phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
2,
3
] | 154 | RANDOMIZED | FACTORIAL | 9OTHER | 3TRIPLE | true | 0ALL | true | The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol... | Caffeinated alcoholic beverages target young adults with the promise that the caffeine will counteract the sedating effects of alcohol and thus let the consumer remain alert and active longer, while continuing to drink. It is likely that in the minds of some young people, this promise also translates into the idea that... | Neurobehavioral Manifestations Drug Related Sleep Disturbance Alcohol Intoxication | Caffeine Alcohol Alcohol Consumption Residual Effects Family History Psychomotor Vigilance Test Driving Simulation Reaction Time | null | 4 | arm 1: Caffeinated Alcoholic beer arm 2: Non-Caffeinated Alcoholic beer arm 3: Caffeinated Non-Alcoholic Beer arm 4: Non-Caffeinated, Non-Alcoholic Beer | [
0,
1,
1,
2
] | 4 | [
0,
10,
0,
10
] | intervention 1: Alcoholic Beer plus Caffeine Citrate powder. intervention 2: Alcoholic Non-Caffeinated Beer intervention 3: Non-Alcoholic Beer plus Caffeine Citrate powder. intervention 4: Non-Alcoholic Beer | intervention 1: Caffeinated Alcoholic Beer intervention 2: Non-Caffeinated Alcoholic Beer intervention 3: Caffeinated Non-Alcoholic Beer intervention 4: Non-Caffeinated, Non-Alcoholic Beer | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00515294 |
[
4
] | 180 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IP... | IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high b... | Pulmonary Fibrosis Hypertension, Pulmonary | Idiopathic Pulmonary Fibrosis Pulmonary Hypertension | null | 2 | arm 1: 20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks arm 2: 20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Sildenafil citrate (20mg 3 times a day \[TID\] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks) intervention 2: Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks) | intervention 1: Sildenafil Citrate intervention 2: Placebo | 13 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illino... | 0 | NCT00517933 |
[
5
] | 11 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this pilot study is to determine the efficacy and safety of escitalopram administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in young women ages 15-19 years. | The medication in this study is a serotonin reuptake inhibitor (SSRI), a class that is considered the first-line treatment for severe PMS at this time. Although data indicate that young women who have PMS in their teen years report the same symptoms and symptom severity as adult women, clinical trials have not included... | PMS | premenstrual syndrome PMS PMDD treatment SSRI | null | 2 | arm 1: Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. arm 2: Placebo tablets matched to d... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects. intervention 2: Placebo tablets matched... | intervention 1: escitalopram intervention 2: placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00523705 |
[
5
] | 23 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor... | There are a total of six clinic visits involved in this study. All study-related assessments will take place first during the practically defined off period, that is, in the morning after at least 12 hours from the last dose of any antiparkinsonian medication, followed by a repeat assessment once the "on" state is clea... | Parkinson's Disease Gait Impairment | freezing gait festination shuffling balance | null | 2 | arm 1: Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo. arm 2: Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily do... | intervention 1: Methylphenidate (MPD) intervention 2: Placebo | 1 | Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 0 | NCT00526630 |
[
3
] | 170 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass). | null | Sarcopenia | Sarcopenia (loss of muscle mass) | null | 2 | arm 1: MK-0773 arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: MK-0773 50 mg tablets twice daily, 6 month treatment period intervention 2: Placebo tablets twice daily, 6 month treatment period | intervention 1: Comparator: MK-0773 intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00529659 |
[
4
] | 120 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will re... | null | Anemia | null | 1 | arm 1: Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a c... | [
0
] | 1 | [
0
] | intervention 1: Mircera will be administered intravenously every 4 weeks for a total of 52 weeks. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific tar... | intervention 1: Methoxy polyethylene glycol-epoetin beta | 27 | Bregenz | N/A | Austria | 9.7471 | 47.50311
Feldkirch | N/A | Austria | 9.6 | 47.23306
Graz | N/A | Austria | 15.45 | 47.06667
Kufstein | N/A | Austria | 12.16667 | 47.58333
Linz | N/A | Austria | 14.28611 | 48.30639
Salzburg | N/A | Austria | 13.04399 | 47.79941
Sankt Pölten | N/A | Austria | 15.63333 | 48.2
Steyr | N... | 0 | NCT00545571 | |
[
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer. | null | Non-Hodgkin's Lymphoma | Bortezomib Bendamustine Rituximab Relapsed Refractory Mantle Cell Indolent | null | 1 | arm 1: Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 1.3 mg/m\^2 on days 1, 4, 8, 11 intervention 2: 90 mg/m\^2 days 1 and 4 intervention 3: 375 mg/m\^2 day 1 | intervention 1: bortezomib intervention 2: bendamustine intervention 3: rituximab | 3 | Omaha | Nebraska | United States | -95.94043 | 41.25626
New York | New York | United States | -74.00597 | 40.71427
Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00547534 |
[
5
] | 54 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested. | null | Candidemia Invasive Candidiasis | Open-label non-comparative study to evaluate short course of IV anidulafungin followed by oral voriconazole for tx of candidemia/invasive candidiasis. | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin. intervention 2: Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg ... | intervention 1: Anidulafungin intervention 2: Voriconazole | 13 | Brasília | Federal District | Brazil | -47.92972 | -15.77972
Curitiba | Paraná | Brazil | -49.27306 | -25.42778
Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
São José do... | 0 | NCT00548262 |
[
4
] | 215 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder. | null | Bipolar Disorder | Lamotrigine Prevention of relapse or recurrence of a mood episode Bipolar I disorder | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: lamotrigine 100mg/day or 200mg/day intervention 2: placebo once daily | intervention 1: lamotrigine intervention 2: Placebo | 60 | Aichi | N/A | Japan | 130.62158 | 32.51879
Chiba | N/A | Japan | 140.11667 | 35.6
Chiba | N/A | Japan | 140.11667 | 35.6
Chiba | N/A | Japan | 140.11667 | 35.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 3... | 0 | NCT00550407 |
[
3,
4
] | 256 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | false | The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine... | Most studies evaluating treatments PE include intravaginal ejaculatory latency time (IELT) in the definition of PE. It has been estimated that PE affects 30-40% of the male population, but is paradoxically a condition for which they are least likely to seek help.
Men with PE exhibit abnormal autonomic reflex pathways ... | Premature Ejaculation | Premature Ejaculation Lidocaine Prilocaine EMLA® cream topical anesthetics | null | 3 | arm 1: Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria. arm 2: Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria. arm 3: Subjects will all receive PSD502 if they wish to continue in the t... | [
1,
2,
1
] | 2 | [
0,
0
] | intervention 1: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with... | intervention 1: PSD502, contains a mixture of lidocaine and prilocaine intervention 2: Placebo | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00556478 |
[
4
] | 307 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera o... | null | Renal Anemia, Chronic | null | 2 | arm 1: Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks. arm 2: Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifi... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1.2 mcg/kg SC monthly, starting dose intervention 2: 0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose | intervention 1: Methoxy polyethylene glycol-epoetin beta intervention 2: Darbepoetin alfa | 76 | Adelaide | N/A | Australia | 138.59863 | -34.92866
Clayton | N/A | Australia | 145.11667 | -37.91667
Gosford | N/A | Australia | 151.34399 | -33.4244
Parkville | N/A | Australia | 144.95 | -37.78333
Reservoir | N/A | Australia | 145.0 | -37.71667
Aalst | N/A | Belgium | 4.0355 | 50.93604
Roeselare | N/A | Belgium | 3.1... | 0 | NCT00559273 | |
[
2,
3
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The goal of this clinical research study is to find the highest tolerable dose of Azacytidine (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). The safety and effectiveness of... | 5-azacytidine is designed to "turn off" the growth of cancer cells. This may be increased by ara-C, which is designed to kills leukemia cells by helping to stop the cells from dividing.
If you are found to be eligible to take part in this study, you will be assigned to a treatment group. You will be randomly assigned ... | Acute Myelogenous Leukemia Myelodysplastic Syndrome Leukemia | Acute Myelogenous Leukemia AML Myelodysplastic Syndrome MDS Leukemia | null | 4 | arm 1: Group 1 = Low-Dose Ara-C + Azacitidine-Level 0
Low-Dose Ara-C: 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days Azacitidine (AZA): 37.5 mg/m\^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days arm 2: Group 2 = Low-Dose Ara-C + Azacitidine-Level 1
Low-Dose Ara-C: 100 mg/m\^2 Daily continuo... | [
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days intervention 2: Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days
Arms 3 and 4 at High-dose = 1 g/m\... | intervention 1: Azacitidine intervention 2: Ara-C | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00569010 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cyc... | null | Metastatic Breast Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: bortezomib:1.3 mg/m2 IVP over 3-5 sec. days 1, 4, 8, 11 of 21 day cycle doxorubicin: 20 mg/m2 IV over 3-5 min. days 1,8 (one hour after bortezomib) of 21 day cycle | intervention 1: PS-341, doxorubicin | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00574236 | |
[
4
] | 25 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology.
