163 Indianapolis | Indiana | United States | -86.15804 | 39.76838 South Bend | Indiana | United States | -86.25001 | 41.68338 Houston | Texas | United States | -95.36327 | 29.76328 London | N/A | United Kingdom | -0.12574 | 51.50853
9
0
0
0
NCT00859339
6TERMINATED
2011-04-01
2009-03-01
Noah Hahn, M.D.
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 ]
60
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).
null
Neoplasms
null
1
arm 1: BIBW 2992 high dose, once daily, continuous, monotherapy
[ 0 ]
1
[ 0 ]
intervention 1: patients to receive continuous oral daily dosing of BIBW 2992
intervention 1: BIBW 2992
4
Guildford | N/A | United Kingdom | -0.57427 | 51.23536 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 Sutton | N/A | United Kingdom | -0.2 | 51.35
60
0
0
0
NCT00875433
1COMPLETED
2011-04-01
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
[ 3 ]
386
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undet...
This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in cli...
Hepatitis C
Hepatitis C TMC435 Peginterferon alpha-2a PegIFNalpha-2a RBV Ribavirin Placebo
null
5
arm 1: Participants will receive TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants conti...
[ 0, 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks. intervention 2: Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks. intervention 3: PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (...
intervention 1: TMC435 intervention 2: Ribavirin (R) intervention 3: PegIFNα-2a (P) intervention 4: Placebo
71
Los Angeles | California | United States | -118.24368 | 34.05223 Jacksonville | Florida | United States | -81.65565 | 30.33218 Orlando | Florida | United States | -81.37924 | 28.53834 Palm Harbor | Florida | United States | -82.76371 | 28.07807 Chicago | Illinois | United States | -87.65005 | 41.85003 New Orleans | Lou...
386
0
0
0
NCT00882908
1COMPLETED
2011-04-01
2009-06-01
Tibotec Pharmaceuticals, Ireland
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 ]
298
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.
null
Erectile Dysfunction
Erectile Dysfunction E.D.
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: One dose 30 minutes prior to initiation of sexual activity intervention 2: One dose 30 minutes prior to initiation of sexual activity intervention 3: One dose 30 minutes prior to initiation of sexual activity
intervention 1: Placebo intervention 2: Avanafil intervention 3: Avanafil
51
Phoenix | Arizona | United States | -112.07404 | 33.44838 Laguna Hills | California | United States | -117.71283 | 33.61252 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 Aur...
298
0
0
0
NCT00895011
1COMPLETED
2011-04-01
2009-04-01
VIVUS 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 ]
54
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2\~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).
Leukotriene B4 (LTB4) and the cysteinyl-leukotrienes LTC4, LTD4 and LTE4 are potent proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway. They are secreted from eosinophils and other inflammatory cells such as mast cells and macrophages. The primary action of leukotrienes includes...
Atopic Dermatitis
Atopic dermatitis Montelukast
null
2
arm 1: The group received active medication (montelukast 4 mg or 5mg once daily) for 8 weeks followed by a crossover to 8 weeks of placebo after 2-weeks washout period. arm 2: The group received placebo medication (ascorbic acid) for 8 weeks followed by a crossover to 8 weeks of active medication (montelukast 4 mg or 5...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" ...
intervention 1: Montelukast first, then placebo intervention 2: Placebo first, then Montelukast
1
Seoul | N/A | South Korea | 126.9784 | 37.566
86
0
0
0
NCT00903357
1COMPLETED
2011-04-01
2009-08-01
Pyun BokYang
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 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.
null
Breast Cancer Bone Diseases
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: up to 2400 mg; oral tablet
intervention 1: Vitamin D
1
Stanford | California | United States | -122.16608 | 37.42411
8
0
0
0
NCT00904423
6TERMINATED
2011-04-01
2009-04-01
Mark Pegram
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 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H f...
This is a Phase 3, 2-part, randomized, double-blind, placebo-controlled, parallel group multicenter study of orally administered ivacaftor in subjects with cystic fibrosis (CF) 6 to 11 years of age who have the G551D-CFTR mutation and a forced expiratory volume in 1 second (FEV1) between 90% and 105% predicted (using K...
Cystic Fibrosis
Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes
null
2
arm 1: Subjects who received placebo every 12 hours (q12h) for up to 48 weeks. arm 2: Subjects who received 150 mg of ivacaftor q12h for up to 48 weeks.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 150-mg tablet given orally q12h for up to 48 weeks intervention 2: Tablet given orally q12h for up to 48 weeks
intervention 1: Ivacaftor intervention 2: Placebo
29
Birmingham | Alabama | United States | -86.80249 | 33.52066 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Glenview | Illinois | United States | -87.78784 | 42.06975 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Iowa City | Iowa | United ...
52
0
0
0
NCT00909727
1COMPLETED
2011-04-01
2009-08-01
Vertex Pharmaceuticals Incorporated
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
423
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents. To determine the adverse event profile of prasugrel in patients with high platelet react...
null
Coronary Artery Disease (CAD)
Clopidogrel VerifyNow PRU Measurements Drug Eluting Stents (DES) Heart Disease Percutaneous Coronary Intervention (PCI) P2Y12 Platelets Platelet Reactivity
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months. intervention 2: 75 mg oral daily maintenance dose up to 6 months.
intervention 1: Prasugrel intervention 2: Clopidogrel
27
Clearwater | Florida | United States | -82.8001 | 27.96585 Jacksonville | Florida | United States | -81.65565 | 30.33218 Rome | Georgia | United States | -85.16467 | 34.25704 Moline | Illinois | United States | -90.51513 | 41.5067 New York | New York | United States | -74.00597 | 40.71427 Portland | Oregon | United Sta...
420
0
0
0
NCT00910299
6TERMINATED
2011-04-01
2009-07-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
56
RANDOMIZED
PARALLEL
null
0NONE
true
0ALL
false
The purpose of this study is to determine the pharmacokinetic profile, safety, and tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy adults.
Ramelteon is a treatment for insomnia approved for use in the United States (US) in July 2005 and in the Philippines and Indonesia in 2008. It is currently under development in the European Union (EU) and Japan. Ramelteon is marketed in the US as ROZEREM® for the treatment of insomnia characterized by difficulty with s...
Insomnia
Sleep Initiation and Maintenance Disorders Drug Therapy
null
5
arm 1: Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. arm 2: Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. arm 3: Adolescents 12 to 17 years of age with insomnia received a single ora...
[ 0, 0, 0, 0, 1 ]
1
[ 0 ]
intervention 1: Ramelteon tablets, orally for one day only.
intervention 1: Ramelteon
2
Overland Park | Kansas | United States | -94.67079 | 38.98223 Kalamazoo | Michigan | United States | -85.58723 | 42.29171
56
0
0
0
NCT00914862
1COMPLETED
2011-04-01
2009-11-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
691
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, a...
null
Type 2 Diabetes Mellitus
diabetes exenatide once weekly Byetta Amylin Lilly
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 2.0mg subcutaneous injection, once a week intervention 2: 5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
intervention 1: exenatide once weekly intervention 2: exenatide twice daily
42
Beijing | N/A | China | 116.39723 | 39.9075 Chengdu | N/A | China | 104.06667 | 30.66667 Chongqin | N/A | China | N/A | N/A Guangzhou | N/A | China | 113.25 | 23.11667 Shanghai | N/A | China | 121.45806 | 31.22222 Ahmedabad | N/A | India | 72.58727 | 23.02579 Aligarh | N/A | India | 78.07464 | 27.88145 Bangalore | N/A ...
678
0
0
0
NCT00917267
1COMPLETED
2011-04-01
2009-07-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The contralateral side will receive the other poss...
The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0.1% vs. 0.4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration ...
Total Knee Arthroplasty Knee Pain
TKA Bilateral Cleveland Clinic UCSD Catheter Nerve block Postoperative pain Femoral Catheter Bilateral Total Knee Arthroplasty Bilateral Femoral Catheter
null
2
arm 1: Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, t...
[ 1, 1 ]
1
[ 0 ]
intervention 1: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups...
intervention 1: 0.1% and 0.4% perineural ropivicaine
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
45
0
0
0
NCT00923598
1COMPLETED
2011-04-01
2009-06-01
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
[ 4 ]
1,066
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.
null
Chronic Obstructive Pulmonary Disease
COPD NVA237 glycopyrronium bromide
null
3
arm 1: Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was av...
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 3: Tiotropium ...
intervention 1: Glycopyrronium bromide intervention 2: Placebo to glycopyrronium bromide intervention 3: Tiotropium
139
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Fort Smith | Arkansas | United States | -94.39855 | 35.38592 Anaheim | California | United States | -117.9145 | 33.83529 Fullerton | California ...
