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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 151 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement. | null | Diabetic Macular Edema | DME Diabetic macular edema ranibizumab Diabetic macular edema with center involvement | null | 3 | arm 1: Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent a... | [
0,
0,
3
] | 3 | [
0,
0,
0
] | intervention 1: 6 mg/ml ranibizumab solution for intravitreal injection intervention 2: 10 mg/ml ranibizumab solution for intravitreal injection intervention 3: Non-treatment control for sham intravitreal injection. | intervention 1: Ranibizumab 0.3 mg intervention 2: Ranibizumab 0.5 mg intervention 3: Sham injection | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00284050 |
[
4
] | 94 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in... | null | Kidney Diseases | Dose optimization immune suppressive regimen enteric-coated mycophenolate sodium EC-MPS renal transplantation kidney transplant maintenance patients Renal transplantation in maintenance | null | 2 | arm 1: Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroid... | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: At a dose of at least 5 mg/day. | intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Tacrolimus intervention 3: Corticosteroids | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00284934 |
[
3
] | 147 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia. | This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat themselves with gel applied to the cervix via an intrava... | Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia (CIN) High-grade Cervical Intraepithelial Neoplasia High-grade Squamous Intraepithelial Lesions (HSIL) Human Papilloma Virus (HPV) High-Grade Cervical Intraepithelial Lesions (CIN 2/3) | null | 2 | arm 1: Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles. arm 2: 0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 5 days of 28 day cycle for 2 cycles intervention 2: 5 days of 28 day cycle | intervention 1: placebo intervention 2: A007 | 29 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Carmichael | California | United States | -121.32828 | 38.61713
Colton | California | United States | -117.31365 | 34.0739
Costa Mesa | Californi... | 0 | NCT00285207 |
[
4
] | 244 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, o... | null | Pain Cancer | Breakthrough Pain in Cancer Patients | null | 1 | arm 1: BEMA Fentanyl | [
0
] | 1 | [
0
] | intervention 1: buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily | intervention 1: BEMA Fentanyl | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT00293020 |
[
3
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Caucasian population. Both forms of osteoarthritis are associated with disability. Conventional treatment (analgesics and the... | STUDY DESIGN: Randomized, placebo-controlled, dose-ranging two-centre study PREPARATIONS FOR INVESTIGATION: Devil's Claw (Allya®)/placebo as tablets
STATISTICAL METHODS:
Analysis on an intention to treat basis.
The following tests will be performed and all statistical significance will be set at p \< 0.05:
Primary ... | Osteoarthritis, Knee Osteoarthritis, Hip | double blind randomised controlled trial phase II Devil's Claw osteoarthritis of the knee osteoarthritis of the hip | null | 4 | arm 1: Sub clinical dose if the 3 doses employed arm 2: Active dose arm 3: Active dose arm 4: Comparator for all active intervention arms | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Dose ranging study so will elucidate dose Frequency is four times daily intervention 2: Placebo has same dosing freq as for active intervention and for same time period | intervention 1: Devil Claw intervention 2: Placebo | 1 | Southampton | Hants | United Kingdom | -1.40428 | 50.90395 | 0 | NCT00295490 |
[
3
] | 55 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in patients with small cell lung cancer (SCLC). | Other objectives of this study are to assess the safety, survival rate, best response, time to disease progression, duration of tumor response, and to explore several potential biomarkers to see how these levels change after administration of SNS-595. | Carcinoma, Small Cell Small Cell Lung Cancer | Lung Squamous Cell Small Cell Carcinoma Cancer Small Cell Lung Cancer | null | 1 | arm 1: SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: SNS-595 | 17 | Sacramento | California | United States | -121.4944 | 38.58157
Stanford | California | United States | -122.16608 | 37.42411
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massac... | 0 | NCT00298896 |
[
3
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | * There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments.
* SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells... | Background: There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new therapeutics. The mainstay of therapy for advanced prostate cancer is androgen deprivation therapy (ADT). Although ADT is effective in the large majority of ... | Prostate Cancer | Sutent Sunitinib Bone Metastatic Hormone-refractory Biomarkers | null | 1 | arm 1: Sunitinib | [
0
] | 1 | [
0
] | intervention 1: Sunitinib 50 mg daily, 4/2 schedule | intervention 1: Sunitinib | 3 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00299741 |
[
4
] | 1,025 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia. | null | Fibromyalgia | Fibromyalgia | null | 2 | arm 1: Placebo, oral administration, twice daily for 12 weeks arm 2: Milnacipran 100mg/day (50mg BID \[twice a day\]) | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Placebo, oral administration, twice daily for 12 weeks intervention 2: Milnacipran 100mg per day (50mg BID \[twice a day\]) | intervention 1: Placebo intervention 2: Milnacipran 100mg | 24 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Fresno | California | United States | -119.77237 | 36.74773
Pismo Beach | California | United States | -120.64128 | 35.14275
Vista | California | United States | -117.24254 | 33.20004
St. Petersburg | Florida | United States | -82.67927 | 27.77086
St. Petersbu... | 0 | NCT00314249 |
[
5
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | null | This investigation will assess the effectiveness of topiramate in reducing ethanol consumption by alcohol dependent subjects. It also will seek to establish whether topiramate can be safely used in this population including whether it might be subject to abuse by alcohol dependent individuals.
A secondary goal of this... | Alcoholism is a disorder that produces extensive morbidity and mortality. Substantial progress has been made in the development of medications that can help to promote abstinence in alcohol dependent individuals. However, investigations of the most promising drugs, particularly naltrexone and acamprosate, suggest that ... | Alcoholism | Alcoholism Heavy Drinking Alcohol Dependence | null | 1 | arm 1: In this open label non-placebo controlled trial all subjects received topiramate, the active medication. Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \&... | [
1
] | 1 | [
0
] | intervention 1: Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \& 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg B... | intervention 1: Topiramate (Topamax) | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00329407 |
[
4
] | 218 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD). | null | Behavioral Symptoms Autistic Disorder | Serious behavioral problems in children and adolescents with AD | null | 4 | arm 1: 5 mg arm 2: 10 mg arm 3: 15 mg arm 4: None | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, once daily, 8 weeks intervention 2: Tablets, Oral, once daily, 8 weeks | intervention 1: Aripiprazole intervention 2: Placebo | 31 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Dothan | Alabama | United States | -85.39049 | 31.22323
Phoenix | Arizona | United States | -112.07404 | 33.44838
Huntington Beach | California | United States | -117.99923 | 33.6603
Sacramento | California | United States | -121.4944 | 38.58157
Stanford | Cal... | 0 | NCT00337571 |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin. | The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin are the standard treatment for ovarian cancer, and are effective for many women. However, in many women the cancer eventually stops respon... | Ovarian Cancer | Platinum Resistant Tumors of Ovarian Origin | null | 1 | arm 1: NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles. | [
0
] | 2 | [
0,
0
] | intervention 1: 60 mg / mL / day / 20-23 Days intervention 2: AUC 5 following IV bolus administration of NOV-002 | intervention 1: NOV-002 intervention 2: Carboplatin | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00345540 |
[
2,
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickle cell disease. | Increasing evidence suggests that pulmonary hypertension, defined by an elevated tricuspid regurgitant jet velocity (TRJV) on echocardiogram, is a major cause of morbidity and mortality in adults with sickle cell disease (SCD). However, both the prevalence and optimal treatment of pulmonary hypertension in children and... | Sickle Cell Disease Pulmonary Hypertension | Sickle Cell Disease Pulmonary Hypertension | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose. | intervention 1: Hydroxyurea | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00350844 |
[
3
] | 10 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chem... | null | Carcinoma, Non-Small-Cell Lung | null | 2 | arm 1: Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.
Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.
Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.
Paclitaxel poliglumex 175 mg/m2... | [
5,
0
] | 3 | [
0,
0,
4
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Paclitaxel poliglumex intervention 2: Carboplatin intervention 3: External beam radiation therapy | 8 | San Francisco | California | United States | -122.41942 | 37.77493
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Chicago | Illinois | United States | -87.65005 | 41.85003
Lawrence | Kansas | United States | -95.23525 | 38.97167
Minneapolis | Minnesota | United States | -93.26384 | 44.979... | 0 | NCT00352690 | |
[
3
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The aim of the study is to determine if atomoxetine treatment combined with motivational enhancement therapy is effective in reducing marijuana use in adult individuals with attention-deficit hyperactivity disorder and marijuana dependence. | The purpose of this study is to determine whether the medication atomoxetine, or Strattera, plus 3 sessions of counseling can help people to reduce the symptoms of ADHD and to help cut back on their marijuana use. Participation in the study is approximately 12 weeks of medication treatment and doctor's visits once a we... | Marijuana Abuse Attention Deficit Disorder With Hyperactivity | null | 2 | arm 1: Atomoxetine plus Motivational Enhancement Therapy arm 2: Placebo plus Motivational Enhancement Therapy | [
0,
2
] | 3 | [
0,
3,
0
] | intervention 1: 25 to 100 mg daily intervention 2: Three sessions intervention 3: 25 to 100 mg daily | intervention 1: Atomoxetine intervention 2: Motivational enhancement therapy intervention 3: Placebo | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00360269 | |
[
4
] | 165 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss. | Acronyms in the Adverse Event Section:
* IUCD Intrauterine Contraceptive Device
* MedDRA Medical Dictionary for Regulatory Activities
This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been re... | Menorrhagia | Idiopathic Menorrhagia | null | 2 | arm 1: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. arm 2: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. intervention 2: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. | intervention 1: Levonorgestrel IUS (Mirena, BAY86-5028) intervention 2: Medroxyprogesterone acetate | 54 | Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Carmichael | California | United States | -121.32828 | 38.61713
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Santa ... | 0 | NCT00360490 |
[
4
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied. | null | Leukemia | Leukemia (chronic myeloid leukemia - chronic phase) | null | 2 | arm 1: 50-180 mg once daily (QD) arm 2: 200-800 mg QD | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, Once daily, 5-7 years intervention 2: Tablets, Oral, Once daily, 5-7 years | intervention 1: Dasatinib intervention 2: Imatinib | 45 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Alhambra | California | United States | -118.12701 | 34.09529
Anaheim | California | United States | -117.9145 | 33.83529
Beverly Hills | California | United States | -118.40036 | 34.07362
Fullerton ... | 0 | NCT00362466 |
[
3
] | 334 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels | null | Chronic Hepatitis C | null | 4 | arm 1: Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less th... | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: tablet intervention 2: Solution for injection intervention 3: tablet intervention 4: tablet | intervention 1: Ribavirin intervention 2: Pegylated Interferon Alfa 2a intervention 3: Placebo intervention 4: Telaprevir | 4 | Call For Information | N/A | Austria | N/A | N/A
Call For Information | N/A | France | N/A | N/A
Call For Information | N/A | Germany | N/A | N/A
Call For Information | N/A | United Kingdom | N/A | N/A | 0 | NCT00372385 | |
[
3
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major hear... | This is a randomized, placebo-controlled, blinded study of intravenous N-acetylcysteine (NAC) for the prevention of postoperative myocardial dysfunction and apoptosis in infants undergoing arterial switch for D-transposition of the great arteries. Subjects will be age 0-3 months, and no distinctions will be made based ... | Transposition of Great Vessels Congenital Heart Disease | N-acetylcysteine Myocardial dysfunction Transposition of the Great Arteries | null | 2 | arm 1: These patients receive a placebo infusion of D5W prior to and after surgery arm 2: These patients receive a loading dose of N-Acetylcysteine 100 mg/kg in D5W IV 1 hour prior to surgery. They receive a maintenance infusion of N-Acetylcysteine 10 mg/kg/hr in D5W IV for 24 hours after surgery. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Loading dose: Subjects randomized to IV NAC will receive a total loading dose of 100 mg/kg of 10% (100 mg/mL) solution. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the loading dose will be 1 mL/kg, anticipated to be 2.5-5 mL in o... | intervention 1: N-acetylcysteine intervention 2: Placebo | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00374088 |
[
4
] | 127 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study. | null | Nasal Polyps | null | 8 | arm 1: Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None | [
0,
2,
0,
0,
2,
0,
2,
2
] | 2 | [
0,
0
] | intervention 1: 100 mcg nasal spray intervention 2: One spray of placebo nasal spray in each nostril once daily for 4 months. | intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo nasal spray | 0 | null | 0 | NCT00378378 | |
[
5
] | 95 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa | null | Parkinson's Disease | Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets. intervention 2: Patients were ins... | intervention 1: Levodopa/carbidopa/entacapone intervention 2: Levodopa/carbidopa | 26 | A Coruña | N/A | Spain | -8.396 | 43.37135
Alcalá de Henares, Madrid | N/A | Spain | N/A | N/A
Alcorcón (Madrid | N/A | Spain | N/A | N/A
Alicante | N/A | Spain | -0.48149 | 38.34517
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Ba... | 0 | NCT00391898 |
[
5
] | 258 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome. | null | Metabolic Syndrome X | rosuvastatin lipoprotein metabolic syndrome | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 10mg intervention 2: 10mg | intervention 1: Rosuvastatin intervention 2: Atorvastatin | 3 | Pusan | N/A | South Korea | 128.3681 | 36.3809
Seoul | N/A | South Korea | 126.9784 | 37.566
Suwon | N/A | South Korea | 127.00889 | 37.29111 | 0 | NCT00395486 |
[
4
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or ten... | null | Dysfunctional Central Venous Access Catheters | TNKase CVA CVAD Central venous access catheter CVA catheter | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was round... | intervention 1: placebo intervention 2: tenecteplase | 0 | null | 0 | NCT00395876 |
[
4
] | 251 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase. | null | Dysfunctional Central Venous Access Catheters | TNKase CVA CVAD Central venous access catheter | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of t... | intervention 1: tenecteplase | 0 | null | 0 | NCT00396318 |
[
5
] | 400 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofeti... | null | Renal Transplantation | RenalTransplantation KidneyTransplantation MPA EC-MPS | null | 2 | arm 1: Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants r... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Enteric-coated mycophenolate sodium supplied as 180 mg tablets. intervention 2: Mycophenolate mofetil supplied as 250 mg capsules. intervention 3: Placebo to mycophenolate sodium matching tablets. intervention 4: Placebo to mycophenolate mofetil matching capsules. | intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Mycophenolate mofetil intervention 3: Placebo to mycophenolate sodium intervention 4: Placebo to mycophenolate mofetil | 53 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Sa... | 0 | NCT00400400 |
[
3
] | 28 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of n... | OBJECTIVES:
* Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
* De... | Prostate Cancer | stage III prostate cancer stage II prostate cancer adenocarcinoma of the prostate stage I prostate cancer stage IV prostate cancer | null | 1 | arm 1: taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and t... | [
0
] | 4 | [
2,
0,
3,
3
] | intervention 1: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day intervention 2: doses up to 400 mg/day intervention 3: SOC care surgery intervention 4: post radical prostatectomy | intervention 1: sargramostim intervention 2: thalidomide intervention 3: conventional surgery intervention 4: neoadjuvant therapy | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00400517 |
[
4
] | 813 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be pho... | null | Abscess Wound Infection Diabetic Foot Ulcer | null | 2 | arm 1: Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. arm 2: Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily follow... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. intervention 2: Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three ... | intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid | 123 | Graz | Styria | Austria | 15.45 | 47.06667