Secondary objectives were:
* To investigate the safety and tolerabili... | The study consisted of 2 phases:
* a 12-week efficacy phase then,
* a 40-week safety extension phase.
All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.
Patients who ... | Hydronephrosis Neurogenic Bladder | child bladder neuropathic alpha blockers | null | 3 | arm 1: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. arm 2: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to tak... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Dose: 0.2 mg/kg/day
Route: oral | intervention 1: Alfuzosin | 12 | Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Laval | N/A | Canada | -73.692 | 45.56995
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Mumbai | N/A | India | 72.88261 | 19.07283
Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412
Warsaw | N/A | Poland | 21.01178 | 52.22977
Moscow | N/A | Russia | 37.61556 | 55.75222
Belgr... | 0 | NCT00576823 |
[
2,
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study is to discover whether children with severe combined immunodeficiency disease (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment other than stem cell transplantation (SCT) exists can be safely and effectively transplanted from HLA mismatched (up to one haplotype) rela... | Donor Stem Cell Processing for Mismatched Donors: Harvested peripheral blood stem cells will be enriched for CD34 cells using the CliniMACS CD34 Reagent system, according to Center for Cell and Gene Therapy (CAGT) SOPs.
Stem Cell Transplant Conditioning
Campath-1H will be given as 3 daily intravenous infusions and wi... | Severe Combined Immunodeficiency Disease Severe Primary Immunodeficiency Disorder Undefined T Cell Deficiency Disorder Wiskott-Aldrick Syndrome | Severe Combined Immunodeficiency Disease Severe Primary Immunodeficiency Disorder Undefined T cell Deficiency Disorder Wiskott-Aldrick Syndrome Allogeneic stem cell transplant Fludarabine monoclonal antibodies | null | 1 | arm 1: all patient will receive an allogeneic transplant with the following conditioning regimen Campath -1H, Fludarabine, Anti-CD45 | [
0
] | 4 | [
2,
0,
2,
3
] | intervention 1: Given intravenous on Days -8,-7, and -6
Campath dose is weight based: for patients less than 15 kg the dose is 3 mg; for patients \>15 kg to 30 kg the dose 5 mg; for patients \> 30 kg the dose is 10 mg intervention 2: Given intravenous on Days -8,-7,-6,-5, and -4
Dose is 30 mg/m2 intervention 3: Given... | intervention 1: Campath -1H intervention 2: Fludarabine intervention 3: Anti-CD45 intervention 4: Stem cell infusion | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00579137 |
[
5
] | 136 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose. | This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth. | Nail Psoriasis Plaque Psoriasis | Nail Psoriasis Plaque Psoriasis | null | 2 | arm 1: etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24 arm 2: etanercept 50 mg SC once weekly for the complete 24 week treatment period | [
1,
1
] | 1 | [
0
] | intervention 1: Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.
Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period. | intervention 1: etanercept | 0 | null | 0 | NCT00581100 |
[
5
] | 34 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) cha... | Memantine (Namenda) is a low-affinity N-methyl-D-aspartate (NMDA) receptor antagonist believed to work by blocking prolonged low-level activation of the NMDA receptor and resultant neuronal damage caused by abnormal glutamatergic activity, yet also allowing normal physiological activity of the NMDA channel. Memantine (... | ADHD | ADHD Namenda | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: tablet, 5-20 mg, twice daily, by mouth, 12 weeks | intervention 1: memantine hydrochloride | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00586573 |
[
0
] | 22 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a po... | The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the s... | End Stage Renal Disease | null | 2 | arm 1: Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list arm 2: Intravenous immune globulin for patients who have living donors with positive cross... | [
5,
5
] | 1 | [
0
] | intervention 1: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments | intervention 1: intravenous immune globulin | 0 | null | 0 | NCT00586716 | |
[
3
] | 311 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) th... | null | Rheumatoid Arthritis | Rheumatoid arthritis Atacicept Adalimumab Humira® | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
1,
2
] | 4 | [
0,
0,
0,
2
] | intervention 1: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. intervention 2: Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by ... | intervention 1: Placebo matched to atacicept intervention 2: Atacicept: with loading dose intervention 3: Atacicept intervention 4: Adalimumab | 2 | Rockland | Massachusetts | United States | -70.91616 | 42.13066
Darmstadt | N/A | Germany | 8.65027 | 49.87167 | 0 | NCT00595413 |
[
5
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | true | GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day 1 (one day after LASIK surgery), Day 7 (on... | LASIK (Laser Keratomileusis in Situ) is a frequently performed procedure to reduce the refractive error of the eye so as to minimize the subsequent need for eyeglasses or contact lenses. The procedure requires the creation of a superficial corneal flap, usually with an instrument known as a microkeratome. During the cr... | Corneal Epithelium Defect | LASIK Ocular Lubricants Corneal Epithelium Wound Healing | null | 2 | arm 1: Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery. arm 2: Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery | [
0,
4
] | 1 | [
0
] | intervention 1: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery | intervention 1: 0.3% hypromellose | 1 | Augusta | Georgia | United States | -81.97484 | 33.47097 | 0 | NCT00598689 |
[
4
] | 798 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the... | null | Schizophrenic Disorders | schizophrenia SWNK | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Oral, once daily, tablets of 400 mg to 800 mg intervention 2: Oral, once daily, tablets of 2 mg to 6 mg | intervention 1: Quetiapine XR intervention 2: Risperidone | 116 | Assebroek | Belgium | Belgium | 3.2623 | 51.19367
Hasselt | Belgium | Belgium | 5.33781 | 50.93106
Liège | Belgium | Belgium | 5.56749 | 50.63373
Montignies-sur-Sambre | Belgium | Belgium | 4.49109 | 50.41081
Roeselare | Belgium | Belgium | 3.12269 | 50.94653
Sint-Denijs-Westrem | N/A | Belgium | 3.67202 | 51.02135
Tou... | 0 | NCT00600756 |
[
4
] | 480 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens | null | Sexual Dysfunctions, Psychological | null | 1 | arm 1: Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
Flibanserin may ... | [
0
] | 1 | [
0
] | intervention 1: Initial dosage:
Patients were to take one 50 mg flibanserin tablet in the evening.
Subsequent dosage titrations:
Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.
Flibans... | intervention 1: flibanserin flexible dose | 68 | Innsbruck | N/A | Austria | 11.39454 | 47.26266
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Wörgl | N/A | Austria | 12.06174 | 47.48906
Braine-l'Alleud | N/A | Belgium | 4.36784 | 50.68363
Edegem | N/A | Belgium | 4.44504 | 51.15662
Ghent | N/A | Belgium | 3.71667 | 51.05
H... | 0 | NCT00601367 | |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this research study is to test the safety of duloxetine and see what effects (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder (depression occurring with binge eating disorder) compared to placebo (inactive pill). | This is a 12-week, double blind, randomized, placebo-controlled, parallel-group, flexible-dose study of duloxetine 60-120 mg/day in patients with BED and comorbid depressive disorders. Patients will be randomly assigned to either duloxetine 30 mg capsules or matching placebo at the baseline visit. The initial dose of s... | Binge Eating Depression | null | 2 | arm 1: Start with 30 mg duloxetine hydrochloride capsule/day to be increased up to 120 mg per day. arm 2: Sugar pill with matching dosage as Duloxetine | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 30 mg/day - 120 mg/day intervention 2: identical to study drug | intervention 1: Duloxetine intervention 2: Placebo | 1 | Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 0 | NCT00607789 | |
[
4
] | 2,417 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder | null | Overactive Bladder | Treatment of overactive bladder | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks. intervention 2: Placebo treatment will be once daily(QD) for 12 weeks. intervention 3: The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks. | intervention 1: Tolterodine ER intervention 2: Placebo intervention 3: Fesoterodine | 227 | Enterprise | Alabama | United States | -85.85522 | 31.31517
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Chandler | Arizona | United States | -111.84125 | 33.30616
Peoria | Arizona | United States | -112.23738 | 33.5806
Tucson | Arizona | United Sta... | 0 | NCT00611026 |
[
3
] | 139 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug). | null | Crohn's Disease | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: administration via oral route twice daily intervention 2: administration via oral route twice daily intervention 3: administration via oral route twice daily intervention 4: administration via oral route twice daily | intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo | 72 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Boulder | Colorado | United States | -105.27055 | 40.01499
Lakewood | Colorado | United States | -105.08137 | 39.70471
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Washington D.C. | Distr... | 0 | NCT00615199 | |
[
4
] | 259 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy | null | Hypertension | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: telmisartan40/amlodipine5 intervention 2: telmisartan80/amlodipine5 | 7 | Chofu, Tokyo | N/A | Japan | N/A | N/A
Nishi-ku, Hiroshima, Hiroshima | N/A | Japan | N/A | N/A
Osaka, Osaka | N/A | Japan | N/A | N/A
Osaka, Osaka | N/A | Japan | N/A | N/A
Shinjuku-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895
Shinjyuku-ku,Tokyo | N/A | Japan | 139.69171 | 35.6895
Suita, Osaka | N/A | Japan | N/A | N... | 0 | NCT00618774 | |
[
2,
3
] | 200 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these you... | This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants \<91 days of age with suspected and complicated intra-abdominal infections.
