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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 1,029 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population. | This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration. | Infectious Diseases | Pediatrics Safety Musculoskeletal System Neurologic Manifestations Joint Diseases Joint Deformities, Acquired | null | 2 | arm 1: Subjects receiving Ciprofloxacin (group followed-up for 5 years) arm 2: Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label intervention 2: Common used dose and route | intervention 1: Ciprofloxacin intervention 2: Non-quinolone antibiotic | 67 | Mobile | Alabama | United States | -88.04305 | 30.69436
Fort Smith | Arkansas | United States | -94.39855 | 35.38592
Corona | California | United States | -117.56644 | 33.87529
Fountain Valley | California | United States | -117.95367 | 33.70918
Long Beach | California | United States | -118.18923 | 33.76696
Orange | C... | 0 | NCT00761462 |
[
5
] | 203 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days. | null | Constipation | Human Experimentation | null | 2 | arm 1: MiraLAX® (polyethylene glycol 3350 powder for solution) arm 2: MALTRIN 500® M500 (maltodextrin 500) | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days. intervention 2: Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days. | intervention 1: Polyethylene glycol 3350 intervention 2: Placebo, maltodextrin 500 powder for solution | 0 | null | 0 | NCT00770432 |
[
5
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. | The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later. | Psoriasis | Psoriasis Plaque Type Psoriasis | null | 2 | arm 1: Topical foam formulation that includes clobetasol propionate (Steroid) arm 2: Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical Clobetasol propionate foam intervention 2: Vehicle foam does not include the active drug. | intervention 1: Clobetasol propionate foam intervention 2: Vehicle foam | 2 | Fremont | California | United States | -121.98857 | 37.54827
Louisville | Kentucky | United States | -85.75941 | 38.25424 | 0 | NCT00842153 |
[
5
] | 59 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug) and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis. | null | Rhinitis, Allergic, Perennial Allergic Rhinitis | fluticasone propionate Vienna Challenge Chamber glucocorticosteroids allergic rhinitis | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Corticosteriod, with anti-inflammatory effects intervention 2: Placebo comparator | intervention 1: Fluticasone propionate intervention 2: Placebo | 1 | Vienna | N/A | Austria | 16.37208 | 48.20849 | 0 | NCT00848965 |
[
3
] | 21 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 2MALE | false | Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product. | null | Hypogonadism | null | 4 | arm 1: Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments. arm 2: Applied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments. arm 3: Applied once daily for 7 days to both ... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Administered Topically | intervention 1: Testosterone MD-Lotion | 4 | Tuscon | Arizona | United States | N/A | N/A
Burbank | California | United States | -118.30897 | 34.18084
New Britain | Connecticut | United States | -72.77954 | 41.66121
San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00857961 | |
[
2
] | 18 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | true | 0ALL | false | This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive control for the corrected QT interval (QTc) p... | This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition, it will determine whether or not there is a trend toward effect of this high dose regimen on the electrocardiogram (ECG), mainly the corrected QT interval (QTc), via comparison to a 400 mg d... | Pharmacokinetics | healthy | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses intervention 2: 400 mg capsule at the 6 hour point | intervention 1: Colchicine intervention 2: Moxifloxacin | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT01018420 |
[
3,
4
] | 70 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload. | null | Liver Iron Overload | iron overload iron chelation therapy B-thalassemia | null | 2 | arm 1: Deferasirox group consists of all participants who were initially randomized to 10 and 20 mg/kg/day deferasirox orally daily in the main study and remained on the same treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative study arm 2: Deferasirox Cro... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 10 mg/kg or 30 mg/kg orally daily intervention 2: 5 mg/kg or 30 mg/kg orally daily | intervention 1: Deferasirox intervention 2: Deferasirox | 4 | Cagliari | N/A | Italy | 9.11917 | 39.23054
Genova | N/A | Italy | 11.87211 | 45.21604
Milan | N/A | Italy | 9.18951 | 45.46427
Torino | N/A | Italy | 11.99138 | 44.88856 | 0 | NCT01033747 |
[
2,
3
] | 7 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment. | Seven male patients with chronic, refractory epilepsy were included in the present study; in all cases antiepileptic treatment with multiple antiepileptic drugs had been unsuccessful in reducing the frequency or the intensity of seizures. Patients selected for this study were all males due to the high risk of thalidomi... | Refractory Epilepsy | Thalidomide Antiepileptic drugs Refractory epilepsy Sedative drugs | null | 1 | arm 1: Open-labeled preliminary trial | [
0
] | 1 | [
0
] | intervention 1: Thalidomide at 200 mg dosage bid was administered during a twelve month period. | intervention 1: 3-phthalimidoglutarimide (Thalidomide) | 0 | null | 0 | NCT01061866 |
[
2
] | 84 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state. | Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain. | Healthy | Healthy subjects Opioid Healthy volunteers | null | 2 | arm 1: Reformulated OXY 80 mg x 1 dose arm 2: Original OxyContin® (OXY) 80 mg x 1 dose | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Reformulated OXY 80-mg tablet x 1 dose taken without food. intervention 2: Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food. | intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl) | 1 | Honolulu | Hawaii | United States | -157.85833 | 21.30694 | 0 | NCT01101191 |
[
4
] | 354 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability. | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. | Back Pain Lower Back Chronic | Low back pain Opioid Transdermal | null | 1 | arm 1: Buprenorphine transdermal patch | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear. intervention 3: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. | intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch | 84 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Haleyville | Alabama | United States | -87.62141 | 34.22649
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | Unite... | 0 | NCT01125917 |
[
2
] | 172 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 1FEMALE | false | The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive contai... | null | Contraception | null | 2 | arm 1: Combination EE/DRSP/ Metafolin \[0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin\] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment f... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Combination EE/DRSP/ Metafolin \[0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin\] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin tr... | intervention 1: EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo intervention 2: EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid | 1 | Neu-Ulm | Bavaria | Germany | 10.01112 | 48.39279 | 0 | NCT01258660 | |
[
3
] | 217 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS). | This was a multicenter, randomized, double blind, placebo controlled, parallel group study, comparing 4 doses of GEn (XP13512) with placebo given once daily to subjects with RLS. Eligible subjects were randomized in equal numbers into 1 of 5 treatment groups (GEn 600 mg, 1200 mg, 1800 mg, or 2400 mg or placebo) for 12 ... | Restless Legs Syndrome | null | 5 | arm 1: GEn (XP13512/GSK1838262) 600 mg arm 2: GEn (XP13512/GSK1838262) 1200 mg arm 3: GEn (XP13512/GSK1838262) 1800 mg arm 4: GEn (XP13512/GSK1838262) 2400 mg arm 5: Placebo | [
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Double-Blind Treatment Phase: 600 mg GEn (XP13512) orally, once daily for 3 days followed by 600 or 1200 mg on days 4-6, followed by 600 or 1200 or 1800 mg on days 7-9, followed by 600 or 1200 or 1800 or 2400 mg on days 10-84. Double-Blind Taper Phase: 600 or 1200 or 1800 mg GEn (XP13512) orally, once d... | intervention 1: GEn (XP13512/GSK1838262) intervention 2: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT01332305 | |
[
3
] | 26 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (... | null | Central Neuropathic Pain Allodynia Spinal Cord Injury | chronic pain central neuropathic pain spinal cord injury dextromethorphan lidocaine combination therapy analgesia | null | 4 | arm 1: 0% MTD Dextromethorphan arm 2: 25% MTD Dextromethorphan arm 3: 50% MTD Dextromethorphan arm 4: 100% MTD Dextromethorphan | [
2,
0,
0,
0
] | 1 | [
0
] | intervention 1: 0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period | intervention 1: Dextromethorphan | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT01435798 |
[
2
] | 9 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | true | 0ALL | false | This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body. | null | Alzheimer Disease | Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging | null | 1 | arm 1: Healthy male or female subjects, between 18 and 85 years of age. | [
0
] | 1 | [
0
] | intervention 1: IV injection, 370MBq (10mCi), single dose | intervention 1: florbetapir F 18 | 1 | Jenkintown | Pennsylvania | United States | -75.12517 | 40.09594 | 0 | NCT01564706 |
[
1
] | 32 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | true | 0ALL | false | A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner. | null | Alzheimer Disease | Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging | null | 2 | arm 1: Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24) arm 2: Cognitively normal with MMSE of 29 or higher; age 50 years ... | [
0,
0
] | 1 | [
0
] | intervention 1: IV injection, 370MBq (10mCi), single dose | intervention 1: florbetapir F 18 | 3 | Baltimore | Maryland | United States | -76.61219 | 39.29038
North East | Maryland | United States | -75.94133 | 39.60011
Long Branch | New Jersey | United States | -73.99236 | 40.30428 | 0 | NCT01565291 |
[
3
] | 225 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer. | null | Breast Cancer | null | 2 | arm 1: Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. arm 2: Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Participants will receive oral Xeloda, 950 mg/m\^2 twice a day on Days 1 to 14 of each 21-day cycle. intervention 2: Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m\^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m\^2 in the Herceptin + Taxotere arm, via IV infusion on D... | intervention 1: Xeloda intervention 2: Taxotere intervention 3: Herceptin | 51 | Adelaide | N/A | Australia | 138.59863 | -34.92866