1,060
0
0
0
NCT00929110
1COMPLETED
2011-04-01
2009-06-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
null
Moderate to Severe Psoriasis
Etanercept Acitretin Psoriasis
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks intervention 2: Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks intervention 3: Acitretin at a dose of 10mg BID for 24 weeks
intervention 1: Etanercept intervention 2: Etanercept + Acitretin intervention 3: Acitretin
10
Daejeon | Korea | South Korea | 127.38493 | 36.34913 Gyeonggido | Korea | South Korea | N/A | N/A Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 Seoul | Korea | South Korea | 126.9784 | 37.566 S0 | Seoul | South Korea | N/A...
59
0
0
0
NCT00936065
1COMPLETED
2011-04-01
2009-07-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
6
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
3TRIPLE
false
1FEMALE
true
This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.
Despite continuing improvements in surgical procedures and ancillary care, post surgery pain continues to be a nearly universal patient experience following major operative procedures. Opioids provide considerable pain relief, but they have multiple adverse side effects and are not entirely effective. For cancer patien...
Sleep Endometrial Neoplasms Pain
Sleep Endometrial Neoplasms Pain
null
2
arm 1: Participants randomized to the zolpidem (intervention) group will receive the FDA approved dose of zolpidem, (10 mg for women \<65; 5 mg for women \> or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) pills will be placed without filler inside two-piece gelatin caps...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants will receive the FDA approved dose of zolpidem, (10 mg for women \<65; 5 mg for women = or \> 65 years) during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery. intervention 2: Participants will receive pla...
intervention 1: zolpidem intervention 2: sugar pill
2
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
5
0
0
0
NCT00936598
6TERMINATED
2011-04-01
2009-07-01
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
[ 0 ]
12
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
This study will: * Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol. * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T st...
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scannin...
Multiple Sclerosis
Inflammation Multiple Sclerosis Glatiramer Acetate Gd enhancing lesions 1.5T protocol 3T protocol Magnetization transfer imaging (MTI) Lesion activity analysis Copaxone
null
1
arm 1: Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
[ 5 ]
1
[ 0 ]
intervention 1: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for ...
intervention 1: Copaxone
1
Buffalo | New York | United States | -78.87837 | 42.88645
12
0
0
0
NCT00937157
1COMPLETED
2011-04-01
2007-09-01
University at Buffalo
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
20
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
true
More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this cardinal complaint is associated with fatigue, pain, and depressed mood in patient with chronic inflammatory disorder. Despite the frequency of this complaint, there is limited efforts to evaluate sleep or the abnormal increases...
Abnormal sleep is reported by more than half of rheumatoid arthritis patients, in addition to the traditional symptoms associated with the disease, such as morning stiffness, pain, and functional debility. When recording brain activity during sleep using electroencephalography or EEG. Sleep abnormalities have been foun...
Rheumatoid Arthritis
Rheumatoid Arthritis
null
2
arm 1: Placebo-participant will receive placebo saline solution via IV route. arm 2: Remicade-Participant will be given 10 mg/kg of drug via IV route.
[ 2, 1 ]
1
[ 0 ]
intervention 1: Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.
intervention 1: Remicade
1
Los Angeles | California | United States | -118.24368 | 34.05223
20
0
0
0
NCT00948610
1COMPLETED
2011-04-01
2008-11-01
University of California, Los Angeles
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 ]
38
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc ...
null
Graft-versus-host Disease Hematopoietic Stem Cell Transplantation
Graft-versus-host disease GVHD Maraviroc non-myeloablative allogeneic stem-cell transplantation Hematopoietic stem cell transplantation
null
3
arm 1: 150mg twice daily arm 2: 300mg twice daily arm 3: 300mg twice daily
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion. intervention 2: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and meth...
intervention 1: Maraviroc 150 MG intervention 2: Maraviroc 300 mg intervention 3: Maraviroc 300 mg Phase II
0
null
38
0
0
0
NCT00948753
1COMPLETED
2011-04-01
2009-06-01
Abramson Cancer Center at Penn Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
118
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
Post-operative nausea and vomiting (PONV) is a frequent complication of surgery, with considerable medical and economic impact. It is also associated with high levels of patient discomfort and dissatisfaction. To many patients, PONV is a distressing event that reportedly is more feared than post-operative pain. The cau...
PONV
PONV Outpatient surgery Laparoscopic abdominal surgery Laparoscopic gynecologic surgery
null
2
arm 1: Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery. arm 2: Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination. intervention 2: Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Dec...
intervention 1: Palonosetron only intervention 2: Palonosetron with Dexamethasone
1
New York | New York | United States | -74.00597 | 40.71427
118
0
0
0
NCT00952133
1COMPLETED
2011-04-01
2009-07-01
NYU Langone Health
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
249
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients with major depressive disorder (MDD).
null
Major Depressive Disorder (MDD)
null
4
arm 1: Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks arm 2: Duloxetine 60 mg capsule po QD without food for 8 weeks arm 3: Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks arm 4: Duloxetine 30 mg capsule po QD without food for 1 week, then 60 ...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: po, QD
intervention 1: Duloxetine hydrochloride
7
Cheong Ju-City | N/A | South Korea | N/A | N/A Goyang-si | N/A | South Korea | 126.835 | 37.65639 Seongnam-si | N/A | South Korea | 127.13778 | 37.43861 Seoul | N/A | South Korea | 126.9784 | 37.566 Sungnam-Si | N/A | South Korea | N/A | N/A Suwon | N/A | South Korea | 127.00889 | 37.29111 Yangsan | N/A | South Korea |...
249
0
0
0
NCT00960986
1COMPLETED
2011-04-01
2009-08-01
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
[ 4 ]
91
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than intramuscular placebo by comparing changes from baseline to 2 hours after the first IM injectio...
null
Schizophrenia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections intervention 2: Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for ...
intervention 1: Rapid-Acting Intramuscular Olanzapine intervention 2: Placebo
11
Aichi | N/A | Japan | 130.62158 | 32.51879 Gunma | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Nara | N/A | Japan | 135.80485 | 34.68505 Okinawa | N/A | Japan | 127.80139 | 26.33583 Osaka | N/A | Japan | 135.50107...
90
0
0
0
NCT00970281
1COMPLETED
2011-04-01
2009-09-01
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 ]
448
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.
null
Type 2 Diabetes Mellitus
Insulin resistance
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 2: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 3: MP-513 tablets, once a day and Metformin tablets, for 24 w...
intervention 1: MP-513 Lowest Dose and Metformin intervention 2: MP-513 Low Dose and Metformin intervention 3: MP-513 Medium Dose and Metformin intervention 4: MP-513 High Dose and Metformin intervention 5: Placebo and Metformin
44
Aalborg | N/A | Denmark | 9.9187 | 57.048 Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165 Vejle | N/A | Denmark | 9.5357 | 55.70927 Falkensee | N/A | Germany | 13.0927 | 52.56014 Hamburg | N/A | Germany | 9.99302 | 53.55073 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Kiel | N/A | Germany | 10.13489 | 54....
447
0
0
0
NCT00971243
1COMPLETED
2011-04-01
2009-08-01
Mitsubishi Tanabe Pharma Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
135
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).
A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), an...
Diabetes Mellitus, Type 2
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.
intervention 1: Lispro Mix 50/50
14
Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Hiroshima | N/A | Japan | 132.45 | 34.4 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Kanagawa | N/A | Japan | 139.91667...
135
0
0
0
NCT00971997
1COMPLETED
2011-04-01
2009-09-01
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, 4 ]
33
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
The investigation will involve a double-blind, placebo controlled, cross-over study examining the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1 standard deviation below the mean on a brie...
null
Multiple Sclerosis
null
1
arm 1: All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
[ 0 ]
1
[ 0 ]
intervention 1: Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the...
intervention 1: armodafinil
1
Kansas City | Kansas | United States | -94.62746 | 39.11417
66
0
0
0
NCT00981084
1COMPLETED
2011-04-01
2009-09-01
University of Missouri, Kansas City
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 ]
160
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
null
Hepatitis C
null
2
arm 1: patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) arm 2: patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/...
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: BI 201335 intervention 2: BI 201335 intervention 3: Pegylated Interferon-alpha intervention 4: Ribavirin (RBV)
intervention 1: BI 201335 intervention 2: BI 201335 intervention 3: Pegylated Interferon-alpha (IFN) intervention 4: Ribavirin (RBV)
28
Tulepo | Mississippi | United States | N/A | N/A New York | New York | United States | -74.00597 | 40.71427 Germantown | Tennessee | United States | -89.81009 | 35.08676 Jackson | Tennessee | United States | -88.81395 | 35.61452 Nashville | Tennessee | United States | -86.78444 | 36.16589 Austin | Texas | United States...
159
0
0
0
NCT00984620
1COMPLETED
2011-04-01
2009-09-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease when associated with memory and/or thinking problems. Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Dise...
Participation in this study requires four visits: a screening visit to ensure eligibility, an initial/baseline visit where the medication is distributed at a dosage lower than the optimal recommended dosage, a four week follow-up visit where the dosage of the medication is increased to the optimal amount, and a final t...