The specific aims of this trial are:
1. To characterize meropenem single-dose and multiple-dose PK in subjects with susp... | Necrotizing Enterocolitis Intra-abdominal Infection | meropenem infants intra-abdominal infection pharmacokinetics safety | null | 1 | arm 1: These
Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA):
Group 1: GA at birth below 32 weeks - PNA \<2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and \<91 days; Group 3: GA at birth 32 weeks or older - PNA \<2 weeks; Group 4: GA at ... | [
0
] | 1 | [
0
] | intervention 1: Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycos... | intervention 1: meropenem | 26 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Oakland | California | United States | -122.2708 | 37.80437
Orange | California | United States | -117.85311 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
New Haven | Co... | 0 | NCT00621192 |
[
3
] | 1,878 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascu... | null | Coronary Disease | null | 5 | arm 1: twice daily dosing, arm 2: twice daily dosing, patients with moderate renal impairment allocated 50mg bid arm 3: twice daily dosing, patients with moderate renal impairment allocated 75mg bid arm 4: twice daily dosing, patients with moderate renal impairment allocated 110mg bid arm 5: matched placebo | [
0,
0,
0,
0,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: matched placebo intervention 2: capsules, twice daily, 26 weeks treatment intervention 3: capsules, twice daily, 26 weeks treatment intervention 4: capsules, twice daily, 26 weeks treatment intervention 5: capsules, twice daily, 26 weeks treatment | intervention 1: placebo intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate intervention 4: dabigatran etexilate intervention 5: dabigatran etexilate | 167 | Clearwater | Florida | United States | -82.8001 | 27.96585
Bouge/Namur | N/A | Belgium | N/A | N/A
Brasschaat | N/A | Belgium | 4.49182 | 51.2912
Edegem | N/A | Belgium | 4.44504 | 51.15662
Genk | N/A | Belgium | 5.50082 | 50.965
Gilly | N/A | Belgium | 4.4789 | 50.42449
Hasselt | N/A | Belgium | 5.33781 | 50.93106
Leu... | 0 | NCT00621855 | |
[
3
] | 53 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090). | Participants eligible to enroll into this rollover protocol will begin study treatment within 2-5 days of their Day 28 study termination visit in Protocol 501-CL-003 (NCT00441090). Participants who met the primary efficacy response criterion in Protocol 501-CL-003 will continue receiving the same study treatment to whi... | Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura ITP Chronic Idiopathic Thrombocytopenic Purpura | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)
Duration - 6 months intervention 2: Dose 10 mg
Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)... | intervention 1: Blinded (placebo) intervention 2: Open Label (Avatrombopag tablets) intervention 3: Blinded (Avatrombopoag tablets) | 12 | Anaheim | California | United States | -117.9145 | 33.83529
Bakersfield | California | United States | -119.01871 | 35.37329
Manchester | Connecticut | United States | -72.52148 | 41.77593
New Port Richey | Florida | United States | -82.71927 | 28.24418
Chicago | Illinois | United States | -87.65005 | 41.85003
New Alba... | 0 | NCT00625443 |
[
0
] | 34 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | true | Reducing tobacco use by adolescents is a national health priority. In recent polls, most adolescent smokers reported having tried unsuccessfully to quit. Smoking cessation treatment during adolescence has the potential to interrupt the progression to nicotine dependence, which is attended by a wide range of negative he... | Tobacco use is the leading preventable cause of death in the United States, and current estimates project that 6.4 million of our nation's youth will die prematurely from a smoking-related disease (Fellows et al., 2002). Extant data suggest that three of every five adolescent smokers are nicotine-dependent, and that so... | Smoking | Youth Smoking Tobacco Adolescent Dependence Teen smoking Smoking and youth Youth and tobacco | null | 1 | arm 1: 6 weeks CBME with optional 4 weeks NRT | [
0
] | 2 | [
5,
0
] | intervention 1: 6 weeks of once a week one-on-one CBME intervention 2: NicoDerm CQ nicotine transdermal patch | intervention 1: CBME intervention 2: Optional NRT | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00631020 |
[
0
] | 5 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age of 18, who have a biopsy proven diagnosis of ... | Cutaneous lupus erythematosus (CLE) is a chronic and often disabling disease which affects the skin. Many patients experience scarring and inflammation of the skin, which often occur on the face. Moderate to severe CLE is most frequently treated with antimalarial drugs such as hydroxychloroquine, quinacrine or chloroqu... | Cutaneous Lupus Erythematosus (CLE) | Cutaneous Lupus Erythematosus CLE lenalidomide revlimid thalidomide derivative drug lupus | null | 2 | arm 1: Open label lenalidomide received. arm 2: Open label lenalidomide received. | [
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Lenalidomide | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00633945 |
[
0
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a few studies with PSG evaluation had some ... | 1. The objective sleep structures of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of composite variables for PSG test (sleep stages, time in bed, total sleep time, sleep efficiency, sleep latency) from baseli... | Schizophrenia | Polysomnograph | null | 2 | arm 1: quetiapine fumarate was administered 25mg on the 1st day,738±41mg/day on the 14th day, and 738±48mg/day on the 28th day. arm 2: haloperidol was administered 2mg on the 1st day,16±7mg/day on the 14th day, and 18±6mg/day on the 28th day. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 600-750mg/day intervention 2: 6-40mg/day | intervention 1: quetiapine fumarate intervention 2: haloperidol | 1 | Guangzhou | Guangdong | China | 113.25 | 23.11667 | 0 | NCT00642369 |
[
5
] | 40 | RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this research is to study how people respond differently to capsaicin in different racial groups and the effect it has on your pain levels. Capsaicin is a natural product made from hot chili peppers that is useful for treating the itch symptoms of skin disease. | To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds. | Healthy | Healthy volunteers | null | 2 | arm 1: Capsaicin 0.1% cream application to the volar side of forearm. arm 2: Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A intervention 2: Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) | intervention 1: Capsaicin intervention 2: Placebo moisturizing cream | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00655811 |
[
3
] | 40 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed:
1. Evaluate the effects of low dose naltrexone compared to placebo ... | Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of th... | Inflammation Crohn's Disease | naltrexone LDN IBD Inflammatory bowel disease | null | 2 | arm 1: placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months arm 2: Subjects are treated in a blinded fashion for 3 months with naltrexone 4.5 mg po for active Crohn's disease followed an open-labelled study where naltrexone is given an a... | [
2,
1
] | 2 | [
0,
0
] | intervention 1: naltrexone 4.5 mg intervention 2: Placebo | intervention 1: Naltrexone-HCl intervention 2: Placebo | 1 | Hershey | Pennsylvania | United States | -76.65025 | 40.28592 | 0 | NCT00663117 |
[
3
] | 6 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis. | null | Arthritis, Gouty | Arthritis Gouty ACZ885 IL1B protein Pain | null | 2 | arm 1: Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. arm 2: Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. | [
0,
1
] | 4 | [
2,
0,
10,
10
] | intervention 1: 10 mg/kg intravenous infusion 250 mL over 2 hours. intervention 2: 12 mg intravenous infusion 50 mL over 30 minutes. intervention 3: 5% glucose in water intravenous infusion. intervention 4: Placebo intravenous infusion. | intervention 1: canakinumab intervention 2: dexamethasone intervention 3: placebo matching canakinumab intervention 4: placebo matching dexamethasone | 4 | Birmingham | Alabama | United States | -86.80249 | 33.52066
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Lausanne | N/A | Switzerland | 6.63282 | 46.516
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 | 0 | NCT00663169 |
[
3
] | 636 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects. | null | Overweight Obesity | overweight obesity pramlintide metreleptin Amylin | null | 8 | arm 1: Placebo matched to pramlintide BID plus placebo matched to metreleptin BID arm 2: 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID arm 3: Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID arm 4: Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID arm 5: Pra... | [
2,
0,
0,
0,
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: subcutaneous injection, twice a day intervention 2: subcutaneous injection, twice a day intervention 3: subcutaneous injection, twice a day intervention 4: subcutaneous injection, twice a day | intervention 1: pramlintide acetate intervention 2: metreleptin intervention 3: placebo-P intervention 4: placebo-M | 36 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Chandler | Arizona | United States | -111.84125 | 33.30616
Santa Rosa | California | United States | -122.71443 | 38.44047