Brisbane | N/A | Australia | 153.02809 | -27.46794
Camperdown | N/A | Australia | 151.17642 | -33.88965
Geelong | N/A | Australia | 144.36069 | -38.14711
Melbourne | N/A | Australia | 144.96332 | -37.814
Melbourne | N/A | Australia | 144.96332 | -37.814
Perth | N/A | A... | 0 | NCT02748213 | |
[
5
] | 135 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The antidepressant medications are among the most commonly prescribed pharmacological agents in patients with mood and anxiety disorder. Despite recent advances in antidepressant pharmacotherapy, there is a pressing need for substantial optimization and improvment of outcome of pharmacotherapy of psychiatric disorders ... | To participate in the study the subjects must be at least 18 years old and give a written informed consent after an oral and written explanation of the study aims and methods. The study sample will include the female and male patients with panic disorder or major depression diagnosis according to DSM-IV criteria. Patie... | Major Depression | Treatment efficacy Safety | null | 1 | arm 1: No comparator | [
0
] | 2 | [
0,
0
] | intervention 1: escitalopram 10-20mg per day 12 weeks intervention 2: bupropion 150-300mg per day 6 weeks | intervention 1: escitalopram intervention 2: bupropion | 1 | Tartu | N/A | Estonia | 26.72509 | 58.38062 | 0 | NCT03927950 |
[
5
] | 318 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect. | Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD | Attention Deficit Hyperactivity Disorder (ADHD) | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day. | intervention 1: Vyvanse (lisdexamfetamine dimesylate) | 46 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
El Centro | California | United States | -115.56305 | 32.792
Rolling Hills Estates | California | United States | -118.35813 | 33.78779
San Francisco | California | United States | -122.41942 | 37.77493
Spring Valley | California | United States | -116.99892 ... | 0 | NCT00500071 | |
[
4
] | 217 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms. | null | ADHD | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day). intervention 2: Placebo | intervention 1: SPD503 (Guanfacine hydrochloride) intervention 2: Placebo | 34 | Phoenix | Arizona | United States | -112.07404 | 33.44838
El Centro | California | United States | -115.56305 | 32.792
Rolling Hills Estates | California | United States | -118.35813 | 33.78779
Gainesville | Florida | United States | -82.32483 | 29.65163
Gainesville | Florida | United States | -82.32483 | 29.65163
Hial... | 0 | NCT00367835 | |
[
3
] | 234 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI). | The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.
In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic ... | Infectious Skin Disease Bacterial Skin Disease | CSSSI | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg intervention 2: Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets | intervention 1: PTK 0796 intervention 2: Linezolid | 11 | Anaheim | California | United States | -117.9145 | 33.83529
Buena Park | California | United States | -117.99812 | 33.86751
Chula Vista | California | United States | -117.0842 | 32.64005
Hawaiian Gardens | California | United States | -118.07284 | 33.8314
Oceanside | California | United States | -117.37948 | 33.19587
... | 0 | NCT03716024 |
[
5
] | 58 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m\^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy. | null | Ovarian Neoplasms | null | 1 | arm 1: Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles | [
0
] | 1 | [
0
] | intervention 1: Caelyx Intravenous, 50 mg/m\^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles | intervention 1: Pegylated Liposomal Doxorubicin hydrochloride | 0 | null | 0 | NCT00727961 | |
[
3
] | 20 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Background:
The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic chemotherapy. Although partial remissions of up to 60% are obtained with conventional regimens, multiple myeloma is essentially an incurable disease with a median survival of approximately 30 months.
Allogeneic stem cel... | Background:
The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic chemotherapy. Although partial remissions of up to 60% are obtained with conventional regimens, multiple myeloma is essentially an incurable disease with a median survival of approximately 30 months.
Allogeneic stem cel... | Multiple Myeloma | Immunoablative Mobilization Apheresis Multiple Myeloma IgG Multiple Myeloma IgA Multiple Myeloma | null | 2 | arm 1: Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor (GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell inf... | [
0,
5
] | 12 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
2,
2
] | intervention 1: 3 subcutaneous (SC) injections of myeloma protein within 10 weeks before stem cell collection the first (week 0), second (week 2), and third injection (week 6) with Id-KLH (0.5 mg SC day 1) intervention 2: Induction chemotherapy: 1.3 mg/m\^2 bolus intravenous injection twice weekly for 2 weeks (days 1, ... | intervention 1: Myeloma Immunoglobulin Idiotype Vaccine intervention 2: Bortezomib intervention 3: Cyclophosphamide intervention 4: Cyclosporine intervention 5: Doxorubicin hydrochloride intervention 6: Etoposide intervention 7: Fludarabine phosphate intervention 8: Prednisone intervention 9: Vincristine Sulfate interv... | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00006184 |
[
4
] | 1,509 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-infer... | This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for Assisted Reproductive ... | In Vitro Fertilization | Infertility Pharmacological effect of drugs Hormones Hormone substitutes and hormone antagonists Pharmacological actions Randomized Multi-center Multi-national Double-blind Active-controlled Non-inferiority | null | 2 | arm 1: Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (org 36286) on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Daily SC... | [
0,
1
] | 8 | [
0,
2,
0,
0,
2,
0,
2,
2
] | intervention 1: On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall. intervention 2: Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and inclu... | intervention 1: Corifollitropin alfa intervention 2: RecFSH / Follitropin beta (Days 1 to 7) intervention 3: Placebo Corifollitropin alfa intervention 4: Placebo RecFSH / follitropin beta intervention 5: RecFSH / Follitropin beta (Days 8 to hCG) intervention 6: Ganirelix intervention 7: hCG intervention 8: Progesterone | 0 | null | 0 | NCT00696800 |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). T... | null | Carcinoma, Non-Small-Cell Lung | temozolomide radiotherapy | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
3
] | intervention 1: Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2). intervention 2: 2 regim... | intervention 1: Temozolomide and radiotherapy intervention 2: Whole brain radiotherapy | 0 | null | 0 | NCT00266812 |
[
2
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes. | null | Narcolepsy With Cataplexy | Endocrine Evaluation cataplexy sodium oxybate (xyrem) | null | 1 | arm 1: * Active Substance: Sodium Oxybate
* Pharmaceutical form: Oral Solution
* Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
* Route of administration: Oral | [
0
] | 1 | [
0
] | intervention 1: * Active Substance: Sodium Oxybate
* Pharmaceutical form: Oral Solution
* Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
* Route of administration: Oral | intervention 1: Sodium Oxybate (Xyrem) | 1 | Liège | N/A | Belgium | 5.56749 | 50.63373 | 0 | NCT00345800 |
[
3
] | 24 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Age related differences in response to a drug could arise from variation in pharmacokinetic (PK) and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies... | null | Essential Thrombocythaemia | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Anagrelide hydrochloride 0.5 mg per capsule; participants will be stable on an anagrelide treatment regimen and will take capsules from their own prescription except on the PK day when the participant specific anagrelide dose will be administered from a controlled study specific supply. intervention 2: ... | intervention 1: anagrelide hydrochloride intervention 2: anagrelide hydrochloride | 5 | Barcelona | N/A | Spain | 2.15899 | 41.38879
Luleå | N/A | Sweden | 22.15465 | 65.58415
Uppsala | N/A | Sweden | 17.63889 | 59.85882
Uppsala | N/A | Sweden | 17.63889 | 59.85882
Belfast | N/A | United Kingdom | -5.92541 | 54.59682 | 0 | NCT00413634 | |
[
3
] | 252 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | null | The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing grade 3/4 neutropenia when given after one of three chemotherapy regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer. This study is considered to be "investigation... | null | Colon Cancer Colorectal Cancer Rectal Cancer | Neulasta® pegfilgrastim Advanced Chemotherapy | null | 2 | arm 1: 6 mg pegfilgrastim arm 2: 6 mg placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, w... | intervention 1: Placebo intervention 2: Pegfilgrastim | 0 | null | 0 | NCT00094809 |
[
3
] | 135 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure | null | Hypertension | Clinical Trial Randomized Controlled Trial Humans Cyclic Nucleotide Phosphodiesterases Type 5 | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: placebo, oral, tablets, once daily, for 28 days intervention 2: PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days intervention 3: PF-00489791 4 mg, oral, tablets, once daily, for 28 days intervention 4: PF-00489791 10 mg, oral, tablets, once daily, for 28 days | intervention 1: placebo intervention 2: PF-00489791 intervention 3: PF-00489791 intervention 4: PF-00489791 | 20 | Los Angeles | California | United States | -118.24368 | 34.05223
Santa Ana | California | United States | -117.86783 | 33.74557
Tustin | California | United States | -117.82617 | 33.74585
Farmington | Connecticut | United States | -72.83204 | 41.71982
Waterbury | Connecticut | United States | -73.0515 | 41.55815
Jackso... | 0 | NCT00422461 |
[
3
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease. | This was a Phase 2, open-label study in male participants with Fabry disease. All participants who met initial eligibility criteria underwent a 28-day screening period, including a 14-day run-in with migalastat (150 milligrams \[mg\] migalastat once a day \[QD\] from Days -28 to -15) to assess eligibility for entering ... | Fabry Disease | Amicus Therapeutics AT1001 Galafold Migalastat Substrate | null | 1 | arm 1: Migalastat was administered orally during the 12-week treatment period and then during the optional 2 treatment extension periods.