Parkinsons Disease With Dementia Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
PDD Parkinson's Disease with Dementia rivastigmine rivastigmine patch open label Parkinson's Disease Parkinsons Disease memory Exelon Exelon Patch
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks.
intervention 1: Rivastigmine Patch 9.5 cm2
1
San Francisco | California | United States | -122.41942 | 37.77493
29
0
0
0
NCT00988117
1COMPLETED
2011-04-01
2010-04-01
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
[ 0 ]
17
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve anxiety symptoms in patients with a variety of anxiety disorders.
Anxious patients treated with even the best currently available anti-anxiety drugs continue to experience significant symptoms. A variety of basic science, animal studies, and human studies support the idea that the neuropeptide oxytocin may be effective against anxiety in humans. For example, plasma oxytocin levels m...
Anxiety Disorders
oxytocin
null
2
arm 1: 20 IU BID for the first week, 40 IU BID for the following two weeks, one week washout, 3 week placebo trial arm 2: Three week placebo trial, one week washout, 20 IU BID for the fifth week, 40 IU BID for the following two weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 20 IU BID or 40 IU BID intervention 2: 20 IU BID or 40 IU BID
intervention 1: Oxytocin intervention 2: Placebo
1
San Diego | California | United States | -117.16472 | 32.71571
0
0
0
0
NCT00989937
6TERMINATED
2011-04-01
2009-02-01
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
[ 3 ]
43
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.
Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately eve...
Breast Cancer
Metastatic
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met
intervention 1: LY573636-sodium
5
Tampa | Florida | United States | -82.45843 | 27.94752 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Portland | Oregon | United States | -122.67621 | 45.52345 Memphis | Tennessee | United States | -90.04898 | 35.14953 Temple | Texas | United States | -97.34278 | 31.09823
33
0
0
0
NCT00992225
1COMPLETED
2011-04-01
2009-09-01
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
[ 0 ]
9
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
3TRIPLE
true
0ALL
false
Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic respons...
Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, i...
Narcotic Abuse
opioid oxycodone NK1 antagonist aprepitant intranasal abuse
null
15
arm 1: Placebo aprepitant/Placebo oxycodone IN/PO arm 2: Placebo aprepitant/ oxycodone 15 IN 0 PO arm 3: Placebo aprepitant/ oxycodone 30 IN 0 PO arm 4: Placebo aprepitant/ oxycodone 0 IN 20 PO arm 5: Placebo aprepitant/ oxycodone 0 IN 40 PO arm 6: Aprepitant 40 mg/ oxycodone 0 IN 0 PO arm 7: Aprepitant 40 mg/ oxycodon...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
9
[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Aprepitant 0mg, p.o. pretreatment intervention 2: Aprepitant 40mg, p.o. pretreatment intervention 3: Aprepitant 200mg, p.o. pretreatment intervention 4: Oxycodone 0mg, p.o. intervention 5: Oxycodone 20mg, p.o. intervention 6: Oxycodone 40mg, p.o. intervention 7: Oxycodone 0mg, IN intervention 8: Oxycodo...
intervention 1: Aprepitant 0mg intervention 2: Aprepitant 40mg intervention 3: Aprepitant 200mg intervention 4: Oxycodone 0mg, p.o. intervention 5: Oxycodone 20mg, p.o. intervention 6: Oxycodone 40mg, p.o. intervention 7: Oxycodone 0mg, IN intervention 8: Oxycodone 15mg, IN intervention 9: Oxycodone 30mg, IN
1
Lexington | Kentucky | United States | -84.47772 | 37.98869
8
0
0
0
NCT00999544
1COMPLETED
2011-04-01
2009-10-01
Sharon Walsh
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 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate whether the addition of the bisphosphonate Zometa (zoledronic acid) used along with standard regimens of chemotherapy, will help to control the need for palliative intervention of malignant pleural effusions due to non-small cell lung cancer.
Malignant pleural effusions are common in late stage non-small cell lung cancer and can lead to significantly increased morbidity in this patient population. The majority of patients are symptomatic due to their malignant effusions. The recurrence rates are thought to be quite high overall and may approach 100% without...
Malignant Pleural Effusion Non Small Cell Lung Cancer
malignant pleural effusion non small cell lung cancer
null
1
arm 1: Zometa administered as a 15 minute IV infusion of either 4 mg, 3.5mg, 3.3 mg or 3.0 mg every 4 weeks based on the patient's baseline calculated creatinine clearance(CrCl)using the Cockcroft-Gault formula.
[ 0 ]
1
[ 0 ]
intervention 1: Zoledronic acid (Zometa) 4mg IV every 4 weeks for 3 treatments with chemotherapy as selected by treating physician
intervention 1: zoledronic acid
1
Rochester | New York | United States | -77.61556 | 43.15478
3
0
0
0
NCT01004510
6TERMINATED
2011-04-01
2009-11-01
Peter Bushunow MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
524
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.
Duloxetine has been studied in pain due to osteoarthritis (OA) in 2 previous placebo controlled clinical trials. In clinical practice, when nonsteroidal anti-inflammatory drugs (NSAIDs) are ineffective in reducing pain due to OA, clinicians often add a second agent without discontinuing NSAIDs. In this study, we will i...
Osteoarthritis Knee Pain
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 30 milligrams (mg) taken by mouth, once daily for 1 week, followed by 60 to 120 mg taken by mouth, once daily for 9 weeks. intervention 2: Taken by mouth, once daily for 10 weeks
intervention 1: Duloxetine intervention 2: Placebo
35
Tucson | Arizona | United States | -110.92648 | 32.22174 Garden Grove | California | United States | -117.94145 | 33.77391 Long Beach | California | United States | -118.18923 | 33.76696 San Diego | California | United States | -117.16472 | 32.71571 Spring Valley | California | United States | -116.99892 | 32.74477 Wil...
524
0
0
0
NCT01018680
1COMPLETED
2011-04-01
2009-11-01
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
[ 4 ]
489
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of ...
in Children Ages \>6 to \<12 with Perennial Allergic Rhinitis (PAR)
Perennial Allergic Rhinitis
null
3
arm 1: 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks arm 2: 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks arm 3: 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks intervention 2: 548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks intervention 3: 0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
intervention 1: Azelastine hydrochloride nasal spray 0.15% intervention 2: Azelastine hydrochloride nasal spray 0.10% intervention 3: Placebo
39
Costa Mesa | California | United States | -117.91867 | 33.64113 Long Beach | California | United States | -118.18923 | 33.76696 Mission Viejo | California | United States | -117.672 | 33.60002 Palo Alto | California | United States | -122.14302 | 37.44188 Sacramento | California | United States | -121.4944 | 38.58157 S...
489
0
0
0
NCT01018862
1COMPLETED
2011-04-01
2009-11-01
Meda Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
470
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalk...
null
Pulmonary Disease, Chronic Obstructive
null
3
arm 1: patient to take 1 inhalation 4 times a day arm 2: patient to take 2 inhalations 4 times a day arm 3: patient to take 2 inhalations of each 4 times a day
[ 0, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 36/206 mcg Four times a day (QID) intervention 2: Open label randomized parallel intervention 3: Open label randomized parallel
intervention 1: Combivent CFC-MDI intervention 2: Combivent Respimat 20/100 mcg intervention 3: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
55
Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Mesa | Arizona | United States | -111.82264 | 33.42227 Berkeley | California | United States | -122.27275 | 37.87159 Riverside | California | United States | -117.39616 | 33.95335 Boulder | Colorado | United ...
465
0
0
0
NCT01019694
1COMPLETED
2011-04-01
2009-11-01
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 ]
56
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
true
1FEMALE
true
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, ...
Women without urinary incontinence or bladder symptoms (healthy controls)will undergo urethral testing prior to randomization to one of 5 medications or placebo. Participants will take an oral medication for 2 weeks and then return for repeat testing.
Urethral Sphincter Activity
null
6
arm 1: Pseudoephedrine 120mg extended release tablets arm 2: Solifenacin 5mg capsule arm 3: Tamsulosin 0.4mg capsule arm 4: Imipramine 25mg tablet arm 5: Cyclobenzaprine 10mg tablet arm 6: Sham
[ 1, 1, 1, 1, 1, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks intervention 2: Tamsulosin 0.4mg by mouth daily for 2 weeks intervention 3: Imipramine 25mg daily by mouth for 2 weeks intervention 4: Cyclobenzaprine 10mg daily by mouth for 2 weeks intervention 5: Lactose capsule 1 by mouth daily for 2 weeks in...
intervention 1: Pseudoephedrine intervention 2: Tamsulosin intervention 3: Imipramine intervention 4: Cyclobenzaprine intervention 5: Lactose capsule intervention 6: Solifenacin
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
56
0
0
0
NCT01028014
1COMPLETED
2011-04-01
2010-04-01
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
[ 4 ]
912
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatm...
null
Type 2 Diabetes Mellitus
diabetes exenatide once weekly Byetta liraglutide Victoza Amylin Lilly
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: subcutaneous injection, 2mg, once weekly intervention 2: subcutaneous injection, forced titration to 1.8mg, once daily
intervention 1: exenatide once weekly intervention 2: liraglutide
108
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Mendoza | N/A | Argentina | -68.84582 | -32.88946 Rosario | N/A | Argentina | -60.63932 | -32.94682 Box Hill | N/A | Australia | 145.12545 | -37.81887 Geelong | N/A | Australia | 144.36069 | -38.14711 Keswick | N/A | Australia | 138.57459 | -34.94178 Vienna | N/A |...