Walnut Creek | California | United States | -122.06496 | 37.90631
Denver | Colorado | United States | -104.9847 | 39.73915
Jacksonville |... | 0 | NCT00673387 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin is effective for triple negative breast cancer. | In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been in use for a long time. Gemcitabine is a treatment that is an effective therapy currently available to patients with this type and stage of breast cancer. Frequently, in cancer therapy, combinations of drugs prove more effective ... | Breast Cancer | Metastatic breast cancer | null | 1 | arm 1: All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m\^2 on Day 1 and Oxaliplatin 100 mg/m\^2 intravenously over 2 hours on Day 2. | [
0
] | 2 | [
0,
0
] | intervention 1: Gemcitabine 1000mg/m\^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal intervention 2: Oxaliplatin 100mg/m\^2 on day 2 every 14 days Cycles of treatment will be repeate... | intervention 1: Gemcitabine intervention 2: Oxaliplatin | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00674206 |
[
4
] | 292 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subj... | null | Non-alcoholic Steatohepatitis Chronic Liver Disease HCV NASH - Nonalcoholic Steatohepatitis HIV Infection Thrombocytopenia Hepatitis C Virus HBV Human Immunodeficiency Virus Liver Diseases Hepatitis B Virus | elective invasive procedure. platelet transfusion chronic liver disease-related thrombocytopenia platelets thrombopoietin | null | 2 | arm 1: placebo, once daily, oral arm 2: 75 mg, once daily, oral | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 75 mg, once daily, oral intervention 2: placebo, once daily, oral | intervention 1: Eltrombopag intervention 2: Placebo | 107 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
San Franc... | 0 | NCT00678587 |
[
4
] | 45 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteri... | null | Tourette Syndrome | null | 5 | arm 1: all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) arm 2: patients to receive one tablet of pramipexole 0.0625 mg QD arm 3: patients to receive one tablet of pramipexole 0.125 mg BID arm 4: patients to receive one tablet of pramipexole 0.125 mg ... | [
1,
1,
1,
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose intervention 2: dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing intervention 3: titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dos... | intervention 1: pramipexole 0.125 mg BID intervention 2: pramipexole 0.0625 mg QD intervention 3: pramipexole 0.125 mg TID intervention 4: pramipexole 0.25 mg BID intervention 5: pramipexole 0.0625 mg BID | 14 | Bradenton | Florida | United States | -82.57482 | 27.49893
Tampa | Florida | United States | -82.45843 | 27.94752
Columbus | Georgia | United States | -84.98771 | 32.46098
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
Manhasset | New York | United States | -73.69957 | 40.79788
New York | New York | Un... | 0 | NCT00681863 | |
[
4
] | 508 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamu... | This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than ... | Skin Infections, Bacterial | infection retapamulin secondarily-infected traumatic lesions placebo | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. intervention 2: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. | intervention 1: Retapamulin Ointment, 1% intervention 2: Placebo ointment | 54 | Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Fresno | California | United States | -119.77237 | 36.74773
Irvine | California | United States | -117.82311 | 33.66946
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | Calif... | 0 | NCT00684177 |
[
5
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The primary objective of this study is to investigate potential differences between four treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%. Differin is approved by the Food and Drug Administration (FDA) to treat acne. | Subjects will be enrolled and randomized in a 1:1:1:1 ratio to one of four treatment intervention groups. All Subjects will be treated once-daily for 12 weeks with Differin® Gel, 0.1%. The four intervention groups were designated according to follow-up strategies as follows:
* More frequent than normal office visits
*... | Acne Vulgaris | null | 4 | arm 1: This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12. arm 2: This group will receive a daily electronic reminder by email, text pager, or phone message (approximatel... | [
0,
0,
0,
0
] | 5 | [
0,
5,
5,
5,
5
] | intervention 1: All Subjects will treat the face once daily in the evening. intervention 2: This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12. intervention 3: This group... | intervention 1: Adapalene intervention 2: frequent visits intervention 3: electronic reminder intervention 4: Parent reminder intervention 5: Standard of care | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00696449 | |
[
4
] | 568 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise. | null | Type 2 Diabetes | DPP-4 inhibitors HBA1c Incretins | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 5mg, oral tablet, once daily for 24 weeks intervention 2: oral tablet, once daily for 24 weeks | intervention 1: Saxagliptin intervention 2: Placebo | 30 | Hefei | Anhui | China | 117.28083 | 31.86389
Beijing | China | China | 116.39723 | 39.9075
Chongqing | China | China | 106.55771 | 29.56026
Fuzhou | Fujian | China | 119.30611 | 26.06139
Guangzhou | Guangdong | China | 113.25 | 23.11667
Shijiazhuang | Hebei | China | 114.47861 | 38.04139
Changsha | Hunan | China | 112.... | 0 | NCT00698932 |
[
3
] | 405 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza. | null | Acute, Uncomplicated Human Influenza | null | 2 | arm 1: 600 mg peramivir administered as bilateral 2-mL intramuscular injection. arm 2: Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 600 mg peramivir administered as bilateral 2-mL intramuscular injection intervention 2: Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection. | intervention 1: Peramivir intervention 2: Placebo | 123 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Mountain Home | Arkansas... | 0 | NCT00705406 | |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy. | null | Excessive Sleepiness | null | 2 | arm 1: Armodafinil treatment (200 mg/day) - Study drug was supplied as 50 mg tablets and the dose was titrated from a starting dose of 50 mg taken once daily in the morning (before 0800), increasing to 100 mg/day on Day 2, 150 mg/day on day 5, and then 200 mg/day beginning Day 8 and continuing through the end of the tw... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14. intervention 2: Matching Placebo do... | intervention 1: Armodafinil intervention 2: Placebo | 9 | Burlingame | California | United States | -122.36608 | 37.5841
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Stanford | California | United States | -122.16608 | 37.42411
Boston | Massachusetts | United States | -71.05977 | 42.35843
Newton ... | 0 | NCT00711516 | |
[
0
] | 4 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has... | Patients who take part in the study will have an initial visit and undergo a CT guided core biopsy. Using tissue from a CT guided core biopsy, microarray analysis will be performed to help predict which of the two drugs appears to be better suited to individual genomic factors. The results will result in being assigned... | Ovarian Cancer | Persistent Ovarian Cancer Genomic directed salvage chemotherapy Genomic Microarray | null | 2 | arm 1: Liposomal Doxorubicin - Chemotherapy single agent systemic. arm 2: Topotecan - Chemotherapy single agent systemic. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Liposomal Doxorubicin 40 mg/m2 q 28 days intervention 2: 1. Topotecan (daily x 5 days of a 21 day cycle)
2. Per amendment #15: Topotecan (days 1, 8, 15 of a 28 day cycle) | intervention 1: Liposomal Doxorubicin intervention 2: Topotecan | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00720096 |
[
5
] | 83 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control. | null | Type 2 Diabetes Mellitus | diabetes exenatide sitagliptin Amylin Lilly metformin thiazolidinedione | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: subcutaneous injection (5mcg or 10mcg), twice a day intervention 2: oral administration (100mg), once a day in the morning intervention 3: subcutaneous injection (5mcg or 10mcg), twice a day intervention 4: oral administration (100mg), once a day in the morning | intervention 1: exenatide intervention 2: sitagliptin intervention 3: placebo intervention 4: placebo | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00729326 |
[
4
] | 643 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder... | null | Chronic Constipation | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral, once daily intervention 2: Oral, once daily | intervention 1: Matching Placebo intervention 2: Linaclotide | 105 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tuscon | Arizona | United S... | 0 | NCT00730015 | |
[
5
] | 1,039 | NA | SINGLE_GROUP | null | 0NONE | false | 0ALL | true | This prospective surveillance trial will gather safety information for Optison when it is used in routine practice. | null | Echocardiography | Surveillance Optison Perflutren Echocardiography Subjects receive Optison during enhanced echocardiography | null | 1 | arm 1: Open Label | [
5
] | 1 | [
0
] | intervention 1: The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed.
