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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
0
] | 183 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph in... | Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-ac... | Staphylococcal Skin Infections Abscesses Furunculosis Staphylococcus Aureus MRSA Infection | Abscesses Furunculosis Staphylococcus aureus colonization Staphylococcal Skin Infections MRSA | null | 2 | arm 1: Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. arm 2: All members of the household (over the age of 6 months) will be asked to follow the study protocol. | [
1,
1
] | 3 | [
0,
0,
5
] | intervention 1: Apply ointment to the anterior nares twice daily for 5 days. intervention 2: Bathe with liquid soap daily for 5 days. intervention 3: Follow key hygiene tips indefinitely. Tips are:
* Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
* Use liquid(pour ... | intervention 1: 2% Mupirocin Ointment intervention 2: 4% Chlorhexidine liquid soap intervention 3: Hygiene protocol | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 162 | 0 | 0 | 0 | NCT00731783 | 1COMPLETED | 2010-12-01 | 2008-07-01 | Washington University School of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC. | OUTLINE: This is a multi-center study.
* Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose... | Non-Small Cell Lung Cancer | null | 1 | arm 1: * Pemetrexed (Alimta) 500mg/m\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy in 2.0 Gy fractions. ... | [
0
] | 2 | [
0,
4
] | intervention 1: Pemetrexed (Alimta) 500mg/\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles intervention 2: Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.
The planned radiation dose is 60 Gy i... | intervention 1: Pemetrexed intervention 2: Radiation Therapy | 18 | Chicago | Illinois | United States | -87.65005 | 41.85003
Evanston | Illinois | United States | -87.69006 | 42.04114
Galesburg | Illinois | United States | -90.37124 | 40.94782
Bloomington | Indiana | United States | -86.52639 | 39.16533
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indianapolis | Indiana ... | 8 | 0 | 0 | 0 | NCT00732303 | 6TERMINATED | 2010-12-01 | 2009-01-01 | Hoosier Cancer Research Network | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 2,122 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.
The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy... | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: open label arm 2: open label | [
0,
0
] | 2 | [
0,
0
] | intervention 1: safety and efficacy of linagliptine 5 mg open label intervention 2: efficacy and safety of the combination linagliptine and pioglitazone | intervention 1: linagliptine 5 mg intervention 2: linagliptine 5 mg and pioglitazone 30 mg | 232 | Chula Vista | California | United States | -117.0842 | 32.64005
Spring Valley | California | United States | -116.99892 | 32.74477
Walnut Creek | California | United States | -122.06496 | 37.90631
Northglenn | Colorado | United States | -104.9872 | 39.88554
Hollywood | Florida | United States | -80.14949 | 26.0112
Miam... | 2,121 | 0 | 0 | 0 | NCT00736099 | 1COMPLETED | 2010-12-01 | 2008-08-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 103 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the durability of effect of Droxidopa in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency. | Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pres... | Neurogenic Orthostatic Hypotension Non-Diabetic Autonomic Neuropathy Multiple System Atrophy Dopamine Beta Hydroxylase Deficiency | NOH Neurogenic Orthostatic Hypotension Orthostatic hypotension PAF Pure Autonomic Failure MSA Multiple System Atrophy Neuropathy Autonomic Failure Parkinson Dopamine Deficiency Dopamine Droxidopa | null | 2 | arm 1: Study medication arm 2: Placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day intervention 2: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, th... | intervention 1: Droxidopa intervention 2: Placebo | 54 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Sun City | Arizona | United States | -112.27182 | 33.59754
Fountain Valley | California | United States | -117.95367 | 33.70918
Oxnard |... | 353 | 0 | 0 | 0 | NCT00738062 | 1COMPLETED | 2010-12-01 | 2008-01-01 | Chelsea Therapeutics | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
5
] | 73 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).
Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and... | null | Pulmonary Arterial Hypertension | pulmonary arterial hypertension PAH treprostinil sodium inhalation ventavis iloprost | null | 1 | arm 1: Solution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Inhaled treprostinil | 15 | Birmingham | Alabama | United States | -86.80249 | 33.52066
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Kansas City | Kansas | United States | -94.62746 | 39.11417
New Hyde Park | New York | United States | -73.68791 | 40.7351
New York | ... | 73 | 0 | 0 | 0 | NCT00741819 | 1COMPLETED | 2010-12-01 | 2008-09-01 | United Therapeutics | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 21 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will examine whether pretreatment with D-cycloserine before cognitive behavioral therapy can reduce impairments still present in people with stable cases of schizophrenia as well as determine which traits make schizophrenics most likely to respond to D-cycloserine treatment. | Schizophrenia is a debilitating chronic condition that affects approximately 1 % of Americans, who experience symptoms such as hallucinations, delusions, and disorders of thought and movement. These symptoms are described as positive symptoms, because they are experienced in addition to what healthy individuals experie... | Schizophrenia | Paranoid Schizophrenia Paranoid Delusions CBT D-Cycloserine | null | 2 | arm 1: Participants will receive D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and they will receive placebo 1 hour before a CBT session on Week 2. arm 2: Participants will receive placebo 1 hour before a CBT session on Week 1, and they will receive D-cycloserine 1 hour before a CB... | [
0,
0
] | 2 | [
0,
5
] | intervention 1: Single, fixed 50-mg dose of D-cycloserine administered 1 hour prior to a CBT session intervention 2: One-hour talk therapy session with a trained clinician aimed at increasing cognitive flexibility by examining alternative explanations to everyday situations | intervention 1: D-cycloserine intervention 2: Cognitive Behavioral Therapy | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 21 | 0 | 0 | 0 | NCT00742079 | 1COMPLETED | 2010-12-01 | 2006-09-01 | 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
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.
Each subject will receive oral lithium carbonate or placebo for six weeks. In... | null | Spinal Cord Injury | Spinal Cord Injury | null | 2 | arm 1: Placebo tablet arm 2: Lithium Carbonate tablet, 250mg | [
2,
0
] | 2 | [
0,
0
] | intervention 1: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course o... | intervention 1: Lithium Carbonate intervention 2: Placebo | 2 | Beijing | N/A | China | 116.39723 | 39.9075
Taichung | N/A | Taiwan | 120.6839 | 24.1469 | 40 | 0 | 0 | 0 | NCT00750061 | 1COMPLETED | 2010-12-01 | 2008-08-01 | China Spinal Cord Injury Network | 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 |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied. | Study Drugs:
Alemtuzumab and rituximab are both monoclonal antibodies. Monoclonal antibodies are proteins designed to attach to a protein on the surface of the leukemia cell. By attaching to the leukemia cell, monoclonal antibodies alert the immune system to target that cell and kill it.
Study Groups:
If you are fou... | Chronic Lymphocytic Leukemia Leukemia | Chronic Lymphocytic Leukemia Leukemia CLL PLL SLL Rituximab Rituxan Alemtuzumab Campath | null | 3 | arm 1: Group 1: 375 mg/m\^2 IV Rituximab Alone arm 2: Group 2: 30 mg SQ Alemtuzumab Alone arm 3: Group 3: 375 mg/m\^2 Rituximab + 30 mg SQ Alemtuzumab | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: 375 mg/m\^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4. intervention 2: Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12... | intervention 1: Rituximab intervention 2: Alemtuzumab | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 1 | 0 | 0 | 0 | NCT00771602 | 6TERMINATED | 2010-12-01 | 2008-08-01 | 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
] | 526 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease. | In Crohn's disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines.This occurs because the immune system (the part of the body that fights off infection) has an abnormal and overactive response against the intestine and bow... | Crohn's Disease | Interleukin-12 Inflammation Research study Ustekinumab CNTO1275 Interleukin-23 | null | 10 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None | [
2,
0,
0,
0,
2,
2,
2,
0,
2,
0
] | 10 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Induction phase (Week 0-8) (IP) - Placebo IV group intervention 2: Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group intervention 3: Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group intervention 4: Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group intervention 5: Ma... | intervention 1: Placebo (IP) intervention 2: Ustekinumab 1mg/kg (IP) intervention 3: Ustekinumab 3 mg/kg (IP) intervention 4: Ustekinumab 6 mg/kg (IP) intervention 5: Placebo IV - Responder - Placebo SC (MP) intervention 6: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP) intervention 7: Ustekinumab IV - Respo... | 174 | Mobile | Alabama | United States | -88.04305 | 30.69436
Scottsdale | Arizona | United States | -111.89903 | 33.50921
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Roseville | California | United States | -121.28801 | 38.75212
San Carlos | C... | 1,003 | 0 | 0 | 0 | NCT00771667 | 1COMPLETED | 2010-12-01 | 2008-12-01 | Centocor, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 343 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling. | To simulate an over-the-counter (OTC) setting, each potential subject was expected to read the label text on the outside of the study package and determine whether and how to use the study product without provider direction or assistance. The study product, Plan B® 1.5, was to be dispensed only to those subjects who ap... | Emergency Contraception | null | 1 | arm 1: One tablet for emergency contraception | [
0
] | 1 | [
0
] | intervention 1: One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse. | intervention 1: DR-104 | 5 | San Francisco | California | United States | -122.41942 | 37.77493
Atlanta | Georgia | United States | -84.38798 | 33.749
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 299 | 0 | 0 | 0 | NCT00777556 | 1COMPLETED | 2010-12-01 | 2008-10-01 | Duramed Research | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 76 | RANDOMIZED | CROSSOVER | null | 3TRIPLE | false | 0ALL | false | A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions of brain while performing measures of inhibi... | Three age groups of subjects will be studied: school age children (aged 9-12), older adolescents (age 15-17 years) and young adults (age 20-25 years). Twenty subjects will be studied in each group. All subjects must meet criteria for ADHD, combined type and be either treatment naïve or currently taking and responding w... | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder ADHD | null | 2 | arm 1: The subject will be administered their usual dose of Concerta the morning of the FMRI scan in a double blind fashion arm 2: The subject will be administered a placebo the morning of the FMRI scan in a double blind fashion | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of Concerta that are made to appear similar to placebo capsules. The subject will be administered their usual dose of Concerta the morning of the scan. intervention 2: The collaborator (Ortho-McNiel Janssen Scientific ... | intervention 1: methylphenidate-OROS intervention 2: Placebo | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 43 | 0 | 0 | 0 | NCT00778310 | 1COMPLETED | 2010-12-01 | 2008-11-01 | 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 |