911
0
0
0
NCT01029886
1COMPLETED
2011-04-01
2010-01-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
180
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse...
null
Alzheimer's Disease
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability
intervention 1: semagacestat
71
Phoenix | Arizona | United States | -112.07404 | 33.44838 Sun City | Arizona | United States | -112.27182 | 33.59754 Tucson | Arizona | United States | -110.92648 | 32.22174 Costa Mesa | California | United States | -117.91867 | 33.64113 Fresno | California | United States | -119.77237 | 36.74773 Laguna Hills | Califor...
180
0
0
0
NCT01035138
1COMPLETED
2011-04-01
2009-12-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registere...
null
Obesity
gastric bypass surgery
null
1
arm 1: Patients assigned to treatment group for up to 6 months of therapy.
[ 0 ]
1
[ 0 ]
intervention 1: 60mg capsule three times a day for up to 6 months
intervention 1: Orlistat
1
Albany | New York | United States | -73.75623 | 42.65258
19
0
0
0
NCT01035333
1COMPLETED
2011-04-01
2009-11-01
Albany College of Pharmacy and Health Sciences
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
151
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease
null
Pulmonary Disease, Chronic Obstructive
null
3
arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler
[ 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Comparison of low and high doses on exercise endurance time in COPD patients intervention 2: Comparison of low and high doses on exercise endurance time in COPD patients intervention 3: Comparison of low and high dose and placebo on exercise endurance time in COPD patients intervention 4: Comparison of ...
intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Placebo intervention 4: Olodaterol (BI 1744) intervention 5: Olodaterol (BI 1744) Placebo
19
Daw Park | South Australia | Australia | 138.58407 | -34.98975 Clayton | Victoria | Australia | 145.11667 | -37.91667 Heidelberg | Victoria | Australia | 145.06667 | -37.75 Melbourne | Victoria | Australia | 144.96332 | -37.814 Gänserndorf | N/A | Austria | 16.72016 | 48.33925 Neumarkt am Wallersee | N/A | Austria | 13...
433
0
0
0
NCT01040130
1COMPLETED
2011-04-01
2010-01-01
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
[ 4 ]
157
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease.
null
Pulmonary Disease, Chronic Obstructive
null
3
arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: Olodaterol (BI 1744) placebo inhaled orally from the Respimat inhaler
[ 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Comparison of low and high dose on exercise endurance time in COPD patients intervention 2: Comparison of low and high dose on exercise endurance time in COPD patients intervention 3: Comparison of low and high dose and placebo on exercise endurance time in COPD patients intervention 4: Comparison of lo...
intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Placebo intervention 4: Olodaterol (BI1744) intervention 5: Olodaterol (BI 1744) placebo
19
Hallein | N/A | Austria | 13.1 | 47.68333 Leoben | N/A | Austria | 15.09144 | 47.3765 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662 Leuven | N/A | Belgium | 4.70093 | 50.87959 Liège | N/A | Belgium | 5.56749 | 50.63373 Vancouver | British Columbia | Canada | -123.11934 | 49.2...
446
0
0
0
NCT01040793
1COMPLETED
2011-04-01
2010-01-01
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 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
Ionizing radiation is a toxic agent and widely accepted form of treatment for various types of cancer. Despite advances in medical technology, radiation therapy still causes severe early and late skin effects. Radiation-induced dermatitis occurs in approximately 80% of patients. Important consequences of radiation-indu...
Specifically, this clinical pilot study will develop data necessary to calculate a sample size for a larger study to be conducted through the National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) mechanism. Specifically, this pilot project will investigate: 1) if curcumin can prevent or alleviate r...
Breast Cancer
Radiation dermatitis in breast cancer patients
null
2
arm 1: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks). arm 2: Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks).
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks) intervention 2: Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (\~4-7 weeks)
intervention 1: Curcumin C3 Complex intervention 2: Placebo
1
Rochester | New York | United States | -77.61556 | 43.15478
30
0
0
0
NCT01042938
1COMPLETED
2011-04-01
2008-01-01
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
[ 2 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is an initial study to determine if CXCR4 inhibitor AMD 3100 or plerixafor may be a potential treatment for neutropenia due to CXCR4 mutations, the myelokathexis or WHIM (warts, hypogammaglobulinemia, immunodeficiency and myelokathexis) syndrome. This is the initial study of this concept and will involve up to 6 p...
This is an open label, single Center, phase I study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating do...
Neutropenia
neutropenia myelokathexis WHIM syndrome AMD 3100 plerixafor Myelokathexis syndrome Neutropenia due to mutations of CXCR-4
null
1
arm 1: SINGLE arm study with increasing doses of Plerixafor
[ 0 ]
1
[ 0 ]
intervention 1: The study will examine the hematological effects/safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4. Plerixafor will be administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating doses of AMD 3100, 20 micrograms per kilogram (mcg/kg), 40 micrograms per kilo...
intervention 1: AMD3100 or plerixafor
1
Seattle | Washington | United States | -122.33207 | 47.60621
6
0
0
0
NCT01058993
1COMPLETED
2011-04-01
2010-10-01
University of Washington
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through complement-dependent cytotoxicity (CDC) and antibody-dependent...
Ofatumumab is an IgG1κ fully human monoclonal antibody (mAb) that specifically recognizes an epitope on the human differentiation antigen CD20 molecule. In vitro and in vivo studies demonstrated that ofatumumab depletes CD20 positive (CD20+) B cells through complement-dependent cytotoxicity (CDC) and antibody-dependent...
Leukaemia, Lymphocytic, Chronic
null
1
arm 1: ofatumumab , 300mg followed by 7 weekly infusions 2000 mg, followed by 4 monthly infusions 2000mg
[ 0 ]
1
[ 0 ]
intervention 1: ofatumumab , 300mg followed by 7 weekly infusions 2000 mg, followed by 4 monthly infusions 2000mg
intervention 1: ofatumumab 100 mg, 1000 mg / vial
7
Aichi | N/A | Japan | 130.62158 | 32.51879 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Nagasaki | N/A | Japan | 129.88333 | 32.75 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566
10
0
0
0
NCT01077622
1COMPLETED
2011-04-01
2009-09-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
12
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
To determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.
null
Normal Pressure Hydrocephalus
Amyloid Normal pressure hydrocephalus (NPH) Positron Emission Tomography (PET) Standard uptake value ratios (SUVR)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: All subjects will receive an IV dose of \[18F\]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 MBq.
intervention 1: [18F]Flutemetamol
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
12
0
0
0
NCT01092546
6TERMINATED
2011-04-01
2010-03-01
GE Healthcare
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
77
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a randomized placebo-controlled study to be conducted in two parallel study arms for a six month period (three doses). Approximately 10 eligible patients per center will be enrolled and will receive afamelanotide (16 mg implants) or placebo according to the following dosing regimen: * Group A will be administe...
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...
Erythropoietic Protoporphyria
Erythropoietic Protoporphyria EPP Afamelanotide
null
2
arm 1: Dose: 16 mg implant; release of 16 mg over 7 to 10 days Mode of administration: Subcutaneous implantation Frequency: Every 60 days (on Days 0, 60 and 120) arm 2: Dose: 16 mg implant; Mode of administration: Subcutaneous implantation Frequency: Every 60 days (on Days 0, 60 and 120)
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total) intervention 2: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)
intervention 1: Afamelanotide intervention 2: Placebo
6
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Francisco | California | United States | -122.41942 | 37.77493 New York | New York | United States | -74.00597 | 40.71427 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Galveston | Texas | United States | -94.7977 | 29.30135 Salt Lake Ci...
77
0
0
0
NCT01097044
1COMPLETED
2011-04-01
2010-04-01
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
[ 3 ]
4
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
Available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.
Compulsive hoarders perform significantly worse than healthy controls on standard attention tasks. These data suggest that the inability to sustain focus may interfere with hoarders' ability to organize, categorize and make decisions about discarding possessions. Stimulants are first-line treatments for ADHD, improve C...
Hoarding Disorder
Hoarding
null
1
arm 1: Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
intervention 1: Methylphenidate ER
2
Hartford | Connecticut | United States | -72.68509 | 41.76371 New York | New York | United States | -74.00597 | 40.71427
4
0
0
0
NCT01100268
1COMPLETED
2011-04-01
2010-04-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
163
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. Multicenter, open-label, within-patient comparative study of Lymphoseek a...
In patients with primary melanoma and breast cancer, lymph node status is often a strong predictor of outcome and influences the course of treatment a patient may follow after surgery. In an effort to reduce the morbidity and costs of detection of lymph node metastases, surgical oncologists have developed a method by w...