Graz | N/A | Austria | 15.45 | 47.06667
Vienna | N/A | Austria | 16.37208 | 48.20849
Bornem | N/A | Belgium | 4.24364 | 51.09716
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Edegem | N/A | Belgium | 4.44504 | 51.15662
Dobrich ... | 0 | NCT00402727 | |
[
0
] | 110 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation. | Atrial fibrillation (AF) is the most common heart rhythm disorder in the US and it is associated with shortness of breath, palpitations, stroke occurrence and increased mortality. Traditional treatment for AF includes anticoagulation, drugs that slow the heart rate and antiarrhythmic agents. More recently, catheter bas... | Atrial Fibrillation | Atrial fibrillation Atrial arrhythmia | null | 2 | arm 1: Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. arm 2: Subjects do not receive membrane-active anti-arrhythmic medications after ablation. | [
5,
5
] | 2 | [
0,
1
] | intervention 1: Above drugs prescribed per established guidelines for treatment of AF intervention 2: A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the ... | intervention 1: propafenone; flecainide; sotalol; dofetilide intervention 2: Radiofrequency catheter ablation | 2 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00408200 |
[
5
] | 58 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of ... | null | Stroke | Cerebral Infarction acute ischemic stroke Brain ischemia | null | 1 | arm 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour | [
0
] | 1 | [
0
] | intervention 1: 0.6 mg/kg of Alteplase is intravenously administered | intervention 1: Alteplase | 1 | Hokkaido | N/A | Japan | N/A | N/A | 0 | NCT00412867 |
[
4
] | 558 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population. | null | Asthma | Moderate asthma Severe asthma | null | 2 | arm 1: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily arm 2: budesonide HFA pMDI 160 μg x 2 actuations twice daily | [
1,
1
] | 2 | [
0,
0
] | intervention 1: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily intervention 2: Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily | intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Budesonide HFA pMDI | 39 | Anaheim | California | United States | -117.9145 | 33.83529
Chula Vista | California | United States | -117.0842 | 32.64005
Fresno | California | United States | -119.77237 | 36.74773
Fullerton | California | United States | -117.92534 | 33.87029
Los Angeles | California | United States | -118.24368 | 34.05223
National... | 0 | NCT00419757 |
[
4
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to develop and implement an evidence based protocol for the secondary prevention of osteoporotic fractures and falls, and to determine how compliance with this intervention improves muscle strength and functional status following a fracture. | Following a fracture, few persons are screened or treated for osteoporosis (Feldstein et al). It is not surprising, then, that the risk of future osteoporotic fractures remains high. Although little data exists on the secondary prevention of osteoporosis, calcium, vitamin D, and bisphosphonates have all been shown to b... | Osteoporosis | disease/disorder proneness/risk osteoporotic fractures accidental falls aging | null | 1 | arm 1: calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention | [
5
] | 3 | [
0,
0,
5
] | intervention 1: alendronate 70mg /cholecalciferol 2800IU orally once weekly intervention 2: calcium carbonate 500mg /cholecalciferol 200IU orally twice daily intervention 3: personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications | intervention 1: alendronate with cholecalciferol intervention 2: calcium carbonate with cholecalciferol intervention 3: Falls prevention measures | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00421343 |
[
4
] | 237 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and object... | null | Sinusitis | null | 2 | arm 1: Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. arm 2: Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID | [
0,
2
] | 2 | [
0,
0
] | intervention 1: MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days intervention 2: Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days | intervention 1: MFNS and antibiotic intervention 2: Matching Placebo nasal spray plus antibiotic | 0 | null | 0 | NCT00423176 | |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain. | Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, ... | Pelvic Pain | chronic pain pelvic pain nicotine patch | null | 3 | arm 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. arm 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. arm 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day. | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. intervention 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. intervention 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime ... | intervention 1: Placebo intervention 2: Nicotine (5 mg) intervention 3: Nicotine (10 mg) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00440505 |
[
4
] | 117 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment wit... | null | Hepatitis C, Chronic | null | 1 | arm 1: PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks | [
0
] | 2 | [
2,
0
] | intervention 1: Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks | intervention 1: PegIntron (peginterferon alfa-2b) intervention 2: Rebetol (ribavirin) | 0 | null | 0 | NCT00441584 | |
[
2
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN). | Open-label, non-randomized and dose escalation study in which groups of 3-6 patients with squamous cell carcinoma of the head and neck will receive sequentially increased dosages of azacitidine SC injection in combination with a fixed dose of cisplatin IV injection until dose-limiting toxicity is demonstrated in 2 of t... | Squamous Cell Carcinoma | Head and Neck Cancer | null | 1 | arm 1: Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Patients will receive Azacitidine and cisplatin. | [
0
] | 2 | [
0,
0
] | intervention 1: SC azacitidine intervention 2: cisplatin 75 mg/m\^2 day 8 every 28 days | intervention 1: Azacitidine intervention 2: Cisplatin | 1 | Kansas City | Missouri | United States | -94.57857 | 39.09973 | 0 | NCT00443261 |
[
4
] | 134 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently... | NCT00415623 (protocol A0531085) | Hypertension | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks | intervention 1: Amlodipine | 9 | Chikushino-shi | Fukuoka | Japan | 130.5156 | 33.49631
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181
Yokohama | Kanagawa | Japan | 139.65 | 35.43333
Iruma | Saitama | Japan | 139.368 | 35.818
Koshigaya | Saitama | Japan | 139.78916 | 35.89035
Edogawa-ku | Tokyo | Japan... | 0 | NCT00443456 | |
[
4
] | 526 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 w... | null | Onychomycosis | Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses | null | 4 | arm 1: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks arm 2: Vehicle (placebo) for 48 weeks arm 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks arm 4: Vehicle (placebo) for 24 weeks | [
0,
2,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks intervention 2: Vehicle (placebo) once daily for 48 weeks intervention 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks intervention 4: Vehicle (placebo) once... | intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo | 23 | Novato | California | United States | -122.5697 | 38.10742
Northglenn | Colorado | United States | -104.9872 | 39.88554
Melbourne | Florida | United States | -80.60811 | 28.08363
Newnan | Georgia | United States | -84.79966 | 33.38067
Chicago | Illinois | United States | -87.65005 | 41.85003
Overland Park | Kansas | Un... | 0 | NCT00443820 |
[
4
] | 518 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 w... | null | Onychomycosis | Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses | null | 4 | arm 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks arm 2: vehicle (placebo) applied once daily for 48 weeks arm 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks arm 4: vehicle (place... | [
0,
2,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks intervention 2: vehicle (placebo) applied once daily for 48 weeks intervention 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks interventi... | intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo | 22 | Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
North Chicago | Illinois | United States | -87.84118 | 42.32558
Lutherville | Maryland | United States | -76.62608 | 39.42122
Milford | Mass... | 0 | NCT00443898 |
[
2
] | 32 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers | null | Hepatitis C | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 300 mg BID intervention 2: 450 mg BID intervention 3: 100 mg BID intervention 4: 300 mg TID intervention 5: Placebo | intervention 1: PF-00868554 intervention 2: PF-00868554 intervention 3: PF-00868554 intervention 4: PF-00868554 intervention 5: Placebo | 4 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Dundee | N/A | United Kingdom | -2.97489 | 56.46913 | 0 | NCT00445315 | |
[
4
] | 96 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. | This is a randomized placebo-controlled trial.