Treatment Period:
* Migalastat 25 mg BID for Weeks 1 and 2 (Day 1 through the morning dose on Day 14).
* Migalastat 100 mg BID for Weeks 3 and 4 (Day 15 through the morning dose on... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: migalastat HCl | 5 | Los Angeles | California | United States | -118.24368 | 34.05223
Decatur | Georgia | United States | -84.29631 | 33.77483
Bethesda | Maryland | United States | -77.10026 | 38.98067
New York | New York | United States | -74.00597 | 40.71427
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00214500 |
[
5
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units.
In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each su... | This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.
In Stage 1, the compar... | Healthy | Hylenex subcutaneous infusion hyaluronidase rHuPH20 recombinant human hyaluronidase | null | 2 | arm 1: Normal Saline (NS) and Hylenex arm 2: Lactated Ringer's (LR) and Hylenex | [
0,
0
] | 1 | [
0
] | intervention 1: 150 Units in 1mL | intervention 1: recombinant human hyaluronidase | 1 | Kalamazoo | Michigan | United States | -85.58723 | 42.29171 | 0 | NCT00656370 |
[
2,
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this study is to eval... | Type 1 Gaucher disease, the most common form, accounts for more than 90% of all cases and does not involve the central nervous system (CNS). Typical manifestations of type 1 Gaucher disease include hepatomegaly, splenomegaly, thrombocytopenia, bleeding tendencies, anemia, hypermetabolism, skeletal pathology, growth ret... | Gaucher Disease | Gaucher disease, Enzyme Replacement Therapy | null | 1 | arm 1: 15-60 U/kg every other week via intravenous infusion | [
0
] | 1 | [
0
] | intervention 1: 15-60 U/kg every other week via intravenous infusion | intervention 1: GA-GCB | 3 | Jerusalem | N/A | Israel | 35.21633 | 31.76904
Bucharest | N/A | Romania | 26.10626 | 44.43225
Belgrade | N/A | Serbia | 20.46513 | 44.80401 | 0 | NCT00391625 |
[
0
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems. | Evidence-based psychosocial treatments have recently been developed. However, very little data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common co-occurring disorder in adolescent SUD is atten... | Attention Deficit Hyperactivity Disorder Substance Abuse | Adolescent ADHD SUD | null | 2 | arm 1: placebo plus individual cognitive behavioral therapy arm 2: atomoxetine plus individual cognitive behavioral therapy | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder intervention 2: Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder | intervention 1: Atomoxetine intervention 2: Placebo | 1 | Denver | Colorado | United States | -104.9847 | 39.73915 | 1 | NCT00399763 |
[
4
] | 91 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of... | The TOF-Watch® SX has been used for neuromuscular monitoring in all
clinical trials with sugammadex. In clinical practice however, a PNS is commonly
used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. I... | Neuromuscular Blockade | null | 4 | arm 1: sugammadex 1.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm) arm 2: sugammadex 1.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm) arm 3: sugammadex 4.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm) arm 4: sugammadex 4.0 mg/kg, TOF-Watch® S... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on act... | intervention 1: sugammadex | 0 | null | 1 | NCT00535496 | |
[
3
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD). | null | Constipation | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
0,
0,
0,
0
] | 2 | [
0,
10
] | intervention 1: Oral intervention 2: placebo | intervention 1: N-methylnaltrexone bromide (MOA-728) intervention 2: placebo | 41 | Mobile | Alabama | United States | -88.04305 | 30.69436
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Hot Springs | Arkansas ... | 1 | NCT00547586 | |
[
4
] | 9,809 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia. | The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use... | Schizophrenia | null | 2 | arm 1: Normally in the range of 4 to 20 mg/day arm 2: Normally in the range of 2 to 8 mg/day | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (... | intervention 1: Sertindole intervention 2: Risperidone | 0 | null | 1 | NCT00856583 | |
[
3
] | 68 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have... | OBJECTIVES:
* Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
* Determine the feas... | Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer | stage III ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer | null | 1 | arm 1: paclitaxel, cisplatin and liposomal doxorubicin | [
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: cisplatin intervention 2: liposomal doxorubicin intervention 3: paclitaxel | 104 | Tucson | Arizona | United States | -110.92648 | 32.22174
Davis | California | United States | -121.74052 | 38.54491
Duarte | California | United States | -117.97729 | 34.13945
Hayward | California | United States | -122.0808 | 37.66882
Livermore | California | United States | -121.76801 | 37.68187
Oakland | California ... | 0 | NCT00003896 |
[
3
] | 137 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma. | In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers | Carcinoma, Hepatocellular | Cancer Liver Cancer Hepatocellular carcinoma (HCC) | null | 1 | arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) | [
0
] | 1 | [
0
] | intervention 1: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) | intervention 1: Sorafenib (Nexavar, BAY43-9006) | 23 | Los Angeles | California | United States | -118.24368 | 34.05223
New York | New York | United States | -74.00597 | 40.71427
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Bruxelles - Brussel | N/A | Belgium | N/A | N/A
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A... | 0 | NCT00044512 |
[
2,
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase I/II trial is studying the side effects and best dose of oblimersen when given together with doxorubicin and docetaxel and to see how well they work in treating women with metastatic or locally advanced breast cancer. Drugs used in chemotherapy, such as doxorubicin and docetaxel, work in different ways to st... | PRIMARY OBJECTIVES:
I. To evaluate the pharmacokinetics of G3139, doxorubicin and docetaxel in breast cancer patients receiving G3139/AT therapy. (Phase I) II. To determine the safety of bcl-2 antisense oligonucleotide G3139 (GenasenseTM) together with docetaxel plus doxorubicin (AT) in patients with metastatic and lo... | Male Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer | null | 1 | arm 1: PHASE I (COMPLETED AS OF 8/16/04): Patients receive oblimersen IV continuously on days 1-6 interrupted only to administer doxorubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 6. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 7-13 or pegfilgrastim SC on day 7. Treatment rep... | [
0
] | 8 | [
2,
0,
0,
2,
2,
3,
10,
10
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given SC intervention 5: Given SC intervention 6: Undergo surgical resection intervention 7: Optional correlative studies intervention 8: Optional correlative studies | intervention 1: oblimersen sodium intervention 2: doxorubicin hydrochloride intervention 3: docetaxel intervention 4: filgrastim intervention 5: pegfilgrastim intervention 6: therapeutic conventional surgery intervention 7: pharmacological study intervention 8: laboratory biomarker analysis | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00063934 | |
[
2,
3
] | 61 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | RATIONALE: Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining everolimus with gefitinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and b... | OBJECTIVES:
Primary
* Determine the maximum tolerated dose of everolimus when given in combination with gefitinib in patients with progressive glioblastoma multiforme or (progressive castrate metastatic prostate cancer -closed to accrual as of 10/19/2006). (Phase I)
* Determine the safety and efficacy of this regimen... | Brain and Central Nervous System Tumors Prostate Cancer | adult glioblastoma recurrent prostate cancer recurrent adult brain tumor stage IV prostate cancer adult giant cell glioblastoma adult gliosarcoma | null | 1 | arm 1: •Phase I: Patients receive oral everolimus on day 1 and oral gefitinib once daily on days 8-21. Beginning on day 22, patients receive oral everolimus once weekly and oral gefitinib once daily. Treatment with the combination continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6... | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: everolimus intervention 2: gefitinib | 2 | New York | New York | United States | -74.00597 | 40.71427
Barcelona | N/A | Spain | 2.15899 | 41.38879 | 0 | NCT00085566 |
[
3
] | 95 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared. | Clofarabine is a chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Ara-C is a chemotherapy drug which is approved for the treatment of AML and MDS. Although there is experience with the combination of both drugs, there have not been trials that explored the particular dose... | Acute Myeloid Leukemia Myelodysplastic Syndrome | Acute Myeloid Leukemia AML High-Risk Myelodysplastic Syndrome MDS Clofarabine Cytarabine ara-C | null | 2 | arm 1: Clofarabine intravenous (IV) 30 mg/m\^2 daily times 5 days arm 2: Clofarabine IV 30 mg/m\^2 daily times 5 days + Ara-C 20 mg/m\^2 subcutaneously daily times 14 days. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1-hour IV infusion 30 mg/m\^2 daily times 5 days (Days 1-5) intervention 2: 20 mg/m\^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour). | intervention 1: Clofarabine intervention 2: Ara-C | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00088218 |
[
0
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: This clinical trial is studying how ... | OBJECTIVES:
Primary
* Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).