[
3
] | 158 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks | null | Rheumatoid Arthritis | Arthritis | null | 7 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None | [
0,
0,
0,
0,
0,
0,
0
] | 2 | [
2,
0
] | intervention 1: Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20). intervention 2: Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20). | intervention 1: LY2127399 intervention 2: Placebo | 48 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Calabasas | California | United States | -118.63842 | 34.15778
Upland | California | United States | -117.64839 | 34.09751
Vero Beach | Florida | United States | -80.39727 | 27.63864
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Dallas | Te... | 204 | 0 | 0 | 0 | NCT00785928 | 1COMPLETED | 2010-12-01 | 2008-10-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The study objectives are to assess safety, tolerability and gene expression after a single dose of non-viral CFTR gene therapy (pGM169/GL67A) administered to the nose and lungs of patients with cystic fibrosis. | The trial is designed as single administration to nose and lung. Initially, in Part A, 3 patients will be dosed individually one week apart with 10 ml (26.5mg pDNA) via nebuliser and a nasal dose equivalent to 10% of this (based on relative surface area calculations: conducting airways approximate 540 cm2; nasal epithe... | Cystic Fibrosis | Single dose Pilot Safety Gene expression Tolerability CFTR gene Cystic fibrosis Non-viral | null | 3 | arm 1: Received a nebulized dose 20ml via an breath-actuated nebulizer arm 2: Received a nebulized dose 10ml via an breath-actuated nebulizer arm 3: Received a nebulized dose 5ml via an breath-actuated nebulizer | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Received a nebulized dose via an breath-actuated nebulizer | intervention 1: pGM169/GL67A | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 35 | 0 | 0 | 0 | NCT00789867 | 1COMPLETED | 2010-12-01 | 2008-11-01 | Imperial College London | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | false | The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen. | null | Allergic Rhinitis | null | 2 | arm 1: Topical ASP-1001 arm 2: Placebo for Topical ASP-1001 | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. intervention 2: 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. | intervention 1: ASP-1001 nasal spray intervention 2: Placebo for ASP-1001 | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 40 | 0 | 0 | 0 | NCT00791102 | 1COMPLETED | 2010-12-01 | 2010-01-01 | University of Chicago | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 175 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this study is to compare the relative efficacy and safety of SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of onychomycosis of the toenail. Both the test and the reference formulatio... | Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel designed study comparing a dosing regimen of 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd) to the approved dosing regimen of 200 mg taken with breakfast of SPORANOX® (itraconazole)... | Onychomycosis | Onychomycosis | null | 3 | arm 1: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd) arm 2: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma). arm 3: Two placebo capsules taken approximately 30 minutes prior to breakfast | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd) intervention 2: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma). intervention 3: Two placebo capsules taken approximately 30 minutes prior to break... | intervention 1: SUBA-itraconazole intervention 2: Itraconazole intervention 3: Placebo | 8 | Altamonte Springs | Florida | United States | -81.36562 | 28.66111
Miami | Florida | United States | -80.19366 | 25.77427
Boise | Idaho | United States | -116.20345 | 43.6135
Salisbury | North Carolina | United States | -80.47423 | 35.67097
Portland | Oregon | United States | -122.67621 | 45.52345
Mt. Pleasant | South ... | 175 | 0 | 0 | 0 | NCT00791219 | 1COMPLETED | 2010-12-01 | 2008-11-01 | Halcygen Pharmaceuticals Limited | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 937 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD. | null | Pulmonary Disease, Chronic Obstructive | null | 4 | arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: 12mcg inhaled twice daily from the Aerolizer inhaler arm 4: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice da... | [
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients intervention 4: Placebo devices for compar... | intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Formoterol intervention 4: Placebo | 98 | Capital Federal | N/A | Argentina | N/A | N/A
Mar del Plata | N/A | Argentina | -57.5562 | -38.00042
Mendoza | N/A | Argentina | -68.84582 | -32.88946
Quilmes | N/A | Argentina | -58.25454 | -34.72065
San Juan Bautista | N/A | Argentina | -58.27623 | -34.80896
Florianópolis | N/A | Brazil | -48.54917 | -27.59667
Porto ... | 934 | 0 | 0 | 0 | NCT00796653 | 1COMPLETED | 2010-12-01 | 2009-01-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This prospective, randomized, comparative clinical trial evaluates the effect of either oral doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease. | Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline is for... | Blepharitis | Meibomian gland dysfunction Lid margin disease doxycycline azithromycin essential fatty acid | null | 2 | arm 1: Oral doxycycline arm 2: Topical azithromycin daily to the conjunctival culdesac | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Oral doxycycline 100mg bid intervention 2: topical 1% azithromycin daily to eye | intervention 1: doxycycline intervention 2: azithromycin | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 31 | 0 | 0 | 0 | NCT00803452 | 1COMPLETED | 2010-12-01 | 2008-07-01 | University of Louisville | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 83 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active contro... | null | Hepatitis B Virus | Chronic HBV Asian adult subjects with chronic HBV, in immune tolerant phase, and positive for hepatitis B e antigen (HBeAg) | null | 3 | arm 1: All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (... | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 600 mg monotherapy supplied in film-coated tablets. intervention 2: Tenofovir disoproxil fumarate was supplied in 300 mg tablets intervention 3: Telbivudine 600 mg and Tenofovir 300 mg were purchased in commercial packs. Patients were instructed to take medication(s) orally every morning either with or ... | intervention 1: Telbivudine intervention 2: Tenofovir intervention 3: Telbivudine plus tenofovir | 1 | Hong Kong | N/A | China | 114.17469 | 22.27832 | 46 | 0 | 0 | 0 | NCT00805675 | 1COMPLETED | 2010-12-01 | 2008-11-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 157 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Evaluate the effectiveness of a topical preparation of zinc to treat cold sores. | Zinc salts irreversibly inhibit herpes virus replication in vitro and are effective in treating herpes infections in vivo and have been shown in a clinical trial to be a effective topical treatment for HSL. Zinc salt solutions applied to herpetic lesions decrease viral load and markedly improve healing rates, relieving... | Herpes Simplex Labialis | Cold sores Zinc HSL Herpes simple labialis | null | 2 | arm 1: Oral swabs containing homeopathic Zinc gluconate arm 2: placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 33mmol/l of ionic zinc intervention 2: placebo swab | intervention 1: Zicam (Ionic zinc) intervention 2: placebo | 3 | Tempe | Arizona | United States | -111.90931 | 33.41477
Santa Fe | New Mexico | United States | -105.9378 | 35.68698
New York | New York | United States | -74.00597 | 40.71427 | 157 | 0 | 0 | 0 | NCT00809809 | 1COMPLETED | 2010-12-01 | 2008-12-01 | Integrative Medicine Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
3
] | 150 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing scars that were made from trocars following arthroscopic shoulder surgery. | null | Scar Prevention Scar Reduction | AZX100 Patient and Observer Scar Assessment Scale POSAS Visual Analog Scale VAS Trocar Scarring Scar reduction Scar prevention | null | 2 | arm 1: Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline). arm 2: Three trocar sites on each patient received one dose of placebo (saline). | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three... | intervention 1: Placebo intervention 2: AZX100 | 5 | Pasadena | California | United States | -118.14452 | 34.14778
DeLand | Florida | United States | -81.30312 | 29.02832
Orlando | Florida | United States | -81.37924 | 28.53834
Greenville | North Carolina | United States | -77.36635 | 35.61266
Austin | Texas | United States | -97.74306 | 30.26715 | 150 | 0 | 0 | 0 | NCT00811577 | 1COMPLETED | 2010-12-01 | 2009-01-01 | Capstone Therapeutics | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 164 | RANDOMIZED | PARALLEL | 9OTHER | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to see how safe and effective L carnitine taken with cilostazol is compared to placebo taken with cilostazol for people with intermittent claudication. A second purpose of the study is to see if L-carnitine is absorbed into the blood stream. | Peripheral Artery Disease (PAD) is a narrowing of the blood vessels that supply the leg with blood. It is caused by atherosclerosis (hardening of the arteries).
Muscles require oxygen carried by the blood. When the leg muscles do not get enough blood and oxygen, this can cause pain, cramping, fatigue, and/or discomfor... | Peripheral Vascular Disease Intermittent Claudication Peripheral Arterial Disease | Peripheral Vascular Disease Peripheral Arterial Disease Intermittent Claudication Peak Walking Time Claudication Onset Time Cilostazol Carnitine | null | 2 | arm 1: 1 tablet cilostazol 100 mg PO BID and 3 capsules L-carnitine 334 mg PO BID arm 2: 1 tablet cilostazol 100 mg PO BID and 3 capsules placebo PO BID | [
1,
2
] | 2 | [
7,
0
] | intervention 1: Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180. intervention 2: Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth tw... | intervention 1: Levocarnitine tartrate intervention 2: cilostazol | 24 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Palo Alto | California | United States | -122.14302 | 37.44188
Sacramento | California | United States | -121.4944 | 38.58157
Sacramento | Cal... | 163 | 0 | 0 | 0 | NCT00822172 | 1COMPLETED | 2010-12-01 | 2008-09-01 | Colorado Prevention 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
] | 302 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double-blind, parallel group comparison study. | null | Parkinson Disease | Ropinirole, advanced Parkinson's disease, L-dopa adjunctive therapy | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group.
The subjects'dose will be titrated according to the recomme... | intervention 1: ropinirole PR/XR intervention 2: ropinirole IR | 54 | Aichi | N/A | Japan | 130.62158 | 32.51879
Aichi | N/A | Japan | 130.62158 | 32.51879
Aichi | N/A | Japan | 130.62158 | 32.51879
Aichi | N/A | Japan | 130.62158 | 32.51879
Akita | N/A | Japan | 140.11667 | 39.71667
Chiba | N/A | Japan | 140.11667 | 35.6
Chiba | N/A | Japan | 140.11667 | 35.6
Chiba | N/A | Japan | 140.1... | 302 | 0 | 0 | 0 | NCT00823836 | 1COMPLETED | 2010-12-01 | 2009-03-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 28 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109 | null | Advanced Colorectal Cancer | null | 1 | arm 1: TAS-109 | [
0
] | 1 | [
0
] | intervention 1: 14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.