The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed t... | Hereditary Angioedema (HAE) | null | 2 | arm 1: DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections. arm 2: Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections. intervention 2: given as three 1mL subcutaneous injections. | intervention 1: ecallantide intervention 2: Phosphate Buffer Saline (PBS), pH 7.0 | 45 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Berkeley | California | United States | -122.27275 | 37.87159
Crescent City | California | United States | -124.20175 | 41.75595
Granad... | 0 | NCT00457015 | |
[
3
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostat... | null | Prostatic Hypertrophy, Benign | null | 2 | arm 1: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. arm 2: One placebo tablet with a glass of water the evening before ablation of pro... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. intervention 2: One placebo tablet with a glass of water the evening befo... | intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo | 1 | Heidelberg | Baden-Wurttemberg | Germany | 8.69079 | 49.40768 | 0 | NCT00461123 | |
[
2,
3
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children. | This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm thre... | Milk Hypersensitivity | Food Allergy Oral Immunotherapy Immunoglobulin E | null | 2 | arm 1: Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians arm 2: None | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks intervention 2: None | intervention 1: cow's milk powder intervention 2: Placebo | 2 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00465569 |
[
4
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the p... | null | Gastroesophageal Reflux Disease (GERD) | pediatrics neonates | null | 3 | arm 1: This is an open label, run-in phase. All patients received Esomeprazole. arm 2: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. arm 3: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 2: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 3: Double Blind Placebo | intervention 1: Open Label Run In Esomeprazole intervention 2: Double Blind Esomeprazole intervention 3: Double Blind Placebo | 25 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Atlanta | Georgia | United States | -84.38798 | 33.749
Park Ridge | Illinois | United States | -87.84062 | 42.01114
Louisville | Kentucky | United States | -85.75941 | 38.25424
Marrero | Louisiana | United States | -90.10035 | 29.89937
Newton | Massachusetts | U... | 0 | NCT00468559 |
[
3
] | 308 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients | null | Dry Eye Syndromes | Dry Eye Syndromes OPC-12759 | null | 3 | arm 1: 0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. arm 2: 1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. arm 3: 2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: comparison of different dosages of drug intervention 2: comparison of different dosages of drug intervention 3: comparison of different dosages of drug | intervention 1: placebo intervention 2: 1% OPC-12759 ophthalmic suspension intervention 3: 2% OPC-12759 ophthalmic suspension | 6 | Chubu Region | N/A | Japan | N/A | N/A
Kansai Region | N/A | Japan | N/A | N/A
Kanto Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A
Shikoku Region | N/A | Japan | N/A | N/A
Tohoku Region | N/A | Japan | N/A | N/A | 0 | NCT00475319 |
[
3
] | 360 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN) | This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily ... | Post Herpetic Neuralgia PHN Neuropathy Nerve Pain | Post Herpetic Neuralgia PHN Neuropathy Nerve Pain Topical | null | 3 | arm 1: Np-1 cream and placebo gabapentin arm 2: gabapentin caps and placebo cream arm 3: placebo cream and capsules | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks intervention 2: 1800mg/day capsules for 4 weeks intervention 3: placebo cream and caps | intervention 1: EpiCept-NP-1 Cream intervention 2: Gabapentin Capsules intervention 3: placebo | 1 | New Delhi | N/A | India | 77.2148 | 28.62137 | 0 | NCT00475904 |
[
5
] | 52 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration. | Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC... | Dehydration | dehydration fluid therapy pediatrics emergency medicine hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rHuPH20 | null | 1 | arm 1: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours. | [
0
] | 1 | [
0
] | intervention 1: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours. | intervention 1: hyaluronidase (human recombinant)/rehydration fluid | 0 | null | 0 | NCT00477152 |
[
4
] | 137 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for st... | null | Cerebral Palsy Neurological Conditions Mental Retardation Sialorrhea | Mental Retardation Neurological Impairment Cerebral Palsy Drooling Neurological Conditions | null | 1 | arm 1: Arm receiving study drug | [
5
] | 1 | [
0
] | intervention 1: Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver | intervention 1: Oral Glycopyrrolate Liquid | 7 | Lakewood | Colorado | United States | -105.08137 | 39.70471
Atlanta | Georgia | United States | -84.38798 | 33.749
Bayside | New York | United States | -73.77708 | 40.76844
Akron | Ohio | United States | -81.51901 | 41.08144
Mantua | Ohio | United States | -81.22399 | 41.28394
Bethany | Oklahoma | United States | -97.6... | 0 | NCT00491894 |
[
5
] | 660 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD. | null | Chronic Obstructive Pulmonary Disease, COPD | Chronic Obstructive Pulmonary Disease, COPD | null | 2 | arm 1: Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily arm 2: Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Symbicort (budesonide/formoterol turbuhaler 320/9ug) intervention 2: Spiriva (tiotropium bromide 18ug) | intervention 1: Symbicort (budesonide/formoterol turbuhaler 320/9ug) intervention 2: Spiriva (tiotropium bromide 18ug) | 93 | Concord | New South Wales | Australia | 151.10381 | -33.84722
Sydney | New South Wales | Australia | 151.20732 | -33.86785
Auchenflower | Queensland | Australia | 152.99213 | -27.47443
Carina Heights | Queensland | Australia | 153.09126 | -27.50721
North Mackay | Queensland | Australia | 149.17941 | -21.12009
Adelaide ... | 0 | NCT00496470 |
[
4
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exercises alone in impro... | Patellofemoral pain syndrome is a leading cause of knee pain in persons under 45 and is particularly common in women. The prevailing theory for the etiology of patellofemoral pain is an imbalance in force or timing of the pull of the knee extensor muscles on the patella resulting in improper tracking of the patella in ... | Patellofemoral Pain Syndrome | Botulinum toxin type A Patellofemoral pain syndrome Knee Injuries Exercise Therapy | null | 2 | arm 1: Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program arm 2: Placebo injection + exercise | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain intervention 2: Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus laterali... | intervention 1: Botulinum toxin A + exercise intervention 2: Placebo | 1 | Richmond | Virginia | United States | -77.46026 | 37.55376 | 0 | NCT00496964 |
[
4
] | 578 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis | null | Bacterial Conjunctivitis | null | 2 | arm 1: Gatifloxacin 0.5% Eye Drops arm 2: Placebo Eye Drops | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily intervention 2: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily | intervention 1: Gatifloxacin 0.5% eye drops intervention 2: placebo eye drops | 1 | Gretna | Louisiana | United States | -90.05396 | 29.91465 | 0 | NCT00509873 | |
[
3
] | 230 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo. | The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo. | Pediculus Humanus Capitis Head Lice | Head Lice Lice Infestation Pediculosis Pediculosis Capitis | null | 4 | arm 1: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 2: Subjects are treated either once (day1) or twice (day 1 and 7) with either ... | [
1,
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: Vehicle Only intervention 2: BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo... | intervention 1: Placebo intervention 2: BGC20-0582 | 1 | Florida City | Florida | United States | -80.47922 | 25.44789 | 0 | NCT00528021 |
[
3
] | 27 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study investigated the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol, salmeterol and placebo. | null | Chronic Obstructive Pulmonary Disease | COPD cycle ergometry exercise testing spirometry cardiovascular salbutamol indacaterol chronic obstructive pulmonary disease | null | 6 | arm 1: Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo ... | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am). intervention 2: Single dose indacaterol matching placebo via Concept 1 device intervention 3: Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI... | intervention 1: Indacaterol intervention 2: Placebo intervention 3: Salmeterol | 1 | Antwerp | N/A | Belgium | 4.40026 | 51.22047 | 0 | NCT00531050 |
[
3,
4