Breast Cancer Melanoma
Lymphoseek Breast Cancer Melanoma Experimental
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: The total volume of Lymphoseek injection will be between 0.1 - 1.0 mL.
intervention 1: Lymphoseek
8
Birmingham | Alabama | United States | -86.80249 | 33.52066 La Jolla | California | United States | -117.2742 | 32.84727 San Francisco | California | United States | -122.41942 | 37.77493 Santa Monica | California | United States | -118.49138 | 34.01949 Tampa | Florida | United States | -82.45843 | 27.94752 Cleveland |...
153
0
0
0
NCT01106040
1COMPLETED
2011-04-01
2010-06-01
Navidea Biopharmaceuticals
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 ]
38
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this research study is to explore the mechanism of action of Mucinex, an oral, over-the-counter, FDA approved expectorant in patients with acute respiratory tract infections.
null
Acute Respiratory Infection
Acute Respiratory Infection Mucociliary Cough Clearance Guaifenesin
null
2
arm 1: Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets arm 2: Given as 2 tablets
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study intervention 2: Placebo given as 2 tablets
intervention 1: Mucinex intervention 2: Placebo
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
38
0
0
0
NCT01114581
1COMPLETED
2011-04-01
2010-04-01
Reckitt Benckiser LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
219
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease. Study phase: II Indication: Alzheimer´s Disease Investigational product, dose schedule and route of administr...
Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease. Study phase: II Indication: Alzheimer´s Disease Study objectives: Primary: To evaluate the efficacy of Lorno...
Alzheimer´s Disease
null
2
arm 1: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. arm 2: Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. intervention 2: Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
intervention 1: Lornoxicam intervention 2: Placebo
0
null
219
0
0
0
NCT01117948
6TERMINATED
2011-04-01
2009-09-01
JSW Lifesciences
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 ]
105
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moder...
null
Asthma
null
4
arm 1: patients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler arm 2: patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler arm 3: patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler arm 4: patients inha...
[ 0, 0, 2, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg) intervention 2: inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg) intervention 3: inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg) intervention 4: placebo inhalation solution
intervention 1: Tiotropium bromide intervention 2: tiotropium bromide intervention 3: tiotropium bromide intervention 4: Placebo
19
Denver | Colorado | United States | -104.9847 | 39.73915 Columbia | Missouri | United States | -92.33407 | 38.95171 Warrensburg | Missouri | United States | -93.73605 | 38.76279 Boys Town | Nebraska | United States | -96.13196 | 41.26111 Canton | Ohio | United States | -81.37845 | 40.79895 Koblenz | N/A | Germany | 7.5...
305
0
0
0
NCT01122680
1COMPLETED
2011-04-01
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
[ 3 ]
91
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherp...
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to a...
Pain Diabetic Neuropathies Neuralgia Postherpetic Neuralgia
Chronic pain Diabetic Neuropathic Pain Neuralgia, Postherpetic Tapentadol hydrochloride extended-release JNS024ER Placebo
null
2
arm 1: Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. arm 2: Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. intervention 2: Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
intervention 1: Tapentadol intervention 2: Placebo
31
Chigasaki | N/A | Japan | 139.40434 | 35.33638 Chūōku | N/A | Japan | 130.67068 | 33.63867 Fukuoka | N/A | Japan | 130.41667 | 33.6 Inashiki | N/A | Japan | 140.32356 | 35.95633 Isesaki | N/A | Japan | 139.2 | 36.31667 Izumisano | N/A | Japan | 135.31667 | 34.41667 Kanuma | N/A | Japan | 139.73333 | 36.55 Katsushika-ku...
91
0
0
0
NCT01124617
1COMPLETED
2011-04-01
2010-06-01
Janssen Pharmaceutical K.K.
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 ]
215
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
true
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea). Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secon...
Dysmenorrhea
null
3
arm 1: Norethisterone 1mg, Ethinyl estradiol 0.02mg arm 2: Norethisterone 1mg, Ethinyl estradiol 0.035mg arm 3: Placebo for NPC-01
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Norethisterone 1mg, Ethinyl estradiol 0.02mg intervention 2: Norethisterone 1mg, Ethinyl estradiol 0.035mg intervention 3: Placebo for NPC-01
intervention 1: NPC-01 intervention 2: IKH-01 intervention 3: Placebo
0
null
208
0
0
0
NCT01129102
1COMPLETED
2011-04-01
2010-05-01
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 ]
305
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is a multicentric, double-blind, placebo-controlled, randomized, parallel group study to estimate the effect of minocycline as add-on to interferon beta-1a (IFN beta-1a) in subjects with relapsing-remitting multiple sclerosis (RRMS).
Interferon beta-1a is the approved standard therapy in RRMS. The beneficial effects of minocycline in the experimental autoimmune encephalomyelitis (EAE) model and its possible inhibitory effect on the degradation of IFN beta-1a suggest that minocycline treatment may have beneficial effects in MS as add-on therapy in s...
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Relapsing-Remitting Interferon-β Rebif® Minocycline
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants who are self-administering Rebif® (IFN beta-1a) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly will also receive minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks. intervention 2: Participants who are se...
intervention 1: Minocycline intervention 2: Placebo
1
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
304
0
0
0
NCT01134627
6TERMINATED
2011-04-01
2006-02-01
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
285
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
null
Dry Eye Syndromes
Dry eye
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 2, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Ophthalmic topical solution, low dose, dosed once/day, 8 weeks intervention 2: Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks intervention 3: Ophthalmic topical solution, high dose, dosed once/day, 8 weeks intervention 4: Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks i...
intervention 1: CP-690,550 Eye drops intervention 2: CP-690,550 Eye drops intervention 3: CP-690,550 Eye drops intervention 4: CP-690,550 Eye drops-vehicle intervention 5: Sodium Hyaluronate
28
Ichinomiya | Aichi-ken | Japan | 136.8 | 35.3 Narashino | Chiba | Japan | 140.04152 | 35.68184 Urayasu | Chiba | Japan | 139.90055 | 35.65879 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Chiba | Japan | Japan | 140.11667 | 35.6 Tokyo | Japan | Japan | 139.69171 | 35.6895 Yokohama | Kanagawa | Japan | 139.65 | 35.43333 ...
285
0
0
0
NCT01135511
1COMPLETED
2011-04-01
2010-07-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
118
RANDOMIZED
CROSSOVER
null
0NONE
false
2MALE
false
The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.
GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).
Prostate Cancer
palliative treatment prostate cancer
null
2
arm 1: Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. arm 2: Triptorelin pamoate suspensi...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock intervention 2: Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.
intervention 1: Triptorelin pamoate intervention 2: Leuprolide acetate
16
Homewood | Alabama | United States | -86.80082 | 33.47177 Daytona Beach | Florida | United States | -81.02283 | 29.21081 Orange City | Florida | United States | -81.29867 | 28.94888 Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768 Carmel | Indiana | United States | -86.11804 | 39.97837 Jeffersonville | Ind...
236
0
0
0
NCT01161563
1COMPLETED
2011-04-01
2010-07-01
Watson 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 ]
564
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.
null
Hypertension
Hypertension Valsartan Amlodipine single pill combination BP control ABPM Hypertensive patients not adequately controlled by mono antihypertensive drugs
null
2
arm 1: Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. arm 2: Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Valsartan/Amlodipine 80/5mg single pill combination (SPC) intervention 2: Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
intervention 1: Valsartan/Amlodipine intervention 2: Nifedipine
1
Beijing | N/A | China | 116.39723 | 39.9075
564
0
0
0
NCT01167153
1COMPLETED
2011-04-01
2010-05-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.
Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.
Schizophrenia Obesity
schizophrenia antipsychotics obesity diabetes
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different ...
intervention 1: Metformin
1
New York | New York | United States | -74.00597 | 40.71427
12
0
0
0
NCT01177709
6TERMINATED
2011-04-01
2008-05-01
Nathan Kline Institute for Psychiatric Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
48
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
null
Healthy
Healthy Volunteers
null
2
arm 1: None arm 2: None
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Warfarin 5 mg once daily intervention 2: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) intervention 3: Warfarin 5 mg + Pitavastatin 4mg
intervention 1: Warfarin intervention 2: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) intervention 3: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
1
Austin | Texas | United States | -97.74306 | 30.26715
85
0
0
0
NCT01178853
1COMPLETED
2011-04-01
2010-07-01
Kowa Research Institute, 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 ]
24
null
PARALLEL
7BASIC_SCIENCE
0NONE
false
2MALE
false
The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH). The safety of tadalafil will also be studied.
null
Benign Prostatic Hyperplasia
null
1
arm 1: 5 mg, administered orally, daily for 10 days
[ 0 ]
1
[ 0 ]
intervention 1: 5 mg, administered orally, daily for 10 days
intervention 1: Tadalafil
1
Munich | N/A | Germany | 11.57549 | 48.13743
24
0
0
0
NCT01183650
1COMPLETED
2011-04-01
2010-07-01
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 ]
116
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient popula...
null
Nocturia
nocturia bladder function
null
5
arm 1: Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. arm 2: Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. arm 3: Study period 1: single dose of de...