Secondary
* Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
* Determine the effect of this drug on th... | Sarcoma | classic Kaposi sarcoma recurrent Kaposi sarcoma | null | 1 | arm 1: Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: valganciclovir | 3 | New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00096538 |
[
3
] | 67 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well gi... | OBJECTIVES:
* Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
* Determine the confirmed and unconfirmed response (partial and complete) probability in patients with me... | Head and Neck Cancer | Recurrent stage IV squamous cell carcinoma hypopharynx larynx lip oral cavity nasopharynx oropharynx paranasal nasal cavity metastatic neck cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days). intervention 2: 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine | intervention 1: gemcitabine intervention 2: paclitaxel | 123 | Anniston | Alabama | United States | -85.83163 | 33.65983
Mobile | Alabama | United States | -88.04305 | 30.69436
Aurora | Colorado | United States | -104.83192 | 39.72943
Denver | Colorado | United States | -104.9847 | 39.73915
Montrose | Colorado | United States | -107.87617 | 38.47832
Wheat Ridge | Colorado | United... | 0 | NCT00100789 |
[
3
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants. | Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS (University of Arkansas for Medical Sciences) only.
Participants will receive two courses of chemotherapy with a regimen called DT PACE + Rituxan. This regimen consists of 6 drugs: Dexam... | Waldenstrom Macroglobulinemia | Waldenstrom | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with \< 50% response to induction) OR MEL-DT PACE (Patients with \> 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive... | intervention 1: DT PACE + Rituxan | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00107614 |
[
3
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | This phase II trial is studying how well 17-AAG works in treating patients with metastatic prostate cancer that did not respond to previous hormone therapy. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing... | PRIMARY OBJECTIVES:
I. Determine the prostate-specific antigen (PSA) response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).
SECONDARY OBJECTIVES:
I. Determine the overall survival and disease-free survival rate in patients treated with ... | Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer | null | 1 | arm 1: Patients receive 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of C... | [
0
] | 2 | [
0,
10
] | intervention 1: Given IV intervention 2: Correlative studies | intervention 1: tanespimycin intervention 2: laboratory biomarker analysis | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00118092 | |
[
5
] | 130 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are to:
* Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac open-chest surgery;
* Determine the influence... | Thousands of patients undergo major non-cardiac open-chest surgery in the United States each year. These surgeries most often consist of lung surgery, in which one lobe of the lung is removed (lobectomy) or the entire lung is removed (pneumonectomy).
A major complication of these non-cardiac open-chest surgeries is th... | Atrial Fibrillation | amiodarone atrial fibrillation surgical procedures, thoracic | null | 2 | arm 1: Amiodarone 1050 mg via continuous intravenous infusion for 24 hours followed by 400 mg orally twice daily for 6 days arm 2: Patients in this group receive no intervention | [
0,
4
] | 1 | [
0
] | intervention 1: None | intervention 1: Amiodarone | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00127712 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | true | Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma for patients who have received at least one prior therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals, Inc. Velcade enters cells and affects the... | Studies at the Myeloma Institute for Research \& Therapy have shown that Velcade is very effective in treating patients who are relapsing after having been treated with at least two lines of prior therapy.
One key factor in multiple myeloma is bone destruction caused by the myeloma cells. Most patients with multiple m... | Multiple Myeloma | Multiple Myeloma | null | 3 | arm 1: Treatment: 1.3 mg/m\^2 arm 2: Treatment: 1.0 mg/m\^2 arm 3: Treatment: 0.7 mg/m\^2 | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Patients will receive two cycles of VELCADE™ (1.3 mg/m2, 1.0 mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21 day cycle. No growth factors or bisphosphonates will be allowed during study treatment. Bone markers will be measured:
Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2-4 hours for 8 hours... | intervention 1: VELCADE™ | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00128921 |
[
4
] | 1,056 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expressed as microalbuminuria. | Diabetic nephropathy is an important cause of morbidity and mortality in patients with either type 1 or type 2 diabetes mellitus. The pathogenesis and natural history of diabetic nephropathy is characterized initially by microalbuminuria followed by a progressive decline in glomerular function. An emerging body of evid... | Diabetic Nephropathy | Diabetes Diabetes Mellitus, Type 2 Albuminuria Diabetic Nephropathy | null | 2 | arm 1: Also known as KRX-101. All patients will be on standard of care ACE or ARBs. arm 2: All patients will be on standard of care ACE or ARBs. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 100 mg sulodexide gelcaps intervention 2: 0 mg gelcap | intervention 1: Sulodexide intervention 2: Placebo | 3 | Chicago | Illinois | United States | -87.65005 | 41.85003
Melbourne | Victoria | Australia | 144.96332 | -37.814
Groningen | N/A | Netherlands | 6.56667 | 53.21917 | 0 | NCT00130208 |
[
4
] | 581 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia. | null | Osteopenia | Postmenopausal osteoporosis osteopenia zoledronic acid Osteopenia (osteoporosis prevention) | null | 3 | arm 1: Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 arm 2: Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12 arm 3: Placebo given at randomization and Month 12 | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Zoledronic acid 5 mg intravenous intervention 2: Physiologic 0.9% normal saline | intervention 1: Zoledronic Acid intervention 2: Placebo | 1 | East Hanover | New Jersey | United States | -74.36487 | 40.8201 | 0 | NCT00132808 |
[
2,
3
] | 16 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine ... | null | Stage IV (Metastatic) Breast Cancer | Breast cancer | null | 3 | arm 1: Weekly intravenous infusion of 80 mg/m\^2 ABI-007, followed by an infusion of 15 mg/m\^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vino... | [
0,
0,
0
] | 4 | [
0,
0,
0,
2
] | intervention 1: Weekly intravenous infusions over 30 minutes. intervention 2: Weekly intravenous infusions over 10-30 minutes, immediately after ABI-007. Vinorelbine is commercially available and was not supplied by the Sponsor. intervention 3: Trastuzumab was administered to participants who had HER-2-neu positive tum... | intervention 1: ABI-007 intervention 2: vinorelbine intervention 3: Trastuzumab intervention 4: G-CSF | 2 | Duarte | California | United States | -117.97729 | 34.13945
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00140140 |
[
3
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma. | * Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are re... | Waldenstrom's Macroglobulinemia Lymphoplasmacytic Lymphoma | thalidomide rituximab Waldenstrom's | null | 1 | arm 1: Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks
Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later. | [
0
] | 2 | [
0,
0
] | intervention 1: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks. intervention 2: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later. | intervention 1: Thalidomide intervention 2: Rituximab | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00142116 |
[
4
] | 10,917 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function. | null | Coronary Disease Ventricular Dysfunction, Left | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Ivabradine intervention 2: Placebo | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00143507 | |
[
2
] | 24 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years | null | Hypertension | Olmesartan PK in children | null | 1 | arm 1: Children less than 6 years old received 0.3 mg/kg. Children 6 years old or older received 40 mg, if they weighed 35 kg or more; 20 mg if they weighed less than 35 kg. | [
0
] | 1 | [
0
] | intervention 1: Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight. | intervention 1: Olmesartan medoxomil | 5 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
La Jolla | California | United States | -117.2742 | 32.84727
Louisville | Kentucky | United States | -85.75941 | 38.25424
Kansas City | Missouri | United States | -94.57857 | 39.09973
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00151814 |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped. | To date, the aggressive treatment (Tx) of chronic insomnia has been evaluated in terms of whether maintenance therapy is possible. While what constitutes maintenance therapy is a matter of debate, there are two studies which show that benzodiazepine receptor agonists (BZRAs) 1) are effective when used intermittently fo... | Insomnia Primary Insomnia Psychophysiologic Insomnia | Insomnia Sleep zolpidem Ambien Hypnotics | null | 4 | arm 1: QHS dosing with placebo (i.e. nightly dose) arm 2: QHS dosing with 10mg of zolpidem (i.e. nightly dose) arm 3: Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed arm 4: Monitor only condition (no placebo, no drug). | [
2,
1,
0,
4
] | 2 | [
0,
0
] | intervention 1: 10 mg of Zolpidem intervention 2: None | intervention 1: Zolpidem intervention 2: Sugar Pill | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00156533 |
[
0
] | 45 | RANDOMIZED | PARALLEL | 9OTHER | 3TRIPLE | true | 0ALL | false | The purpose of this study is to examine prospectively the safety and efficacy of alefacept in the treatment of subjects with severe alopecia areata of the scalp. Common features between psoriasis and alopecia areata, including immunologic and therapeutic aspects, suggest that alefacept, which has been shown to be a saf... | Alopecia areata (AA) is an autoimmune condition characterised by a T-cell mediated attack on the hair follicle. The inciting antigenic stimulus is unknown. A dense peribulbar lymphocytic infiltrate and reproducible immunologic abnormalities are hallmark features of the condition. The cellular infiltrate primarily consi... | Alopecia Areata | Alopecia Areata | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 1 | [