] | 105 | NON_RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | false | Trauma patients are at high risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE). The incidence of DVT varies greatly from 5-63% among studies depending on patient's individual risk factors, modality of prophylaxis, and methods of detection. The incidence of PE may be as low (0.3-4.3%) but carries ... | Patients with trauma admitted to San Francisco General Hospital and qualify for the study will be assigned to +fondaparinux and no fondaparinux arms based on guidelines that were developed for and are considered the standard of care for the use of low molecular weight heparin in the same group of patients for the same ... | Venous Thromboembolism | deep vein thrombosis venous thromboembolism pulmonary embolism | null | 4 | arm 1: Patients at high risk for venous thromboembolism (criteria: age\>=40, pelvic fracture, lower extremity fracture, shock on presentation, spinal cord injury, head injury with Abbreviated Injury Scale (AIS) \>=3). These patients will receive fondaparinux 2.5mg via subcutaneous administration (SubQ) daily. arm 2: Pa... | [
0,
1,
0,
1
] | 2 | [
0,
1
] | intervention 1: fondaparinux 2.5mg SubQ daily for DVT prophylaxis to be started by treating physicians once deemed safe and to be discontinued once patient in discharged from the hospital or at discretion of treating physicians. intervention 2: Sequential compression devices at all times during the patient's hospital a... | intervention 1: fondaparinux sodium intervention 2: sequential compression devices | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00531843 |
[
3
] | 9 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia | null | Neuralgia | null | 2 | arm 1: AGN201781 50 mg capsules three-time daily for 2 weeks arm 2: placebo 50 mg capsules three-times daily for 2 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: AGN201781 50 mg capsules three-times daily for 2 weeks intervention 2: placebo 50 mg capsules three-times daily for 2 weeks | intervention 1: AGN201781 intervention 2: placebo | 2 | St Leonards | New South Wales | Australia | 151.19836 | -33.82344
Kiel | N/A | Germany | 10.13489 | 54.32133 | 0 | NCT00533351 | |
[
0
] | 228 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery | null | Dry Eye Syndrome | null | 2 | arm 1: Carboxymethylcellulose and Glycerin based artificial tear arm 2: Carboxymethylcellulose based artificial tear | [
0,
1
] | 2 | [
0,
0
] | intervention 1: As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake intervention 2: As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake | intervention 1: Carboxymethylcellulose and Glycerin based artificial tear intervention 2: Carboxymethylcellulose | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00544713 | |
[
3
] | 199 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 2MALE | true | The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia. | null | Schizophrenia | null | 3 | arm 1: None arm 2: 4mg/day arm 3: matching placebo | [
0,
1,
2
] | 3 | [
0,
0,
10
] | intervention 1: This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study interventio... | intervention 1: vabicaserin intervention 2: risperidone intervention 3: placebo | 33 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Escondido | California | United States | -117.08642 | 33.11921
Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California | United States | -118.25508 | 34.14251
San D... | 0 | NCT00563706 | |
[
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention. | The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).
The primary endpoint ... | Acute Myocardial Infarction ST Elevation MI STEMI | INOT44 NOMI | null | 2 | arm 1: Inhaled Nitric oxide administered at 80 parts per million (ppm) arm 2: Inhaled nitrogen gas (Placebo) administered at 80 ppm | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Nitric oxide for inhalation intervention 2: Nitrogen gas (placebo) for inhalation | intervention 1: Nitric Oxide intervention 2: Placebo | 14 | Mobile | Alabama | United States | -88.04305 | 30.69436
Miami | Florida | United States | -80.19366 | 25.77427
Chicago | Illinois | United States | -87.65005 | 41.85003
Kansas City | Kansas | United States | -94.62746 | 39.11417
Boston | Massachusetts | United States | -71.05977 | 42.35843
The Bronx | New York | United... | 0 | NCT00568061 |
[
5
] | 116 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | true | 0ALL | false | The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery | null | Bacterial Infections Eye Infections Cataract Extraction | null | 2 | arm 1: One drop two times a day for two days and once a day for the next five days arm 2: One drop three times a day for seven days | [
1,
1
] | 2 | [
0,
0
] | intervention 1: One drop two times a day for two days and once a day for the next five days. intervention 2: One drop three times a day for seven days | intervention 1: AzaSite Eye Drops intervention 2: Vigamox Eye Drops | 13 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Mission Hills | California | United States | -120.43683 | 34.68609
Miami | Florida | United States | -80.19366 | 25.77427
Panama City | Florida | United States | -85.65983 | 30.15946
Atlanta | Georgia... | 0 | NCT00575380 | |
[
0
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or sq... | The main objective of this study was to establish the safety and efficacy of midazolam in patients with skin cancer undergoing outpatient Mohs micrographic surgery. Patients were randomized in a double-blind placebo-controlled study of a single-dose midazolam syrup for efficacy in producing safe anxiolysis of short dur... | Basal Cell Carcinoma Squamous Cell Carcinoma Skin Cancer Anxiety | mohs micrographic surgery skin cancer anxiety basal cell carcinoma squamous cell carcinoma midazolam versed | null | 3 | arm 1: Single-dose midazolam arm 2: None arm 3: None | [
1,
2,
0
] | 4 | [
0,
10,
0,
0
] | intervention 1: Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup. intervention 2: The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam. intervention 3: Lidoc... | intervention 1: Randomized Midazolam intervention 2: Placebo intervention 3: Local Anesthesia intervention 4: Prospective Midazolam | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00578214 |
[
3
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to assess how effective celecoxib is in limiting production of a hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression of an existing cancer. To answer this ques... | We propose to test the hypothesis that celecoxib, a specific inhibitor of cyclooxygenase -2 (COX-2), will effectively inhibit the enzymatic activity in all tissues sampled after oral administration of celecoxib for 7 days preoperatively. One hundred twenty patients (120) undergoing standard surgical resection for the t... | Colorectal Adenoma Colorectal Carcinoma | null | 2 | arm 1: 400 mg Celecoxib the study drug will be given for 7 days before surgery arm 2: Placebo in a one to one randomization prior to surgery | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 400 mg twice a day for 7 days prior to surgery intervention 2: one tablet of placebo will be given for 7 days prior to surgery | intervention 1: Celecoxib intervention 2: Placebo | 1 | Birmingham | Alabama | United States | -86.80249 | 33.52066 | 0 | NCT00582660 | |
[
2,
3
] | 18 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in two groups of patients and one group of healthy controls. The patient groups will be those with mild or moderate hepatic impairment or moderate renal disease. | null | Colonoscopy Bowel Preparation | null | 3 | arm 1: Patients with moderate renal impairment arm 2: Healthy volunteers arm 3: Patients with mild/moderate hepatic impairment. | [
0,
1,
0
] | 1 | [
0
] | intervention 1: BLI-800 oral solution (two doses) | intervention 1: BLI-800 | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00583713 | |
[
0
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abno... | Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study ... | Diastolic Heart Failure | Heart Failure, Congestive | null | 2 | arm 1: Heart failure patients assigned to atorvastatin arm 2: None | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Atorvastatin - 40 mg orally daily for 6 months intervention 2: placebo | intervention 1: Atorvastatin intervention 2: placebo | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00585611 |
[
4
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis | null | Allergic Conjunctivitis | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution intervention 3: sterile ophthalmic solution | intervention 1: Bepreve (bepotastine besilate ophthalmic solution) 1.5% intervention 2: placebo comparator intervention 3: Bepotastine Besilate Ophthalmic Solution 1.0% | 1 | Irvine | California | United States | -117.82311 | 33.66946 | 0 | NCT00586664 | |
[
2
] | 7 | RANDOMIZED | null | 0TREATMENT | 1SINGLE | true | 0ALL | false | A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings will be taken. The s... | Modafinil, a drug primarily used in the treatment for narcolepsy, is also being using in treating attention problems found in Attention Deficit Hyperactive Disorder (ADHD). This study will investigate the efficacy of Modafinil upon attention deficits found in tinnitus patients by assessing pre-attentional and attention... | Tinnitus | P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
10
] | intervention 1: 200 mg/day, morning dose intervention 2: Sugar pill once per day in the morning. | intervention 1: Modafinil intervention 2: Placebo | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00591019 |
[
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a ... | null | Melanoma | Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage III or IV melanoma | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: One group treatment study | intervention 1: Temozolomide (TMZ) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00591370 |
[
3
] | 70 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back.