Number of cycles: until unacceptable toxicity or disease progression requires discontinuation. | intervention 1: TAS-109 | 3 | East 34th Street, New York | New York | United States | -74.00597 | 40.71427
Holcombe Boulevard, Houston | Texas | United States | -95.36327 | 29.76328
West Magnolia Avenue, Fort Worth | Texas | United States | -97.32085 | 32.72541 | 26 | 0 | 0 | 0 | NCT00824161 | 6TERMINATED | 2010-12-01 | 2009-01-01 | Taiho 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 | |
[
2,
3
] | 20 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or l... | Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are \>35 years old and display exudative, active polypoidal choroidal vasculopathy (PCV) in 1 eye. PCV is defined as choroidal neovascula... | Polypoidal Choroidal Vasculopathy | polypoidal choroidal vasculopathy choroidal neovascularization ranibizumab Lucentis | null | 2 | arm 1: Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab arm 2: Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab | [
0,
0
] | 1 | [
0
] | intervention 1: ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician | intervention 1: ranibizumab 0.5 or 0.3 mg/0.05 cc | 1 | Augusta | Georgia | United States | -81.97484 | 33.47097 | 20 | 0 | 0 | 0 | NCT00837330 | 1COMPLETED | 2010-12-01 | 2006-05-01 | Southeast Retina Center, Georgia | 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
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Lenalidomide has shown significant efficacy in the treatment of anemia associated with both 5q- and non 5q- MDS patients. The mechanism(s) of action of lenalidomide in MDS is still to be determined, but given the differences in response rates seen, it is probable that the mechanism is different for patients with 5q- di... | null | Myelodysplastic Syndrome | stage (IPSS low and INT-1) RBC transfusion-dependent non-del 5q MDS | null | 1 | arm 1: Lenalidomide 10mg po daily/ CSA 250mg orally twice daily | [
0
] | 2 | [
0,
0
] | intervention 1: Lenalidomide 10mg po daily intervention 2: CSA 250mg orally twice daily | intervention 1: lenalidomide intervention 2: cyclosporine A | 1 | New York | New York | United States | -74.00597 | 40.71427 | 6 | 0 | 0 | 0 | NCT00840827 | 6TERMINATED | 2010-12-01 | 2008-12-01 | Weill Medical College of Cornell University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to see if treatment with Ginkgo improves cognitive function in people with multiple sclerosis who have cognitive problems. | Objectives:
Primary objective: Determine the difference between subjects treated with Ginkgo biloba (GB) and subjects treated with placebo for 12 weeks on the performance of a battery of neuropsychological tests that are frequently impaired in Multiple Sclerosis (MS): the Stroop test, the Paced Auditory Serial Additio... | Multiple Sclerosis Cognitive Ability, General | Ginkgo biloba Multiple Sclerosis Cognition Neuropsychological Tests Neurobehavioral Manifestations Quality of life Randomized Controlled Trials Placebos Double-Blind Method | null | 2 | arm 1: Subjects with multiple sclerosis and documented cognitive impairment will be randomized to take the intervention or placebo. arm 2: Subjects with multiple sclerosis and documented cognitive impairment will be randomized to receive the placebo. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 120 mg orally twice a day for 12 weeks intervention 2: One capsule orally twice a day for 12 weeks | intervention 1: Ginkgo biloba intervention 2: Placebo | 2 | Portland | Oregon | United States | -122.67621 | 45.52345
Seattle | Washington | United States | -122.33207 | 47.60621 | 120 | 0 | 0 | 0 | NCT00841321 | 1COMPLETED | 2010-12-01 | 2009-01-01 | US Department of Veterans Affairs | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | The specific aim of this Phase I/II study is to assess the safety of intravenous administered Morpholino oligomer directed against exon 51 (AVI-4658 PMO). | Primary outcome is safety, tolerability and dose selection for future studies. | Duchenne Muscular Dystrophy | null | 6 | arm 1: Subjects in this group will receive a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period arm 2: Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute per... | [
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline in 6 dose cohorts. | intervention 1: AVI-4658 for Injection | 2 | London | England | United Kingdom | -0.12574 | 51.50853
Newcastle upon Tyne | England | United Kingdom | -1.61396 | 54.97328 | 19 | 0 | 0 | 0 | NCT00844597 | 1COMPLETED | 2010-12-01 | 2009-01-01 | Sarepta Therapeutics, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 25 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | true | 1FEMALE | false | This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or coming back. | PRIMARY OBJECTIVES:
I. To determine the effect of six months of acolbifene 20 mg/day on Ki-67 in high risk premenopausal women with baseline hyperplasia +/- atypia and Ki-67 positivity of \>= 2%..
SECONDARY OBJECTIVES:
I. To determine the effect of six months of acolbifene 20 mg/day on mammographic breast density in... | Breast Cancer | null | 1 | arm 1: Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: acolbifene hydrochloride | 1 | Kansas City | Kansas | United States | -94.62746 | 39.11417 | 25 | 0 | 0 | 0 | NCT00853996 | 1COMPLETED | 2010-12-01 | 2009-02-01 | University of Kansas Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 53 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 2MALE | true | This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. The behavioral intervention will consist of an 8-week course of contingency management (CM) throu... | At the baseline, all eligible participants underwent informed consent; completed baseline assessments; received rapid HIV testing; provided specimens for syphilis, gonorrhea and chlamydia testing; and received a medical examination. Those who reported a high-risk sexual or drug exposure episode with an HIV-positive or ... | Amphetamine-Related Disorders HIV HIV Infections | Methamphetamine HIV Post-exposure prophylaxis HIV seronegativity | null | 1 | arm 1: Participants are provided contingency management vouchers for methamphetamine abstinence, and can initiate postexposure prophylaxis (Truvada; 1 pill daily for 28 days) after non-occupational exposure to HIV. | [
0
] | 2 | [
0,
5
] | intervention 1: At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada). intervention 2: Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for... | intervention 1: Truvada intervention 2: CM | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 53 | 0 | 0 | 0 | NCT00856323 | 1COMPLETED | 2010-12-01 | 2009-01-01 | Friends Research Institute, Inc. | 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
] | 21 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder. | null | Overactive Bladder Neurogenic Detrusor Overactivity | Study of fesoterodine in pediatric overactive bladder patients | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8 | intervention 1: Fesoterodine | 9 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Long Beach | California | United States | -118.18923 | 33.76696
Overland Park | Kansas | United States | -94.67079 | 38.98223
Overland Park | Kansas | United States | -94.67079 | 38.98223
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Troy | M... | 41 | 0 | 0 | 0 | NCT00857896 | 1COMPLETED | 2010-12-01 | 2009-03-01 | 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 |
[
3
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer. | OUTLINE: This is a multi-center study.
* Dasatinib -100 mg administered once daily per oral route for 28 consecutive days.
* Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if ... | Prostate Cancer | null | 1 | arm 1: Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy | [
0
] | 3 | [
0,
0,
3
] | intervention 1: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days intervention 2: Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). intervention 3: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the ... | intervention 1: Dasatinib intervention 2: Leuprolide Acetate (LHRH Analogue) intervention 3: Radical Prostatectomy | 6 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Gainesville | Florida | United States | -82.32483 | 29.65163
Chicago | Illinois | United States | -87.65005 | 41.85003
Galesburg | Illinois | United States | -90.37124 | 40.94782
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Norfolk | Virginia... | 1 | 0 | 0 | 0 | NCT00860158 | 6TERMINATED | 2010-12-01 | 2009-03-01 | Noah Hahn, M.D. | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients. | In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many set... | Cardiac Surgery Cardiopulmonary Bypass | null | 2 | arm 1: Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion) arm 2: Control drug: Human serum albumin (HSA 50g/L) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day. intervention 2: Human serum albumin (HSA 50g/L) | intervention 1: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) intervention 2: Human serum albumin (HSA 50g/L) | 2 | Linz | N/A | Austria | 14.28611 | 48.30639
Brussels | N/A | Belgium | 4.34878 | 50.85045 | 60 | 0 | 0 | 0 | NCT00860405 | 1COMPLETED | 2010-12-01 | 2009-03-01 | Fresenius Kabi | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | DESIGN: This single center, double-blinded, randomized phase II study is being conducted to assess the efficacy of a rifabutin based regimen to eliminate S. aureus colonization in HIV infected individuals. Individuals must have HIV infection and a skin and skin structure infection (SSSI) in the prior 6 months to be eli... | null | Staphylococcus Aureus HIV Infections | Staphylococcus aureus colonization eradication HIV rifabutin | null | 2 | arm 1: Subjects will be assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole arm 2: Subjects will be assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole | [
1,
2
] | 2 | [
0,
0
] | intervention 1: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days intervention 2: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days | intervention 1: rifabutin plus trimethoprim sulfamethoxazole intervention 2: placebo plus trimethoprim-sulfamethoxazole | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 12 | 0 | 0 | 0 | NCT00869518 | 6TERMINATED | 2010-12-01 | 2009-07-01 | 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
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | null | 0NONE | true | 1FEMALE | true | Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whether the pharmacokine... | null | Healthy | Healthy Volunteers | null | 1 | arm 1: Healthy volunteers received two doses of Tenofovir, Emtricitabine, Atazanavir and Ritonavir administered twice (on day 6 - 10 and day 20 - 25 after day of Follicular phase); with pharmacokinetic measurements at 6 - 10 days after menses and then again at day 20 - 25 after menses. | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: tenofovir 300 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle) intervention 2: emtricitabine 200 mg on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 da... | intervention 1: tenofovir intervention 2: emtricitabine intervention 3: atazanavir intervention 4: ritonavir | 1 | Birmingham | Alabama | United States | -86.80249 | 33.52066 | 24 | 0 | 0 | 0 | NCT00869960 | 1COMPLETED | 2010-12-01 | 2009-03-01 | University of Alabama at Birmingham | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 8 | NA | SINGLE_GROUP | null | 0NONE | false | 0ALL | true | The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load \< 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replic... | The "PLUS" study is a prospective, longitudinal pilot study to measure the effect of therapy intensification (with raltegravir and possible addition of a study PI or NNRTI-Non-Nucleoside Reverse Transcriptase Inhibitor) on HIV-1 DNA/RNA levels in the gut-associated lymphoid tissue (GALT) and blood in patients on ART wi... | HIV Infections | HIV persistence reservoirs residual replication gut gut-associated lymphoid tissue treatment experienced | null | 1 | arm 1: Intensification with raltegravir 400mg PO BID +/- a study PI or NNRTI | [
0
] | 3 | [
0,
0,
0
] | intervention 1: The baseline ART regimen will be intensified with raltegravir 400mg orally (PO) twice daily (BID) (all participants) +/- a study NNRTI or protease inhibitor (PI) (at the option of the participant and the study clinical team). intervention 2: Subjects who are not already on an NNRTI and who are suitable ... | intervention 1: raltegravir intervention 2: Study NNRTI intervention 3: Study PI | 2 | San Francisco | California | United States | -122.41942 | 37.77493
San Francisco | California | United States | -122.41942 | 37.77493 | 8 | 0 | 0 | 0 | NCT00884793 | 1COMPLETED | 2010-12-01 | 2008-09-01 | University of California, San Francisco | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 76 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 ... | null | Rheumatoid Arthritis | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration intervention 2: 8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration | intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: tocilizumab [RoActemra/Actemra] | 24 | Vitoria-Gasteiz | Alava | Spain | -2.67268 | 42.84998
Villajoyosa | Alicante | Spain | -0.23346 | 38.50754
Ávila | Avila | Spain | -4.69951 | 40.65724
Menorca | Balearic Islands | Spain | N/A | N/A
Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939
Palma de Mallorca | Balearic Islands | Spain | 2.65024 |... | 76 | 0 | 0 | 0 | NCT00887341 | 1COMPLETED | 2010-12-01 | 2009-05-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 100 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | false | Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be t... | null | Hypercholesterolemia Flushing | Niacin Hypercholesterolemia Flushing | null | 4 | arm 1: Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 2: Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 3: Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to ... | [
1,
1,
1,
2
] | 3 | [
10,
0,
10
] | intervention 1: Apple pectin 2000mg intervention 2: Aspirin 325 mg intervention 3: Placebo | intervention 1: Apple pectin intervention 2: Aspirin 325 mg intervention 3: Placebo | 1 | Kansas City | Kansas | United States | -94.62746 | 39.11417 | 100 | 0 | 0 | 0 | NCT00895193 | 1COMPLETED | 2010-12-01 | 2009-01-01 | Patrick Moriarty, MD, FACP, FACC | 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
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period. | Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks. | Interstitial Cystitis Painful Bladder Syndrome | Bladder Pain GAG replacement therapy IC/PBS | null | 2 | arm 1: 20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period arm 2: 20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Weekly 20 mL Intravesical instillation intervention 2: The identical buffer used in Uracyst for the same administration | intervention 1: 2% sodium chondroitin sulfate intervention 2: Placebo | 20 | Boulder | Colorado | United States | -105.27055 | 40.01499
Denver | Colorado | United States | -104.9847 | 39.73915
Farmington | Connecticut | United States | -72.83204 | 41.71982
Plantation | Florida | United States | -80.23184 | 26.13421
Wellington | Florida | United States | -80.24144 | 26.65868
Columbus | Georgia |... | 98 | 0 | 0 | 0 | NCT00919113 | 1COMPLETED | 2010-12-01 | 2009-07-01 | Watson Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 340 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it. | null | Attention Deficit Hyperactivity Disorder | null | 5 | arm 1: Extended-release methylphenidate 18 milligrams per day (mg/day) to 54 mg/day, based on weight, given once daily (QD) and orally (po) as a capsule for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the taper phase. arm 2: None arm 3: Taken in tablet form QD po for the 8-week double-bli... | [
1,
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Taken in tablet form QD po. intervention 2: Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, QD po as a capsule for the 8-week double-blind treatment phase. intervention 3: Placebo given as a tablet for LY2216684 blind QD po for the 8-week double-blind treatment phase, followed ... | intervention 1: LY2216684 intervention 2: Methylphenidate intervention 3: Placebo (tablet) intervention 4: Placebo (capsule) | 19 | Spring Valley | California | United States | -116.99892 | 32.74477
Bradenton | Florida | United States | -82.57482 | 27.49893
Gainesville | Florida | United States | -82.32483 | 29.65163
Orlando | Florida | United States | -81.37924 | 28.53834
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lincoln | Nebr... | 388 | 0 | 0 | 0 | NCT00922636 | 1COMPLETED | 2010-12-01 | 2009-06-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Background:
* Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2 proteins (receptors) to appear on the cell surface and cause tumors to grow.