[ 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration intervention 2: Placebo melt tablet for sublingual administration
intervention 1: Desmopressin intervention 2: Placebo
36
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Ōbu | Aichi-ken | Japan | 136.94947 | 35.01756 Asahi | Chiba | Japan | 140.65 | 35.71667 Yoshida | Fukui | Japan | N/A | N/A Chikushino-shi | Fukuoka | Japan | 130.5156 | 33.49631 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 ...
229
0
0
0
NCT01184859
1COMPLETED
2011-04-01
2010-07-01
Ferring Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
47
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with com...
null
Pneumonia, Bacterial
ampicillin sodium/sulbactam sodium Unasyn-S community acquired pneumonia bacterial pneumonia
null
1
arm 1: ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
[ 0 ]
1
[ 0 ]
intervention 1: ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
intervention 1: ampicillin sodium/sulbactam sodium
22
Seto-shi | Aichi-ken | Japan | N/A | N/A Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181 Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181 Yanagawa | Fukuoka | Japan | 130.4 | 33.16667 Asahikawa | Hokkaido | Japan | 142.36489 | 43.77063 Sapporo | Hokkaido | Japan | 141...
47
0
0
0
NCT01189487
1COMPLETED
2011-04-01
2010-10-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
20
RANDOMIZED
CROSSOVER
null
0NONE
false
1FEMALE
false
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy menstrual bleeding.
null
Menorrhagia
Cyclic Heavy Menstrual Bleed Menorraghia
null
2
arm 1: Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8. arm 2: Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
[ 0, 0 ]
1
[ 0 ]
intervention 1: Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
intervention 1: tranexamic acid
1
Cypress | California | United States | -118.03729 | 33.81696
37
0
0
0
NCT01190150
1COMPLETED
2011-04-01
2010-08-01
Ferring 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 ]
389
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study is a phase 2 study in patients with essential hypertension.
null
Hypertension
hypertension blood pressure LCZ696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor ARNi Essential hypertension
null
4
arm 1: LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week. arm 2: LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week. arm 3: LCZ696 200 mg LCZ696 plus placebo for one week, the...
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: LCZ696 intervention 2: matching placebo to LCZ696
intervention 1: LCZ696 intervention 2: Placebo
34
Shijiazhuang | Hebei | China | 114.47861 | 38.04139 Tianjin | Tianjin Municipality | China | 117.17667 | 39.14222 Hangzhou | Zhejiang | China | 120.16142 | 30.29365 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Chongqing | N/A | China | 106.55771 | 29.56026 Yokohama | Kanagawa ...
389
0
0
0
NCT01193101
1COMPLETED
2011-04-01
2010-08-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
306
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
1FEMALE
false
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
null
Cesarean Delivery
Nausea Vomiting
null
3
arm 1: Prophylaxis with metoclopramide and phenylephrine infusion. arm 2: Prophylactic phenylephrine infusion and placebo antiemetics arm 3: Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion
[ 1, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion intervention 2: Prophylactic phenylephrine infusion after spinal and placebo antiemetics intervention 3: Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
intervention 1: Metoclopramide intervention 2: Phenylephrine infusion intervention 3: Combination Group
1
Durham | North Carolina | United States | -78.89862 | 35.99403
300
0
0
0
NCT01216410
1COMPLETED
2011-04-01
2008-12-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
42
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.
null
Alzheimer's Disease
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days intervention 2: Administered orally as capsules, daily for 14 days
intervention 1: LY2886721 intervention 2: Placebo
1
Glendale | California | United States | -118.25508 | 34.14251
42
0
0
0
NCT01227252
1COMPLETED
2011-04-01
2010-12-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
189
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this study is to optimize drug exposure in the target population.
null
Atrial Fibrillation Atrial Flutter
Betrixaban MK-4448 nonvalvular atrial fibrillation
null
3
arm 1: Participants on betrixaban 30 mg and concomitant baseline amiodarone arm 2: Participants with lower weights arm 3: Participants with higher weights
[ 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Patients on Amiodarone intervention 2: Betrixaban 60 mg once a day with food on Day 0 through Day 25 intervention 3: Betrixaban 90 mg once a day with food on Day 0 through Day 25 intervention 4: Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment.
intervention 1: Amiodarone intervention 2: Betrixaban 60 mg intervention 3: Betrixaban 90 mg intervention 4: Betrixaban 30 mg
0
null
189
0
0
0
NCT01229254
1COMPLETED
2011-04-01
2010-09-01
Portola Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
This is a within-participant comparison study to investigate the efficacy of a 28-day regimen of MK-0873 2% cream twice a day (b.i.d.) compared to MK-0873 vehicle (matching placebo) b.i.d. as well as to a positive control comparator calcitriol 0.0003% (3 µg/g) in participants with plaque psoriasis. In order to be enrol...
null
Psoriasis Plaque Psoriasis
null
8
arm 1: Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D. arm 2: Participants were randomized to received MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on...
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Approximately 3 to 5 mg of MK-0873 2% cream per cm\^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area. intervention 2: Approximately 3 to 5 mg matching placebo to MK-0873 2% cream per cm\^2 of body area in 2 div...
intervention 1: MK-0873 2% Cream intervention 2: MK-0873 vehicle (placebo) Cream intervention 3: Calcitriol Cream
2
Fort Myers | Florida | United States | -81.84059 | 26.62168 Miramar | Florida | United States | -80.23227 | 25.98731
24
0
0
0
NCT01235728
1COMPLETED
2011-04-01
2010-11-01
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
[ 2 ]
24
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to be conducted in renal allograft recipients was requested by State Food and Drug Administration (SFDA) to provide further guidance for...
null
Transplant Rejection Renal Transplantation
Organ Transplants Anti-Rejection Therapy Pharmacokinetics
null
1
arm 1: Subjects must be taking sirolimus (1 mg tablet formulation) with or without concomitant medications, unless specifically excluded below, for prophylaxis of renal rejection.
[ 0 ]
1
[ 0 ]
intervention 1: Sirolimus, 1 mg, white, triangular tablets, daily dose, dosages of any of these medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.
intervention 1: Sirolimus
2
Chongqing | N/A | China | 106.55771 | 29.56026 Shanghai | N/A | China | 121.45806 | 31.22222
24
0
0
0
NCT01236378
1COMPLETED
2011-04-01
2010-12-01
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 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The duration of participation in this study is approximat...
null
Depressive Disorder, Major
null
1
arm 1: LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), or severe hepatic impairment (Child-Pugh C)
[ 0 ]
1
[ 0 ]
intervention 1: Administered orally
intervention 1: LY2216684
3
Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 San Antonio | Texas | United States | -98.49363 | 29.42412
36
0
0
0
NCT01241435
1COMPLETED
2011-04-01
2010-10-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.
null
Healthy Volunteer
null
5
arm 1: 2mg administered once on day 1 (single dose) arm 2: 5mg administered once on day 1 (single dose) arm 3: 10 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose) arm 4: 14 mg administered on day 1 (single dose) and following a 7 day washou...
[ 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Administered orally intervention 2: Administered orally
intervention 1: LY3009104 intervention 2: Placebo
1
Honolulu | Hawaii | United States | -157.85833 | 21.30694
51
0
0
0
NCT01247350
1COMPLETED
2011-04-01
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
[ 0 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 10...
null
Peritonsillar Abscess
Peritonsillar Abscess Quinsy Penicillin Metronidazole Recurrence
null
2
arm 1: After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess arm 2: After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
[ 1, 2 ]
1
[ 0 ]
intervention 1: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days
intervention 1: penicillin and metronidazole in peritonsillar abscess
1
Helsinki | N/A | Finland | 24.93545 | 60.16952
200
0
0
0
NCT01255670
1COMPLETED
2011-04-01
2010-02-01
Helsinki University Central Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
561
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with Intermittent Claudication.
null
Stage II Peripheral Arterial Occlusive Disease Intermittent Claudication Fontaine Stage II PAOD
Alprostadil Prostaglandin E1 Prostavasin® PAOD
null
2
arm 1: Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral arm 2: Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours. 4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostagla...
intervention 1: Alprostadil (Prostaglandin E1) intervention 2: Pentoxifylline intervention 3: Placebo to Pentoxifylline oral intervention 4: Placebo to Alprostadil (Prostaglandin E1) intravenous
36
Aachen | N/A | Germany | 6.08342 | 50.77664 Bad Säckingen | N/A | Germany | 7.94612 | 47.55371 Berlin | N/A | Germany | 13.41053 | 52.52437 Bottrop | N/A | Germany | 6.9285 | 51.52392 Cologne | N/A | Germany | 6.95 | 50.93333 Dortmund | N/A | Germany | 7.466 | 51.51494 Dresden | N/A | Germany | 13.73832 | 51.05089 Düss...