The purpose ... | null | Breast Cancer | breast cancer adenocarcinoma of the breast cardiac safety Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center | null | 1 | arm 1: single arm study | [
0
] | 1 | [
0
] | intervention 1: AC \[Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)\] Followed By Paclitaxel (P) | intervention 1: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00591851 |
[
3
] | 117 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension | null | Primary Open Angle Glaucoma Ocular Hypertension | null | 4 | arm 1: A single drop of each, once daily in study eye for 28 days arm 2: A single drop of each, once daily in study eye for 28 days arm 3: A single drop of each, once daily in study eye for 28 days arm 4: A single drop of each, once daily in study eye for 28 days | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207. intervention 4: None | intervention 1: PF-03187207 intervention 2: Latanoprost 0.005% intervention 3: PF-03187207 Vehicle intervention 4: Latanoprost Vehicle | 13 | Narashino | Chiba | Japan | 140.04152 | 35.68184
Shimachi | Chiba | Japan | N/A | N/A
Kawasaki | Kanagawa | Japan | 139.71722 | 35.52056
Kasukabe | Saitama | Japan | 139.74966 | 35.98308
Fuji | Shizuoka | Japan | 138.68333 | 35.16667
Mishima | Shizuoka | Japan | 138.91667 | 35.11667
Susono | Shizuoka | Japan | 138.9069... | 0 | NCT00595101 | |
[
0
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors. | null | Uveal Melanoma | Melanoma Eye Avastin | null | 1 | arm 1: AVASTIN | [
0
] | 1 | [
0
] | intervention 1: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be giv... | intervention 1: AVASTIN | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00596362 |
[
0
] | 54 | NON_RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to determine, with Positron Emission Tomography (PET), the role of nitric oxide in the age-associated effect on fatty acid and glucose delivery on myocardial substrate metabolism. | Aging is associated with an increased incidence and severity of various cardiovascular disorders. Previously, our laboratory has demonstrated an age-related shift in the substrates used by the heart for metabolism from primarily fatty acids to primarily glucose. Furthermore, other institutions have demonstrated that a ... | Cardiovascular Diseases | PET Heart metabolism Nitric oxide Myocardial remodeling | null | 5 | arm 1: 20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME. arm 2: 25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 sepa... | [
1,
1,
1,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging intervention 2: aids in nitric oxide production intervention 3: alpha agonist; 10 μg/kg/min infusion during PET study | intervention 1: L-NAME intervention 2: L-Arginine intervention 3: Phenylephrine | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00603720 |
[
3
] | 59 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules. | A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
Stable liver transplant patients who fulfill all I/E criteria will be en... | Liver Failure | Tacrolimus Pharmacokinetics Liver Transplantation | null | 1 | arm 1: Prograf was administrated BID, doses per product labeling, with an interval of 12±1 hours between the morning and evening doses. Patients continued on the same dose from Day 0 through Day 7. On Day 8, all patients were converted to LCP Tacro QD for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro ... | [
0
] | 2 | [
0,
0
] | intervention 1: In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8.
LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in th... | intervention 1: LCP Tacro intervention 2: Prograf | 1 | Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 0 | NCT00608244 |
[
5
] | 315 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis. | null | Rhinitis, Allergic, Perennial | Perennial allergic rhinitis; fluticasone furoate nasal spray | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo | intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo | 37 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Wheaton | Maryland | United States | -77.05526 | 39.03983
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Plymouth | Minnesota | United States | -93.45551 | 45.01052
St Louis... | 0 | NCT00609674 |
[
3
] | 178 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes. | null | Diabetes Diabetes Mellitus, Type 1 | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily intervention 2: Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily intervention 3: Treat-to-target dose titration scheme, injection s.c., once daily interventi... | intervention 1: insulin degludec intervention 2: insulin degludec intervention 3: insulin glargine intervention 4: insulin aspart | 33 | Walnut Creek | California | United States | -122.06496 | 37.90631
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Idaho Falls | Idaho | United States | -112.03414 | 43.46658
Des Moines | Iowa | United States | -93.60911 | 41.60054
Hyattsville | Maryland | United States | -76.94553 | 38.95594
Chattanooga | Ten... | 0 | NCT00612040 | |
[
5
] | 345 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder. | This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time) Phase 4 study of oxybutynin chloride OROS in participants with overactive bladder. The to... | Urinary Bladder, Overactive | Overactive bladder Oxybutynin chloride OROS | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up t... | intervention 1: Oxybutynin chloride OROS | 0 | null | 0 | NCT00613327 |
[
5
] | 58 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | true | 1FEMALE | false | The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood. | We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal st... | Pain | Essure sterilization pain management intrauterine lidocaine infusion | null | 2 | arm 1: Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization arm 2: Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes intervention 2: 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes | intervention 1: Lidocaine intervention 2: Sterile Saline | 2 | Portland | Oregon | United States | -122.67621 | 45.52345
Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00613834 |
[
3
] | 83 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea. | null | Papulopustular Rosacea | rosacea papulopustular azelaic acid foam | null | 2 | arm 1: Participants received azelaic acid foam, 15% topically twice daily for 12 weeks arm 2: Participants received vehicle foam topically twice daily for 12 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 15% foam to be applied topically twice daily intervention 2: Active-ingredient-free vehicle to be applied topically twice daily | intervention 1: Azelaic acid intervention 2: Vehicle foam | 7 | Denver | Colorado | United States | -104.9847 | 39.73915
Olathe | Kansas | United States | -94.81913 | 38.8814
Henderson | Nevada | United States | -114.98194 | 36.0397
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Mason | Ohio | United States | -84.30994 | 39.36006
Austin | Texas | United States | -... | 0 | NCT00617903 |
[
5
] | 67 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spina... | Research Summary
