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 ]
23
RANDOMIZED
SINGLE_GROUP
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.
This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimetho...
Abscess
abscess Abscesses in the pediatric emergency population
null
2
arm 1: subjects with abscesses less than 5cm will be randomized to either study med or placebo arm 2: Placebo after incision and drainage of abscess less than 5 cm.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days intervention 2: Placebo caps or suspension every 12 hours for 10 days
intervention 1: oral trimethoprim/sulfamethoxazole intervention 2: Placebo
1
Houston | Texas | United States | -95.36327 | 29.76328
23
0
0
0
NCT00691600
1COMPLETED
2010-04-01
2007-12-01
Baylor College of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The following primary hypotheses will be tested: 1. During Step 1: Major Depressive Disorder (MDD) or Chronic Low Back Pain (CLBP) in \< 40% of the initial 60 subjects treated with duloxetine (DUL) + Clinical Management(CM) during the first 8 weeks will respond (response is defined as a Montgomery Asberg Depression Ra...
This is a two-part study. Step 1 is an 8-week long open-label trial of duloxetine (DUL) + clinical management (CM), titrated up to 90 mg/day, for older adults with comorbid major depressive disorder (MDD) and chronic low back pain (CLBP). At week 8, if subjects have not responded, the dose of duloxetine is increased to...
Major Depressive Disorder Back Pain Aged
null
1
arm 1: Duloxetine + clinical management NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED.
[ 0 ]
1
[ 0 ]
intervention 1: Duloxetine up to 120 mg/day + Clinical Management
intervention 1: Duloxetine
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
30
0
0
0
NCT00696293
1COMPLETED
2010-04-01
2007-05-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
498
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Extina (ketoconazole) Foam, 2% was approved for marketing in the United States (US) in June 2007. Extina foam is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. The approved dosing regimen is twice daily for 4 weeks. The treatment of recurrent seborrheic d...
This is an open-label, multicenter, single-group study to assess the long-term safety of twice daily treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis. The study subjects must have seborrheic dermatitis with an Investigator's Static Global Assessment (ISGA) of 2, 3, or 4 at baseline....
Dermatitis, Seborrheic
Phase 4 Seborrheic Ketoconazole Dermatitis
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: Foam, 2%, Extina will be applied twice daily (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest. Study product should be applied at the first sign of a seborrheic dermatitis flare, and twice daily applications should continue until the area(s) has cleare...
intervention 1: Ketoconazole
0
null
498
0
0
0
NCT00703846
1COMPLETED
2010-04-01
2008-06-01
Stiefel, a GSK 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 ]
18
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389). The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) a...
null
Cancer
Cancer advanced solid tumors
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m\^2 for normal hepatic function. intervention 2: E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m\^2 for mild hepatic impairment (Child-Pugh A) intervention 3: E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m\^2 fo...
intervention 1: E7389 intervention 2: E7389 intervention 3: E7389
2
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Utrecht | N/A | Netherlands | 5.12222 | 52.09083
18
0
0
0
NCT00706095
1COMPLETED
2010-04-01
2008-02-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).
Patients with chronic refractory ITP are eligible for a 6- to 12-week therapeutic trial. After 24 months of treatment, patients who continue to demonstrate a sustained response, in the investigator's judgment, will be offered the opportunity to receive ongoing therapy.
Purpura, Thrombocytopenic, Idiopathic
Adult Refractory Immune Thrombocytopenic Purpura (ITP)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: R935788 tablets
intervention 1: Fostamatinib Disodium / R935788
2
New York | New York | United States | -74.00597 | 40.71427 Cleveland | Ohio | United States | -81.69541 | 41.4995
18
0
0
0
NCT00706342
1COMPLETED
2010-04-01
2007-01-01
Rigel 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 ]
61
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6\~18 years with chronic tic disorders or Tourette's disorder
null
Chronic Motor or Vocal Tic Disorder Tourette's Disorder
Chronic Motor Tic disorder Chronic Phonic Tic disorder Tourette's disorder Aripiprazole Abilify Children Adolescent
null
2
arm 1: Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) arm 2: Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Initial dose : 2mg, Maximum dose : 20mg intervention 2: Initial dose: 2mg, Maximum dose:20mg
intervention 1: aripiprazole intervention 2: placebo
6
Inchon | N/A | South Korea | 126.6251 | 35.55479 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566
60
0
0
0
NCT00706589
1COMPLETED
2010-04-01
2008-10-01
Korea Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
34
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in subjects with suboptimal CD4+ T-cell recovery ...
The majority of HIV-infected subjects with virologic suppression on antiretroviral therapy (ART) have a marked increase in CD4+ T-cell counts over the first year on treatment. However, a portion of these individuals show a suboptimal immune response and remain at an elevated risk for disease progression. The use of the...
HIV Infections
CCR5 antagonist CD4 T-cell count immune activation treatment experienced
null
1
arm 1: Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
[ 0 ]
1
[ 0 ]
intervention 1: The maraviroc doses were 150 mg orally twice daily, 300 mg orally twice daily, or 600 mg orally twice daily, depending on the pharmacokinetic interaction with a subject's pre-study ART and non-ART drug regimen according to the package insert.
intervention 1: Maraviroc
29
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 Wa...
34
0
0
0
NCT00709111
1COMPLETED
2010-04-01
2009-01-01
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
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
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
null
Neoplasms
solid tumor Axitinib Pharmacokinetics Phase 1
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.
intervention 1: Axitinib (AG-013736)
1
Kobe | Hyōgo | Japan | 135.183 | 34.6913
6
0
0
0
NCT00726752
1COMPLETED
2010-04-01
2008-07-01
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 ]
499
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.
null
Acute Coronary Syndrome
Asia Lipitor Pre-treatment in Acute Coronary Syndrome
null
2
arm 1: None arm 2: None
[ 0, 5 ]
2
[ 0, 0 ]
intervention 1: 80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days. intervention 2: 40mg daily after PCI for 30 days.
intervention 1: Atorvastatin intervention 2: Atorvastatin
26
Guangzhou | Guangdong | China | 113.25 | 23.11667 Changsha | Hunan | China | 112.97087 | 28.19874 Shenyang | Liaoning | China | 123.43278 | 41.79222 Shenyang | Liaoning | China | 123.43278 | 41.79222 Qingdao | Shandong | China | 120.38042 | 36.06488 Hangzhou | Zhejiang | China | 120.16142 | 30.29365 Beijing | N/A | Chi...
495
0
0
0
NCT00728988
1COMPLETED
2010-04-01
2008-09-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
Fluticasone (Advair), an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD. Fluticasone/salmeterol has been shown to significantly improve forced expiratory volume (FEV1) and decrease COPD symptoms (Calverley et al. 2003, 2007). Inhaled corticosteroids hav...
RATIONALE: Chronic obstructive pulmonary disease (COPD) is a term that describes a disease state in which there is chronic irreversible airflow limitation. It has been well documented that patients with COPD have disturbed sleep. Certain published reports suggest that more than 50% of COPD patients have sleep complain...
COPD
COPD sleep daytime somnolence
null
2
arm 1: 1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks. arm 2: 1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received P...
[ 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1 puff bid inhaled intervention 2: 1 puff bid inhaled intervention 3: Placebo 1 puff bid inhaled intervention 4: i puff bid inhaled
intervention 1: Advair 250 intervention 2: Placebo- matched intervention 3: Placebo intervention 4: Advair 250 - matched
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
20
0
0
0
NCT00731770
1COMPLETED
2010-04-01
2009-01-01
Milton S. Hershey Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
510
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluati...
null
Cystic Fibrosis
null
3
arm 1: patient to receive low dose tiotropium once daily arm 2: patient to receive high dose tiotropium once daily arm 3: patient to receive placebo once daily
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: patient to receive placebo matching active drug once daily intervention 2: patient to recieve high dose tiotropium once daily intervention 3: patient to receive low dose tiotropium once daily
intervention 1: Placebo Respimat intervention 2: Tiotropium bromide 5 mcg intervention 3: tiotropium bromide-low dose-2.5mcg
107
Tucson | Arizona | United States | -110.92648 | 32.22174 San Diego | California | United States | -117.16472 | 32.71571 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 Orlando | Florida | United...
510
0
0
0
NCT00737100
1COMPLETED
2010-04-01
2008-09-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
322
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of l...
This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD patients. Study with completed results acquired from Horizon in 2024.
Chronic Obstructive Pulmonary Disease
COPD Patients
null
2
arm 1: Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles arm 2: MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles intervention 2: same frequency as study drug using the same method of delivery
intervention 1: MP-376 intervention 2: Placebo
39
Haleyville | Alabama | United States | -87.62141 | 34.22649 Hueytown | Alabama | United States | -86.99666 | 33.45122 Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Glendale | Arizona | United States | -112.18599 | 33.53865 Phoenix | Arizona | United ...
322
0
0
0
NCT00739648
1COMPLETED
2010-04-01
2008-10-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF for patients with myelodysplasia and leukemia.
The primary objective of this study is to determine the feasibility and toxicity of decitabine, ARA-C and G-CSF for patients with myelodysplasia, refractory acute leukemia and poor performance status acute leukemia.
Myelodysplasia Leukemia
myelodysplasia refractory leukemia acute leukemia
null
1
arm 1: Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: chemotherapy
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
9
0
0
0
NCT00740181
6TERMINATED
2010-04-01
2008-08-01
Brown University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
true
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.
Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intrave...
Anemia Pregnancy Complications
iron deficiency anemia pregnancy third trimester intravenous iron efficacy a randomized trial Female Ferric Compounds/therapeutic use* Infusions, Intravenous Hematologic/therapy*
null
2
arm 1: In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. arm 2: Women in the IV-group received 500 mg iron sucrose...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out. intervention 2: Women in the IV-group received 5...
intervention 1: Ferli-6® (Continental Pharm co., ltd.) intervention 2: Venofer® (Vifor AG, St. Gallen, Switzerland)
1
Bangkok | Bangkok | Thailand | 100.50144 | 13.75398
80
0
0
0
NCT00746551
1COMPLETED
2010-04-01
2008-09-01
Mahidol University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
455
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.
null
Type 2 Diabetes
null
2
arm 1: Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin arm 2: Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue) intervention 2: Placebo tablets given orally once daily for 24 weeks (short-term ...
intervention 1: Saxagliptin, 5 mg + insulin intervention 2: Placebo + insulin
80
Tempe | Arizona | United States | -111.90931 | 33.41477 Fresno | California | United States | -119.77237 | 36.74773 Lomita | California | United States | -118.31507 | 33.79224 Northridge | California | United States | -118.53675 | 34.22834 San Diego | California | United States | -117.16472 | 32.71571 Spring Valley | C...
455
0
0
0
NCT00757588
1COMPLETED
2010-04-01
2008-11-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
108
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The Disease Activity Score (DAS) is a system of measurement developed in the 1980s that uses certain criteria, including joint counts and patient perceived disease activity, to measure disease activity in people with Rheumatoid Arthritis . More recently, the European League against Rheumatism (EULAR) has developed a ne...
null
Rheumatoid Arthritis
EULAR-RAID active rheumatoid arthritis etanercept
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Etanercept 50 mg once a week
intervention 1: Etanercept
17
Amiens | N/A | France | 2.3 | 49.9 Amiens | N/A | France | 2.3 | 49.9 Belfort | N/A | France | 6.85385 | 47.64218 Berck | N/A | France | 1.6 | 50.4 Bonneville | N/A | France | 6.40726 | 46.0802 Cahors | N/A | France | 1.43663 | 44.4491 Corbeil-Essonnes | N/A | France | 2.48757 | 48.60603 Créteil | N/A | France | 2.4656...
108
0
0
0
NCT00768053
1COMPLETED
2010-04-01
2008-10-01
Wyeth is now a wholly owned subsidiary of Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
44
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.
null
Choroidal Neovascularization Age-Related Maculopathy
null
1
arm 1: 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
[ 0 ]
2
[ 0, 2 ]
intervention 1: 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. intervention 2: Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
intervention 1: dexamethasone intervention 2: ranibizumab
3
San Antonio | Texas | United States | -98.49363 | 29.42412 Sydney | New South Wales | Australia | 151.20732 | -33.86785 Manila | N/A | Philippines | 120.9822 | 14.6042
44
0
0
0
NCT00775411
1COMPLETED
2010-04-01
2008-11-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
106
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).
null
Alzheimer's Disease
null
2
arm 1: There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks. arm 2: There will be a 14 day period when all partic...
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization. intervention 2: Donepezil 1 capsule (5 mg) orally, once daily for 14 days. Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84). intervention 3: Matching placebo to donepezil, 1 capsule (5 m...
intervention 1: Comparator: Placebo 5mg (run in) intervention 2: Donepezil 5 - 10 mg intervention 3: Comparator: Placebo 5-10 mg intervention 4: Donepezil 10 mg
0
null
106
0
0
0
NCT00777608
1COMPLETED
2010-04-01
2008-12-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
326
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
null
Vitreomacular Adhesion
null
2
arm 1: 125µg intravitreal injection of ocriplasmin arm 2: placebo intravitreal injection
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 125µg ocriplasmin intravitreal injection intervention 2: Placebo intravitreal injection
intervention 1: 125 µg Ocriplasmin intervention 2: Placebo
41
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Beverly Hills | California | United States | -118.40036 | 34.07362 Huntington Beach | California | United States | -117.99923 | 33.6603 Los Angeles...
326
0
0
0
NCT00781859
1COMPLETED
2010-04-01
2008-12-01
ThromboGenics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
422
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign pro...
null
Benign Prostatic Hyperplasia
null
3
arm 1: 2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks. arm 2: 5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks. arm 3: Placebo tablet taken by mouth once a day for 12 w...
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: oral, daily intervention 2: oral, daily intervention 3: oral, daily
intervention 1: Tadalafil 2.5 mg intervention 2: Tadalafil 5 mg intervention 3: Placebo
6
Chiba | N/A | Japan | 140.11667 | 35.6 Hiroshima | N/A | Japan | 132.45 | 34.4 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kyoto | N/A | Japan | 135.75385 | 35.02107 Osaka | N/A | Japan | 135.50107 | 34.69379 Tokyo | N/A | Japan | 139.69171 | 35.6895
816
0
0
0
NCT00783094
1COMPLETED
2010-04-01
2008-11-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
1
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was u...
Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was no...
Renal Impairment
Gabapentin Pharmacokinetics
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 100-200mg once a day intervention 2: 200-500mg once a day intervention 3: 400-1000mg (200-500 mg twice a day)
intervention 1: Gabapentin intervention 2: Gabapentin intervention 3: Gabapentin
1
Saijyo-shi | Ehime | Japan | N/A | N/A
1
0
0
0
NCT00785772
6TERMINATED
2010-04-01
2010-03-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
RANDOMIZED
FACTORIAL
0TREATMENT
3TRIPLE
true
0ALL
true
Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be related to health. Mel...
Problem of Interest: Current treatments for ulcerative colitis are not always effective, and often have serious side effects. Therefore, there is considerable interest in finding alternative treatments for this disease. Physiologic data suggest that melatonin is important in gastrointestinal (GI) tract physiology and ...
Ulcerative Colitis
Ulcerative Colitis Melatonin Gastrointestinal Irritable Bowel syndrome Sleep Pilot Study
null
2
arm 1: Placebo -- lactose pill. arm 2: Melatonin
[ 2, 1 ]
2
[ 0, 10 ]
intervention 1: Study Pill (5 mg/d) taken once daily, preferably an hour before bedtime, for 12 weeks. intervention 2: Study Placebo taken once daily, preferably an hour before bedtime, for 12 weeks.
intervention 1: Melatonin intervention 2: Placebo
2
Atlanta | Georgia | United States | -84.38798 | 33.749 Atlanta | Georgia | United States | -84.38798 | 33.749
0
0
0
0
NCT00790478
6TERMINATED
2010-04-01
2009-01-01
Emory 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 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progr...
Up to 61 patients (male and female) meeting the inclusion and exclusion criteria will be enrolled into this trial in two stages. All enrolled patients will be treated with R788 at 200 mg PO bid until disease progression. In the initial stage of the study, a total of 19 patients will be enrolled and treated with Fostama...
T Cell Lymphoma
T Cell Lymphoma Lymphoma
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 200 mg PO BID
intervention 1: Fostamatinib Disodium
10
San Francisco | California | United States | -122.41942 | 37.77493 Stanford | California | United States | -122.16608 | 37.42411 Atlanta | Georgia | United States | -84.38798 | 33.749 Boston | Massachusetts | United States | -71.05977 | 42.35843 Rochester | Minnesota | United States | -92.4699 | 44.02163 Omaha | Nebras...
18
0
0
0
NCT00798096
1COMPLETED
2010-04-01
2009-03-01
Rigel 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 ]
709
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
null
Major Depressive Disorder
Major Depressive Disorder
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 25 mg tablet, once daily dosing for 8 weeks intervention 2: 50 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 2: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 3: placebo
78
Arcadia | California | United States | -118.03534 | 34.13973 Beverly Hills | California | United States | -118.40036 | 34.07362 Cerritos | California | United States | -118.06479 | 33.85835 Garden Grove | California | United States | -117.94145 | 33.77391 Los Alamitos | California | United States | -118.07256 | 33.8030...
699
0
0
0
NCT00798707
1COMPLETED
2010-04-01
2008-12-01
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
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objectives: 1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib 2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL. Secondary Obje...
The Study Drugs: Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Bortezomib is designed to block a protein that plays a role in cell function and growt...
Lymphoma
Relapsed T-Cell Non-Hodgkin's Lymphoma Refractory T-Cell Non-Hodgkin's Lymphoma NHL T-cell NHL vorinostat SAHA Suberoylanilide Hydroxamic Acid MSK-390 Zolinza Bortezomib Velcade LDP-341 MLN341 PS-341 Peripheral T-cell lymphoma CD 30 + anaplastic large cell lymphoma Angioimmunoblastic T-cell lymphoma Angiocentric/nasal ...
null
1
arm 1: Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m\^2 intravenous (IV) on Days 1, 4, 8, 11.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study. intervention 2: Dose of 1.3 mg/m\^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.
intervention 1: Vorinostat intervention 2: Bortezomib
1
Houston | Texas | United States | -95.36327 | 29.76328
1
0
0
0
NCT00810576
6TERMINATED
2010-04-01
2009-01-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
182
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses. Secondary objectives were to evaluate the long-term effect on relapse rate, disability ...