The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water inject... | intervention 1: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) | 1 | Princeton | New Jersey | United States | -74.65905 | 40.34872 | 0 | NCT00730964 |
[
5
] | 189 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks wi... | null | Anemia | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: iv 0.6 micrograms/kg every 2 weeks | intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] | 16 | Ahmedabad | N/A | India | 72.58727 | 23.02579
Bangalore | N/A | India | 77.59369 | 12.97194
Chennai | N/A | India | 80.27847 | 13.08784
Coimbatore | N/A | India | 76.96612 | 11.00555
Gujarat | N/A | India | N/A | N/A
Hyderabad | N/A | India | 78.45636 | 17.38405
Kerala | N/A | India | N/A | N/A
Kolkata | N/A | India | ... | 0 | NCT00737711 | |
[
5
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most ... | null | Erectile Dysfunction Metabolic Syndrome | Vardenafil Erectile Dysfunction Double-blind study | null | 2 | arm 1: Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks arm 2: Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks intervention 2: Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks | intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo | 19 | Cham | Bavaria | Germany | 12.65501 | 49.22565
Regensburg | Bavaria | Germany | 12.10161 | 49.01513
Hamburg | City state of Hamburg | Germany | 9.99302 | 53.55073
Frankfurt am Main | Hesse | Germany | 8.68417 | 50.11552
Marburg | Hesse | Germany | 8.77069 | 50.80904
Stuhr | Lower Saxony | Germany | 8.75 | 53.03333
Bonn... | 0 | NCT00738400 |
[
3
] | 153 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg on... | A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome. | Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome | prostatitis, chronic pelvic pain | null | 3 | arm 1: 4 mg daily arm 2: Silodosin 8 mg daily arm 3: 1 placebo capsule daily | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Silodosin 8 mg daily intervention 2: Placebo intervention 3: Silodosin 4 mg daily | intervention 1: Silodosin 8 mg intervention 2: Placebo intervention 3: Silodosin 4 mg | 22 | San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Columbus | Georgia | United States | -84.98771 | 32.46098
Roswell | Georgia | United States | -84.36159 | 34.02316
Jeffersonville | Indiana | United States | -85.73718 | 38.27757
West Des Moines | Iow... | 0 | NCT00740779 |
[
3
] | 495 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm... | null | Diabetes Mellitus, Type 2 | null | 0 | null | null | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: BI 10773 intervention 2: placebo intervention 3: sitagliptin | 116 | Chula Vista | California | United States | -117.0842 | 32.64005
Mission Viejo | California | United States | -117.672 | 33.60002
Pasadena | California | United States | -118.14452 | 34.14778
Spring Valley | California | United States | -116.99892 | 32.74477
Walnut Creek | California | United States | -122.06496 | 37.90... | 0 | NCT00749190 | |
[
4
] | 541 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women. | The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:
* G-ER 1200 mg daily (single evening dose)
* G-ER 1800 mg daily (dosed asymmetrically; 600 mg in AM/1200 mg in PM) compared to placebo in reducing the average daily frequency and severity score of moderate to sever... | Hot Flashes | Hot flashes Hot flushes Postmenopausal symptoms Vasomotor symptoms | null | 3 | arm 1: Gabapentin extended-release (G-ER) 1200 mg arm 2: Gabapentin extended-release (G-ER) 1800 mg arm 3: Placebo 1200 mg or 1800 mg | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: G-ER 1200 mg daily dosage given as two 600-mg tablets. intervention 2: G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening. intervention 3: Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the mor... | intervention 1: Gabapentin Extended-Release (G-ER) 1200 mg intervention 2: Gabapentin Extended-Release (G-ER) 1800 mg intervention 3: Placebo | 45 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Montgomery | Alabama | United States | -86.29997 | 32.36681
Tempe | Arizona | United States | -111.90931 | 33.41477
Tucson | Arizona | United States | -110.92648 | 32.22174
Berkely | California | United States | N/A | N/A
La Mesa | California | United States |... | 0 | NCT00755417 |
[
5
] | 39 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The overall purpose of this research is to determine if there is a relationship between your symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment. | In this study we will be using Memantine (Namenda®) in an investigational fashion with individuals with very mild to mild dementia. Donepezil (Aricept®) is approved by the Food and Drug Administration for the treatment of Alzheimers disease. Memantine (Namenda®) is currently approved by the Food and Drug Administration... | Dementia | Dementia of the Alzheimer type | Prot_SAP_000.pdf:
RESEARCH PROTOCOL
CORTICOLIMBIC DEGENERATION AND TREATMENT
OF DEMENTIA
AUGUST 26, 2008
Corticolimbic Degeneration and Treatment of Dementia 8-26-2008
PRINCIPAL INVESTIGATOR
John G. Csernansky, M.D.
... | 4 | arm 1: Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine arm 2: Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with Donepezil (Aricept®). arm 3: Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) ... | [
4,
1,
1,
4
] | 2 | [
0,
0
] | intervention 1: Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 1... | intervention 1: Memantine (Namenda®) intervention 2: Donepezil (Aricept®) | 0 | null | 0 | NCT00768261 |
[
5
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterog... | null | Hyperglycemia | Hyperglycemia Glycemic control | null | 1 | arm 1: All subjects placed on insulin infusion. | [
5
] | 1 | [
0
] | intervention 1: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL | intervention 1: Insulin | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00779701 |
[
5
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This proposal is to fund a pilot study to assess feasibility and refine methodology for an intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study will collect cohorts of patients who have carefully controlled standardised dose titration and monitoring with an assessment of drug resp... | The Response to Oral Agents in Diabetes (ROAD) study aims to address the limitations of observational data by creating a prospective study of incident users of oral agents. For the first six months the research team will ensure a protocol driven dose titration, standardised monitoring of adherence, response and side ef... | Diabetes Mellitus, Type 2 | Diabetes therapies Pharmacogenetics | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
1,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 30mg daily increased to 60mg if HbA1c \> 7% at 3 months intervention 2: Sitagliptin 100mg daily for 6 months intervention 3: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c \>7% at 3 months. 6 months duration intervention 4: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte ... | intervention 1: Gliclazide MR intervention 2: Sitagliptin intervention 3: Pioglitazone intervention 4: Metformin | 1 | Dundee | N/A | United Kingdom | -2.97489 | 56.46913 | 0 | NCT00780715 |
[
3
] | 13 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a phase II study of Nilotinib for patients with advanced GIST that cannot be surgically removed. Patients are candidates for the study if their tumors have progressed on imatinib and sunitinib or if they were intolerant to these drugs. Patients may have received other investigational therapies as well. We are t... | Nilotinib is an oral drug. The dose is 400 mg twice daily
Patients are evaluated every 8 weeks for disease response. Blood work is assessed for safety initially weekly, then every 4 weeks. Physical exams are performed initially weekly and then decreased to every 4 weeks after the first month. | Gastrointestinal Stromal Tumors | GIST Nilotinib | null | 0 | null | null | 1 | [
0
] | intervention 1: 400 mg orally twice daily until disease progression, intolerability or withdrawal of consent | intervention 1: Nilotinib | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00782834 |
[
2,
3
] | 327 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye. | null | Dry Eye Syndromes | Dry eye | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
0,
1,
2
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks intervention 2: Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks intervention 3: Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks intervention 4: Ophthalmic topical solution,... | intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: Cyclosporine intervention 6: CP-690,550 Vehicle | 27 | Chandler | Arizona | United States | -111.84125 | 33.30616
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Artesia | California | United States | -118.08312 | 33.86585
Centennial | Colorado | United States | -104.87692 | 39.57916
Ormond Beach | Florida |... | 0 | NCT00784719 |
[
3
] | 408 | null | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed | null | Diabetes Mellitus, Type 2 | null | 0 | null | null | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: BI 10773 intervention 2: placebo intervention 3: metformin | 74 | Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Mar del Plata | N/A | Argentina | -57.5562 |... | 0 | NCT00789035 | |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Primary objective:
To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM).
Secondary objectives:
To determine clinical and laboratory factors which are associated with increased risk of VTE
If it is determined that ASA reduces the incidence of V... | Study Drug:
Aspirin is designed to make blood less "sticky" and reduce its chances of clotting. By making blood less sticky, it may be less likely to allow a clot to form.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 stud... | Glioblastoma | Brain Hematologic Disorder Venous Thromboembolism Glioblastoma Aspirin Placebo VTE ASA DVT | null | 2 | arm 1: Aspirin 325 mg/day orally arm 2: Tablet/day orally | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 325 mg daily by mouth intervention 2: Tablet daily by mouth | intervention 1: Aspirin intervention 2: Placebo | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00790452 |
[
3
] | 215 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH | This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quali... | Nocturia Prostatic Hyperplasia | nocturia BPH benign prostate hyperplasia nocturia in men with benign prostate hyperplasia | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 1 | [
0
] | intervention 1: α1-adrenergic antagonist | intervention 1: silodosin | 27 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Laguna Hills | California | United States | -117.71283 | 33.61252
San Diego | California | United States | -117.16472 | 32.71571
Aventura | Florida | United States | -80.13921 | 25.95648
Clearwater | Florida | United States | -82.8001 | 27.96585
Orlando | Flori... | 0 | NCT00793819 |
[
4
] | 347 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan. | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD chronic obstructive pulmonary disease indacaterol long acting β2-agonist | null | 3 | arm 1: Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available ... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 3: Placebo was supplied in powder filled capsules with a single dose dry powder... | intervention 1: Indacaterol 150 μg capsules intervention 2: Indacaterol 300 μg capsules intervention 3: Placebo capsules | 60 | Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
New Territories | N/A | Hong Kong | 114.11095 | 22.42441
Ahmedabad | N/A | India | 72.58727 | 23.02579
Bangalore | N/A | India | 77.59369 | 12.97194
Coimbatore | N/A | India | 76.96612 | 11.00555
Coimbatore | N/A | India | 76.96612 | 11.00555
India | N/A | India | 75.3... | 0 | NCT00794157 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus adminis... | Study participants were screened up to 14 days prior to their elective cardiac surgery. For the purpose of this study, hypertension was defined as systolic blood pressure (SBP) ≥140 mm Hg immediately prior to initiation of study drug.