Purpose of Study This prospective, randomized, blinded controlled trial will be conducted to evaluate post-operative pain control and physical therapy outcomes in primary total knee arthroplasty (TKA) with the use of spinal analgesia and intra-operative posterior capsular injections of ropivicaine 0.5... | Osteoarthritis | null | 2 | arm 1: Subjects receive intra-op saline injection per protocol arm 2: Subjects receive intra-op Ropivicaine 0.5% injection per protocol | [
2,
0
] | 2 | [
10,
0
] | intervention 1: 20 cc of sterile, injectable saline intervention 2: Ropivicaine | intervention 1: Placebo saline injection intervention 2: Ropivicaine 0.5% | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00620828 | |
[
5
] | 596 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life | null | Seasonal Allergic Rhinitis | levocetirizine Xyzal Seasonal Allergic Rhinitis total symptom score quality of life | null | 2 | arm 1: Matched placebo tablets once daily arm 2: 5 mg levocetirizine dihydrochloride tablet | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 5mg daily (oral tablet) for 14 days intervention 2: 0mg (matching oral tablet)for 14 days | intervention 1: levocetirizine dihydrochloride intervention 2: placebo | 26 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Huntington Beach | California | United States | -117.99923 | 33.6603
Long Beach | California | United States | -118.18923 | 33.76696
Los... | 0 | NCT00621959 |
[
4
] | 66 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentan... | This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 day... | Pain Cancer | Pain Cancer Fentanyl JNS020QD | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is ... | intervention 1: Fentanyl | 1 | Kitakyushu | N/A | Japan | 130.85034 | 33.85181 | 0 | NCT00641667 |
[
3
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldeh... | Approximately 32 subjects will be enrolled in ascending dosing cohorts of 8 subjects each. Each subject will receive an oral dose of study drug (fomepizole or placebo) with concomitant ethanol with group assignment in a randomized 1:1:1:1 ratio (2 subjects each group) on Study Day 1. Each subject is their own intra-sub... | Aldehyde Dehydrogenase-2 (ALDH2) Deficiency | acetaldehyde ethanol ALDH2 | null | 4 | arm 1: Participants receive alternating study treatment (oral fomepizole 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. arm 2: Participants receive alternating study treatment (oral fomepizole 3.0 mg/kg or placebo) on 2 seq... | [
0,
0,
0,
0
] | 3 | [
0,
0,
10
] | intervention 1: None intervention 2: None intervention 3: oral dose of ethanol (0.5 g/kg) | intervention 1: Antizol intervention 2: Placebo intervention 3: Ethanol | 1 | Honolulu | Hawaii | United States | -157.85833 | 21.30694 | 0 | NCT00661141 |
[
3
] | 63 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly... | OBJECTIVES:
Primary
* To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin.
Secondary
* To determine the overall response ... | Lung Cancer | stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
4
] | intervention 1: Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two... | intervention 1: Carboplatin intervention 2: Docetaxel intervention 3: radiation therapy | 15 | Orlando | Florida | United States | -81.37924 | 28.53834
Baltimore | Maryland | United States | -76.61219 | 39.29038
Cleveland | Ohio | United States | -81.69541 | 41.4995
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
Clarksville | Tenness... | 0 | NCT00664105 |
[
3
] | 103 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | null | The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparis... | null | Pain | Analgesic effect | null | 3 | arm 1: None arm 2: None arm 3: Placebo matching AZD1386 | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 95mg, oral solution, single dose intervention 2: 500mg, capsule, single dose intervention 3: AZD1386 Placebo oral solution | intervention 1: AZD1386 intervention 2: Naproxen intervention 3: Placebo | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00672646 |
[
4
] | 60 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate. | Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20... | Gastric Acid Human Experimentation | null | 3 | arm 1: Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension arm 2: Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet arm 3: Sodium Bicarbonate 1680 mg Oral Suspension | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. intervention 2: Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. intervention 3: Sodium bicarbonate. Single dose. | intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium intervention 3: sodium bicarbonate | 0 | null | 0 | NCT00674115 | |
[
3
] | 1,084 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.... | null | Nonvalvular Atrial Fibrillation | Anticoagulant Treatment Risk Factors For Stroke | null | 5 | arm 1: AZD0837 450 mg arm 2: AZD0837 200 mg arm 3: AZD0837 300 mg arm 4: AZD0837 150 mg arm 5: Vitamin-K antagonist at INR 2-3 | [
0,
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: ER tablet, PO, once daily for a period of 3-9 months. intervention 2: Tablet, PO for a period of 3-9 months. intervention 3: ER tablet, PO, twice daily for a period of 3-9 months | intervention 1: AZD0837 intervention 2: Vitamin-K antagonist at INR 2-3 intervention 3: AZD0837 | 0 | null | 0 | NCT00684307 |
[
5
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made f... | Structure:
Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:
1. Prednisolone Aceta... | Allergic Conjunctivitis | Allergic conjunctivitis | null | 4 | arm 1: Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 2: Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 d... | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 2: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. ... | intervention 1: Prednisolone Acetate 1% intervention 2: Prednisolone Acetate 0.12% intervention 3: Loteprednol Etabonate 0.2% intervention 4: Placebo | 1 | Andover | Massachusetts | United States | -71.137 | 42.65843 | 0 | NCT00689078 |
[
2
] | 21 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers. | null | Dry Eye | normal volunteers anti-infective tobramycin | null | 3 | arm 1: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension arm 2: TOBREX® Ophthalmic Solution arm 3: TOBRADEX® Ophthalmic Suspension | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline intervention 2: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline intervention 3: TOBREX Ophthalmic Solution 1 drop each eye at baseline | intervention 1: TOBRADEX Ophthalmic Suspension intervention 2: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension intervention 3: TOBREX Ophthalmic Solution | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00695435 |
[
3
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2% | A double-blind, randomized, 2-way crossover, safety, pharmacokinetic/-dynamic (PK/PD) study of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution administered in male and female patients with moderate to severe erythematous rosacea.