* An experimental procedure developed for treating patien... | Background:
* We have constructed a single retroviral vector that contains a chimeric T cell receptor (CAR) that recognizes the Her-2 tumor antigen, which can be used to mediate genetic transfer of this CAR with high efficiency (greater than 30%) without the need to perform any selection.
* In co-cultures with Her-2 p... | Metastatic Cancer | Metastatic Cancer Tumor Regression Immunotherapy Safety Cancer | null | 1 | arm 1: Cancer that has invaded other parts of the body | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 720,000 IU/kg every 8 hours for a maximum of 15 doses intervention 2: 60 mg/kg/day x 2 days intravenously (IV) in 250 ml 5% dextrose in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour intervention 3: 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. intervention 4: 3... | intervention 1: in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin intervention 2: Cyclophosphamide intervention 3: Fludarabine intervention 4: Mesna | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 1 | 0 | 0 | 0 | NCT00924287 | 6TERMINATED | 2010-12-01 | 2008-11-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 404 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo). | null | Chronic Plaque-type Psoriasis | Moderate to severe chronic plaque-type psoriasis AIN457 dermatology | null | 4 | arm 1: Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12 arm 2: Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12 arm 3: Early loading induction - "Early": se... | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9 intervention 3: Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5 intervention 4: Placebo - "Placebo": Placebo administere... | intervention 1: AIN457 intervention 2: AIN457A intervention 3: AIN457A intervention 4: Placebo | 62 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Pasadena | California | United States | -118.14452 | 34.14778
San Diego | California | United States | -117.16472 | 32.71571
Newnan | Georgia | United States | -84.79966 | 33.38067
Snellville | Geor... | 887 | 0 | 0 | 0 | NCT00941031 | 1COMPLETED | 2010-12-01 | 2009-07-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the efficacy of 2 different doses of intramuscular (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in the blood of patients with tropical calcific pancreatitis. | Tropical calcific pancreatitis (TCP) is a form of chronic pancreatitis unique to developing countries. Patients with TCP often have malabsorption leading to nutritional deficiencies. We have noted that vitamin D deficiency is common in patients with TCP. The ideal regimen for supplementing vitamin D3 in chronic pancrea... | Pancreatitis, Chronic | Tropical calcific pancreatitis Tropical chronic pancreatitis Chronic pancreatitis Vitamin D Vitamin D deficiency Cholecalciferol Intramuscular vitamin D3 | null | 3 | arm 1: IM Vitamin D3 3,00,000 Units single dose arm 2: IM vitamin D3 6,00,000 Units single dose arm 3: Oral vitamin D3 500 Units/ day | [
1,
1,
1
] | 1 | [
0
] | intervention 1: Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose
Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose
Arm 3 - Oral vitamin D3 500 Units/day for 6 months | intervention 1: Vitamin D3 (Cholecalciferol) | 1 | Lucknow | Uttar Pradesh | India | 80.92313 | 26.83928 | 40 | 0 | 0 | 0 | NCT00956839 | 1COMPLETED | 2010-12-01 | 2009-07-01 | Sanjay Gandhi Postgraduate Institute of Medical Sciences | 2OTHER_GOV | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 383 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study was to identify an appropriate dose of
MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis. | Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months. | Osteoporosis | Osteoporosis Postmenopausal MK-5442 | null | 6 | arm 1: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months. arm 2: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months. arm 3: Following a 2... | [
0,
0,
0,
0,
0,
2
] | 4 | [
0,
0,
7,
7
] | intervention 1: MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months. intervention 2: Dose-matched oral placebo to MK-5442 intervention 3: Vitamin D3, two 400 IU tablets daily throughout the study. intervention 4: Participants who had a calcium intake of less than 1200 mg/day at baselin... | intervention 1: MK-5442 intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium carbonate | 0 | null | 380 | 0 | 0 | 0 | NCT00960934 | 6TERMINATED | 2010-12-01 | 2009-10-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 789 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | null | The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's respo... | 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 | null | 5 | arm 1: 150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21. arm 2: 150 subjects (100 aged 18-64 and 50 aged greater than or equal to 65) to receive 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21. arm 3: 150 subjects (100 age... | [
0,
0,
0,
0,
0
] | 2 | [
0,
2
] | intervention 1: AS03 adjuvant administered with 3.75, 7.5, or 15 mcg inactivated H1N1 vaccine. intervention 2: Inactivated influenza H1N1 vaccine with AS03 adjuvant, delivered intramuscularly (IM) as 3.75, 7.5, or 15 micrograms per dose; and inactivated influenza H1N1 vaccine without adjuvant, delivered intramuscularly... | intervention 1: AS03 intervention 2: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A | 7 | Stanford | California | United States | -122.16608 | 37.42411
Decatur | Georgia | United States | -84.29631 | 33.77483
Iowa City | Iowa | United States | -91.53017 | 41.66113
Baltimore | Maryland | United States | -76.61219 | 39.29038
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Seattle | Washington | Unite... | 789 | 0 | 0 | 0 | NCT00963157 | 1COMPLETED | 2010-12-01 | 2009-09-01 | 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 |
[
0
] | 16 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic obstructive pulmonary disease (COPD) and contribute to poor health-related quality of life in this population. Several small, uncontrolled studies and published case reports have provided evidence that inhaled fentanyl, a powerful p... | null | Chronic Obstructive Pulmonary Disease | inhaled fentanyl dyspnea exercise COPD | null | 2 | arm 1: nebulized 0.9% saline placebo arm 2: nebulized fentanyl citrate (50 mcg) | [
2,
0
] | 2 | [
0,
0
] | intervention 1: single dose, 50 mcg of nebulized fentanyl citrate intervention 2: single dose, 0.9% saline solution | intervention 1: fentanyl intervention 2: normal saline (placebo) | 1 | Kingston | Ontario | Canada | -76.48098 | 44.22976 | 32 | 0 | 0 | 0 | NCT00974220 | 1COMPLETED | 2010-12-01 | 2010-01-01 | Queen's 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
] | 13 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease. | Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA. | Renal Disease | Renal disease Contrast agent MRA | null | 2 | arm 1: Each subject will receive one injection of Dotarem 0.2ml/kg. arm 2: Each subject will undergo a TOF Magnetic Resonance Angiography | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Each subject will receive one injection of Dotarem 0.2ml/kg intervention 2: Each subject will undergo a TOF MRA | intervention 1: Dotarem intervention 2: Time of Flight | 1 | Bloomington | Indiana | United States | -86.52639 | 39.16533 | 20 | 0 | 0 | 0 | NCT00980681 | 6TERMINATED | 2010-12-01 | 2009-09-01 | Guerbet | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Hypothesis:
The investigators suspect that significant degrees of iron overload in subjects with SCD result in decreased red cell survival, abnormal endothelial function and markedly dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude of these effects is proportional not only ... | Patients with sickle cell anemia often require blood transfusion as part of the treatment for their disease. Since each teaspoon of packed red blood cells contains about 5 mg of iron and humans have no way to get rid of excess iron, the levels of iron in sickle cell patients increase rapidly with each transfusion. Too ... | Anemia, Sickle Cell Transfusion Hemosiderosis | Sickle Cell Disease Sickle Cell Anemia Iron Overload Chelation Therapy Iron overload from blood transfusions Heart rate variability Autonomic dysfunction | null | 1 | arm 1: Single Arm study, all subjects to receive study medication, deferasirox (Exjade). | [
5
] | 1 | [
0
] | intervention 1: Treatment starting dose of 20mg/kg/day based on subjects baseline LIC (liver iron concentration) and gradually escalate the dose to a maximum of 35 mg/kg/day based upon toxicity. Duration is up to a max of 12 months. | intervention 1: deferasirox | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | 0 | 0 | 0 | NCT00981370 | 6TERMINATED | 2010-12-01 | 2009-04-01 | Children's Hospital Los Angeles | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,030 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in ... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted. | intervention 1: insulin degludec intervention 2: insulin glargine | 187 | Bay Minette | Alabama | United States | -87.77305 | 30.88296
Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Goodyear | Arizona | United States | -112.35821 | 33.43532
Anaheim | California | United States | -117.9145 | 33.83529
Concord | California ... | 1,023 | 0 | 0 | 0 | NCT00982644 | 1COMPLETED | 2010-12-01 | 2009-09-01 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 483 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual ... | Apathy is reported by up to 30% of patients with major depressive disorder (MDD) and is hypothesized to be a treatment emergent adverse effect associated with selective serotonin reuptake inhibitor medication. While there is currently no consistent method for treating apathy among psychiatrists, it has been proposed th... | Major Depressive Disorder | Major Depressive Disorder Apathy Duloxetine Hydrochloride SSRI Escitalopram | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 60-120 milligrams (mg) taken once daily (QD) by mouth (po) for 8 weeks; with option for additional 2 weeks. intervention 2: 10-20 mg taken QD po for 8 weeks; with option for additional 2 weeks. | intervention 1: Duloxetine intervention 2: Escitalopram | 15 | Everton Park | Queensland | Australia | 152.9884 | -27.40732