On the day of surgery, an IV bolus dose of clevidipine (Bolus 1 - pre-anesthesia) wa... | Hypertension | Hypertension Antihypertensive Agent Calcium Channel Blocker | null | 1 | arm 1: Patients were sequentially assigned to one of following three planned dose cohorts for Bolus 1 within the clevidipine arm:
* Cohort 1: clevidipine 250 µg (0.5 mL)
* Cohort 2: clevidipine 500 µg (1 mL)
* Cohort 3: clevidipine 125 µg (0.25 mL or 0.5 mL of a 1:1 solution) | [
0
] | 1 | [
0
] | intervention 1: Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (\<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL). | intervention 1: clevidipine | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00799604 |
[
2
] | 66 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | null | This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants. The study will also assess the safety and tolerability of the SC and IV formulations. In Part 1 of th... | null | Breast Cancer | null | 7 | arm 1: Healthy male participants will receive Herceptin 6 mg/kg IV on Day 1. arm 2: Female participants with HER2-positive breast cancer will receive Herceptin 6 mg/kg IV on Day 1. arm 3: Healthy male participants will receive Herceptin 6 mg/kg SC on Day 1. arm 4: Healthy male participants will receive Herceptin 10 mg/... | [
0,
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Herceptin will be administered IV or SC at various dosages (depending upon the cohort to which the participant is assigned) on Day 1. | intervention 1: Herceptin | 3 | East Bentleigh | N/A | Australia | N/A | N/A
Christchurch | N/A | New Zealand | 172.63333 | -43.53333
Grafton | N/A | New Zealand | 174.76566 | -36.86029 | 0 | NCT00800436 | |
[
5
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia. | Schizophrenia is a chronic brain disease affecting approximately 1% of Americans. Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but they are not a cure, are often taken for long periods of time, and can have severe side effects. Other, secondary medications can provide relief fr... | Schizophrenia | Schizoaffective Disorder | null | 3 | arm 1: Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects. arm 2: Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects. ... | [
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Daily tablets of 10 to 30 mg intervention 2: Daily tablets of 8 to 24 mg intervention 3: Daily tablets of 10 to 30 mg intervention 4: Daily tablets of 850 to 2550 mg intervention 5: Daily tablets of 20 to 40 mg intervention 6: Daily tablets of 1 to 2 mg | intervention 1: Olanzapine intervention 2: Perphenazine intervention 3: Aripiprazole intervention 4: Metformin intervention 5: Simvastatin intervention 6: Benztropine | 13 | Colton | California | United States | -117.31365 | 34.0739
Palo Alto | California | United States | -122.14302 | 37.44188
New Haven | Connecticut | United States | -72.92816 | 41.30815
Miami | Florida | United States | -80.19366 | 25.77427
Augusta | Georgia | United States | -81.97484 | 33.47097
Glen Burnie | Maryland ... | 0 | NCT00802100 |
[
3
] | 89 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary ... | null | Bronchiectasis | null | 1 | arm 1: Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study. | [
0
] | 1 | [
0
] | intervention 1: 75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator | intervention 1: AZLI | 24 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Orange | California | United States | -117.85311 | 33.78779
Denver | Colorado | United States | -104.9847 | 39.73915
Farmington | Connecticut | Un... | 0 | NCT00805025 | |
[
5
] | 145 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral ant... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve t... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner intervention 2: The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total ... | intervention 1: biphasic insulin aspart 30 intervention 2: biphasic human insulin 30 intervention 3: metformin | 1 | Beijing | Beijing Municipality | China | 116.39723 | 39.9075 | 0 | NCT00807092 | |
[
5
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. | A double-blind (neither the patient nor the physician know the name of the study drug), 6-month, multicenter, placebo-controlled trial to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. The target dose of galantamine is 24 mg/day and nimodipine w... | Dementia | Dementia Mixed Dementia Galantamine Reminyl ER Nimodipine | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day. intervention 2: Nimodipine 30 mg 3 times a day (tid). intervention 3: Matching placebo three times a day (tid). | intervention 1: Galantamine intervention 2: Nimodipine intervention 3: Placebo | 0 | null | 0 | NCT00814658 |
[
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.
The purpose of this study is to investigate safety (if there are any s... | null | Postoperative Pain | Postoperative pain shoulder surgery opioid | null | 2 | arm 1: 5.0 mL SABER-Bupivacaine/Once arm 2: 5.0 mL SABER-Placebo/Once | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once intervention 2: Injectable Solution; 5.0 mL SABER-Placebo/Once | intervention 1: SABER-Bupivacaine intervention 2: SABER-Placebo | 9 | Westmead | New South Wales | Australia | 150.98768 | -33.80383
Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586
Adelaide | South Australia | Australia | 138.59863 | -34.92866
Toorak Gardens | South Australia | Australia | 138.63639 | -34.93478
Geelong | Victoria | Australia | 144.36069 | -38.14711
Hampton | V... | 0 | NCT00818363 |
[
3,
4
] | 84 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to compare the effectiveness of lithium combined with riluzole to riluzole combined with placebo in people with amyotrophic lateral sclerosis. | Amyotrophic lateral sclerosis (ALS) is a rare, neurodegenerative disorder that results in progressive wasting and paralysis of voluntary muscles.
In this double blind, randomized, placebo-controlled clinical trial, researchers will evaluate the safety and effectiveness of the drug lithium given in combination with ril... | Amyotrophic Lateral Sclerosis | Amyotrophic lateral sclerosis ALS Lou Gehrig's disease riluzole lithium neurodegeneration | null | 2 | arm 1: Participants randomized to lithium/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., participants have an equal chance of getting randomized to lithium vs. placebo). arm 2: Participants randomized to placebo/riluzole (randomization is 1:1 lithium/riluzole to placebo/riluzole, i.e., parti... | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Participants will receive capsules that contain 150 milligrams (mg) lithium carbonate. Participants will be randomized to lithium/riluzole or placebo/riluzole and treated for 52 weeks. Participants originally randomized to placebo who fail (progress) will crossover to lithium for the remainder of the tr... | intervention 1: Lithium Carbonate intervention 2: Riluzole intervention 3: placebo | 37 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Indianapolis ... | 0 | NCT00818389 |
[
3
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate essential hypertension. | null | Hypertension | hypertension systolic blood pressure exercise test cardiovascular disease aliskiren valsartan | null | 2 | arm 1: For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 ... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Aliskiren was supplied in 150 mg tablets. intervention 2: Valsartan was supplied in 160 mg capsules. intervention 3: Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg. intervention 4: Placebo to valsartan was supplied in capsules matching valsartan 160 mg. | intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo to aliskiren intervention 4: Placebo to valsartan | 8 | Pardubice | N/A | Czechia | 15.77659 | 50.04075
Prague | N/A | Czechia | 14.42076 | 50.08804
Budapest | N/A | Hungary | 19.04045 | 47.49835
Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539
Pilisvörösvár | N/A | Hungary | 18.90893 | 47.61386
Szentendre | N/A | Hungary | 19.07561 | 47.66943
Singapore | N/A | Singapore |... | 0 | NCT00819767 |
[
4
] | 1,123 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease. | null | Chronic Obstructive Pulmonary Disease (COPD) | respiratory dyspnea breathlessness COPD indacaterol long-acting β2-agonist | null | 2 | arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manuf... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]). intervention 3: Placebo to indacaterol was provided in powder-filled... | intervention 1: Indacaterol 150 µg intervention 2: Salmeterol 50 µg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol | 144 | Anniston | Alabama | United States | -85.83163 | 33.65983
Fairhope | Alabama | United States | -87.90333 | 30.52297
Jasper | Alabama | United States | -87.27751 | 33.83122
Mobile | Alabama | United States | -88.04305 | 30.69436
Glendale | Arizona | United States | -112.18599 | 33.53865
Phoenix | Arizona | United States... | 0 | NCT00821093 |
[
5
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the safety, tolerability, and efficacy of Alefacept in patient with moderate to severe atopic dermatitis who could not be adequately controlled with topical therapies. | Atopic dermatitis is a chronic inflammatory skin disease associated with cutaneous hyper-reactivity to environmental triggers that are generally innocuous to healthy, nonatopic individuals (Leung et al. 2004). Acute eczematous skin lesions in atopic dermatitis are characterized by marked epidermal intercellular edema (... | Atopic Dermatitis | Atopic Dermatitis chronic skin | null | 1 | arm 1: Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis at a dose of 15mg IM every week for 12 weeks. Unlike other "biologics" for the treatment of skin diseases, the use of alefacept is not associated with increased infection, con... | [
0
] | 1 | [
0
] | intervention 1: Alefacept 15mg IM every week for 12 weeks | intervention 1: Alefacept | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00832585 |
[
0
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | null | The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal.
Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits due to the known fat necrosis effects on fat tissue after study ... | This study is a randomized, double-blind study of 21 subjects. Participants in this study will be healthy, non-obese (BMI \<30) subjects over 25 with two localized, symmetrical, and contralateral areas of fat deposition on the abdomen or flanks and on the buttocks or thighs that have proven resistant to diet and exerci... | Obesity | null | 3 | arm 1: Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections arm 2: Group A will serve as a control and will receive only injections of saline as a placebo. arm 3: Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral... | [
0,
2,
1
] | 2 | [
0,
0
] | intervention 1: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections intervention 2: Group A will serve as a con... | intervention 1: Phosphatidylcholine Deoxycholate intervention 2: Saline | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00851747 | |
[
5
] | 1,009 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | false | 0ALL | false | This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease. | null | Asthma Coronary Artery Disease Pulmonary Disease, Chronic Obstructive | regadenoson CVT 3146 asthma coronary artery disease pulmonary disease, chronic obstructive | null | 4 | arm 1: Matching intravenous (IV) bolus injection, subjects with Asthma arm 2: 0.4mg / 5mL intravenous bolus injection, subjects with Asthma arm 3: Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) arm 4: 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstru... | [
2,
0,
2,
0
] | 2 | [
0,
0
] | intervention 1: IV intervention 2: IV | intervention 1: Regadenoson intervention 2: Placebo | 48 | Montgomery | Alabama | United States | -86.29997 | 32.36681
Anaheim | California | United States | -117.9145 | 33.83529
Encinitas | California | United States | -117.29198 | 33.03699
Fullerton | California | United States | -117.92534 | 33.87029
Huntington Beach | California | United States | -117.99923 | 33.6603
Long ... | 0 | NCT00862641 |
[
2,
3
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation ... | This is a single-dose, open-labeled, non-randomized, two-period study of Cysteamine Bitartrate Delayed-release Capsules (RP103) and Cystagon® in up to 10 patients (male or female) with nephropathic cystinosis under fasting conditions. It will involve a 4 night check-in to a clinical research center.
Study with complet... | Cystinosis | cystinosis cysteamine inheritable disease orphan disease CTNS protein, human nephropathic cystinosis | null | 2 | arm 1: Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg arm 2: Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
Duration of Treatment and Dose: Reference Period up to four doses Q6H. intervention 2: Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
Duration of treatment and Dose: Single dose of Test Product a... | intervention 1: Cystagon® intervention 2: RP103 | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00872729 |
[
5
] | 66 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 1SINGLE | true | 0ALL | null | The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects. | null | Anti-biotic Resistance | null | 2 | arm 1: moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water arm 2: gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1 drop in study eye three times a day for 14 days intervention 2: 1 drop in study eye four times a day for 14 days | intervention 1: moxifloxacin 0.5% HCI ophthalmic solution intervention 2: gatifloxacin ophthalmic solution 0.3% | 2 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 | 0 | NCT00874887 | |
[
3
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM. | null | Diabetes Mellitus, Type 2 | null | 5 | arm 1: patient to receive a BI 10773 low dose tablet and a placebo tablet once daily arm 2: patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily arm 3: patient to receive two tablets of BI 10773 middle dose once daily arm 4: patient to receive a BI 10773 high dose tablet and a placebo tablet... | [
0,
0,
0,
0,
2
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Placebo tablets once a day intervention 2: Placebo tablets once a day intervention 3: BI 10773 middle dose tablets once a day intervention 4: BI 10773 high dose tablets once a day intervention 5: BI 10773 middle dose tablets once a day intervention 6: Placebo tablets once a day intervention 7: BI 10773 ... | intervention 1: Placebo (middle dose) intervention 2: Placebo intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: BI 10773 intervention 6: Placebo (high dose) intervention 7: BI 10773 intervention 8: Placebo (low dose) | 5 | Hachioji, Tokyo | N/A | Japan | N/A | N/A
Koganei, Tokyo | N/A | Japan | N/A | N/A
Nakano-ku, Tokyo | N/A | Japan | N/A | N/A
Suita, Osaka | N/A | Japan | N/A | N/A
Yokohama, Kanagawa | N/A | Japan | N/A | N/A | 0 | NCT00885118 | |
[
5
] | 1,421 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea. | null | Rosacea | null | 2 | arm 1: Oracea as monotherapy arm 2: Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Take once daily in the morning intervention 2: Take once daily in the morning | intervention 1: doxycycline (Oracea®) 40 mg modified release as monotherapy intervention 2: doxycycline (Oracea®) 40 mg modified release as add-on therapy | 1 | Lexington | Kentucky | United States | -84.47772 | 37.98869 | 0 | NCT00892281 | |
[
4
] | 305 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD). | null | Symptomatic Gastroesophageal Reflux Disease (sGERD) | Gastroesophageal Reflux Disease GERD | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed. intervention 2: One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed. | intervention 1: rabeprazole sodium intervention 2: Placebo | 98 | Athens | Alabama | United States | -86.97219 | 34.80243
Huntsville | Alabama | United States | -86.58594 | 34.7304
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Encinitas | California | U... | 0 | NCT00911534 |
[
3
] | 205 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 mon... | null | Postmenopausal Osteoporosis | null | 3 | arm 1: 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. arm 2: 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast arm 3: 100 mg risedronate tablet DRFB (delayed release... | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast. intervention 2: 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast intervention 3: 100 mg delayed release (DRFB) risedronate tablet administ... | intervention 1: 150 mg intervention 2: 75 mg intervention 3: 100 mg | 6 | Daytona Beach | Florida | United States | -81.02283 | 29.21081
Fort Myers | Florida | United States | -81.84059 | 26.62168
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Evansville | Indiana | United States | -87.55585 | 37.97476
Austin | Texas | United States | -97.74306 | 30.26715
Dallas | Texas | United S... | 0 | NCT00918749 | |
[
3
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3... | null | Atopic Dermatitis | Dermatitis, Atopic | null | 2 | arm 1: Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. arm 2: Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atop... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical Ointment intervention 2: Topical Ointment | intervention 1: CD2027 Ointment 3 mcg/g, twice daily intervention 2: Vehicle Ointment, twice daily | 14 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Longmont | Colorado | United States | -105.10193 | 40.16721
Miami | Florida | United States | -80.19366 | 25.77427
Louisville | Kentucky | ... | 0 | NCT00919763 |
[
0
] | 20 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | false | To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.