0
] | intervention 1: Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12. | intervention 1: Alefacept | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00167102 |
[
3
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism. | Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning. The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and r... | Autistic Disorder | Autism | null | 2 | arm 1: Placebo, liquid solution flexible dose 0.5 to 5ml every morning (AM) arm 2: Fluoxetine, 20mg/5ml solution, flexible dose 0.5 to 5ml every AM | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule. intervention 2: Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, f... | intervention 1: Fluoxetine intervention 2: Placebo | 2 | New York | New York | United States | -74.00597 | 40.71427
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00183339 |
[
0
] | 11 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy. | The primary objective of this study is to determine whether the novel NMDA antagonist memantine, FDA approved for use in moderate to severe alzheimers dementia, may reduce the neurocognitive deficits associated with right unilateral ECT treatments in patients receiving ECT for a severe and relatively refractory Major D... | Depressive Disorder, Major | null | 2 | arm 1: Patients received a placebo capsule starting the day before ECT begins and while receiving ECT arm 2: Patients receive memantine starting the day before ECT begins and while receiving ECT | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT intervention 2: Patients received a placebo capsule starting the day before ECT begins and while receiving ECT | intervention 1: memantine intervention 2: Placebo Oral Capsule | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00186498 | |
[
4
] | 151 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be admini... | null | Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: atomoxetine: 0.5 mg/kg/day every day (QD),by mouth (PO) for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year arm 2: placebo every day (QD), by mouth (PO) for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Atomoxetine Hydrochloride intervention 2: placebo | 11 | Badajoz | N/A | Spain | -6.97061 | 38.87789
Barcelona | N/A | Spain | 2.15899 | 41.38879
Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283
Espluges de Llobregat | N/A | Spain | N/A | N/A
Madrid | N/A | Spain | -3.70256 | 40.4165
Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939
Sabadell | N/A | Spain | 2.... | 0 | NCT00191945 | |
[
4
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | true | Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an epi... | null | Bipolar Disorder | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a mi... | intervention 1: Divalproex Sodium ER intervention 2: Placebo | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00194116 | |
[
4
] | 87 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg ... | BACKGROUND:
The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the beta-2 adrenergic receptor.
DESIGN NARRATIVE:
Participants were homozygous for arginine or glycine at the 16th amino-ac... | Asthma | null | 2 | arm 1: B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone hydroflouroalkane (HFA), followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA arm 2: B16 Gly... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina) intervention 2: 240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries) | intervention 1: salmeterol intervention 2: beclomethasone HFA | 7 | San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Boston | Massachusetts | United States | -71.05977 | 42.35843
St Louis | Missouri | United States | -90.19789 | 38.62727
Winston-Sale... | 0 | NCT00200967 | |
[
0
] | 59 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purposes of this study are:
* to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares, sleep disturbance and overall function in recently combat-exposed returnees from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).
* to evaluate t... | Trauma-related nightmares and sleep disruption that follow combat exposure are distressing and frequently treatment resistant symptoms that impair quality of life and overall function. These symptoms closely resemble core nighttime symptoms of posttraumatic stress disorder (PTSD), and are increasingly recognized in ret... | Stress Disorders, Post-Traumatic Sleep Disorders | Prazosin Paroxetine Stress Disorders, Post-Traumatic Sleep Disorders | null | 3 | arm 1: Prazosin arm 2: Paroxetine arm 3: Placebo | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: taken by mouth, twice daily, titrated up to efficacy or a maximum of 5 mg at 10a and 25 mg at bedtime for duration of study intervention 2: 20 mg taken at 10a for duration of the study intervention 3: Placebo | intervention 1: prazosin intervention 2: paroxetine intervention 3: Placebo | 2 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Fort Lewis | Washington | United States | -122.58344 | 47.06171 | 0 | NCT00202449 |
[
3,
4
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocyti... | Microscopic colitis is an increasingly diagnosed cause of chronic diarrhea, with two main subtypes: collagenous and lymphocytic colitis. Uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis, but few treatments have been evaluated in randomized controlled trials. Thus,... | Lymphocytic Colitis Diarrhea | Lymphocytic Colitis diarrhea budesonide | Prot_SAP_ICF_000.pdf:
A Randomized, Double-Blind, Placebo-
Controlled Trial of Budesonide For The
Treatment Of Active Lymphocytic Colitis
NCT00217022
May 17, 2017
A R a n d o mize d, D o u ble -Bli n d, Pl ace b o -C o ntr olle d Tri al of
B u des o ni de F or T he Tre at me nt Of Acti v... | 2 | arm 1: 9 mg daily arm 2: three tablets daily | [
1,
2
] | 2 | [
10,
0
] | intervention 1: Placebo, 3 tablets daily intervention 2: 9 mg daily (three tablets) | intervention 1: Placebo intervention 2: Budesonide | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00217022 |
[
3,
4
] | 146 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio. | null | Iron Deficiency Anemia | Anemia. | null | 3 | arm 1: 125 mg sodium ferric gluconate weekly x 8 weeks arm 2: 250 mg sodium ferric gluconate complex weekly x 4 weeks arm 3: 325 mg ferrous sulfate three times daily x 8 weeks | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 125 mg weekly x 8 weeks intervention 2: 250 mg weekly x 4 intervention 3: 325 mg ferrous sulfate orally three times daily x 8 weeks | intervention 1: Sodium Ferric Gluconate Complex intervention 2: Sodium Ferric Gluconate Complex intervention 3: Oral Iron | 43 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mesa | Arizona | United States | -111.82264 | 33.42227
Los Angeles | California | United States | -118.24368 | 34.05223
Torrance | California | United States | -118.34063 | 33.83585
New Haven | Connecticut | United States | -72.92816 | 41.30815
Evanston | Illi... | 0 | NCT00223977 |
[
5
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode. | Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipola... | Bipolar II Disorder Major Depressive Episode | Bipolar II Disorder Major Depressive Episode | null | 1 | arm 1: Ziprasidone monotherapy, 20-60 mg BID. | [
0
] | 1 | [
0
] | intervention 1: Ziprasidone 20-60 mg BID, taken orally. | intervention 1: Ziprasidone | 2 | New York | New York | United States | -74.00597 | 40.71427
Plano | Texas | United States | -96.69889 | 33.01984 | 0 | NCT00237666 |
[
5
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder. | Social anxiety disorder (also known as social phobia) is an Axis I anxiety disorder characterized by intense fear and avoidance of social or performance situations in which one might be scrutinized. Its onset is typically in the early teen years. It is the third most common mental disorder in the United States, exceede... | Social Anxiety Disorder Social Phobia Alcohol Use Disorder Alcohol Abuse Alcohol Dependence | Pharmacotherapy Self medication | null | 2 | arm 1: Active medication containing the drug Paroxetine arm 2: A Placebo medication that appears just like the active medication but does not contain placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day intervention 2: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day. | intervention 1: Paroxetine intervention 2: Placebo | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00246441 |
[
0
] | 20 | NON_RANDOMIZED | PARALLEL | 9OTHER | 0NONE | true | 2MALE | false | The purpose of this study is to evaluate the cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone system which is involved in the regulation of the blood pressure. Earlier studies have shown that high RAS activity is associated with a... | The purpose of this study is to evaluate the regional cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both ty... | Hypoglycemia Cognitive Impairment | Hypoglycemia Cognitive impairment PET CalCAP | null | 2 | arm 1: 10 healthy men were characterized by having high basal RAS activity. arm 2: 10 healthy men were characterized by having either a low basal RAS activity. | [
0,
0
] | 1 | [
0
] | intervention 1: Hyperinsulinaemic induced hypoglycaemia | intervention 1: Human insulin | 1 | Hillerød | Hillerød | Denmark | 12.30081 | 55.92791 | 0 | NCT00264641 |
[
3
] | 110 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults. | null | Falciparum Malaria | null | 1 | arm 1: Single Arm, Open label study | [
0
] | 1 | [
0
] | intervention 1: dose of 2000 mg Azithromycin plus 600 mg chloroquine base | intervention 1: Azithromycin plus chloroquine | 2 | Tumaco | Departamento de Nariño | Colombia | -78.79275 | 1.79112
Bambolim | Goa | India | 73.8531 | 15.46361 | 0 | NCT00282919 | |
[
3
] | 750 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly. | For cigarette smokers who intend to stop smoking, most treatment guidelines recommend abrupt cessation. There is evidence from some small studies that gradually reducing the number of cigarettes per day smoked may increase success in quitting. In this study, we will randomize smokers who want to quit smoking in the nex... | Smoking Cessation | Smoking Cessation Tobacco | null | 3 | arm 1: Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges. arm 2: Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. arm 3: Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. | [
0,
1,
1
] | 5 | [
5,
5,
5,
0,
0
] | intervention 1: Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the qui... | intervention 1: Reduction Phone Counseling intervention 2: Abrupt Phone Counseling intervention 3: Minimal Abrupt Phone Counseling intervention 4: Pre-Quit Nicotine Lozenges intervention 5: Post-Quit Nicotine Lozenges | 1 | Burlington | Vermont | United States | -73.21207 | 44.47588 | 0 | NCT00297492 |