The duration of the extension study per participants was 40 weeks broken down as follows: * 24-week double-blind treatment period, * 16-week post-treatment elimination follow-up period.
Multiple Sclerosis
null
6
arm 1: Placebo (for teriflunomide) once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 2: Teriflunomide 7 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks arm 3: Teriflunomide 14 mg once daily concomitantly with interferon-β \[IFN-β\] for 24 additional weeks a...
[ 2, 0, 0, 2, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Film-coated tablet Oral administration intervention 2: Film-coated tablet Oral administration intervention 3: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection intervention 4: Solution in prefilled syringe for subcutaneous injection
intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Interferon-β [IFN-β] intervention 4: Glatiramer Acetate [GA]
7
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Vienna | N/A | Austria | 16.37208 | 48.20849 Laval | N/A | Canada | -73.692 | 45.56995 Berlin | N/A | Germany | 13.41053 | 52.52437 Milan | N/A | Italy | 12.59836 | 42.78235 Barcelona | N/A | Spain | 2.15899 | 41.38879 Guildford | N/A | United Kingdom | -0...
239
0
0
0
NCT00811395
1COMPLETED
2010-04-01
2007-10-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.
The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment w...
Raynaud
Secondary Raynaud's Phenomenon
null
2
arm 1: Subjects will receive tadalafil 20mg every other day for the first month, and then placebo for the second month. arm 2: Subjects will receive placebo for the first month, and tadalafil 20mg orally every other day for the second month.
[ 0, 0 ]
1
[ 0 ]
intervention 1: Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil
intervention 1: Tadalafil
1
Chicago | Illinois | United States | -87.65005 | 41.85003
19
0
0
0
NCT00822354
1COMPLETED
2010-04-01
2008-09-01
Northwestern University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
216
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8 mg twice daily is superior to placebo in th...
null
Schizophrenia
Acute Exacerbation of Schizophrenia
null
3
arm 1: MK-8998, 6 mg twice a day (BID) for Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period arm 2: Olanzapine, 5 mg BID for Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period arm 3: Placebo Comparator to MK-8998 or olanzapine
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: MK-8998 6 mg capsules twice daily with food on Days 1 through 7. On Day 8, dosage will be increased to 8 mg capsules twice daily. Treatment period is 4 weeks. There will be a period of time when all participants will receive placebo. intervention 2: Olanzapine 5 mg tablets twice daily with food on Days ...
intervention 1: MK-8998 intervention 2: Comparator: Olanzapine intervention 3: Comparator: Placebo
0
null
216
0
0
0
NCT00827918
1COMPLETED
2010-04-01
2009-03-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for...
null
Non Insulin Dependent Diabetes Pregnancy
Non Insulin Dependent Diabetes Pregnancy
null
2
arm 1: Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. Aft...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education. They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy. At each clinic visit ...
intervention 1: Metformin intervention 2: Insulin
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
28
0
0
0
NCT00835861
1COMPLETED
2010-04-01
2008-08-01
University of North Carolina, Chapel Hill
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex; howev...
null
Retinal Disease
Central Serous Chorioretinopathy Finasteride Proscar Retinal Eye Disease
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Participants received 5mg of oral finasteride daily for three months.
intervention 1: Finasteride
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
5
0
0
0
NCT00837252
1COMPLETED
2010-04-01
2009-02-01
National Eye Institute (NEI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying th...
OBJECTIVES: Primary * Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma. * Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients. Secondary * Determine response of these patients after 90 days of treatment with sunitin...
Kidney Cancer
stage I renal cell cancer stage II renal cell cancer stage III renal cell cancer stage IV renal cell cancer
null
1
arm 1: None
[ 0 ]
3
[ 0, 3, 3 ]
intervention 1: oral intervention 2: IV intervention 3: Surgery
intervention 1: sunitinib malate intervention 2: neoadjuvant therapy intervention 3: therapeutic conventional surgery
1
Buffalo | New York | United States | -78.87837 | 42.88645
20
0
0
0
NCT00849186
1COMPLETED
2010-04-01
2007-08-01
Roswell Park Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purposes of this study are to assess whether subjects treated with BOTOX will: 1. have a decrease in the frequency and intensity of migraine headaches 2. experience improvements in quality of life 3. experience a reduction in the frequency of health care services obtained.
null
Migraine Headache
migraine headache Botulinum Toxin Type A BOTOX BTX-A
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: 100 Units - Dilution: 25U/ml (4:1 BOTOX/preservative free saline)
intervention 1: Botulinum Toxin Type A
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
35
0
0
0
NCT00850421
6TERMINATED
2010-04-01
2004-04-01
HealthPartners 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
[ 0 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
2MALE
false
The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.
The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two weeks. At ba...
Healthy Volunteers
growth hormone releasing hormone
null
1
arm 1: Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
[ 0 ]
1
[ 0 ]
intervention 1: Tesamorelin 2mg subcutaneous daily x 2 weeks
intervention 1: Growth Hormone Releasing Hormone (Tesamorelin)
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
13
0
0
0
NCT00850564
1COMPLETED
2010-04-01
2009-02-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg...
null
Genetic Disorders Hereditary Angioedema
null
1
arm 1: Weekly administration of 50 IU/kg Recombinant Human C1 Inhibitor
[ 5 ]
1
[ 0 ]
intervention 1: 50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period.
intervention 1: Recombinant Human C1 Inhibitor
2
Leiden | N/A | Netherlands | 4.49306 | 52.15833 Târgu Mureş | N/A | Romania | 24.55747 | 46.54245
25
0
0
0
NCT00851409
1COMPLETED
2010-04-01
2009-06-01
Pharming Technologies B.V.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
712
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.
null
Erectile Dysfunction
ED Erectile Dysfunction Dysfunction Erectile
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.
intervention 1: avanafil
40
Birmingham | Alabama | United States | -86.80249 | 33.52066 Homewood | Alabama | United States | -86.80082 | 33.47177 Tucson | Arizona | United States | -110.92648 | 32.22174 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 San Diego | Califor...
712
0
0
0
NCT00853606
1COMPLETED
2010-04-01
2009-03-01
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
[ 5 ]
232
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
Marcelle Cedars, M.D., Victor Fujimoto, M.D., Mitch Rosen, M.D., Heather Huddleston, M.D., Paolo Rinaudo, M.D., Anthony Dobson, M.D., and Shehua Shen, M.D. from the UCSF Department of Obstetrics and Gynecology and Reproductive Sciences are conducting a study to learn about ovarian stimulation and oocyte maturation to i...
We observe during (In vitro fertilization) IVF, there are deviations in oocyte morphology and maturity within an individual cohort and that oocyte degeneration, and failed fertilization exist. Regardless, even if fertilization occurs, a large proportion of embryos fail to progress through the pre-implantation stages of...
Infertility
Infertility Pregnancy in vitro fertilization
null
2
arm 1: Bravelle arm 2: Saline
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger. intervention 2: 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
intervention 1: Bravelle(follicle stimulating hormone) intervention 2: Saline ( placebo)
1
San Francisco | California | United States | -122.41942 | 37.77493
188
0
0
0
NCT00854373
1COMPLETED
2010-04-01
2006-06-01
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
[ 5 ]
255
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.
null
Type 2 Diabetes Mellitus
diabetes exenatide Byetta sitagliptin Januvia Amylin Lilly
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day intervention 2: exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day
intervention 1: exenatide and sitagliptin intervention 2: exenatide and placebo
36
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Morón | N/A | Argentina | -58.62205 | -34.65118 Adelaide | N/A | Australia | 138.59863 | -34.92866 Geelong | N/A | Australia | 144.36069 | -38.14711 Melbourne | N/A | Australia | 144.96332 | -37.814 Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Aßlar | N/A | G...
255
0
0
0
NCT00870194
1COMPLETED
2010-04-01
2009-03-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
null
Hot Flashes
hot flashes hot flushes vasomotor symptoms postmenopausal
null
5
arm 1: Oral once a day for 28 days arm 2: Oral once a day for 28 days arm 3: Oral once a day for 28 days arm 4: Oral once a day for 28 days arm 5: Oral once a day for 28 days
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 10 mg Oral once a day for 28 days. intervention 2: 25 mg Oral once a day for 28 days intervention 3: 50 mg Oral once a day for 28 days. intervention 4: 100 mg Oral once a day for 28 days intervention 5: Placebo Oral once a day for 28 days
intervention 1: RAD1901 intervention 2: RAD1901 intervention 3: RAD1901 intervention 4: RAD1901 intervention 5: Placebo
1
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
100
0
0
0
NCT00875420
1COMPLETED
2010-04-01
2009-03-01
Radius Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.
This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/...
Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma
Epithelial Ovarian Cancer FIGO (International Fed of Gyn and Ob)Stage III or Stage IV Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma Failing
null
1
arm 1: Administration of Ontak IV for treatment of epithelial ovarian cancer
[ 0 ]
1
[ 0 ]
intervention 1: Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
intervention 1: Ontak
1
San Antonio | Texas | United States | -98.49363 | 29.42412
19
0
0
0
NCT00880360
1COMPLETED
2010-04-01
2007-02-01
The University of Texas Health Science Center at San Antonio
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
188
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
null
Dry Eye Syndromes
null
2
arm 1: Instillation,4 times/day for 4 weeks arm 2: Instillation,6 times/day for 4 weeks
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: OPC-12759 Ophthalmic suspension 2% intervention 2: Hyalein Mini Ophthalmic solution 0.1%
intervention 1: OPC-12759 Ophthalmic suspension intervention 2: Hyalein Mini Ophthalmic solution
5
Kagoshima | N/A | Japan | 130.55 | 31.56667 Matsuyama | N/A | Japan | 132.76574 | 33.83916 Nagoya | N/A | Japan | 136.90641 | 35.18147 Osaka | N/A | Japan | 135.50107 | 34.69379 Tokyo | N/A | Japan | 139.69171 | 35.6895
188
0
0
0
NCT00885079
1COMPLETED
2010-04-01
2009-05-01
Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This research study will evaluate the effects of aspirin and dipyridamole alone and in combination on the blood flow in the vessels of the legs. We will examine how these medications are able to inhibit the clotting of platelets in the vessels of patients with PAD, and thereby affect the blood flow in the legs. Platele...
Dipyridamole has been reformulated to guarantee systemic bioavailability and steady state levels compatible with inhibition of platelet aggregation ex vivo (1). This newly formulated dipyridamole has been shown to roughly equal in efficacy to low dose aspirin in the secondary prevention of stroke and the drug combinati...
Peripheral Arterial Disease
Peripheral Arterial Disease PAD Claudication Peripheral Vascular Disease
null
3
arm 1: All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vita...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study. intervention 2: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately ...
intervention 1: Dipyridamole 200mg and Aspirin 25mg bid: intervention 2: Dipyridamole 200 mg bid intervention 3: Aspirin 25 mg bid
3
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
25
0
0
0
NCT00906035
6TERMINATED
2010-04-01
2002-09-01
University of Pennsylvania
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
894
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressu...
null
Hypertension
null
2
arm 1: Telmisartan 80 mg arm 2: Telmisartan80mg/Hydrochlorothiazide25mg
[ 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Telmisartan 80mg intervention 2: Telmisartan 80mg intervention 3: Hydrochlorothiazide25mg
intervention 1: Telmisartan intervention 2: Telmisartan intervention 3: Hydrochlorothiazide
106
Athens | Alabama | United States | -86.97219 | 34.80243 Mobile | Alabama | United States | -88.04305 | 30.69436 Lomita | California | United States | -118.31507 | 33.79224 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Louisville | Ke...
888
0
0
0
NCT00926289
1COMPLETED
2010-04-01
2009-06-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
170
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study is designed to examine the effects of combined buprenorphine and voucher incentives to promote abstinence from illicit opiate use, along with or without computer-delivered therapy, during treatment of opioid dependence.
The Community Reinforcement Approach (CRA) with contingency management (CM) is a widely researched and demonstrably efficacious drug abuse treatment. This treatment is derived from drug self-administration research and a behavioral analysis of drug dependence, where abused drugs are thought to compete successfully with...
Opiate Addiction
Opioid Dependence Opiates Hydrocodone Oxycodone Oxycontin Narcotic Abuse
null
2
arm 1: In this arm, participants are administered Suboxone and therapy is delivered by a computer. Fluency training is provided. The participant then listens through headphones and reads the information on the screen. They progress through various modules that involve education regarding high risk situations for potent...
[ 1, 1 ]
4
[ 0, 5, 5, 5 ]
intervention 1: Dosage Form: Oral Tablet; Dosage 6, 12, or 18 mg; Frequency; Daily; Duration 12 weeks intervention 2: Computer-delivered Community Reinforcement Approach intervention 3: Therapist-delivered therapy intervention 4: Contingency management (vouchers) for providing a drug negative urine sample.
intervention 1: Suboxone intervention 2: CRA intervention 3: Therapy intervention 4: CM
1
Little Rock | Arkansas | United States | -92.28959 | 34.74648
170
0
0
0
NCT00929253
1COMPLETED
2010-04-01
2007-09-01
Virginia Polytechnic Institute and State University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
99
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
null
Pulmonary Disease, Chronic Obstructive
null
4
arm 1: BI1744 Low Dose once daily arm 2: BI 1744 Med Dose once daily arm 3: Placebo once daily arm 4: Foradil 12 mcg twice daily
[ 0, 0, 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: BI1744 Respimat Med Dose Once Daily intervention 2: 1744 low dose intervention 3: Placebo Respimat and Foradil Placebo intervention 4: Foradil 12 mcg twice daily and Placebo Respimat
intervention 1: BI 1744 intervention 2: bi1744 intervention 3: Placebo intervention 4: Foradil
11
Tampa | Florida | United States | -82.45843 | 27.94752 Overland Park | Kansas | United States | -94.67079 | 38.98223 Lafayette | Louisiana | United States | -92.01984 | 30.22409 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Easley | South Caroli...
376
0
0
0
NCT00931385
1COMPLETED
2010-04-01
2009-06-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not been assessed. The aim of the present st...
Hypercholesterolemia is a major risk factor for atherosclerosis and coronary heart disease (CHD).\[1\] Epidemiological and clinical studies have demonstrated that aggressive lowering of low-density lipoprotein cholesterol (LDL-C) reduces morbidity and mortality in patients with or without CHD.\[1-3\] LDL consists of an...
Hypercholesterolemia
hypercholesterolemia statins simvastatin ezetimibe LDL particles
null
2
arm 1: All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg (n=50) or simvastatin/ezetimibe 10/10 mg (n=50) dail...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: SIMVASTATIN 40 mg/day for 3 months intervention 2: SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months
intervention 1: SIMVASTATIN 40 mg intervention 2: SIMVASTATIN/EZETIMIBE 10/10 mg
1
Ioannina | Ioannina | Greece | 20.85189 | 39.66486
100
0
0
0
NCT00932620
1COMPLETED
2010-04-01
2009-06-01
University of Ioannina
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 ]
96
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is: * To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control. * To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.
null
Stroke
null
4
arm 1: hCG 385 µg (10,000 international unit \[IU\]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation arm 2: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of...
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation intervention 2: hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation intervention 3: h...
intervention 1: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 2: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 3: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) intervention 4: Saline Placebo
23
Orange | California | United States | -117.85311 | 33.78779 Calgary | Alberta | Canada | -114.08529 | 51.05011 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Toronto | Ontario | Canada | -79.39864 | 43.70643 Montreal | Quebec | Canada | -73.58781 | 45.50884 Guntur | Andhra Pradesh | India | 80.45729 | 16.29974 H...
96
0
0
0
NCT00938314
6TERMINATED
2010-04-01
2009-08-01
Stem Cell Therapeutics Corp.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
306
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.
null
Dental Pain
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 1, 2 ]
4
[ 0, 0, 0, 10 ]
intervention 1: 1 single injection at day of dental surgical extraction intervention 2: 1 single injection at day of dental surgical extraction intervention 3: 1 single injection at day of dental surgical extraction intervention 4: 1 single injection at day of dental surgical extraction
intervention 1: Diclofenac HPBCD intervention 2: Diclofenac HPBCD intervention 3: Diclofenac HPBCD intervention 4: Placebo s.c.
6
Kobyłka | N/A | Poland | 21.19589 | 52.33953 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Zgierz | N/A | Poland | 19.40623 | 51.85561 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 London | N/A | United Kingdom | -0.12574 | 51.50853
306
0
0
0
NCT00942448
1COMPLETED
2010-04-01
2009-09-01
IBSA Institut Biochimique SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
805
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
true
0ALL
null
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Participants will inclu...
Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization to declare a pandemic on June 11, 2009. Data from several cohorts in...
Influenza
H1N1, influenza A viruses, vaccine, elderly, TIV
null
4
arm 1: 200 subjects (100 ages 18-64 years and 100 aged greater than or equal to 65 years) to receive: Day 0, 15 mcg H1N1 Vaccine + placebo; Day 21, 15 mcg H1N1 Vaccine + trivalent influenza vaccine (TIV); and Day 42, placebo. arm 2: 200 subjects (100 ages 18-64 years and 100 aged greater than or equal to 65 years) to r...
[ 0, 0, 0, 0 ]
3
[ 2, 2, 0 ]
intervention 1: Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle. intervention 2: Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle. interve...
intervention 1: Trivalent inactivated influenza vaccine intervention 2: Inactivated H1N1 Vaccine intervention 3: Placebo
5
Decatur | Georgia | United States | -84.29631 | 33.77483 St Louis | Missouri | United States | -90.19789 | 38.62727 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Nashville | Tennessee | United States | -86.78444 | 36.16589 Houston | Texas | United States | -95.36327 | 29.76328
805
0
0
0
NCT00943878
1COMPLETED
2010-04-01
2009-08-01
National Institute of Allergy and Infectious Diseases (NIAID)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
98
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to s...
Moderate to Severe Pain Due to Diabetic Polyneuropathy
null
2
arm 1: A placebo tablet to match the active reference treatment arm 2: Oxycodone Naloxone tablets
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Oxycodone Naloxone tablets intervention 2: Placebo Oxycodone Naloxone tablets
intervention 1: Oxycodone Naloxone intervention 2: Placebo tablets
1
Ludwigshafen | N/A | Germany | 9.06138 | 47.81663
98
0
0
0
NCT00944697
1COMPLETED
2010-04-01
2009-07-01
Mundipharma Research GmbH & Co KG
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.
null
Schizophrenia
Acute schizophrenia
null
1
arm 1: Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.