To evaluate the cost effectiveness and possible side effects ... | Study design:
Prospective, randomized and controlled study involving 20 patients, 10 in each group. The de-airing time and the efficiency of the techniques will be assessed by trans-esophageal echocardiography (TEE) and trans-cranial echo-doppler monitoring (TCD). The cardiologists analyzing the TEE recordings will be... | Aortic Valve Disorder | Cardiac de-airing CO2 insufflation Air emboli Trans cranial doppler Intraoperative echocardiography | null | 2 | arm 1: Lund de-airing technique arm 2: carbon-dioxide insufflation will be provided to the open mediastinal wound in a standardized manner | [
0,
1
] | 2 | [
3,
0
] | intervention 1: In these patients the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the conclusion of the surgical procedure, the LV preload will first now be successively increased. When no air is seen on TEE monitoring in th... | intervention 1: Lund de-airing technique intervention 2: carbon-dioxide insufflation | 0 | null | 0 | NCT00934596 |
[
2
] | 31 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 2MALE | false | The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies. | null | Hypercholesterolemia, Dyslipidemia | Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor | null | 2 | arm 1: Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks arm 2: Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 40 mg once daily for 2 weeks intervention 2: Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks | intervention 1: Simvastatin intervention 2: Placebo | 0 | null | 0 | NCT00935259 |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is designed to understand the pharmacokinetics of different oral formulations of CK-1827452 being considered for future studies in patients with heart failure. This study will compare the pharmacokinetics and safety and tolerability of both modified-release (MR) and immediate-release (IR) oral formulations o... | null | Heart Failure | omecamtiv mecarbil | null | 3 | arm 1: Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. arm 2: Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. arm 3: Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 50 mg MR CK-1827452 BID for 10 days intervention 2: 37.5 mg IR CK-1827452 TID for 10 days intervention 3: 100 mg MR CK-1827452 BID for 10 days | intervention 1: CK-1827452 intervention 2: CK-1827452 intervention 3: CK-1827452 | 3 | Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143 | 0 | NCT00941681 |
[
4
] | 203 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses. | null | Actinic Keratoses | Peplin Actinic keratosis PEP005 | null | 2 | arm 1: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days arm 2: Vehicle gel once daily for 2 consecutive days | [
1,
2
] | 2 | [
0,
0
] | intervention 1: two day treatment intervention 2: two day treatment | intervention 1: PEP005 (ingenol mebutate) Gel intervention 2: Vehicle gel | 17 | Hot Springs | Arizona | United States | N/A | N/A
San Diego | California | United States | -117.16472 | 32.71571
Alpharetta | Georgia | United States | -84.29409 | 34.07538
Arlington Heights | Illinois | United States | -87.98063 | 42.08836
Buffalo Grove | Illinois | United States | -87.95979 | 42.15141
Evansville | In... | 0 | NCT00942604 |
[
5
] | 1 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression. | Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currentl... | Bipolar Disorder | Bipolar Disorder Depression Treatment-Resistant ketamine antidepressant glutamate | null | 2 | arm 1: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. arm 2: Patients receive both treatme... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: a single IV infusion of ketamine, IV 0.5 mg/kg intervention 2: a single IV infusion of midazolam, 0.045 mg/kg | intervention 1: ketamine intervention 2: midazolam | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00947791 |
[
5
] | 162 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 1SINGLE | true | 0ALL | false | A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers. | At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of t... | Acne Vulgaris | acne irritation objective sensory methods | null | 1 | arm 1: Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model | [
0
] | 2 | [
0,
0
] | intervention 1: A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks. intervention 2: A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks | intervention 1: Tretinoin Facial Gel intervention 2: Adapalene/Benzoyl Peroxide Facial Gel | 1 | Broomall | Pennsylvania | United States | -75.35658 | 39.9815 | 0 | NCT00952523 |
[
2,
3
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat... | Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of dantrolene, by determining the treatment related adverse events, in participants with cVSP after SAH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies and 3) to determine efficacy trends of dantrole... | Cerebral Vasospasm After Subarachnoid Hemorrhage | vasospasm subarachnoid hemorrhage neurocritical care dantrolene vasorelaxation | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1.25 mg/kg IV once over 60 min intervention 2: 2.5 mg/kg IV once over 60 min | intervention 1: Dantrolene intervention 2: Dantrolene | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Worcester | Massachusetts | United States | -71.80229 | 42.26259 | 0 | NCT00964548 |
[
2,
3
] | 34 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose. | null | Healthy Volunteers | null | 2 | arm 1: Active experimental drug arm 2: Active comparator | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Single orally administered dose of 500 mg naproxen intervention 2: Single orally administered dose of PL 3100 (500 mg naproxen) | intervention 1: Naproxen intervention 2: PL 3100 | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00966641 | |
[
4
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study ... | null | Rheumatoid Arthritis | NOS | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: IV solution, IV, 10 mg/Kg, Once monthly, 1 year intervention 2: IV solution, IV, 5 mg/Kg, Once monthly, 1 year | intervention 1: Abatacept intervention 2: Abatacept | 0 | null | 0 | NCT00989235 |
[
5
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department. | null | Sedation | ketamine propofol procedural sedation moderate procedural sedation in the ED | null | 2 | arm 1: propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation arm 2: ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation | [
1,
1
] | 2 | [
0,
0
] | intervention 1: propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation intervention 2: ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation | intervention 1: propofol intervention 2: Ketamine | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00997321 |
[
2
] | 38 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast. | The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young, healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast. On ... | Healthy | Healthy bioavailability | null | 2 | arm 1: One single dose of Colcrys™ 0.6mg taken by mouth on day 1 arm 2: One single dose of Colcrys™ 0.6mg taken by mouth on day 1 | [
0,
0
] | 1 | [
0
] | intervention 1: 0.6 mg taken by mouth on day 1 | intervention 1: Colcrys™ (colchicine) | 0 | null | 0 | NCT01001052 |
[
3
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE
* Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.
PURPOSE
* This randomized phase II trial, assess in patients with brain metastases from solid tumors, wh... | Primary Outcome Measures
* Objective Response Rates
Secondary Outcome Measures
* Survival Free of Brain Metastases progression
* Overall Survival
* Systemic Side effects
Objectives
Primary
* Compare objective response rates in both arms of treatment
Secondary
* Compare survival free of progression in both arms ... | Brain Neoplasms | Brain metastases Temozolomide Whole-brain radiotherapy Phase II trial | null | 2 | arm 1: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide. arm 2: Whole brain irradiation a... | [
0,
1
] | 2 | [
0,
4
] | intervention 1: None intervention 2: None | intervention 1: Temozolomide intervention 2: Whole brain irradiation | 1 | México | D.F | Mexico | -103.57339 | 22.76088 | 0 | NCT01015534 |
[
5
] | 26 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne. | null | Acne Vulgaris | Mild to moderate acne vulgaris | null | 2 | arm 1: Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks arm 2: Generic clindamycin 1% gel plus tretinoin 0.025% cream | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: applied once daily for 12 weeks intervention 2: Topical clindamycin applied each morning for 12 weeks intervention 3: Tretinoin 0.025% cream each evening for 12 weeks | intervention 1: clindamycin phosphate 1.2% and tretinoin 0.025% intervention 2: clindamycin 1% gel intervention 3: tretinoin 0.025% cream | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT01047189 |
[
5
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days. | This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. A... | Atopic Dermatitis | Atopic Dermatitis Open-Label Topical Cream Eczema Vanos | null | 1 | arm 1: Fluocinonide Cream 0.1% open label | [
5
] | 1 | [
0
] | intervention 1: 0.1% Cream, One Application, Twice Daily, 14 Days | intervention 1: Fluocinonide Cream 0.1% | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT01049243 |
[
4
] | 248 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain. | This is a double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug is assigned by chance), placebo-controlled, parallel group (a medical research study comparing the response in 2 or more groups of participant... | Low Back Pain | Chronic low back pain Tramadol Hydrochloride (HCl) acetaminophen | null | 2 | arm 1: Participants will receive 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily ... | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7 intervention 2: Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7 inte... | intervention 1: Tramadol HCl/acetaminophen Extended Release intervention 2: Placebo intervention 3: Tramadol HCl/acetaminophen Extended Release intervention 4: Placebo | 0 | null | 0 | NCT01112267 |
[
3
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity. | null | Dentine Hypersensitivity | potassium nitrate tooth sensitivity dentin sensitivity | null | 3 | arm 1: Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. arm 2: Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. arm 3: Participants to app... | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: 5% potassium nitrate solution intervention 2: 2.5% potassium nitrate solution intervention 3: Sterile water | intervention 1: 5% Potassium nitrate intervention 2: 2.5% Potassium nitrate intervention 3: Sterile water | 1 | Fort Wayne | Indiana | United States | -85.12886 | 41.1306 | 0 | NCT01115452 |
[
3
] | 36 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | true | 0ALL | false | An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens. | null | Tooth Erosion | enamel erosion tooth remineralization tooth erosion | null | 5 | arm 1: Test fluoride dentifrice and test fluoride MR arm 2: Test fluoride dentifrice and sterile water rinse arm 3: Placebo dentifrice and test fluoride rinse arm 4: Marketed fluoride dentifrice with sterile water rinse arm 5: Placebo dentifrice and sterile water rinse | [
0,
0,
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Test fluoride toothpaste and test fluoride mouth rinse intervention 2: United Kingdom marketed fluoride toothpaste intervention 3: Sterile water rinse | intervention 1: Sodium fluoride intervention 2: Sodium monoflurophosphate intervention 3: Sterile water | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT01128972 |
[
4
] | 143 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 2MALE | false | The primary purpose of this project is to evaluate the effectiveness of behavioral treatment compared to standard drug therapy for symptoms of OAB in male veterans. | Overactive bladder (OAB) is a very common and bothersome condition manifested by urgency, frequent urination, urge urinary incontinence, and nocturia. Drug therapy with oxybutynin or tolterodine is the most common approach to treatment of OAB in VA Medical Center clinics and is the standard of care nationally. Although... | Overactive Bladder | Overactive bladder Behavioral treatment Drug therapy Lower urinary tract symptoms Urinary incontinence Clinical trial | null | 2 | arm 1: Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training arm 2: Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg | [
0,
1
] | 2 | [
5,
0
] | intervention 1: Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks. intervention 2: Individually titrated, extended-release oxybu... | intervention 1: Behavioral training intervention 2: Oxybutynin chloride, extended-release | 2 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Decatur | Georgia | United States | -84.29631 | 33.77483 | 0 | NCT01187498 |
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