[
4
] | 1,179 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d). | null | Genital Herpes | Herpes simplex genital herpes famciclovir valacyclovir Recurrent genital herpes | null | 2 | arm 1: Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Famciclovir 500 mg tablet intervention 2: Valacyclovir 500 mg capsule intervention 3: Famciclovir placebo, matching in size, color and forms of famciclovir tablet. intervention 4: Valacyclovir placebo, matching in size, color and forms of valacyclovir capsule. | intervention 1: Famciclovir intervention 2: Valacyclovir intervention 3: Placebo matching famciclovir intervention 4: Placebo matching valacyclovir | 66 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Jonesboro | Arkansas | Un... | 0 | NCT00306787 |
[
4
] | 933 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and to... | null | Chronic Obstructive Pulmonary Disease (COPD) | Roflumilast Salmeterol COPD Chronic obstructive pulmonary disease | null | 2 | arm 1: Roflumilast 500 µg
underlying medication: salmeterol 50 μg, twice daily, inhaled arm 2: Placebo
underlying medication: salmeterol 50 μg, twice daily, inhaled | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 500 µg, once daily, oral administration in the morning intervention 2: once daily | intervention 1: Roflumilast intervention 2: Placebo | 134 | Linz | N/A | Austria | 14.28611 | 48.30639
Neusiedl/See | N/A | Austria | N/A | N/A
Perg | N/A | Austria | 14.63333 | 48.25
Salzburg | N/A | Austria | 13.04399 | 47.79941
Sankt Pölten | N/A | Austria | 15.63333 | 48.2
Steyr | N/A | Austria | 14.42127 | 48.04274
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A ... | 0 | NCT00313209 |
[
2
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with so... | null | Cancer | Cancer Tumors Phase I E7389 | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2. | intervention 1: E7389 | 1 | Kashiwa | Chiba | Japan | 139.97732 | 35.86224 | 0 | NCT00326950 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this trial is to to determine the safety and effectiveness of therapeutic combination - Clofarabine and Cytarabine for the treatment of AML and MDS. | Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS patients showed promising results.
This study is done to confirm the findings from previous studies. Primary objective is to determine the overall response rate (complete response \[CR\] plus partial response \[PR\]); secondary o... | Acute Myelogenous Leukemia Myelodysplastic Syndromes Chronic Myelogenous Leukemia | AML MDS CML Relapsed Refractory Chemo treatment Clofarabine Cytarabine standard or poor cytogenetic risk AML untreated high-risk (>10% blasts) MDS CML in accelerated phase or blast crisis Elderly AML patients with risk of anthracycline toxicity | null | 1 | arm 1: Five consecutive days of clofarabine 40 mg/m\^2 IVI over 1 hour followed 4 hours later by cytarabine 1000 mg/m\^2 IVI over 2 hours | [
0
] | 1 | [
0
] | intervention 1: Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity | intervention 1: Clofarabine and Cytarabine | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00334074 |
[
3
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial.
In addition, this study will provide preliminary data on the safety of i... | Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) estimate that after 15 years of known diabetes, the p... | Diabetic Retinopathy | diabetic macular edema avastin bevacizumab anti-VEGF retinal thickness visual acuity DME | null | 5 | arm 1: Laser photocoagulation at baseline arm 2: 1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks arm 3: 2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks arm 4: 1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks) arm 5: 1.25 mg intravitreal inje... | [
1,
0,
0,
0,
0
] | 5 | [
3,
0,
0,
0,
0
] | intervention 1: Laser photocoagulation at baseline; If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart intervention 2: 1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks intervention 3: 2.5 mg intravitreal injection of bevacizumab a... | intervention 1: Laser Photocoagulation intervention 2: Bevacizumab intervention 3: Bevacizumab intervention 4: Bevacizumab intervention 5: Bevacizumab | 34 | Loma Linda | California | United States | -117.26115 | 34.04835
Palm Springs | California | United States | -116.54529 | 33.8303
Santa Barbara | California | United States | -119.69819 | 34.42083
Walnut Creek | California | United States | -122.06496 | 37.90631
Fort Lauderdale | Florida | United States | -80.14338 | 26... | 0 | NCT00336323 |
[
3
] | 263 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and 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) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing ... | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
10
] | intervention 1: tablet intervention 2: tablet intervention 3: Solution for injection intervention 4: matching placebo tablet | intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa 2a intervention 4: Placebo | 37 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Englewood ... | 0 | NCT00336479 | |
[
0
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study objective is to assess the long term safety and effectiveness of Enteryx device in commercial use. The long-term effects beyond one year of treatment with Enteryx have not been established. | The Enteryx procedure kit is indicated for endoscopic injection into the region of the lower esophageal sphincter (LES) for the treatment of symptoms due to gastroesophageal reflux disease (GERD) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors (PPI's).
The stu... | Gastroesophageal Reflux | GERD Gastroesophageal Reflux Disease Reflux Enteryx | null | 1 | arm 1: Those receiving Enteryx treatment | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Enteryx | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00346905 |
[
5
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the proportion of participants receiving pRBC (packed red blood cells) transfusions (from the day of su... | This is a randomized (the study medication is assigned by chance), parallel-arm (each group of participants will be treated at the same time), open-label (all people know the identity of the intervention), multicenter study. The study consists of screening phase of 21 days, treatment phase of 15 days, follow-up phase o... | Hemostasis, Surgical | Hemostasis, Surgical Epoetin alfa Surgery Abdomen Pelvis PROCRIT pRBC Blood transfusion Packed red blood cell transfusion | null | 2 | arm 1: Participants will receive PROCRIT (epoetin alfa). arm 2: Participants will receive standard of care. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery. intervention 2: Participants will receive standard of care based on the Institution's treatment policy. | intervention 1: Epoetin alfa intervention 2: Standard of Care | 0 | null | 0 | NCT00350519 |
[
2,
3
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radi... | Rationale: Surgery and radiation are often used as treatments for brain metastases, or tumors in the brain that originate from other parts of the body. It is currently unknown whether patient survival or time to progression would experience additional benefits through the addition of chemotherapy. Previous research doe... | Brain Tumor Brain Metastases | Recurrent Symptomatic | null | 1 | arm 1: Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin | [
0
] | 2 | [
0,
0
] | intervention 1: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2. intervention 2: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. | intervention 1: carboplatin intervention 2: temozolomide | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00362817 |
[
4
] | 901 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension. | null | Hypertension | Systolic hypertension hypertension aliskiren blood pressure ramipril HTN | null | 2 | arm 1: Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg arm 2: Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + h... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning intervention 2: Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning intervention 3: Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning intervention 4: Amlodipine 5 mg or 10 mg... | intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Hydrochlorothiazide intervention 4: Amlodipine | 1 | East Hanover | New Jersey | United States | -74.36487 | 40.8201 | 0 | NCT00368277 |
[
4
] | 138 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year. | null | Gastroesophageal Reflux Disease GERD Heartburn | gastroesophageal reflux disease GERD heartburn | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
3
] | 3 | [
0,
0,
0
] | intervention 1: nizatidine (axid) intervention 2: nizatidine (axid) intervention 3: placebo | intervention 1: nizatidine (axid) intervention 2: nizatidine (axid) intervention 3: placebo | 26 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Searcy | Arkansas | United States | -91.73625 | 35.25064
Madiera | Californi... | 0 | NCT00373334 |
[
3
] | 47 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy. | A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter or port. Catumaxomab will be administered as a 3-hour constant ra... | Ovarian Cancer | Epithelial Cancer Epithelial Carcinoma Epithelial Ovarian Cancer Epithelial Ovarian Carcinoma Fallopian Tube Cancer Fallopian Tube Carcinoma Ovarian Cancer Ovarian Carcinoma Ovarian Epithelial Cancer Ovarian Epithelial Carcinoma Peritoneal Cancer Peritoneal Carcinoma Advanced Epithelial Ovarian Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Catumaxomab administered as four 3-hour, constant-rate, intraperitoneal (IP) infusions of 10, 20, 50, 150 microgram (mcg). | intervention 1: catumaxomab | 12 | Tucson | Arizona | United States | -110.92648 | 32.22174
Stanford | California | United States | -122.16608 | 37.42411
Orlando | Florida | United States | -81.37924 | 28.53834
Hinsdale | Illinois | United States | -87.93701 | 41.80086
South Bend | Indiana | United States | -86.25001 | 41.68338
Louisville | Kentucky | U... | 0 | NCT00377429 |
[
3
] | 11 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objective:
1\. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces longer event free survival time in patients age \> or = 60 years with untreated Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for, or not placed on, st... | 5-aza is a chemotherapy drug with activity in leukemia and MDS. Researchers hope that VPA will increase the effects of 5-aza. Low-dose Cytarabine (ara-C) is considered the standard of care for the treatment of leukemia and MDS in older patients not eligible for other therapies.