[ 0 ]
1
[ 0 ]
intervention 1: Tablet, oral, once daily
intervention 1: Quetiapine XR (Seroquel XR)
2
Johor Bahru | Johor Bahru | Malaysia | 103.7578 | 1.4655 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412
35
0
0
0
NCT00954122
1COMPLETED
2010-04-01
2009-09-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purposes of this study are to evaluate the safety and tolerability of neratinib in combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary information on whether the combination of the two drugs h...
null
Advanced Malignant Solid Tumors
HKI-272 Vinorelbine Combination Solid Tumor Neratinib Nerlynx PB-272
null
1
arm 1: Neratinib: 240 mg administered daily by mouth continuously, Vinorelbine: 25 mg/m\^2 administered IV on Day 1 and 8 of 21 day cycle
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Neratinib intervention 2: Vinorelbine
2
Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895
6
0
0
0
NCT00958724
1COMPLETED
2010-04-01
2009-07-01
Puma Biotechnology, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study aims to determine whether citalopram is a useful, well-tolerated, and safe treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The study hypothesis is that citalopram will be better than placebo in producing clinical improvement and reductions in abdominal pain. It is al...
This study aims to determine the relative efficacy, tolerability, and safety of the citalopram in the treatment of pediatric functional recurrent abdominal pain (FAP) in children and adolescents ages 7 to 18 years, inclusive. The goal is to recruit and randomize 100 subjects to citalopram or placebo. Secondary aims inc...
Abdominal Pain Anxiety
Abdominal Pain Anxiety
null
2
arm 1: Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2). arm 2: Placebo administered in capsules identical to those containing citalopra...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects. interve...
intervention 1: Citalopram intervention 2: Placebo
1
Columbus | Ohio | United States | -82.99879 | 39.96118
81
0
0
0
NCT00962039
1COMPLETED
2010-04-01
2004-07-01
John V. Campo, 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
[ 0 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
This study is a pilot study examining the effect of extended-release niacin (Niaspan ®) on flow-mediated vasodilation (FMD) of the brachial artery, among human immunodeficiency virus (HIV)-1 infected individuals with low high density lipoprotein (HDL). Brachial artery diameter will be measured by high-resolution ultras...
Low high density lipoprotein (HDL) and a lipid pattern consistent with atherogenic dyslipidemia are also common in the human immunodeficiency virus (HIV)infected population and is likely due, in large part, to the chronic inflammatory effect of HIV infection per se. While highly active antiretroviral therapy (HAART) an...
HIV Infections Dyslipidemia Endothelial Dysfunction
Human immunodeficiency virus Low high density lipoprotein Endothelial function Flow-mediated vasodilation
null
2
arm 1: Subjects in this arm will be given 12 weeks of extended release niacin. Intervention: extended release niacin (Niaspan) starting at 500 mg by mouth daily and titrated to a maximum dose of 1500 mg by mouth daily. Titration will depend on patient tolerability. arm 2: Subjects in this arm will be monitored for 12 w...
[ 0, 4 ]
1
[ 0 ]
intervention 1: Active arm subjects will start extended release niacin (Niaspan) at 500 mg per night (by mouth once a daily) and titrate to a maximum tolerated dose (not exceeding 1500 mg per night (by mouth once a day) for 12 weeks. Titration will depend on patient tolerability of Niaspan.
intervention 1: extended release niacin
1
Honolulu | Hawaii | United States | -157.85833 | 21.30694
20
0
0
0
NCT00986986
1COMPLETED
2010-04-01
2007-11-01
University of Hawaii
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 ]
190
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.
null
Healthy Volunteers
Endoscopy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Celecoxib 100mg tablet twice a day with meal for 2 weeks intervention 2: Loxoprofen 60mg tablet three times a day with meal for 2 weeks intervention 3: Placebo tablet three times a day with meal for 2 weeks
intervention 1: Celecoxib intervention 2: Loxoprofen intervention 3: Placebo
3
Yokohama | Kanagawa | Japan | 139.65 | 35.43333 Minato-ku | Tokyo | Japan | N/A | N/A Shinjuku-ku | Tokyo | Japan | N/A | N/A
189
0
0
0
NCT00994461
1COMPLETED
2010-04-01
2009-11-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
165
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).
null
Glaucoma, Open-Angle Ocular Hypertension
null
4
arm 1: One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. arm 2: One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29...
[ 0, 0, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. intervention 2: One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the eveni...
intervention 1: AGN-210669 ophthalmic solution, 0.1% intervention 2: AGN-210669 ophthalmic solution, 0.075% intervention 3: AGN-210669 ophthalmic solution, 0.05% intervention 4: bimatoprost ophthalmic solution 0.03%
1
Rochester | New York | United States | -77.61556 | 43.15478
165
0
0
0
NCT01001195
1COMPLETED
2010-04-01
2009-11-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 5 ]
62
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.
null
Liver Transplantation Postreperfusion Syndrome
null
2
arm 1: The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft. arm 2: The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 0.2 mg/kg as bolus 1 minute before reperfusion intervention 2: 10 ml of normal saline
intervention 1: Nafamostat intervention 2: Normal saline
1
Seoul | Seoul | South Korea | 126.9784 | 37.566
62
0
0
0
NCT01001403
1COMPLETED
2010-04-01
2009-03-01
Seoul National University Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
50
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
false
The primary objective of this study is to determine the alterations in quality of life and self-esteem after BOTOX® injections in the glabella in depressed and non-depressed patients. The secondary objective of this study are: * to assess wrinkles improvement * to evaluate depressive symptoms using Beck Depression In...
The study consists of two groups: one with diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and other without diagnosis of depression. Subjects with depression will be part of group 1. They must be using a therapeutic dose of antidep...
Depression Quality of Life
Depression Botulinum toxin Glabella Quality of life Self-steem
null
2
arm 1: Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist. arm 2: Subjects with no diagnosis of depressio...
[ 1, 1 ]
1
[ 0 ]
intervention 1: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.
intervention 1: Botulinum Toxin Type A
1
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
50
0
0
0
NCT01004042
1COMPLETED
2010-04-01
2009-10-01
Brazilan Center for Studies in Dermatology
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
288
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
null
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.
null
Dry Eye Syndrome
null
3
arm 1: Glycerin and Polysorbate 80 based artificial tear arm 2: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear arm 3: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
[ 1, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1-2 drops in each eye, as needed, but at least twice daily intervention 2: 1-2 drops in each eye, as needed, but at least twice daily intervention 3: 1-2 drops in each eye, as needed, but at least twice daily
intervention 1: Glycerin and Polysorbate 80 based artificial tear intervention 2: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear intervention 3: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
1
San Diego | California | United States | -117.16472 | 32.71571
288
0
0
0
NCT01010282
1COMPLETED
2010-04-01
2009-11-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
36
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharm...
null
Primary Hypercholesterolemia Mixed Hyperlipidemia
null
3
arm 1: In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). ...
[ 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets intervention 2: 81 mg oral tablet once daily for 7 days intervention 3: 75 mg oral tablet once daily for 7 days intervention 4: 40 mg oral tablet once daily for 7 days intervention 5: placebo oral tablet once daily fo...
intervention 1: niacin (+) laropiprant intervention 2: Comparator: aspirin intervention 3: Comparator: clopidogrel intervention 4: Comparator: laropiprant intervention 5: Comparator: placebo
0
null
92
0
0
0
NCT01012219
1COMPLETED
2010-04-01
2009-11-01
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
[ 5 ]
246
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.
Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and ...
Migraine
migraine treatment satisfaction
null
1
arm 1: Single arm study (Sumavel DosePro)
[ 5 ]
2
[ 1, 0 ]
intervention 1: Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration intervention 2: subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
intervention 1: Sumavel DosePro intervention 2: Sumatriptan
21
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Newport Beach | California | United States | -117.92895 | 33.61891 Santa Monica | California | United States | -118.49138 | 34.01949 Boulder | Colorado | United States | -105.27055 | 40.01499 Pembroke P...
242
0
0
0
NCT01016834
1COMPLETED
2010-04-01
2009-11-01
Zogenix, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.
This is a single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately 40 male and female subjects will be enrolled (...
Acne Vulgaris
null
2
arm 1: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene arm 2: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene intervention 2: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
intervention 1: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene intervention 2: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
0
null
40
0
0
0
NCT01016977
1COMPLETED
2010-04-01
2009-10-01
Stiefel, a GSK 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 ]
247
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
null
Major Depressive Disorder
Depression
null
3
arm 1: The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only. arm 2: The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in...
[ 0, 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 15 mg, oral, twice daily (BID) intervention 2: 20 mg, oral, once daily (QD) intervention 3: Placebo capsules to match AZD7268 intervention 4: Placebo tablets to match encapsulated escitalopram
intervention 1: AZD7268 intervention 2: Escitalopram intervention 3: Placebo capsules intervention 4: Placebo tablets
17
Birmingham | Alabama | United States | -86.80249 | 33.52066 Garden Grove | California | United States | -117.94145 | 33.77391 San Diego | California | United States | -117.16472 | 32.71571 New Haven | Connecticut | United States | -72.92816 | 41.30815 Bradenton | Florida | United States | -82.57482 | 27.49893 Jacksonvi...