Spring Hill | Queensland | Australia | 153.02311 | -27.46141
Glenside | South Australia | Australia | 138.63375 | -34.94275
Dandenong | Victoria | Australia | 145.2 | -37.98333
Frankston | Victoria | Australia | 145.12291 | -38.14458
Prahran | Victoria | Aust... | 483 | 0 | 0 | 0 | NCT00985504 | 1COMPLETED | 2010-12-01 | 2009-09-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 667 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain. | This is a randomized, outpatient, multicenter, double-blind study (blinded to patient and to study doctor) comparing NUCYNTA to oxycodone IR in the treatment of patients with acute (new onset) low back pain who also have associated leg pain that radiates (travels down) below the knee. Patients will be screened for stud... | Pain Back Pain Low Back Pain Back Pain With Radiation | Acute Low Back Pain Low Back Pain With Leg Pain Below The Knee Radiculopathy, Oxycodone Tapentadol NUCYNTA | null | 2 | arm 1: NUCYNTA 50 75 or 100 mg every 4 to 6 hours for up to 10 days as needed for pain arm 2: Oxycodone IR 5 10 or 15 mg every 4 to 6 hours for up to 10 days as needed for pain | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain intervention 2: 5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain | intervention 1: NUCYNTA intervention 2: Oxycodone IR | 74 | Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Fresno | California | United States | -119.77237 | 36.74773
Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California... | 645 | 0 | 0 | 0 | NCT00986180 | 1COMPLETED | 2010-12-01 | 2009-09-01 | Ortho-McNeil Janssen Scientific Affairs, 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
] | 82 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | 1. In order to compare the benefit, side effects, and patient preference of Ropinirole prolonged release when used in once-daily or twice-daily dosing
2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release | 1. Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release
2. Cross over study design:
* Group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months
* Group 2: twice dai... | Parkinson Disease | Parkinson disease Ropinirole | null | 2 | arm 1: Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing arm 2: Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing | [
1,
1
] | 1 | [
0
] | intervention 1: Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily | intervention 1: Ropinirole Prolonged release | 2 | Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566 | 122 | 0 | 0 | 0 | NCT00986245 | 1COMPLETED | 2010-12-01 | 2009-09-01 | 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
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal in... | This is a randomized (treatment group assigned by chance), open-label (all involved people know the identity of the study drug), active-controlled study to evaluate the improvement in social functioning among participants with schizophrenia taking LAI risperidone and oral risperidone tablet. The study drug will be admi... | Schizophrenia | Schizophrenia Risperidone Risperdal | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection. intervention 2: ... | intervention 1: Risperidone long acting injectables intervention 2: Risperidone tablets | 1 | Ansan | N/A | South Korea | 127.55845 | 37.21795 | 45 | 0 | 0 | 0 | NCT00992407 | 1COMPLETED | 2010-12-01 | 2007-12-01 | 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
] | 26 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this medicine works well, it is difficult to know how much medicine a patient needs. Many things affect how much medicine a patient needs and doses can be very different from patient to patient. It is important for patients to get ... | Warfarin is the most commonly used oral anticoagulant medication. Due to the difficulty in determining an individual's proper warfarin dose, therapy is typically initiated with a standard dose followed by INR monitoring with frequent dose adjustment to ensure the medicine is working properly. Unfortunately, therapeutic... | Blood Clotting | Warfarin Pharmacogenetic | null | 2 | arm 1: Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing. arm 2: Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by warfarin pharmacogenetic dosing (warfarin dosing using genetic information incorpor... | [
1,
0
] | 2 | [
6,
0
] | intervention 1: Warfarin pharmacogenetic dosing incorporated into a validated clinical algorithm displayed in a computer (PERMIT) management interface intervention 2: Usual care warfarin dosing | intervention 1: warfarin pharmacogenetic dosing intervention 2: Warfarin | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 26 | 0 | 0 | 0 | NCT00993200 | 1COMPLETED | 2010-12-01 | 2009-08-01 | Robert Pendleton | 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
] | 145 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy. | null | Diabetes Mellitus, Type 2 | Metabolic Diseases Glucose Metabolism Disorders Diabetes GLP-1 Lilly | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. intervention 2: Administered by SC injection, QW for 12 weeks. | intervention 1: LY2189265 intervention 2: Placebo | 6 | Chiba | N/A | Japan | 140.11667 | 35.6
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kochi | N/A | Japan | 133.53333 | 33.55
Kyoto | N/A | Japan | 135.75385 | 35.02107
Osaka | N/A | Japan | 135.50107 | 34.69379
Tokyo | N/A | Japan | 139.69171 | 35.6895 | 145 | 0 | 0 | 0 | NCT01001104 | 1COMPLETED | 2010-12-01 | 2009-10-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,324 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). | null | Chronic Obstructive Pulmonary Disease | COPD NVA FEV1 | null | 2 | arm 1: Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication. arm 2: Placebo delivered once daily via SDDPI. At V... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI) intervention 2: Placebo inhalation capsules were provided for use via a SDDPI | intervention 1: Glycopyrronium bromide intervention 2: Placebo | 96 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Fairhope | Alabama | United States | -87.90333 | 30.52297
Glendale | Arizona | United States | -112.18599 | 33.53865
Los Angeles | California | United States | -118.24368 | 34.05223
Walnut Creek | California | United States | -122.06496 | 37.90631
Newark | Del... | 817 | 0 | 0 | 0 | NCT01005901 | 1COMPLETED | 2010-12-01 | 2009-10-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 286 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin. | null | Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus Saxagliptin Randomised Double-blind | null | 2 | arm 1: Saxagliptin 5 mg arm 2: Metformin 500 -1000 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 5 mg, oral tablet, once daily intervention 2: 500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy | intervention 1: Saxagliptin intervention 2: Metformin | 51 | Brussels (woluwe-st-lambert) | Belgium | Belgium | 4.34878 | 50.85045
Halen | Belgium | Belgium | 5.11096 | 50.94837
Lommel | Belgium | Belgium | 5.31349 | 51.23074
Oostham | Belgium | Belgium | 5.17877 | 51.10374
Sint-Gillis-Waas | Belgium | Belgium | 4.12374 | 51.21914
Zoersel | Belgium | Belgium | 4.71296 | 51.26825... | 286 | 0 | 0 | 0 | NCT01006590 | 1COMPLETED | 2010-12-01 | 2009-10-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas | null | Psoriasis Vulgaris | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Applied once daily intervention 2: Applied once daily | intervention 1: LEO 80190 intervention 2: Hydrocortisone | 1 | Saint-Etienne | N/A | France | 4.39 | 45.43389 | 40 | 0 | 0 | 0 | NCT01007591 | 1COMPLETED | 2010-12-01 | 2009-10-01 | LEO Pharma | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 222 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. | Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. | Cerebral Arterial Diseases | carotid or vertebral artery disease Contrast agent MRA | null | 1 | arm 1: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. | [
0
] | 2 | [
0,
10
] | intervention 1: Each subject will receive one injection of Dotarem 0.2ml/kg intervention 2: Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA) | intervention 1: Dotarem intervention 2: TOF MRA | 1 | Bloomington | Indiana | United States | -86.52639 | 39.16533 | 622 | 0 | 0 | 0 | NCT01010932 | 1COMPLETED | 2010-12-01 | 2009-10-01 | Guerbet | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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
] | 211 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. | Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA | Cerebral Arterial Diseases | carotid or vertebral artery disease Contrast agent MRA | null | 1 | arm 1: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. | [
0
] | 2 | [
0,
10
] | intervention 1: Each subject will receive one injection of Dotarem 0.2ml/kg intervention 2: Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA) | intervention 1: Dotarem intervention 2: TOF MRA | 1 | Bloomington | Indiana | United States | -86.52639 | 39.16533 | 585 | 0 | 0 | 0 | NCT01012674 | 1COMPLETED | 2010-12-01 | 2009-10-01 | Guerbet | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine.
MA abusing participants will undergo a 1-day outpatient screening and if i... | The safety of using atomoxetine in MA users will be characterized by measuring the cardiovascular effects of MA and by determining the occurrence of adverse reactions during treatment with atomoxetine and placebo. We will evaluate atomoxetine (0 and 40 mg, BID) and MA doses (0 and 30 mg, IV).
Participants will be rand... | Methamphetamine Abuse Methamphetamine Dependence | crystal meth methamphetamine substance abuse | null | 2 | arm 1: As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third... | [
2,
1
] | 2 | [
0,
0
] | intervention 1: As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for ... | intervention 1: Atomoxetine, then Placebo intervention 2: Placebo, then Atomoxetine | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 8 | 0 | 0 | 0 | NCT01019707 | 6TERMINATED | 2010-12-01 | 2009-10-01 | University of California, Los Angeles | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 38 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 1SINGLE | true | 0ALL | true | To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis. | Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.