561
0
0
0
NCT01263925
1COMPLETED
2011-04-01
2001-04-01
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
[ 4 ]
218
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
0NONE
true
0ALL
false
Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.
null
Healthy
Amyloid Magnetic resonance imaging Positron Emission Tomography Standard uptake value ratios Healthy Subjects
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
intervention 1: [18F] Flutemetamol
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
181
0
0
0
NCT01265394
1COMPLETED
2011-04-01
2010-12-01
GE Healthcare
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
250
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.
null
Sore Throat Due to a Common Cold
Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
null
2
arm 1: one single dose arm 2: one single dose
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: one single dose intervention 2: one single dose
intervention 1: Lidocaine 8mg + CPC 2mg intervention 2: Lidocaine 1mg + CPC 2mg
1
Erfurt | N/A | Germany | 11.03283 | 50.9787
250
0
0
0
NCT01265446
1COMPLETED
2011-04-01
2010-12-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.
Introduction and Rationale: Bronchiolitis is a common problem with significant morbidity, and occasional mortality among young infants. Diagnostic testing, indications for hospitalization, eligibility criteria for discharge and therefore, the length of hospital stay for bronchiolitis vary globally, suggesting a lack o...
Bronchiolitis
Bronchiolitis L-Epinephrine 3% Hypertonic Saline Clinical Severity Score
null
2
arm 1: L-Epinephrine and Normal Saline (0.9%) arm 2: L-Epinephrine and Hypertonic Saline (3%)
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 1.5ml of 1:1,000 L-Epinephrine and 4 ml of 0.9% Normal Saline intervention 2: 1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline
intervention 1: L-Epinephrine and Normal Saline (0.9%) intervention 2: L-Epinephrine and Hypertonic Saline (3%)
1
Kathmandu | Bagmati Zone | Nepal | 85.3206 | 27.70169
100
0
0
0
NCT01276821
1COMPLETED
2011-04-01
2011-01-01
Dr. Aayush Khanal, MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
185
RANDOMIZED
CROSSOVER
null
0NONE
false
0ALL
true
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an Internasal Corticosteroid (INCS)
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an INCS. Subjects will be randomized to 1 of 2 tr...
Perennial Allergic Rhinitis
perennial allergic rhinitis PAR
null
2
arm 1: ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered. arm 2: mometasone nasal inhalation 200 μg once daily in first interven...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week. intervention 2: mometasone nasal inhalation 200 μg once daily for one week
intervention 1: ciclesonide hydrofluoroalkane (HFA) nasal aerosol intervention 2: mometasone nasal inhalation
6
Mission Viejo | California | United States | -117.672 | 33.60002 San Diego | California | United States | -117.16472 | 32.71571 North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 Minneappolis | Minnesota | United States | N/A | N/A Skillman | New Jersey | United States | -74.7146 | 40.42011 San Anto...
351
0
0
0
NCT01287364
1COMPLETED
2011-04-01
2011-02-01
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 ]
41
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to con...
null
Advanced Cancer
null
1
arm 1: Part A, Cycle 1 (28 days): Intravenous doses of LY2090314 starting at 10 milligram (mg) were given on Day 1 followed by 10 mg LY2090314, 500 milligram per square meter (mg/m\^2) pemetrexed (intravenous dose), and 5 or 6 area under the concentration-time curve (AUC) intravenous dose of carboplatin on Day 8. Part...
[ 0 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain.
intervention 1: LY2090314 intervention 2: pemetrexed intervention 3: Carboplatin intervention 4: ranitidine
2
Tampa | Florida | United States | -82.45843 | 27.94752 Nashville | Tennessee | United States | -86.78444 | 36.16589
41
0
0
0
NCT01287520
1COMPLETED
2011-04-01
2007-11-01
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 ]
236
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.
null
Conjunctivitis, Allergic
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: administered daily to each eye for 2 weeks following allergen challenge using a CAC model intervention 2: administered daily to each eye for 2 weeks following allergen challenge using a CAC model
intervention 1: Mapracorat intervention 2: Vehicle
1
Rochester | New York | United States | -77.61556 | 43.15478
236
0
0
0
NCT01289431
1COMPLETED
2011-04-01
2011-02-01
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
[ 2 ]
180
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches. The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate ...
null
Healthy
null
2
arm 1: Capsugel (T), oral administration arm 2: Qualicaps (R), oral administration
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 150 mg Capsugel (T) intervention 2: 150 mg Qualicaps (R)
intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate
1
Mannheim | N/A | Germany | 8.46694 | 49.4891
360
0
0
0
NCT01290757
1COMPLETED
2011-04-01
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
[ 2 ]
22
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study employing administration of two oral formulations of crizotinib (OLF and FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled to obtain at least 20 evaluable subjects who...
null
Healthy
relative bioavailability pharmacokinetics crizotinib oral liquid formulation formulated capsule
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days.
intervention 1: crizotinib
1
Brussels | N/A | Belgium | 4.34878 | 50.85045
44
0
0
0
NCT01297595
1COMPLETED
2011-04-01
2011-03-01
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 ]
60
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
null
The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hou...
Purpose:
Healthy
null
4
arm 1: Aggrenox alone arm 2: Aggrenox and omeprazole arm 3: Omeprazole alone arm 4: Aggrenox and omeprazole
[ 1, 0, 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Aggrenox 1 capsule twice daily for 7 days intervention 2: Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days intervention 3: Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days intervention 4: omeprazole 80 once daily for 7 days
intervention 1: Aggrenox alone intervention 2: Aggrenox and omeprazole intervention 3: Aggrenox and omeprazole intervention 4: Omeprazole alone
1
Tempe | Arizona | United States | -111.90931 | 33.41477
225
0
0
0
NCT01303445
1COMPLETED
2011-04-01
2011-03-01
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 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.
In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon ...
Urinary Tract Problem
Remifentanil Laryngeal mask airway removal Hemodynamic changing Infusion Ureterorenoscopy
null
2
arm 1: Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery arm 2: Control:Remifentanil stopped at the end of the surgery
[ 1, 4 ]
1
[ 0 ]
intervention 1: 1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
intervention 1: remifentanil
1
Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987
0
0
0
0
NCT01303627
1COMPLETED
2011-04-01
2011-02-01
Diskapi Teaching and Research 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
[ 2 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.
null
Healthy
null
3
arm 1: 1 tablet BI 10773, oral administration with 240 ml water arm 2: 1 tablet simvastatin, oral administration with 240 ml water arm 3: 1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
[ 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Medium dose oral administration intervention 2: Medium dose oral administration intervention 3: Medium dose oral administration intervention 4: Medium dose oral administration
intervention 1: BI 10773 intervention 2: simvastatin intervention 3: simvastatin intervention 4: BI 10773
1
Biberach | N/A | Germany | 8.03333 | 48.33333
53
0
0
0
NCT01304329
1COMPLETED
2011-04-01
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 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.
null
Healthy
null
2
arm 1: Tablet, oral administration with 240 mL water arm 2: Tablets, oral administration with 240 mL water
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily intervention 2: Digoxin 0.5 mg as single dose
intervention 1: Digoxin plus BI 10773 intervention 2: Digoxin
1
Biberach | N/A | Germany | 8.03333 | 48.33333
40
0
0
0
NCT01306175
1COMPLETED
2011-04-01
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 ]
16
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
null
Healthy Volunteers
Diabetes Mellitus, Type 2
null
2
arm 1: Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods. arm 2: Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY26082...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Administered orally intervention 2: Administered orally.
intervention 1: LY2608204 Reference intervention 2: LY2608204 Test
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
30
0
0
0
NCT01313286
1COMPLETED
2011-04-01
2011-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
27
NA
SINGLE_GROUP
null
1SINGLE
true
0ALL
false
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.
null
Antimicrobial Effectiveness
null
0
null
null
2
[ 0, 0 ]
intervention 1: 10.5 ml applicator preoperative skin preparation intervention 2: 10.5 ml applicator
intervention 1: ChloraPrep One-Step intervention 2: 70% isopropyl alcohol
1
Sterling | Virginia | United States | -77.4286 | 39.00622
27
0
0
0
NCT01314703
1COMPLETED
2011-04-01
2011-03-01
CareFusion
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 ]
190
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
false
The study seeks to identify genomic markers associated with aspirin resistance.
Not desired
Platelet Dysfunction Due to Aspirin
genomic markers aspirin resistance
null
1
arm 1: All subjects took 7-10 days of 81 mg aspirin
[ 5 ]
1
[ 0 ]
intervention 1: aspirin 81mg, 7-10 days
intervention 1: aspirin
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
132
0
0
0
NCT01361620
1COMPLETED
2011-04-01
2007-12-01
George Washington 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 ]
24
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
0ALL
true
The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration
Diazepam is a medication that is used for the treatment of seizures. It was approved by the Food and Drug Administration (FDA) for use in the United States and is currently sold as Valium® tablets, Diazepam Injection and Diastat® rectal gel. This study will evaluate two intranasal (nasal spray) formulations of diazepa...