Twenty male and female subjects with moderate to severe erythematous ro... | Erythematous Rosacea | erythematous rosacea facial gel brimonidine ophthalmic solution | null | 2 | arm 1: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after four hours arm 2: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartr... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours intervention 2: One 1-g application of COL-118 facial gel vehicle (0.0 mg br... | intervention 1: 0.18% COL-118 facial gel (1.8 mg brimonidine) intervention 2: 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) intervention 3: Advanced Eye Relief intervention 4: COL-118 facial gel vehicle | 1 | Broomall | Pennsylvania | United States | -75.35658 | 39.9815 | 0 | NCT00697541 |
[
0
] | 99 | NON_RANDOMIZED | PARALLEL | 9OTHER | 0NONE | true | 0ALL | false | This study will examine activation of a brain circuit that regulates emotion in depressed patients before and after treatment to see which areas of the brain are involved in chronic depression. | Major depressive disorder can be a recurrent problem for many people, interfering with their ability to function normally in day-to-day life. Although research shows that activation in certain brain areas corresponds to certain emotional functions, it is not well known which specific changes in brain functioning are re... | Depression | Emotional Circuitry fMRI | null | 2 | arm 1: The depressed participants in this arm will be given Lexapro. arm 2: The nondepressed participants in this arm will not be given any intervention for depression. | [
0,
4
] | 1 | [
0
] | intervention 1: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day | intervention 1: Lexapro | 0 | null | 0 | NCT00749125 |
[
5
] | 296 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery... | This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Cl... | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder With Hyperactivity Methylphenidate Concerta | null | 1 | arm 1: Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects. | [
0
] | 1 | [
0
] | intervention 1: Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects. | intervention 1: OROS Methylphenidate | 0 | null | 0 | NCT00758160 |
[
5
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses. | null | Dry Eye Syndromes | null | 2 | arm 1: Optive Eyedrops arm 2: Hylocomod Eyedrops | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Eyedrops as required, but at least 3 times per day intervention 2: Eyedrops as required, but at least 3 times per day | intervention 1: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® intervention 2: Sodium hyaluronate | 1 | London | London | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00761202 | |
[
4
] | 103 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation | null | Gingival Diseases | null | 3 | arm 1: commercially available Fluoride toothpaste arm 2: fluoride/triclosan/copolymer toothpaste arm 3: fluoride/herbal toothpaste | [
2,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Brush twice daily intervention 2: Brush twice daily intervention 3: Brush twice daily | intervention 1: Fluoride intervention 2: Triclosan and fluoride intervention 3: Herbal Ingredient and fluoride | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00761930 | |
[
4
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The objective is to develop a method to determine active ingredient uptake in oral care products. | null | Dental Plaque | null | 2 | arm 1: fluoride toothpaste from Thailand arm 2: fluoride/triclosan/copolymer toothpaste | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Brush half mouth once with assigned study treatment intervention 2: Brush half mouth once with assigned study treatment | intervention 1: Fluoride intervention 2: Fluoride and triclosan | 1 | Bangkok | Bangkok 10110 | Thailand | 100.50144 | 13.75398 | 0 | NCT00762853 | |
[
0
] | 24 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 2DOUBLE | false | 0ALL | false | Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity. | null | Allergic Rhinitis Allergic Conjunctivitis | allergy skin testing eye drops antihistamines | null | 2 | arm 1: participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days arm 2: participants received o... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day intervention 2: placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day | intervention 1: olopatadine intervention 2: placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00775658 |
[
4
] | 780 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyri... | The study will be carried out among children aged ≥ 8 to \< 14 years (boys) and ≥ 8 to \< 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending pri... | Malaria Intermittent Preventive Treatment | Malaria Intermittent preventive treatment Efficacy Safety Tolerability Schoolchildren Uganda | null | 4 | arm 1: Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets arm 2: Dihydroartemisinin-... | [
1,
1,
2,
1
] | 4 | [
0,
0,
0,
10
] | intervention 1: 25 mg/kg po once on day 0 intervention 2: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0 intervention 3: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2) intervention 4: dosed as for amodiaquine (10mg/kg po daily on days 1, 2) | intervention 1: sulfadoxine-pyrimethamine intervention 2: amodiaquine + sulfadoxine-pyrimethamine intervention 3: dihydroartemisinin-piperaquine intervention 4: Placebo | 0 | null | 0 | NCT00852371 |
[
4
] | 253 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. | This was a phase III, 2-part multicenter study. Part I was an 26-week parallel-group, randomized, placebo-controlled design consisting of an 8 week baseline period, a 2 week double-blinded titration period, 12 week maintenance period, and a 4 week tapering-off period. After completing the baseline period, patients were... | Partial Epilepsy | epilepsy | null | 4 | arm 1: ESL 800mg daily arm 2: ESL 1200mg daily arm 3: placebo arm 4: All patients were treated with only ESL during Part II. | [
0,
0,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: oral tablet, 800 mg or 1200 mg once daily intervention 2: once daily placebo comparator intervention 3: Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a max... | intervention 1: eslicarbazepine acetate intervention 2: placebo (Part I) intervention 3: ESL - Open-label Extension (Part II) | 1 | S. Mamede Do Coronado | N/A | Portugal | N/A | N/A | 0 | NCT00957372 |
[
5
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion. | Introduction: Many complications in liver resection surgery, such as post-operative hepatic insufficiency, sepsis, and multi-organ liver failure, have been attributed to ischemia-reperfusion injury and the release of pro-inflammatory agents. Previous studies had shown that ketamine inhibited the synthesis of interleuki... | Hepatectomy | hepatectomy IL 6 organ failure ketamine Pringle | null | 2 | arm 1: Ketamine: 0.25 mg/kg, intravenously, one dose. arm 2: Placebo: saline solution | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Ketamine: 0.25 mg/kg, intravenously, one dose. intervention 2: saline solution | intervention 1: Ketamine intervention 2: Placebo | 1 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 | 0 | NCT00978757 |
[
3
] | 124 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | To compare intraocular pressure lowering effectiveness of a new fixed combination drug. | This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a n... | Primary Open Angle Glaucoma Ocular Hypertension | Open-angle glaucoma Ocular hypertension POAG Treatment | null | 2 | arm 1: IOP Dorzolamide-Timolol-Brimonidine group arm 2: IOP dorzolamide-timolol group | [
1,
1
] | 1 | [
0
] | intervention 1: Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Lab... | intervention 1: dorzolamide-timolol-brimonidine | 1 | Montemorelos | Nuevo León | Mexico | -99.82865 | 25.18909 | 0 | NCT01062971 |
[
4
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only throug... | null | Alcohol Dependence | PUFAs Alcoholism Treatment Effectiveness | null | 4 | arm 1: Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA; arm 2: Naltrexone chlorhydrate 50 mg arm 3: Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone... | [
0,
1,
2,
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil. intervention 2: Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of ... | intervention 1: Naltrexone intervention 2: PUFAs intervention 3: Placebo intervention 4: Naltrexone + Placebo | 1 | São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 | 0 | NCT01211769 |
[
2
] | 24 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This was an open label, three way study in participants with symptomatic allergic rhinitis. The following 3 treatments were administered to each subject during dosing periods 1, 2 and 3, respectively:
* Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of ... | null | Allergic Rhinitis | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1 intervention 2: Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later ... | intervention 1: Ketorolac Tromethamine intervention 2: Oxymetazoline Hydrochloride intervention 3: Fluticasone Propionate | 1 | Adelaide | N/A | Australia | 138.59863 | -34.92866 | 0 | NCT01365650 | |
[
5
] | 31 | NON_RANDOMIZED | PARALLEL | 9OTHER | 0NONE | true | 0ALL | true | This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotyp... | null | HIV | Pharmacokinetics Clinical Pharmacology Pharmacogenomics HIV | null | 2 | arm 1: A pre-screening genetic test determines CYP3A5 expressor status arm 2: A pre-screening genetic test determines CYP3A5 non-expressor status | [
1,
1
] | 1 | [
0
] | intervention 1: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days | intervention 1: Atazanavir | 1 | Aurora | Colorado | United States | -104.83192 | 39.72943 | 0 | NCT01388543 |
[
0
] | 197 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 1FEMALE | false | Objectives
To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:
1. To determine whe... | null | Breast Feeding Contraception | Breastfeeding rates Contraceptive continuation Birth control pills Lactation | null | 2 | arm 1: Study Arm A is one of two interventions (Combined estrogen-progestin pill) arm 2: Study Arm B is one of two interventions (Progestin-only pill) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo intervention 2: .35 mg norethindrone once a day orally | intervention 1: Combined estrogen-progestin pill intervention 2: Progestin-only pill | 0 | null | 0 | NCT01465022 |
[
5
] | 150 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 wee... | null | Hepatitis B, Chronic | null | 2 | arm 1: Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up. arm 2: Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once w... | [
0,
0
] | 1 | [
0
] | intervention 1: Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks | intervention 1: peginterferon alfa-2a [Pegasys] | 7 | Busan | N/A | South Korea | 129.03004 | 35.10168
Daegu | N/A | South Korea | 128.59111 | 35.87028
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 |... | 0 | NCT01519921 |
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