Before you can start treatment on this s... | Acute Myelogenous Leukemia Myelodysplastic Syndrome Leukemia | Acute Myelogenous Leukemia AML Myelodysplastic Syndrome Leukemia MDS Azacytidine 5-Azacytidine 5-aza Vidaza 5-AZC AZA-CR Ladakamycin Ara-C Cytarabine Cytosar DepoCyt Cytosine arabinosine hydrochloride Valproic Acid VPA Depakene | null | 2 | arm 1: 5-Azacytidine (5-Aza) 75 mg/m\^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m\^2 orally daily, each for 7 days arm 2: Low-Dose Ara-C 20 mg twice daily subcutaneously for 10 days. | [
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 75 mg/m\^2 daily for 7 days (days 1-7) via subcutaneous injection. intervention 2: 20 mg twice daily via subcutaneous injection for 10 days. intervention 3: 50 mg/m\^2 orally daily days 1-7. | intervention 1: 5-Azacytidine intervention 2: Ara-C intervention 3: Valproic Acid (VPA) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00382590 |
[
4
] | 679 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine. | null | Migraine, Without Aura | sumatriptan succinate, naproxen sodium, parallel group, double-blind, placebo-controlled, Combination product, migrainous headache Probable migraine, a sub-type of Migraine probable migraine, | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: sumatriptan 85mg / naproxen sodium 500mg intervention 2: Placebo to match Treximet tablets | intervention 1: sumatriptan succinate / naproxen sodium intervention 2: Placebo | 70 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Anaheim | California | United States | -117.9145 | 33.83529
Buena Park | Californi... | 0 | NCT00387881 |
[
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation th... | null | Transfusional Iron Overload β-thalassemia Major Pediatric Rare Anemia | β-thalassemia major iron overload deferasirox pediatric rare anemia | null | 1 | arm 1: Initial dose of 10 mg/kg, dose modifications of ± 5 or 10 mg/kg were based on participant response. | [
0
] | 1 | [
0
] | intervention 1: Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or de... | intervention 1: Deferasirox | 4 | Lyon | N/A | France | 4.84671 | 45.74846
Cagliari | N/A | Italy | 9.11917 | 39.23054
Genova | N/A | Italy | 11.87211 | 45.21604
Torino | N/A | Italy | 11.99138 | 44.88856 | 0 | NCT00390858 |
[
4
] | 528 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.
Secondary objective: To assess the safety and tolerability of ciclesonide. | null | Asthma | Bronchial Asthma | null | 3 | arm 1: double-blind arm 2: double-blind arm 3: double-blind | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Ciclesonide MDI 40 µg BID over twelve weeks intervention 2: Ciclesonide MDI 80 µg BID over twelve weeks intervention 3: Placebo MDI over twelve weeks | intervention 1: Ciclesonide intervention 2: Ciclesonide intervention 3: Placebo | 6 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Budapest | N/A | Hungary | 19.04045 | 47.49835
Mexico | N/A | Mexico | -98.43784 | 18.88011
Warsaw | N/A | Poland | 21.01178 | 52.22977
Moscow | N/A | Russia | 37.61556 | 55.75222
Midrand | N/A | South Africa | 28.118 | -25.976 | 0 | NCT00392288 |
[
3
] | 197 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m\^2 or Taxol 175 mg/m\^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy. Bevacizumab was administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3... | null | Breast Cancer | Adjuvant therapy Bevacizumab Abraxane Early stage breast cancer | null | 2 | arm 1: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m\^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46). arm 2: Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m\^2 Taxol plus Bevacizumab for four cycles (weeks 9-16)... | [
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8). intervention 2: 260 mg/m\^2 IV on day 1 of each of four 2-week cycle, represen... | intervention 1: Adriamycin and Cytoxan (AC) intervention 2: ABI-007 intervention 3: Taxol intervention 4: Bevacizumab intervention 5: pegfilgrastim | 27 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Sedona | Arizona | United States | -111.76099 | 34.86974
Denver | Colorado | United States | -104.9847 | 39.73915
Torrington | Connecticut | United States | -73.12122 | 41.80065
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Minneapolis | Minnes... | 0 | NCT00394251 |
[
4
] | 655 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone. | There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% is type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, a... | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy | null | 4 | arm 1: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. arm 2: Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. arm 3: Alogliptin 25 mg, tablets, orally, once dai... | [
0,
1,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin tablets. intervention 2: Pioglitazone tablets. intervention 3: Matching placebo tablets. | intervention 1: Alogliptin intervention 2: Pioglitazone intervention 3: Placebo | 161 | Columbiana | Alabama | United States | -86.60721 | 33.17817
Hueytown | Alabama | United States | -86.99666 | 33.45122
Huntsville | Alabama | United States | -86.58594 | 34.7304
Northport | Alabama | United States | -87.57723 | 33.22901
Tucson | Arizona | United States | -110.92648 | 32.22174
Jonesboro | Arkansas | Unit... | 0 | NCT00395512 |
[
5
] | 77 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | Chronic sinusitis is reported to be one of the most widespread disorders in the United States. It can be caused by a variety of reasons such as allergy, infection and/or defects in T-cells which help regulate immune function. Medication and other costs related to treatment of nasal and sinus infections are estimated to... | Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. They are a part of the normal gastrointestinal flora and have safely been used to boost immune responses in patients with perennial and seasonal allergic rhinitis. Their exact mechanism of benefit is unkn... | Chronic Rhinosinusitis | null | 2 | arm 1: Placebo pills on same schedule as active intervention. arm 2: L. rhamnosus R0011 strain | [
2,
1
] | 2 | [
0,
10
] | intervention 1: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks intervention 2: Placebo pill | intervention 1: probiotic containing L.rhamnosus R0011 strain intervention 2: Placebo | 0 | null | 0 | NCT00396162 | |
[
4
] | 316 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to measure the effectiveness and assess the safety of two dosages of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder. | Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and ho... | Schizoaffective Disorder Psychotic Disorder | Schizoaffective Disorder antipsychotic paliperidone placebo | null | 3 | arm 1: Paliperidone ER 12mg/day paliperidone er for 6 weeks arm 2: Paliperidone ER 6mg/day paliperidone er for 6 weeks arm 3: Placebo Placebo for 6 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 6mg/day paliperidone er for 6 weeks intervention 2: 12mg/day paliperidone er for 6 weeks intervention 3: Placebo for 6 weeks | intervention 1: Paliperidone ER intervention 2: Paliperidone ER intervention 3: Placebo | 0 | null | 0 | NCT00397033 |
[
5
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.
During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnose... | IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has demonstrated efficacy in the treatment of depression as well as in several pain syndromes including diabetic peripheral neuropathy and fib... | Irritable Bowel Syndrome | IBS irritable bowel syndrome irritable bowel | null | 1 | arm 1: 12-week, open-label trial of duloxetine in subjects with IBS. | [
5
] | 1 | [
0
] | intervention 1: 30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician. | intervention 1: duloxetine | 1 | Belmont | Massachusetts | United States | -71.17867 | 42.39593 | 0 | NCT00401258 |
[
3
] | 159 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome. | This was a proof-of-concept study and not powered for statistical comparisons.