Epilepsy
null
3
arm 1: Diazepam Nasal Suspension - 10 mg arm 2: Diazepam Nasal Spray Solution - 10 mg arm 3: Diazepam injection IV - 5 mg
[ 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose. intervention 2: IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.
intervention 1: Diazepam intervention 2: Diazepam
1
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
72
0
0
0
NCT01364558
1COMPLETED
2011-04-01
2011-02-01
University of Minnesota
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human imm...
This is a Phase II, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), controlled, single centre study. The study consists of 3 phases including, the screening phase (4 weeks before administration of study medication), treatment phase (48 weeks), and ...
Human Immunodeficiency Virus 1
Human immunodeficiency virus 1 Acquired immunodeficiency syndrome Immunologic deficiency syndrome Darunavir/ritonavir Darunavir Ritonavir Nucleoside reverse transcriptase inhibitors (NRTIs) Prezista
null
2
arm 1: Monotherapy: darunavir/ritonavir (DRV/r) will be administered for 48 weeks. arm 2: DRV/r along with 2 nucleoside reverse transcriptase inhibitors (NRTIs) will be administered for 48 weeks and whenever possible, participants should take these medications at the same time. Switch of NRTIs will be allowed in the ev...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks intervention 2: Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks intervention 3: 2 NRTIs will be admi...
intervention 1: Darunavir(DRV) intervention 2: Ritonavir intervention 3: 2 nucleoside reverse transcriptase inhibitors (NRTIs)
0
null
30
0
0
0
NCT01391013
1COMPLETED
2011-04-01
2009-06-01
Janssen-Cilag S.p.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
1FEMALE
false
This is a pharmacokinetics and safety study over 3 weekly applications.
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
Healthy
PK and safety Pharmacokinetic profile (PK) and safety
null
6
arm 1: Patch was placed on abdomen, buttock then the upper torso excluding breast. Intervention: AG200-15 patch arm 2: Patch was placed on abdomen, upper torso excluding breast then the buttock. Intervention: AG200-15 patch arm 3: Patch was placed on the buttock, abdomen, then the upper torso excluding breast. Inter...
[ 0, 0, 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
intervention 1: AG200-15
2
Lincoln | Nebraska | United States | -96.66696 | 40.8 Neptune City | New Jersey | United States | -74.02792 | 40.20011
68
0
0
0
NCT01422135
1COMPLETED
2011-04-01
2011-02-01
Agile Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
This study evaluates if itraconazole causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need, largely expressed as the lack of durable response. New therapies that extend surviva...
Prostate Cancer Prostatic Neoplasms Castrate-resistant Prostate Cancer (CRPC) Androgen-insensitive Prostate Cancer Hormone-refractory Prostate Cancer Metastatic Disease
null
1
arm 1: 600 mg/day oral (PO)
[ 0 ]
1
[ 0 ]
intervention 1: 600 mg/day oral (PO) IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-\[4-(4-{\[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl\]methoxy}phenyl)piperazin-1-yl\]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
intervention 1: Itraconazole
1
Stanford | California | United States | -122.16608 | 37.42411
4
0
0
0
NCT01450683
6TERMINATED
2011-04-01
2010-09-01
Stanford University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
28
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.
This study will investigate the effect of dosing with 25 μg GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor, in asthmatic subjects aged 5 to 11. GW642444 is currently under development as the long-acting beta-agonist component of a combination product containing an inhaled corticosteroid and a lo...
Asthma
Asthma Tolerability Safety Pharmacokinetics GW642444
null
2
arm 1: 8-11 years old; Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence. Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dos...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: GW642444 25 μg; Novel dry powder inhaler intervention 2: Matching placebo; Novel dry powder inhaler
intervention 1: GW642444 intervention 2: Placebo
5
Cypress | California | United States | -118.03729 | 33.81696 Huntington Beach | California | United States | -117.99923 | 33.6603 Denver | Colorado | United States | -104.9847 | 39.73915 Normal | Illinois | United States | -88.99063 | 40.5142 Medford | Oregon | United States | -122.87559 | 42.32652
53
0
0
0
NCT01453296
1COMPLETED
2011-04-01
2010-08-01
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
[ 5 ]
72
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
A reduction in alertness and lower levels of performance are commonly associated with the common cold. Paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of p...
null
Common Cold
Paracetomol Caffeine Common cold
null
2
arm 1: Paracetamol and caffeine arm 2: Paracetamol
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Paracetamol 1000 mg and caffeine 130 mg intervention 2: Paracetamol 1000 mg
intervention 1: Paracetamol and Caffeine intervention 2: Paracetamol
1
Cardiff | Wales | United Kingdom | -3.18 | 51.48
142
0
0
0
NCT01466348
1COMPLETED
2011-04-01
2011-02-01
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
[ 0 ]
18
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
0ALL
false
Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances shown to interact with a variety of medications. However, unanswered questions remain regarding the causative ingredients and mechanisms underlying such drug-grapefruit juice interactions. Compounds in grapefruit juice called fu...
Participants: Healthy volunteers of any race/ethnicity, ranging in age from 18 to 65 years, will be enrolled. Procedures (methods): Procedures will include administration of water, furanocoumarin-free grapefruit juice, or grapefruit juice with fexofenadine; placement of an intravenous (IV) line; and collection of bloo...
Food-drug Interaction
null
6
arm 1: This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover desi...
[ 5, 5, 5, 5, 5, 5 ]
1
[ 0 ]
intervention 1: This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized cross...
intervention 1: Fexofenadine
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
18
0
0
0
NCT01526213
1COMPLETED
2011-04-01
2009-09-01
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 ]
71
RANDOMIZED
PARALLEL
1PREVENTION
1SINGLE
true
1FEMALE
true
The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be a serious problem for manufacturers and a risk to consumers; health by ingesting substances whose effects are not desired. Therefore, the main objective of this paper is to analyze the effect of dietary supplements Omega-3 wit...
The assignment of women to distinct groups was carried out following the classification criteria established by (NCEP, 2002), and performed by the research team. Women were randomly assigned to one of three parallel groups, in a near 1:1:1 ratio. Group 1 (n=20) took two capsules per day of less oxidized oil (containing...
Overweight
blood cholesterol blood lipid profile triglycerides commercial pills fish oil lipid peroxidation Circulating lipidic profile
null
3
arm 1: Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 1 took 2 capsules/day of one of the less oxidiz...
[ 0, 0, 0 ]
3
[ 7, 7, 0 ]
intervention 1: Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were dis...
intervention 1: Less oxidized oil and diet intervention 2: More oxidized oil and diet intervention 3: Hypercholesterolemic diet
1
Elche | Alicante | Spain | -0.70107 | 38.26218
57
0
0
0
NCT01799720
1COMPLETED
2011-04-01
2010-10-01
Universidad Miguel Hernandez de Elche
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 ]
132
NA
SINGLE_GROUP
null
0NONE
false
0ALL
true
Vitamin B12 has several important functions in the body, two of which are production of red blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient, abnormal red blood cells form. These cells are called megaloblasts. The end result is a decreased number of red blood cells; a condition...
BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population. METHODS: Serum vitamin B12 and methylmalonic acid (MMA...
Vitamin B12 Deficiency
hemodialysis viatmin B12 deficiency Epogen
null
1
arm 1: Those with an MMA over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
[ 0 ]
1
[ 0 ]
intervention 1: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and t...
intervention 1: Vitamin B12
1
Staten Island | New York | United States | -74.13986 | 40.56233
57
0
0
0
NCT01876732
1COMPLETED
2011-04-01
2009-06-01
Northwell Health
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
50
RANDOMIZED
PARALLEL
null
2DOUBLE
true
0ALL
true
The aim of this study is to evaluate the effect of Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice.
This randomized clinical trial study was approved by ethics committee of Zahedan University of Medical Sciences and conducted in pediatric clinic of Zahedan dental school in 2010. Among the patients referred to the clinic, forty six children aged 4-6 years (±2 months) were selected according to the inclusion criteria....
Cooperative Behaviour Dental Anxiety
film modelling dental anxiety cooperative behaviour children
null
2
arm 1: Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room. In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cav...
[ 1, 0 ]
4
[ 5, 5, 0, 3 ]
intervention 1: Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children. interv...
intervention 1: tell- show- do intervention 2: film modelling intervention 3: injection of local anesthesia solution intervention 4: occlusal cavity preparation
1
Zahedan | N/A | Iran | 60.8629 | 29.4963
45
0
0
0
NCT01908127
1COMPLETED
2011-04-01
2010-09-01
Zahedan University of Medical Sciences
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
137
NON_RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
1FEMALE
true
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH...
1. Aim -We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the d...
Infertility
ICSI Suboptimal Ovarian Response rLH
null
3
arm 1: The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 arm 2: On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on t...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: recombinant follicle stimulation intervention 2: recombinant luteinizing hormone intervention 3: recombinant follicle stimulation hormone
intervention 1: fix dose r-FSH (Gonal-f) intervention 2: r-LH supplementation intervention 3: r-FSH (Gonal-f)
0
null
0
0
0
0
NCT02108223
1COMPLETED
2011-04-01
2009-01-01
Sisli Hamidiye Etfal Training and Research 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