245
0
0
0
NCT01020799
1COMPLETED
2010-04-01
2009-11-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
20
RANDOMIZED
CROSSOVER
null
0NONE
true
2MALE
false
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
To support Linezolid NDA in China.
Healthy Volunteers
Bio-equivalence Linezolid OS Linezolid tablet
null
2
arm 1: Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG. arm 2: Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: 1. Linezolid OS 600 MG 2. Linezolid Tablet 600 MG intervention 2: 1. Linezolid Tablet 600 MG 2. Linezolid OS 600 MG
intervention 1: Linezolid intervention 2: Linezolid
1
Shanghai | N/A | China | 121.45806 | 31.22222
40
0
0
0
NCT01055769
1COMPLETED
2010-04-01
2010-03-01
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
[ 5 ]
115
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).
This is 12 week, open label (all people involved know the identity of the intervention), prospective (study following participants forward in time), single arm, multicenter study (when more than one hospital or medical school team work on a medical research study) of OROS methylphenidate HCl. The study will consist of ...
Attention Deficit Disorder With Hyperactivity
Attention Deficit Hyperactivity Disorder Methylphenidate hydrochloride Methylphenidate CONCERTA
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depe...
intervention 1: OROS Methylphenidate HCl
0
null
113
0
0
0
NCT01060150
1COMPLETED
2010-04-01
2008-07-01
Janssen Korea, Ltd., Korea
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
The purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating cholestyramine and Tang to determine the accuracy...
The primary objective of this study is to evaluate patient acceptability of 2 doses of orange-flavored generic Questran (cholestyramine) versus orange-flavored Tang Drink Mix (a commercial powdered orange drink without cholestyramine) via 2 BASA scales. A second objective is to assess the 2 different versions of the BA...
Healthy
Bile acid sequestrant Resin Cholesterol Diabetes mellitus Lipids Glucose Bile Acid Sequestrant Acceptability Scale (BASA)validation study
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Cholestyramine 4 grams one time dose intervention 2: Cholestyramine 12 grams one dose, one day intervention 3: Tang one dose one day
intervention 1: Cholestyramine intervention 2: Cholestyramine intervention 3: Tang
1
Louisville | Kentucky | United States | -85.75941 | 38.25424
126
0
0
0
NCT01062269
1COMPLETED
2010-04-01
2010-01-01
Louisville Metabolic and Atherosclerosis Research Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
28
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
null
Type 2 Diabetes Mellitus
null
4
arm 1: 500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition arm 2: 500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition arm 3: 1000 mg metformin (Diabex): Single oral dose of 1000 mg metfo...
[ 5, 5, 5, 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Tablets, Oral, 500 mg, Once daily, single dose intervention 2: Tablets, Oral, 500 mg, Once Daily, single dose intervention 3: Tablets, Oral, 1000 mg, Once daily, single dose intervention 4: Tablets, Oral, 1000 mg, Once daily, single dose
intervention 1: metformin (Diabex) intervention 2: metformin (Glucophage™) intervention 3: metformin (Glucophage™) intervention 4: metformin (Diabex)
1
Austin | Texas | United States | -97.74306 | 30.26715
109
0
0
0
NCT01068730
1COMPLETED
2010-04-01
2010-02-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
6
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
2MALE
false
The rationale for this study is to investigate the absorption, metabolism and excretion of \[14C\]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any metabolites, if possible, of \[14C\]PF 02341066 in humans.
null
Healthy Volunteer
radiolabeled healthy volunteers
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: oral suspension, single 250 mg dose of PF 02341066 containing approximately 100 µCi of \[14C\]PF 02341066
intervention 1: PF-02341066
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
6
0
0
0
NCT01082380
1COMPLETED
2010-04-01
2010-03-01
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
[ 4 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
This is a single blind, single dose, crossover study to investigate the relative efficacy of terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is to investigate safety of terbutaline Turbuhal...
null
Asthma
Terbutaline Turbuhaler Efficacy Asthma Japanese salbutamol Bricanyl
null
2
arm 1: Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler® arm 2: salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
[ 0, 0 ]
4
[ 0, 0, 10, 10 ]
intervention 1: 0.4 mg, inhalation, single dose intervention 2: 200 μg, inhalation, single dose intervention 3: Placebo pMDI 2 inhalations intervention 4: Placebo Turbuhaler 1 inhalation
intervention 1: Terbutaline Turbuhaler® intervention 2: Salbutamol pMDI intervention 3: pMDI placebo pMDI intervention 4: Placebo Turbuhaler®
1
Tokyo | N/A | Japan | 139.69171 | 35.6895
46
0
0
0
NCT01096017
1COMPLETED
2010-04-01
2010-03-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
45
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
2MALE
false
This clinical study will attempt to find out why in early studies in healthy volunteers, injections under the skin of pasireotide were associated with temporary increases in both fasting and post-meal glucose levels, along with possible increases in insulin and glucagon levels. Glucose refers to the amount of sugar in ...
This was a Phase 2, double-blinded, single-center study to assess the effects of pasireotide on insulin secretion and glucose metabolism in healthy male volunteers. Subjects who had given written informed consent and had been shown to satisfy the inclusion and exclusion criteria underwent baseline tests. An oral glucos...
Hyperglycemia
null
3
arm 1: n=19. Pasireotide 600 µg sc bid arm 2: n=19. Pasireotide 900 µg sc bid arm 3: n=7. Due to increased severity of gastro-intestinal side effects, this arm was discontinued. These participants were only included in the safety analysis.
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Pasireotide 600 μg (batch number Y050DE) or 900 μg bid (batch number Y1270908) for subcutaneous injection. Placebo (batch number Y069HC) for subcutaneous injection.
intervention 1: pasireotide
1
San Diego | California | United States | -117.16472 | 32.71571
45
0
0
0
NCT01128192
1COMPLETED
2010-04-01
2009-08-01
Robert R. Henry, 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 ]
480
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
Not required
Acne
null
3
arm 1: treatment of acne for 12 weeks arm 2: Treatment of acne for 12 weeks arm 3: Treatment if acne for 12 weeks as placebo
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Treatment of acne vulgaris intervention 2: Treatment of acne vulgaris intervention 3: treatment of acne vulgaris
intervention 1: Tretinoin microsphere 0.1% intervention 2: Brand Retin-A Micro tretinoin microsphere gel 0.1% intervention 3: placebo microsphere gel
1
Land O' Lakes | Florida | United States | -82.45759 | 28.2189
480
0
0
0
NCT01135069
1COMPLETED
2010-04-01
2009-10-01
Spear 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 ]
90
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on ...
null
Colorectal Cancer
null
1
arm 1: None
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Oral repeating dose intervention 4: Oral repeating dose
intervention 1: bevacizumab [Avastin] intervention 2: eloxatin intervention 3: capecitabine [Xeloda] intervention 4: erlotinib [Tarceva]
12
Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939 Sabadell, Barcelona | Barcelona | Spain | N/A | N/A Terrassa | Barcelona | Spain | 2.01667 | 41.56667 Burgos | Burgos | Spain | -3.70184 | 42.34106 Santander | Cantabria | Spain | -3.80444 | 43.46472 Huesca | Huesca | Spain | -0.4087 | 42.13615 Jaén | Ja...
90
0
0
0
NCT01135498
1COMPLETED
2010-04-01
2006-11-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
386
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.
The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due to the considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an importa...
Acute Rhinosinusitis
BNO 1016, acute rhinosinusitis
null
2
arm 1: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days arm 2: sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days intervention 2: sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
intervention 1: BNO 1016 intervention 2: Placebo
1
Puchheim | N/A | Germany | 11.35 | 48.15
385
0
0
0
NCT01146860
1COMPLETED
2010-04-01
2010-01-01
Bionorica SE
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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
7BASIC_SCIENCE
3TRIPLE
true
0ALL
false
Insulin resistance is a common condition that can lead to type 2 diabetes. One of the commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that rosiglitazone may work by increasing blood vessel growth i...
Adipocytes play a crucial role in the control of metabolic homeostasis, by sequestering excess calories in the form of triglycerides, and secreting cytokines that control systemic fuel utilization. Sustained excess calorie consumption results in adipocyte hypertrophy and hyperplasia, and like any expanding tissue, requ...
Metabolic Syndrome Insulin Resistance
null
2
arm 1: One 8mg capsule daily for 6 weeks. arm 2: One capsule daily for 6 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: One 8mg capsule daily for 6 weeks. intervention 2: One capsule daily for 6 weeks.
intervention 1: Rosiglitazone intervention 2: Placebo
1
Worcester | Massachusetts | United States | -71.80229 | 42.26259
35
0
0
0
NCT01150981
1COMPLETED
2010-04-01
2006-11-01
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 ]
76
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is defined by insufficient treatment response after a minimum of 1 week therapy with the maximum labelled dose of a non-sedating antihista...
null
Chronic Urticaria
urticaria
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 50 or 100 or 150mg per day intervention 2: Placebo
intervention 1: Miltefosine intervention 2: Placebo
1
Berlin | N/A | Germany | 13.41053 | 52.52437
76
0
0
0
NCT01170949
6TERMINATED
2010-04-01
2008-09-01
Marcus Maurer
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 ]
47
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers. Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.
null
Healthy Subjects
null
2
arm 1: Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3. arm 2: Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: 1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol intervention 2: IV DHE administered at Visit 2 or 3 as per protocol
intervention 1: MAP0004 intervention 2: IV DHE
1
Merthyr Tydfil | Merthyr Tydfil | United Kingdom | -3.37779 | 51.74794
93
0
0
0
NCT01199965
1COMPLETED
2010-04-01
2010-01-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
500
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of great importance for treatment following coronary stenting. Unfortunately the variable platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet therapy. The aim of this prospective single centre...