To improve patient compliance, we have developed a refined formulation in which closer to natural ski... | Psoriasis Vulgaris | psoriasis, indigo naturalis | null | 2 | arm 1: Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study arm 2: Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque l... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks. intervention 2: The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterall... | intervention 1: refined indigo naturalis ointment intervention 2: crude indigo naturalis ointment | 1 | Keelung | N/A | Taiwan | 121.74094 | 25.13089 | 76 | 0 | 0 | 0 | NCT01022502 | 1COMPLETED | 2010-12-01 | 2009-11-01 | Yin-ku Lin | 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
] | 32 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2. | Sexual transmission is responsible for the vast majority of HIV-1 infections among adults worldwide. In sub-Saharan Africa, the region hardest hit by the HIV-1 epidemic, HSV-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with HIV-1. HSV-2 is common in those with, ... | HSV Infection HIV Infection | HSV HIV | null | 2 | arm 1: acyclovir 400 mg orally twice daily arm 2: valacyclovir 1.5 g orally twice daily | [
1,
1
] | 2 | [
0,
0
] | intervention 1: acyclovir 400 mg orally, twice daily for 12 weeks intervention 2: valacyclovir 1.5 g orally, twice daily, for 12 weeks | intervention 1: acyclovir intervention 2: valacyclovir | 1 | Thika | N/A | Kenya | 37.06933 | -1.03326 | 63 | 0 | 0 | 0 | NCT01026454 | 1COMPLETED | 2010-12-01 | 2010-02-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 129 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin). | null | Moderate or Severe Submental Fullness | null | 3 | arm 1: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. arm 2: Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of... | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: Phosphate buffered saline placebo for injection | intervention 1: Deoxycholic acid injection intervention 2: Placebo | 10 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Beverly Hills | California | United States | -118.40036 | 34.07362
Beverly Hills | California | United States | -118.40036 | 34.07362
San Francisco | California | United States | -122.41942 | 37.77493
Naperville | Illinois | United States | -88.14729 | 41.7858... | 129 | 0 | 0 | 0 | NCT01032889 | 1COMPLETED | 2010-12-01 | 2009-12-01 | Kythera Biopharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will ... | 4.2 Methodology
4.2.1 Patient evaluation After providing written informed consent, subject's eligibility will be assessed at a Screening Visit. The subject's general medical history will be recorded. This includes demographic data, history of surgical and cosmetic procedures, dermatological assessment, physical examin... | Sun-induced Wrinkles | Botulinum Toxin Rejuvenation Facial dynamic wrinkles | null | 3 | arm 1: group with intervention of 125 to 170 IU of 'Botulinum toxin' arm 2: Patients who have received 171 to 210 IU of 'Botulinum toxin' arm 3: Patients who have received 211 to 250 U of Botulinum toxi' | [
1,
1,
1
] | 1 | [
0
] | intervention 1: Drug: Botulinum toxin
Indications for eligibility and total doses that will be applied in each part of the face, at visit 1:
Upper face:
* Crow's feet wrinkles - 70 units
* Glabella - 50 units
* Forehead - 40 units
Mid face:
* Lower eyelid - 5 units
* Nasal wrinkles - 20 units
* Malar wrinkles - 10... | intervention 1: Botulinum toxin | 1 | Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 | 85 | 0 | 0 | 0 | NCT01032954 | 1COMPLETED | 2010-12-01 | 2009-11-01 | 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 |
[
5
] | 252 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17). | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain | Ankle Sprain | Ankle Sprain | null | 2 | arm 1: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) arm 2: One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) | [
1,
2
] | 2 | [
0,
10
] | intervention 1: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) intervention 2: One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) | intervention 1: FS-67 Patch intervention 2: Placebo Patch | 23 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Anaheim | California | United States | -117.9145 | 33.83529
Bell Gardens | California... | 252 | 0 | 0 | 0 | NCT01037816 | 1COMPLETED | 2010-12-01 | 2009-12-01 | Hisamitsu Pharmaceutical Co., 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
] | 16 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 0ALL | false | This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):
The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renall... | null | Severe Renal Impairment | null | 2 | arm 1: Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis arm 2: Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2) | [
0,
1
] | 1 | [
0
] | intervention 1: Pitavastatin 4mg single dose | intervention 1: Pitavastatin 4mg | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 16 | 0 | 0 | 0 | NCT01043094 | 1COMPLETED | 2010-12-01 | 2009-12-01 | Kowa Research Institute, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 18 | NA | SINGLE_GROUP | null | 0NONE | true | 0ALL | false | This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI \> 40 kg/m2 will h... | null | Obesity Tuberculosis | Obesity Pharmacokinetics Pharmacodynamics Dose individualization Tuberculosis | null | 1 | arm 1: All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended for daily... | [
0
] | 1 | [
0
] | intervention 1: All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended ... | intervention 1: Ethambutol | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 18 | 0 | 0 | 0 | NCT01048697 | 1COMPLETED | 2010-12-01 | 2010-01-01 | Texas Tech University Health Sciences 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
] | 79 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, we hypothesize t... | The study is conducted at approximately 25 sites in the United States. Subjects selected based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for 5 days. Subjects will be monitored by daily by telephone or home visit to monitor symptoms and complications of influenza for safety and w... | Influenza | influenza influenza like illness | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Tablet, 500 mg with food twice daily for 5 days intervention 2: Tablet, twice daily with food for 5 days | intervention 1: Nitazoxanide intervention 2: Placebo | 1 | Elmira | New York | United States | -76.80773 | 42.0898 | 79 | 0 | 0 | 0 | NCT01056380 | 6TERMINATED | 2010-12-01 | 2010-01-01 | Romark Laboratories L.C. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 109 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | The hypothesis of this study is that the administration of an intra-operative dose of dexmedetomidine will result in adequate analgesia without respiratory depression thereby resulting in an early discharge from the post anesthetic care unit following adenotonsillectomy. | Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression. Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory obstruction in the recovery room following administration of opioids.
As dexmedetomidine provides some analgesia without respiratory ... | Pediatric Adenotonsillectomy Post Operative Analgesia | Adenotonsillectomy Postoperative analgesia Pediatrics | Prot_SAP_000.pdf:
Identifiers: NCT01057381
Unique Protocol ID: H-17558
Title: Dexmedetomidine in Pediatric Tonsillectomy
Date: 3 June 2005
1/12/2021
Human Protocol Report
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=222564
1/8
Institutional Review Board for Baylor College of Medicine and Affili... | 4 | arm 1: Intraoperative administration for analgesia. arm 2: Intra-operative administration of dexmedetomidine 1 mcg/kg for analgesia arm 3: Intra-operative administration of morphine 50 mcg/kg for analgesia arm 4: Intra-operative administration of morphine 100mcg/kg for analgesia | [
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia. intervention 2: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia intervention 3: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia i... | intervention 1: Dexmedetomidine 0.75 mcg/kg intervention 2: Morphine 50 mcg/kg intervention 3: Morphine 100 mcg/kg intervention 4: Dexmedetomidine 1 mcg/kg | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 109 | 0 | 0 | 0 | NCT01057381 | 1COMPLETED | 2010-12-01 | 2005-08-01 | Baylor College of Medicine | 7OTHER | true | true | false | https://cdn.clinicaltrials.gov/large-docs/81/NCT01057381/Prot_SAP_000.pdf | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | 9OTHER | 0NONE | true | 0ALL | false | This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study. | This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment... | Healthy Volunteers | Healthy Volunteers | null | 1 | arm 1: Healthy adult subjects | [
0
] | 2 | [
0,
0
] | intervention 1: pitavastatin (NK-104) 4 mg once daily (QD) intervention 2: lopinavir/ritonavir 800 mg/200 mg | intervention 1: Pitavastatin (NK-104) intervention 2: Lopinavir/ritonavir | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 24 | 0 | 0 | 0 | NCT01057433 | 1COMPLETED | 2010-12-01 | 2010-01-01 | Kowa Research Institute, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 41 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747. | null | Postherpetic Neuralgia | pain delta opioid receptor agonist | null | 3 | arm 1: ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. arm 2: Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo o... | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: ADL5747 intervention 2: Placebo intervention 3: Pregabalin | 1 | West Palm Beach | Florida | United States | -80.05337 | 26.71534 | 75 | 0 | 0 | 0 | NCT01058642 | 6TERMINATED | 2010-12-01 | 2010-01-01 | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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
] | 18 | NA | SINGLE_GROUP | null | 0NONE | true | 0ALL | false | This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight. | null | Obesity Fungal Infection | Echinocandin Obesity Pharmacokinetics Pharmacodynamics Fungal infection | null | 1 | arm 1: Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2. | [
0
] | 1 | [
0
] | intervention 1: Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug) | intervention 1: Caspofungin | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 18 | 0 | 0 | 0 | NCT01062165 | 1COMPLETED | 2010-12-01 | 2010-02-01 | Texas Tech University Health Sciences 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 |
[
5
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 ... | As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhib... | HIV Infections | HIV Protease Inhibitor CCR5 Co-receptor Antagonist treatment naive | null | 1 | arm 1: Drug: lopinavir/ritonavir plus maraviroc | [
0
] | 1 | [
0
] | intervention 1: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria. | intervention 1: lopinavir/ritonavir plus maraviroc | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 1 | 0 | 0 | 0 | NCT01068873 | 6TERMINATED | 2010-12-01 | 2010-04-01 | Temple University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to investigate the effectiveness of a drug called ambrisentan, approved by the FDA for use in pulmonary hypertension (a condition where there is increased pressure in the right side of the heart) in scleroderma patients, to see if this medicine may be beneficial in relieving and/or preventi... | Baseline screening-we will screen you with a baseline review of your history, medications and lab values and you will need to get blood drawn for hemoglobin level, liver function panel and blood pregnancy test for females in child bearing age group. Women are advised strongly to use 2 reliable forms of contraception wh... | Ischemia | Ambrisentan increases digital micro-vascular flow (measured by LDPI) in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to SSc. | null | 2 | arm 1: drug arm
use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow arm 2: those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients | [
1,
2
] | 1 | [
0
] | intervention 1: Subjects will receive ambrisentan 5 mg orally once daily or identical placebo pills for the first 4 weeks and then increased to ambrisentan 10mg once daily\[if the lower dose is tolerated\] or identical placebo pills for the rest of the study. They will be instructed to take the 5mg/pink pills for 4 wee... | intervention 1: ambrisentan | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 20 | 0 | 0 | 0 | NCT01072669 | 1COMPLETED | 2010-12-01 | 2010-02-01 | Soumya Chatterjee | 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
] | 467 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patient... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Will be injected subcutaneously (under the skin) once daily three times weekly. intervention 2: Will be injected subcutaneously (under the skin) once daily administered at the same time each day. | intervention 1: insulin degludec intervention 2: insulin glargine | 105 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Peoria | Arizona | United States | -112.23738 | 33.5806
Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Escondido | California | United States | -117.08642 | 33.11921
La Jolla | Califo... | 467 | 0 | 0 | 0 | NCT01076647 | 1COMPLETED | 2010-12-01 | 2010-03-01 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 4 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 1SINGLE | false | 1FEMALE | false | Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a contributing factor. Changes in motor patterns in the small bowel in IBS patients are quantitative rather than qualitative with no distinc... | Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial, and gut motor dysfunction is considered to be a contributing factor. Dysmotility affects both the small bowel and the colon. Changes in motor patterns in the small bowel in IBS are quan... | Constipation-predominant Irritable Bowel Syndrome | IBS Lubiprostone Small Bowel High Resolution Manometry Delayed Intestinal Transit | null | 2 | arm 1: Same patients are included in both the Lubiprostone arm and the Placebo arm. The reason why the same patients are assigned to two arms is because an effect comparison is done after taking the placebo and later after taking the lubiprostone. arm 2: Same patients are included in both the Lubiprostone arm and the P... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 24mcg PO taken once intervention 2: 24mcg placebo capsule taken once | intervention 1: Lubiprostone intervention 2: Placebo | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 4 | 0 | 0 | 0 | NCT01085643 | 1COMPLETED | 2010-12-01 | 2010-03-01 | Cedars-Sinai Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers. | null | Healthy | Healthy volunteers | null | 6 | arm 1: The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose,... | [
5,
5,
5,
5,
5,
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol intervention 2: IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol intervention 3: Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol. intervention 4: IV DHE administere... | intervention 1: MAP0004 intervention 2: IV Placebo (Saline) intervention 3: Placebo Inhaler intervention 4: IV Dihydroergotamine Mesylate (DHE) | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 60 | 0 | 0 | 0 | NCT01089062 | 1COMPLETED | 2010-12-01 | 2010-03-01 | Allergan | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 56 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | The study will describe the short-term effects the study drug, rivaroxaban, has on the body when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by mouth) for the prevention of blood clotting in the veins after elective total hip or total knee replacement surgery. After providing writte... | The study medication, rivaroxaban, is an oral (by mouth) medication. Rivaroxaban directly inhibits one of the clotting mechanisms in the blood that is involved in the formation of blood clots in the veins in the body. The ability to inhibit blood clotting will be measured. Rivaroxaban is currently approved in the Europ... | Arthritis Osteoarthritis, Knee Osteoarthritis, Hip Thromboembolism | Total Hip Replacement Total Knee Replacement Hip Implant Knee Implant Joint Prosthesis Orthopedic Surgery Rivaroxaban Xarelto Blood Clot | null | 1 | arm 1: Rivaroxaban 10mg tablet daily receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement | [
0
] | 1 | [
0
] | intervention 1: 10mg tablet daily, receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement | intervention 1: Rivaroxaban | 5 | Denver | Colorado | United States | -104.9847 | 39.73915
Hollywood | Florida | United States | -80.14949 | 26.0112
Tamarac | Florida | United States | -80.24977 | 26.21286
Vero Beach | Florida | United States | -80.39727 | 27.63864
Glen Cove | New York | United States | -73.63374 | 40.86232 | 53 | 0 | 0 | 0 | NCT01094886 | 1COMPLETED | 2010-12-01 | 2010-03-01 | Ortho-McNeil Janssen Scientific Affairs, 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
] | 15 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | true | A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). T... | This is a multicenter, randomized, open-label, crossover study in pediatric participants with EPI due to CF. The study will be carried out in infants between 1 and 12 months of age.