The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day o... | Fibromyalgia Syndrome | Fibromyalgia Syndrome Lacosamide Vimpat Harkoseride | null | 2 | arm 1: None arm 2: Lacosamide Tablet 400mg daily | [
2,
0
] | 2 | [
0,
10
] | intervention 1: Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg intervention 2: Matching placebo tablet administered twice daily | intervention 1: Lacosamide intervention 2: Placebo | 25 | Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Santa Ana | California | United States | -117.86783 | 33.74557
Walnut Creek | California | United States | -122.06496 | 37.90631
Deerfield Beach | Florida | United States | -80.09977 | 26.31841
Fort Lauderdale | Florida | United States | -80.14338 | 26.1... | 0 | NCT00401830 |
[
3
] | 310 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation. | null | Chronic Constipation | Constipation Chronic Constipation Microbia linaclotide linaclotide acetate MD-1100 | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
1,
1,
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: oral, once daily. intervention 2: oral, once daily | intervention 1: linaclotide acetate intervention 2: Matching placebo | 60 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Tucson | Arizona | United States | -110.92648 | 32.22174
Sherwood | Arkansas | United States | -92.22432 | 34.81509
Anaheim | California | United States | -117.9145 | 33.83529
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California... | 0 | NCT00402337 |
[
4
] | 44 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks. | null | Hepatitis B Chronic Hepatitis B | HBeAg-positive, chronic hepatitis B telbivudine entecavir viral kinetics | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Entecavir 0.5 mg once daily for 12 weeks. intervention 2: Telbivudine 600 mg once daily for 12 weeks. | intervention 1: Entecavir intervention 2: Telbivudine | 8 | Bucheon,Kyunggi | N/A | South Korea | 126.78306 | 37.49889
Busan | N/A | South Korea | 129.03004 | 35.10168
Daegu | N/A | South Korea | 128.59111 | 35.87028
Incheon | N/A | South Korea | 126.70515 | 37.45646
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South ... | 0 | NCT00412529 |
[
3
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis | Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the... | Arthritis, Rheumatoid | null | 3 | arm 1: Celecoxib with placebo therapy. arm 2: Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms. arm 3: CP-195,543 and Celecoxib dual therapy. | [
1,
5,
0
] | 3 | [
0,
0,
0
] | intervention 1: CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor. intervention 2: Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States \[US\] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis. intervention ... | intervention 1: CP-195,543 intervention 2: celecoxib intervention 3: Methotrexate | 39 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Upland | California | United States | -117.64839 | 34.09751
Boca Raton | Florida | United States | -80.0831 | 26.35869
Clearwater | Florida | United States | -82.8001 | 27.96585
Dunedin | Florida | Un... | 0 | NCT00424294 | |
[
4
] | 262 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period... | null | Alzheimer's Disease | Dementia, Alzheimer's, Rivastigmine, donepezil | null | 2 | arm 1: Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm\^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Rivastigmine 5 cm\^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours. intervention 2: Rivastigmine 10 cm\^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours. | intervention 1: Rivastigmine 5 cm^2 transdermal patch intervention 2: Rivastigmine 10 cm^2 transdermal patch | 23 | Sun City | Arizona | United States | -112.27182 | 33.59754
Costa Mesa | California | United States | -117.91867 | 33.64113
Fresno | California | United States | -119.77237 | 36.74773
Denver | Colorado | United States | -104.9847 | 39.73915
Hialeah | Florida | United States | -80.27811 | 25.8576
Hollywood | Florida | Un... | 0 | NCT00428389 |
[
5
] | 132 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB). | This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB). | Overactive Bladder | Solifenacin succinate Oxybutynin immediate release Xerostomia Overactive bladder | null | 2 | arm 1: Solifenacin succinate: 5 mg tablets, taken orally, once daily arm 2: Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Oral intervention 2: Oral | intervention 1: solifenacin intervention 2: oxybutynin immediate release | 12 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Guelph | Ontario | Canada | -80.25599 | 4... | 0 | NCT00431041 |
[
2
] | 30 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | true | 0ALL | true | The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers. | This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided i... | Healthy | Healthy Volunteers | null | 2 | arm 1: 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days arm 2: Placebo to match ST-246 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 250 mg, 400 mg or 800 mg capsules given once daily for 21 days intervention 2: Capsules to match experimental drug | intervention 1: ST-246 intervention 2: Placebo | 1 | Orlando | Florida | United States | -81.37924 | 28.53834 | 0 | NCT00431951 |
[
4
] | 219 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | false | 0ALL | false | The scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.It has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress.
Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not always ideal becaus... | This study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups.
In each parallel group, Clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design. | Scalp Psoriasis | 1 Galderma, 2 Scalp Psoriasis 3 Subject preference 4 Clobetasol propionate 5 Shampoo | null | 6 | arm 1: Clobetasol propionate Shampoo:
* Dose or Concentration: Clobetasol propionate 0.05% shampoo
* Mode and Frequency of Administration: Topical Once daily to the dry scalp, to be lathered and rinsed after 15 minutes
* Duration of Treatment: 4 weeks as a maximum
Wash-out up to 8 weeks
Corticosteroid 1:
* Dose or ... | [
1,
1,
1,
1,
1,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Twice daily application intervention 2: Twice daily application intervention 3: Twice daily application intervention 4: Twice daily application intervention 5: Twice daily application intervention 6: Twice daily application | intervention 1: C. propionate - Corticosteroid 1 intervention 2: C. propionate- Corticosteroid 2 intervention 3: C. propionate -Corticosteroid 3 intervention 4: Corticosteroid 1- C. propionate intervention 5: Corticosteroid 2 - C. propionate intervention 6: Corticosteroid 3 - C. propionate | 1 | Modena | N/A | Italy | 10.92539 | 44.64783 | 0 | NCT00438399 |
[
4
] | 375 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin. | This is a open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study designed to show that 2 alternative dosing regimens, once weekly and once every-2-weeks (given at doses equivalent to 50 IU/kg 3 times a week) are not inferior to the 3-tim... | Anemia | Anemia Chronic Kidney disease Kidney disease Epoetin alfa Procrit | null | 3 | arm 1: Participants will be administered with epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU) arm 2: Participants will be administered with epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU). arm 3: P... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Epoetin alfa will be administered as a SC injections at initial dose of 50 IU/kg (3 times weekly for 22 weeks) and at initial dose of 10000 IU (once weekly for 22 weeks) intervention 2: Epoetin alfa will be administered as a SC injection at initial dose of 10000 IU (once weekly for 44 weeks). interventi... | intervention 1: Epoetin alfa 3 times weekly /once weekly intervention 2: Epoetin alfa once weekly intervention 3: Epoetin alfa once every two weeks | 62 | Glendale | Arizona | United States | -112.18599 | 33.53865
Tempe | Arizona | United States | -111.90931 | 33.41477
Chula Vista | California | United States | -117.0842 | 32.64005
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Lynwood | Ca... | 0 | NCT00440557 |
[
3
] | 213 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | null | This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with... | null | Irritable Bowel Syndrome | null | 4 | arm 1: Part A: AGN 203818 3mg capsule every 12 hours for 4 weeks arm 2: Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks arm 3: Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks arm 4: Part A: Placebo capsule every 12 hours for 4 weeks | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks intervention 2: Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks intervention 3: Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks intervention 4: Part A: placebo capsule every 12 hours for 4 weeks | intervention 1: AGN 203818 intervention 2: AGN 203818 intervention 3: AGN 203818 intervention 4: placebo | 1 | Orange | California | United States | -117.85311 | 33.78779 | 0 | NCT00441766 | |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo. | This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon resections. Subjects meeting entry criteria were randomized in ... | Post-Operative Ileus | null | 3 | arm 1: None arm 2: Asimadoline 1.0 mg b.i.d. arm 3: Asimadoline 3.0 mg b.i.d. | [
2,
1,
1
] | 2 | [
0,
0
] | intervention 1: Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at ea... | intervention 1: Asimadoline intervention 2: Placebo | 4 | Burlington | Massachusetts | United States | -71.19561 | 42.50482
St Louis | Missouri | United States | -90.19789 | 38.62727
Cleveland | Ohio | United States | -81.69541 | 41.4995
Wynnewood | Pennsylvania | United States | -75.27074 | 40.00289 | 0 | NCT00443040 | |
[
4
] | 111 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients ... | null | Anemia | null | 3 | arm 1: 120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.
Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL. arm 2: Patients randomized to the reference arm continued to receive their ... | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine an... | intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: epoetin alfa intervention 3: darbepoetin alfa | 78 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
El Dorado | Arkansas | United States | -92.66627 | 33.20763
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Bakersfield | California ... | 0 | NCT00454246 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.