Platelet function testing using whole blood aggregometry was performed 48 hours following coronary stenting (either acute coronary syndromes or stable coronary artery disease). The antiplatelet therapy included a loading dose of 600 mg clopidogrel and 500 mg ASA, followed by 75 mg clopidogrel and 100 mg ASA once daily....
Coronary Artery Disease
Clopidogrel ASA Low Response Resistance
null
1
arm 1: If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
[ 0 ]
1
[ 0 ]
intervention 1: ASA 100 mg, ASA 300 mg, ASA 500 mg Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List: In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or pra...
intervention 1: Optimizing ASA and clopidogrel treatment
1
Bochum | North Rhine-Westphalia | Germany | 7.21648 | 51.48165
504
0
0
0
NCT01212302
1COMPLETED
2010-04-01
2008-10-01
Ruhr University of Bochum
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 ]
120
NON_RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Clinical aim: Does reducing the dose of local anesthetic in ultrasound-guided axillary plexus anesthesia have any effect on the success rate and additional parameters of block quality? Methodology: In this prospective cohort study three groups of 40 outpatients each were administered dosages of 1% prilocaine of either ...
Background With the availability of high resolution portable ultrasound equipment, the use of sonography in the field of anesthesia has become more widespread in recent years. The investigators would like to draw attention to a meta-analysis of prospective randomized studies by Abrahams et al. as being representative ...
Other Surgical Procedures
ultrasound methaemoglobin prilocaine regional anesthesia ASA risk groups I-II adult outpatients surgical spectrum covered procedures distal forearm hand
null
3
arm 1: 40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block arm 2: 40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block arm 3: 40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
[ 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg). intervention 2: 40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block intervention 3: 40 outpatients : 30ml prilocaine 1% were...
intervention 1: midazolam intervention 2: prilocaine 1% intervention 3: prilocaine 1% intervention 4: prilocaine 1%
0
null
120
0
0
0
NCT01309360
1COMPLETED
2010-04-01
2009-09-01
Helios Research Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Upper gastrointestinal endoscopy, like many other diagnostic and therapeutic procedures, may be associated with discomfort. Although upper endoscopy is usually of shorter duration and better tolerated by patients, most trials investigating the influence of analgesia and sedation have been performed on patients undergoi...
Aims: This study aims to evaluate sedative effects using intranasal dexmedetomidine in upper gastrointestinal endoscopy. The investigators aim to evaluate the efficacy, side effects and acceptability of sedation using intranasal dexmedetomidine by patients and endoscopist for upper gastrointestinal endoscopy. Methods...
Gastrointestinal Disease
null
2
arm 1: Normal saline was given intranasally arm 2: 1.5mcg dexmedetomidine was given intranasally before procedure
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Dexmedetomidine 1.5mcg/kg was given intranasally intervention 2: Intranasal saline was given
intervention 1: Dexmedetomidine intervention 2: Placebo
0
null
50
0
0
0
NCT01887184
1COMPLETED
2010-04-01
2009-01-01
The University of Hong Kong
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 ]
68
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study examined the influence of ribavirin on the initial virological response in treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000 milligrams (mg) to 1200 mg orally daily depending on body weight...
null
Hepatitis C, Chronic
null
3
arm 1: Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks. arm 2: Participants with chronic hepatitis C, genotype 1, received ribavirin matc...
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Pegylated interferon (PEG-IFN) alfa-2a (40 kilodalton \[KD\]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy. intervention 2: Ribavirin matching placebo orally (PO) twice daily for 6 weeks. intervention 3: Ribavirin, 1000 mg oral...
intervention 1: Pegylated Interferon (PEG-IFN) alfa-2a intervention 2: Placebo intervention 3: Ribavirin
5
Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Hanover | N/A | Germany | 9.73322 | 52.37052 Homburg/ Saar | N/A | Germany | N/A | N/A
132
0
0
0
NCT02716779
1COMPLETED
2010-04-01
2007-04-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
82
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Vi...
null
Eosinophilic Esophagitis (EoE)
eosinophilic esophagitis
null
4
arm 1: None arm 2: Low Dose Group arm 3: Medium Dose Group arm 4: High Dose Group
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: oral suspension intervention 2: oral suspension matching budesonide
intervention 1: budesonide intervention 2: placebo
20
Phoenix | Arizona | United States | -112.07404 | 33.44838 Orange | California | United States | -117.85311 | 33.78779 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 Aurora | Colorado | United States | -104.83192 | 39.72943 Atlanta | Georgia ...
81
0
0
0
NCT00762073
1COMPLETED
2010-04-02
2009-01-08
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
null
Endometriosis
Endometriosis pain tanezumab nerve growth factor questionnaires
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 2, 0 ]
intervention 1: 15 mg IV single dose intervention 2: Placebo IV single dose
intervention 1: Tanezumab intervention 2: Placebo
30
Mobile | Alabama | United States | -88.04305 | 30.69436 Mobile | Alabama | United States | -88.04305 | 30.69436 Mobile | Alabama | United States | -88.04305 | 30.69436 Tucson | Arizona | United States | -110.92648 | 32.22174 San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United ...
47
0
0
0
NCT00784693
6TERMINATED
2010-04-05
2008-12-18
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 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
2MALE
false
The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral dose...
null
Polysomnography
null
4
arm 1: For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064. Part...
[ 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Oral MK-1064 tablets (10 and 50 mg strengths) intervention 2: Oral MK-6096 tablets (5 mg strength) intervention 3: Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
intervention 1: MK-1064 intervention 2: MK-6096 intervention 3: Placebo
0
null
94
0
0
0
NCT02549027
1COMPLETED
2010-04-06
2009-11-06
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 ]
52
RANDOMIZED
CROSSOVER
9OTHER
2DOUBLE
false
0ALL
false
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered onc...
null
Diabetes Mellitus, Type 2 Adult
null
4
arm 1: Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 2: Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM f...
[ 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose intervention 2: Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day intervention 3: Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose intervention 4: Ertuglifl...
intervention 1: Ertugliflozin 2 mg single dose intervention 2: Ertugliflozin 2 mg split into twice daily intervention 3: Ertugliflozin 4 mg single dose intervention 4: Ertugliflozin 4 mg split into twice daily intervention 5: Placebo
0
null
103
0
0
0
NCT01054300
1COMPLETED
2010-04-07
2010-02-17
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
41
RANDOMIZED
PARALLEL
2DIAGNOSTIC
0NONE
true
0ALL
false
The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.
It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the...
Nephropathy
contrast induced nephropathy
null
2
arm 1: Oral N-Acetylcysteine 600 mg arm 2: Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 600 milligrams (mg) intervention 2: 3 milliliters per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure
intervention 1: Oral N-Acetylcysteine intervention 2: Sodium Bicarbonate
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
41
0
0
0
NCT00579995
6TERMINATED
2010-04-08
2005-05-01
University of Nebraska
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
RANDOMIZED
null
0TREATMENT
2DOUBLE
true
1FEMALE
false
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
null
Scar Prevention
Scarring Cicatrix Fibrosis Pathologic Process
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Multiple intradermal injections of EXC 001 and placebo intervention 2: Multiple intradermal injections of EXC 001 and placebo
intervention 1: EXC 001 intervention 2: Placebo
5
La Jolla | California | United States | -117.2742 | 32.84727 Chicago | Illinois | United States | -87.65005 | 41.85003 St Louis | Missouri | United States | -90.19789 | 38.62727 Eugene | Oregon | United States | -123.08675 | 44.05207 Tualatin | Oregon | United States | -122.76399 | 45.38401
69
0
0
0
NCT01037413
1COMPLETED
2010-04-09
2009-12-22
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
66
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
false
0ALL
false
A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple oral doses of GSK1292263
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1292263 when co-administered with metformin. The study will be in 2 parts. Part A will determine the PK of GSK1292263 following single day dosing of type 2 diabetes (T2DM) subjects on metformin. Part B will investigate the...
Diabetes Mellitus, Type 2
Pharmacokinetics Glucose Safety Male Female Metformin Pharmacodynamics Tolerability Type II Diabetes
null
4
arm 1: Part A is open label, in T2DM subjects on established metformin monotherapy. Subjects will receive a single dose of GSK1292263 with food. This will permit a comparison of GSK1292263 exposures in this cohort with those observed in study GPR111598 in which T2DM subjects were drug naïve or washed off prior anti-dia...
[ 5, 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Tablet intervention 2: Tablet intervention 3: Tablet
intervention 1: GSK1292263 intervention 2: GSK1292263 matching placebo intervention 3: Sitagliptin
2
Chula Vista | California | United States | -117.0842 | 32.64005 Miami | Florida | United States | -80.19366 | 25.77427
73
0
0
0
NCT01128621
1COMPLETED
2010-04-12
2009-11-23
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
448
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period. In total 450 participants (all...