The study comprises of a screening period (up to 10 days) followed by 2 treatment periods (10 days each). During the screening period, al... | Cystic Fibrosis Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency Infants with CF | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe nurser at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total d... | intervention 1: EUR-1008 (APT-1008) intervention 2: EUR-1008 (APT-1008) | 6 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Akron | Ohio | United States | -81.51901 | 41.08144
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
Houston | Texas | United Sta... | 42 | 0 | 0 | 0 | NCT01100606 | 1COMPLETED | 2010-12-01 | 2010-06-01 | Forest Laboratories | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation. | null | Type 2 Diabetes | Exenatide Amylin Lilly Byetta Exenatide Once Weekly | null | 4 | arm 1: 2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study. arm 2: Low dose 5 mg exenatide once monthly suspension SC. arm 3: Medium dose 8 mg exenatide once monthly suspension SC. arm 4: High dose 11 mg exenatide once monthly suspension SC. | [
1,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: subcutaneous injection, 2 mg, once a week intervention 2: subcutaneous injection, low dose, once a month intervention 3: subcutaneous injection, medium dose, once a month intervention 4: subcutaneous injection, high dose, once a month | intervention 1: exenatide once weekly intervention 2: exenatide once monthly suspension intervention 3: exenatide once monthly suspension intervention 4: exenatide once monthly suspension | 2 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Lincoln | Nebraska | United States | -96.66696 | 40.8 | 121 | 0 | 0 | 0 | NCT01104701 | 1COMPLETED | 2010-12-01 | 2010-05-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 52 | RANDOMIZED | PARALLEL | 9OTHER | 4QUADRUPLE | false | 0ALL | false | This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD. | This will be a randomized, double-blind, multicenter, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately ... | Attention-Deficit/Hyperactivity Disorder (ADHD) | ADHD Adults | Prot_000.pdf:
Supernus Pharmaceuticals, Inc.
CONFIDENTIAL
30Jun2010
812P201
Version 2.0
This document is confidential. It contains proprietary information of Supernus® Pharmaceuticals, Inc. Any
viewing or disclosure of such information that is not authorized in writing by the Sponsor is strictly prohibited .... | 2 | arm 1: Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day arm 2: Treatment B: Placebo capsules administered orally 3 times a day | [
0,
2
] | 2 | [
0,
0
] | intervention 1: One 50mg immediate-release viloxazine capsule administered orally 3 times a day (150mg total daily dose) for Week 1.
Two 50mg immediate-release viloxazine capsules administered orally 3 times a day (300mg total daily dose) for Weeks 2 to 6. intervention 2: Placebo capsules administered orally 3 times a... | intervention 1: IR Viloxazine intervention 2: Placebo | 4 | Bradenton | Florida | United States | -82.57482 | 27.49893
Libertyville | Illinois | United States | -87.95313 | 42.28308
Owensboro | Kentucky | United States | -87.11333 | 37.77422
Herndon | Virginia | United States | -77.3861 | 38.96955 | 51 | 0 | 0 | 0 | NCT01107496 | 1COMPLETED | 2010-12-01 | 2010-06-01 | Supernus Pharmaceuticals, Inc. | 4INDUSTRY | true | true | false | https://cdn.clinicaltrials.gov/large-docs/96/NCT01107496/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/96/NCT01107496/SAP_001.pdf | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate how platelets recover to normal function in subjects who have symptoms of a heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for planned coronary angiography. | null | Acute Coronary Syndromes | Acute Coronary Syndromes Angina Platelet Function Coronary Angiography Clinical Symptoms of Angina Positive Stress Test | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
0
] | 2 | [
0,
0
] | intervention 1: taken orally, day one, single dose intervention 2: taken orally, day one, single dose | intervention 1: clopidogrel intervention 2: prasugrel | 1 | Munich | N/A | Germany | 11.57549 | 48.13743 | 28 | 0 | 0 | 0 | NCT01107899 | 6TERMINATED | 2010-12-01 | 2009-10-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 388 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD. | null | Chronic Obstructive Pulmonary Disease | COPD | null | 8 | arm 1: NVA237 12.5 µg once daily arm 2: NVA237 25.0 µg once daily arm 3: NVA237 12.5 µg twice daily arm 4: NVA237 50.0 µg once daily arm 5: NVA237 25.0 µg twice daily arm 6: NVA237 100.0 µg once daily arm 7: NVA237 50.0 µg twice daily arm 8: Placebo to NVA237 once daily | [
0,
0,
0,
0,
0,
0,
0,
2
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 2: NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 3: NVA237 12.5 µg via dry powder inhaler twice daily for 28 days du... | intervention 1: NVA237 12.5 µg once daily intervention 2: NVA237 25.0 µg once daily intervention 3: NVA237 12.5 µg twice daily intervention 4: NVA237 50.0 µg once daily intervention 5: NVA237 25.0 µg twice daily intervention 6: NVA237 100.0 µg once daily intervention 7: NVA237 50.0 µg twice daily intervention 8: Placeb... | 29 | Anniston | Alabama | United States | -85.83163 | 33.65983
San Diego | California | United States | -117.16472 | 32.71571
Torrance | California | United States | -118.34063 | 33.83585
Denver | Colorado | United States | -104.9847 | 39.73915
Omaha | Nebraska | United States | -95.94043 | 41.25626
Philadelphia | Pennsylva... | 743 | 0 | 0 | 0 | NCT01119950 | 1COMPLETED | 2010-12-01 | 2010-04-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 13 | RANDOMIZED | CROSSOVER | null | 3TRIPLE | true | 0ALL | false | Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters abs... | null | Anthocyanin Metabolism | anthocyanin omeprazole Prilosec gastric pH proton pump inhibitor PPI nutrition | null | 2 | arm 1: Placebo with berries (blackberries + strawberries) arm 2: Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries) | [
2,
0
] | 2 | [
0,
0
] | intervention 1: omeprazole 20.6 mg tablet with berries (blackberries + strawberries) intervention 2: Placebo with berries (blackberries + strawberries) | intervention 1: omeprazole intervention 2: placebo | 1 | Beltsville | Maryland | United States | -76.90747 | 39.03483 | 22 | 0 | 0 | 0 | NCT01122160 | 1COMPLETED | 2010-12-01 | 2010-05-01 | USDA Beltsville Human Nutrition Research Center | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 91 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with modera... | This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to a... | Pain Low Back Pain Back Pain Osteoarthritis, Knee | Pain Low Back Pain Back Pain Osteoarthritis, Knee Tapentadol Tapentadol Hydrochloride Extended Release | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion. intervention 2: Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally tw... | intervention 1: Tapentadol Hydrochloride intervention 2: Placebo | 19 | Aichi | N/A | Japan | 130.62158 | 32.51879
Amagasaki | N/A | Japan | 135.41667 | 34.71667
Chiba | N/A | Japan | 140.11667 | 35.6
Chikushi | N/A | Japan | 130.78718 | 33.56055
Edogawa City | N/A | Japan | 139.87308 | 35.69225
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukushima | N/A | Japan | 140.46667 | 37.75
Hiratsuka ... | 91 | 0 | 0 | 0 | NCT01124604 | 1COMPLETED | 2010-12-01 | 2010-04-01 | Janssen Pharmaceutical K.K. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 26 | RANDOMIZED | CROSSOVER | null | 4QUADRUPLE | true | 0ALL | false | The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability. | All subjects will receive each intervention during the course of the study. Subjects will complete a 21-day washout period between treatment periods and following last treatment period. | Cognition | Anti-muscarinics Anti-cholinergics Cognition Solifenacin | null | 3 | arm 1: Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day. arm 2: Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form. arm 3: Participants received 21 days of treatment with placebo. | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: tablet intervention 2: capsule intervention 3: tablet | intervention 1: Solifenacin intervention 2: Oxybutynin intervention 3: Placebo | 3 | Blackpool | Lancashire | United Kingdom | -3.05 | 53.81667
Manchester | Lancashire | United Kingdom | -2.23743 | 53.48095
Bradford | Yorkshire | United Kingdom | -1.75206 | 53.79391 | 70 | 0 | 0 | 0 | NCT01126424 | 1COMPLETED | 2010-12-01 | 2010-04-01 | Astellas Pharma Inc | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this research study is to assess how safe, effective (how well it works), and tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been approved by the US Food and Drug Administrati... | The following procedures will be performed at the Screening Visit:
* Obtain informed consent.