All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was...
Hypersensitivity
null
3
arm 1: Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. arm 2: Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. arm 3: Participants were to receive one dos...
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization intervention 2: Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study intervention 3: Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of t...
intervention 1: Placebo run-in dose intervention 2: Sugammadex 4 mg/kg intervention 3: Sugammadex 16 mg/kg intervention 4: Placebo
0
null
448
0
0
0
NCT00988065
1COMPLETED
2010-04-13
2009-09-06
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Drugs used in chemotherapy, such as O(6)-benzylguanine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is st...
OBJECTIVES: * Determine the antitumor activity of O6-benzylguanine and temozolomide in patients with temozolomide-resistant methylguanine methyltransferase-positive or -negative glioblastoma multiforme previously treated with radiotherapy. * Determine, preliminarily, the toxicity of this regimen in these patients. OU...
Brain and Central Nervous System Tumors
adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor adult glioblastoma
null
1
arm 1: Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: O6-benzylguanine intervention 2: temozolomide
2
Bethesda | Maryland | United States | -77.10026 | 38.98067 Bethesda | Maryland | United States | -77.10026 | 38.98067
12
0
0
0
NCT00436436
6TERMINATED
2010-04-14
2006-11-13
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
95
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. T...
null
Hepatitis C
null
5
arm 1: Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. arm 2: Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from ...
[ 2, 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days intervention 2: Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks intervention 3: Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 w...
intervention 1: Comparator: Vaniprevir intervention 2: Comparator: Pegylated-Interferon (Peg-IFN) intervention 3: Comparator: Ribavirin intervention 4: Comparator: placebo
0
null
94
0
0
0
NCT00704184
1COMPLETED
2010-04-14
2008-07-25
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 ]
16
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.
Study Design: This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants). Part II will be conducted only if the primary hypothesis is not...
Insomnia Hepatic Insufficiency
Hepatic Insufficiency
null
4
arm 1: Participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 2: Healthy participants matched to participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm ...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.
intervention 1: Suvorexant
0
null
16
0
0
0
NCT01043926
1COMPLETED
2010-04-14
2010-02-22
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
143
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis. In PTK 0796-CSSI-0804 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic ...
Skin Diseases, Infectious
CSSI Abscess Wound Cellulitis Complicated Skin and Skin Structure Infections (cSSSI)
null
2
arm 1: PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets) arm 2: Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg intervention 2: For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution intervention 3: moxifloxacin 400 mg tab...
intervention 1: PTK 0796 intervention 2: linezolid intervention 3: moxifloxacin
7
Fountain Valley | California | United States | -117.95367 | 33.70918 La Mesa | California | United States | -117.02308 | 32.76783 Oceanside | California | United States | -117.37948 | 33.19587 San Diego | California | United States | -117.16472 | 32.71571 San Jose | California | United States | -121.89496 | 37.33939 Co...
140
0
0
0
NCT00865280
6TERMINATED
2010-04-15
2009-04-04
Paratek Pharmaceuticals Inc
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.
The proposed study of the treatment of a child with congenital leptin deficiency will permit to elucidate key aspects of human endocrine function, and will give new insights on the role of leptin in human endocrine regulation.
Obesity Metabolic Syndrome Diabetes
Congenital leptin deficiency Obesity Metabolic Syndrome Diabetes
null
1
arm 1: Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
[ 0 ]
1
[ 0 ]
intervention 1: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
intervention 1: Recombinant methionyl human leptin
1
Miami | Florida | United States | -80.19366 | 25.77427
0
0
0
0
NCT00659828
1COMPLETED
2010-04-16
2005-06-01
University of Miami
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
73
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in persons with retinitis pigmentosa, Usher type II \& III, and Choroideremia. This research is being done because there are no effective therapies for people with these retinal degenerations. They are genetic disorders that...
This study will involve about 18 visits over 2½ years for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The ...
Retinitis Pigmentosa
Retinitis Pigmentosa eye disease retinal disorder CNTF
null
2
arm 1: NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Implant in Fellow Eye arm 2: NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina Sham Implant in Fellow Eye
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Low Dose intervention 2: High Dose
intervention 1: NT-501 intervention 2: NT-501
12
Beverly Hills | California | United States | -118.40036 | 34.07362 Sacramento | California | United States | -121.4944 | 38.58157 San Francisco | California | United States | -122.41942 | 37.77493 Miami | Florida | United States | -80.19366 | 25.77427 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Minneapo...
68
0
0
0
NCT00447980
1COMPLETED
2010-04-19
2007-01-22
Neurotech 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 ]
51
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of the combination of GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI) over 28 days in subjects ...
Pulmonary Disease, Chronic Obstructive
long-acting beta2-receptor agonist Safety and tolerability pharmacodynamics pharmacokinetics long-acting muscarinic receptor antagonist COPD
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: GSK573719/GW642444 intervention 2: Inactive, excipients only
intervention 1: 500mcg/25mcg once daily intervention 2: Placebo once daily
4
Chester | South Carolina | United States | -81.21426 | 34.70486 Gaffney | South Carolina | United States | -81.64982 | 35.07179 Greenville | South Carolina | United States | -82.39401 | 34.85262 Greenwood | South Carolina | United States | -82.16179 | 34.1954
51
0
0
0
NCT01039675
1COMPLETED
2010-04-20
2010-01-01
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 ]
269
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).
Not Required
ADHD
null
1
arm 1: Lisdexamfetamine Dimesylate (LDX)
[ 0 ]
1
[ 0 ]
intervention 1: optimal dose of 30, 50 or 70 mg once daily
intervention 1: Lisdexamfetamine Dimesylate (LDX)
45
Little Rock | Arkansas | United States | -92.28959 | 34.74648 El Centro | California | United States | -115.56305 | 32.792 Rolling Hills Estates | California | United States | -118.35813 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 Wildomar | California | United States | -117.28004 | 33.598...
265
0
0
0
NCT00764868
1COMPLETED
2010-04-22
2008-11-13
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
88
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-...
null
Non-Small Cell Lung Cancer
NSCLC Tarceva Positron emission technology PET Computerized tomography CT
null
1
arm 1: Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib participants ...
[ 0 ]
3
[ 10, 10, 0 ]
intervention 1: FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie). intervention 2: FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection. intervention 3: Tablets taken orally 150 mg/day.
intervention 1: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) intervention 2: 3'-deoxy-3'-[18F]fluorothymidine (FLT) intervention 3: erlotinib HCl
0
null
85
1
0.011765
1
NCT00453362
1COMPLETED
2010-04-23
2006-12-01
Genentech, 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
1
0
0
0
0
0
0
0
0.00208
[ 3 ]
46
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder. It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ significantly from placebo with respect to th...
null
Panic Disorder
null
3
arm 1: Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. arm 2: Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. arm 3: Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessio...
[ 0, 0, 2 ]
4
[ 5, 0, 0, 0 ]
intervention 1: Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration). intervention 2: 4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period. intervention 3: 12 mg Org 25935 is given in ...
intervention 1: Cognitive-behavioral therapy intervention 2: Org 25935 intervention 3: Org 25935 intervention 4: Placebo
0
null
40
0
0
0
NCT00725725
6TERMINATED
2010-04-23
2008-07-23
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
70
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combini...
PRIMARY OBJECTIVES: I. To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor (DT) and primary DT that is not readily amenable to surgery or radiation therapy. SECONDARY OBJECTIVES: I. Determine the tumor response rate in patients treated with this regimen. II. Correl...
Desmoid Tumor
null
1
arm 1: Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
[ 0 ]
3
[ 0, 0, 10 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies
intervention 1: tamoxifen citrate intervention 2: sulindac intervention 3: laboratory biomarker analysis
1
Monrovia | California | United States | -117.99895 | 34.14806
59
0
0
0
NCT00068419
1COMPLETED
2010-04-26
2004-02-01
Children's Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
8
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
The purpose of this research study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by the treatment for bipolar disorder. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes. ...
The study seeks to enroll 80 patients with sexual dysfunction associated with their bipolar medication regimen over 24 months. Subjects were outpatient females between 18 and 80 years old with no significant symptoms of mania (Young Mania Rating Scale score\<10), and who have been on a steady regimen of medications to ...
Sexual Dysfunction Bipolar Disorder
Sexual Dysfunction Bipolar Disorder
null
2
arm 1: Subjects in this arm will be given 3g/day of Maca Root. arm 2: Subjects in this arm will receive inactive placebo.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 3g/day of Maca Root for 12 weeks. intervention 2: Placebo provided by research pharmacy daily for 12 weeks.
intervention 1: Maca Root intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
8
0
0
0
NCT00575328
6TERMINATED
2010-04-26
2008-02-26
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
[ 5 ]
59
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 y...
This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS coho...
Aortic Valve Stenosis
calcific aortic valve stenosis echocardiography, transthoracic
null
1
arm 1: Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
[ 0 ]
1
[ 0 ]
intervention 1: atorvastatin 40 mg by mouth once daily
intervention 1: atorvastatin (Lipitor)
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
59
0
0
0
NCT00590135
6TERMINATED
2010-04-26
2000-08-01
The Cleveland Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0