* Obtain information about your age and gender.
* Evaluate whether you qualify for the study.
* Document prior negative testing for H. pylori infection (a bacterial infection in the stomach that can cause ulcers) including th... | Barrett Esophagus Gastroesophageal Reflux | null | 1 | arm 1: Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime | [
0
] | 2 | [
0,
3
] | intervention 1: None intervention 2: None | intervention 1: Zegerid (proton pump inhibitor) intervention 2: Bravo pH monitoring | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 22 | 0 | 0 | 0 | NCT01129778 | 6TERMINATED | 2010-12-01 | 2009-11-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 77 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | true | The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers. | null | Gastroduodenal Ulcerations Erosion | NSAID-induced gastroduodenal ulcerations or erosion | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Oral administration intervention 2: Oral administration | intervention 1: PL3100 intervention 2: Naproxen | 2 | Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328 | 77 | 0 | 0 | 0 | NCT01139190 | 1COMPLETED | 2010-12-01 | 2010-07-01 | PLx Pharma | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
4
] | 363 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body. | The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam to... | Psoriasis | Plaque Psoriasis Psoriasis | null | 2 | arm 1: Calcipotriene Foam 0.005%, arm 2: Vehicle Foam | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group intervention 2: Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group | intervention 1: Calcipotriene Foam intervention 2: Vehicle Foam | 26 | Tucson | Arizona | United States | -110.92648 | 32.22174
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
North Miami Beach | Florida | United States | -80.16255 | 25.93315
Newnan | Georgia | United States | -84.79966 | 33.38067
Snellville | Georgia... | 363 | 0 | 0 | 0 | NCT01139580 | 1COMPLETED | 2010-12-01 | 2010-05-01 | 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 |
[
0
] | 114 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare e... | null | Cholangitis | Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis | null | 2 | arm 1: adding 10mg gentamicin to every 10 ml of contrast media arm 2: Identical placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 10mg per 10ml of contrast media intervention 2: Distilled water | intervention 1: gentamicin intervention 2: Placebo | 1 | Tehran | Tehran Province | Iran | 51.42151 | 35.69439 | 114 | 0 | 0 | 0 | NCT01148693 | 1COMPLETED | 2010-12-01 | 2009-12-01 | Tehran University of Medical Sciences | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 28 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 2MALE | false | This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers. | * Adverse Events The whole study discontinuation is determined based on the following criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common Terminology Criteria for Adverse Events (CTCAE)
* Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic parame... | Healthy | healthy male volunteers | null | 2 | arm 1: Period 1: CG100649 will be administered alone on Day 1 -After washout period- Period 2: The combination of CG100649 and ketoconazole tabs together on Day 1 followed by ketoconzzole tabs arm 2: Period 1: The combination of CG100649 and ketoconazole tabs will be administered together on Day 1, followed by ketocona... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time intervention 2: I period: ketoconazole + CG100649 II period: CG 100649 | intervention 1: CG100649 intervention 2: Ketoconazole | 1 | Seoul | N/A | South Korea | 126.9784 | 37.566 | 56 | 0 | 0 | 0 | NCT01154764 | 1COMPLETED | 2010-12-01 | 2009-10-01 | CrystalGenomics, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 404 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator. | null | Glaucoma | null | 2 | arm 1: One drop of T2345 arm 2: One drop | [
0,
1
] | 2 | [
0,
0
] | intervention 1: One drop of T2345 intervention 2: One drop | intervention 1: T2345 intervention 2: Prostaglandin | 1 | Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 | 402 | 0 | 0 | 0 | NCT01156012 | 1COMPLETED | 2010-12-01 | 2009-09-01 | Laboratoires Thea | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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
] | 80 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjec... | null | Rhinitis, Allergic, Perennial | null | 1 | arm 1: MFNS 50 μg spray device. The dose will be as follows:
* 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning. | [
0
] | 1 | [
0
] | intervention 1: MFNS 50 μg spray device
* 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning. | intervention 1: mometasone furoate | 0 | null | 80 | 0 | 0 | 0 | NCT01165424 | 1COMPLETED | 2010-12-01 | 2010-04-01 | Organon and Co | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 148 | NON_RANDOMIZED | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction. | The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment perio... | Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis RRMS Clinically Isolated Syndrome CIS Copaxone glatiramer acetate Autoject 2 | null | 1 | arm 1: Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2). | [
1
] | 2 | [
0,
0
] | intervention 1: 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe. intervention 2: 20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device. | intervention 1: Glatiramer Acetate 20 mg/0.5 mL intervention 2: Glatiramer acetate 20 mg/0.5 mL | 0 | null | 290 | 0 | 0 | 0 | NCT01167426 | 1COMPLETED | 2010-12-01 | 2010-07-01 | Teva Neuroscience, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 16 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a single site, open-label, feasibility study of cognitive behavioral therapy with exposure and response prevention (CBT/ERP) adding the augmentation of D-cycloserine (DCS) for adolescents ages 12-17 with Obsessive Compulsive Disorder (OCD) who are partial or non-responders to first line treatments of CBT or pha... | The primary goal of this study is to examine the feasibility and efficacy of DCS augmentation to CBT/ERP at the end of the session. The main treatment outcome will be measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The secondary goal of the study is to investigate the safety of DCS in adolescents with O... | Obsessive Compulsive Disorder | OCD DCS D-cycloserine CBT E/RP exposure response prevention | null | 2 | arm 1: Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held. arm 2: Participants in this arm received twice-we... | [
1,
1
] | 2 | [
0,
5
] | intervention 1: 50 mg dose of D-cycloserine administered at the end of each session of Cognitive Behavioral Therapy With Exposure and Response Prevention: twice weekly CBT/ERP of 60 minutes intervention 2: Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment se... | intervention 1: D-cycloserine intervention 2: Exposure and Response Prevention (EX/RP) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 16 | 0 | 0 | 0 | NCT01172873 | 1COMPLETED | 2010-12-01 | 2008-09-01 | New York State Psychiatric Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 245 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients. | null | Allergic Conjunctivitis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution | intervention 1: bepotastine besilate ophthalmic solution intervention 2: placebo comparator ophthalmic solution | 1 | Irvine | California | United States | -117.82311 | 33.66946 | 244 | 0 | 0 | 0 | NCT01174823 | 1COMPLETED | 2010-12-01 | 2010-06-01 | Bausch & Lomb Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 21 | NA | SINGLE_GROUP | null | 0NONE | true | 0ALL | false | One in three Americans are obese. Obese subjects may or may not need higher doses of the anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy volunteers compared to that previously shown in non-o... | The incidence of obesity has increased dramatically over the past two decades in the United States (US). Twenty-five percent of adult Americans are now classified as obese. Obesity is associated with physiological alterations that can affect drug clearance and volume of distribution. Obese subjects are often excluded f... | Obesity | Oseltamivir Obesity Influenza Pharmacokinetics in Obesity | null | 1 | arm 1: Oseltamivir 75 mg by mouth every 12 hours for 9 doses | [
0
] | 1 | [
0
] | intervention 1: Capsule, 75 mg by mouth for 9 doses | intervention 1: Oseltamivir | 1 | Paramaus | New Jersey | United States | N/A | N/A | 21 | 0 | 0 | 0 | NCT01179919 | 1COMPLETED | 2010-12-01 | 2010-07-01 | Manjunath Prakash Pai | 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
] | 177 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive b... | null | Hepatitis C | boceprevir hepatitis C bioequivalence SCH 503034 | null | 4 | arm 1: Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition. arm 2: Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then ... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 2: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 3: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted condi... | intervention 1: boceprevir intervention 2: boceprevir intervention 3: boceprevir intervention 4: boceprevir | 0 | null | 354 | 0 | 0 | 0 | NCT01181804 | 1COMPLETED | 2010-12-01 | 2010-06-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to assess the effect of tasisulam as an inhibitor of CYP2C9, using tolbutamide as a probe substrate. This study was to have 3 treatment periods, and continued access in an extension period. Period 1 is 4 days in length. Periods 2 and 3 are each approximately 28 days in length. Due to the e... | null | Lymphoma Advanced Cancer | Advanced or Metastatic Solid Tumors or Lymphoma | null | 1 | arm 1: Three study periods and continued access to tasisulam every 28 days (except Period 1 which was tolbutamide only and lasted 4 days) until disease progression:
Period 1: 500 milligram (mg) tolbutamide administered on Day 1.
Period 2: 500 mg of tolbutamide and individualized tasisulam dose \[based on area under t... | [
0
] | 2 | [
0,
0
] | intervention 1: Administered orally intervention 2: Administered intravenously | intervention 1: Tolbutamide intervention 2: Tasisulam | 5 | Cardiff | South Glamorgan | United Kingdom | -3.18 | 51.48
Sheffield | Trent | United Kingdom | -1.4659 | 53.38297
Leeds | West Yorkshire | United Kingdom | -1.54785 | 53.79648
Leicester | N/A | United Kingdom | -1.13169 | 52.6386
London | N/A | United Kingdom | -0.12574 | 51.50853 | 10 | 0 | 0 | 0 | NCT01185548 | 6TERMINATED | 2010-12-01 | 2010-07-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 339 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assi... | Study ADA113872 will assess the ability of ADVAIR™ DISKUS™ 100/50 mcg, in comparison to FLOVENT™ DISKUS™ 100 mcg, to reduce worsening asthma associated with viral respiratory infections during the fall season in a pediatric population. A number of descriptive measures will be used to assess the reduction in worsening a... | Asthma | pediatric exacerbation viral induced exacerbation asthma | null | 2 | arm 1: FLOVENT™ DISKUS™ 100 mcg is an inhaled corticosteroid indicated in the US for maintenance treatment of asthma as prophylactic therapy in patients 4 years and older. arm 2: ADVAIR™ DISKUS™ 100/50 mcg is a combination product containing a corticosteroid and a long acting beta2 adrenergic agonist indicated for; mai... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: FLOVENT™ DISKUS™ 100 mcg, one inhalation twice daily (BID) from the DISKUS device from randomization through the end of study (week 16). intervention 2: ADVAIR™ DISKUS™ 100/50 mcg is a combination product containing a 100 mcg fluticasone propionate and a 50 mcg salmeterol. One inhalation from the DISKUS... | intervention 1: FLOVENT™ DISKUS™ 100 mcg BID intervention 2: ADVAIR™ DISKUS™ 100/50 mcg BID | 38 | Tucson | Arizona | United States | -110.92648 | 32.22174
Bakersfield | California | United States | -119.01871 | 35.37329
Fresno | California | United States | -119.77237 | 36.74773
Granada Hills | California | United States | -118.52314 | 34.26472
Huntington Beach | California | United States | -117.99923 | 33.6603
Lo... | 339 | 0 | 0 | 0 | NCT01192178 | 1COMPLETED | 2010-12-01 | 2010-08-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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