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
] | 1,584 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria.
Efficacy for flibanserin will be assessed vs. a parallel placebo group. | null | Sexual Dysfunctions, Psychological | null | 4 | arm 1: flibanserin 25 mg b.i.d arm 2: flibanserin 50mg qhs/b.i.d arm 3: flibanserin 50mg b.i.d./100mg qhs arm 4: placebo comparator | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: flibanserin 25 mg b.i.d intervention 2: flibanserin 50mg qhs/b.i.d. intervention 3: flibanserin 50 mg b.i.d/100mg qhs intervention 4: placebo comparator | intervention 1: flibanserin intervention 2: flibanserin 50mg intervention 3: flibanserin 100mg intervention 4: placebo | 77 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Berkeley | California | United States | -122.27275 | 37.87159
Encinitas | California... | 0 | NCT00360555 | |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke. | Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible... | Acute Stroke | Stroke | null | 1 | arm 1: All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy. | [
0
] | 1 | [
0
] | intervention 1: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation | intervention 1: Dual Growth Factor | 1 | Orange | California | United States | -117.85311 | 33.78779 | 0 | NCT00362414 |
[
0
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks. | The study will investigate whether dextro-amphetamine (d-amphetamine) is safe and effective compared to caffeine as an active placebo when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and whether tolerance (loss of therapeutic effect) to the medication will develop over a period of several weeks
... | Obsessive-Compulsive Disorder | D-amphetamine, dextro-amphetamine, stimulant drug | null | 2 | arm 1: dextro-amphetamine capsules, 15 mg per capsule, in Bottles A and B, dose: one from Bottle A each morning and 1 from Bottle B each morning arm 2: caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules, dose was 1 ... | [
0,
3
] | 2 | [
0,
0
] | intervention 1: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks. intervention 2: caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg c... | intervention 1: dextro-amphetamine intervention 2: Sham Comparison | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00363298 |
[
4
] | 115 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients. | null | Arthritis, Psoriatic | null | 2 | arm 1: Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week arm 2: Oral methotrexate (MTX) 15 mg/week | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6. intervention 2: Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6. | intervention 1: Infliximab + methotrexate (IFX + MTX) intervention 2: Methotrexate (MTX) | 0 | null | 0 | NCT00367237 | |
[
3
] | 44 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Patients with heart attacks are treated with medicines to reduce the clotting action of platelets. This study is trying to determine whether erythropoietin alters the clotting action ... | Anti-apoptotic effects of erythropoietin in experimental myocardial infarction (MI) and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of recombinant human erythropoietin (rHuEpo) in acute MI can be tested in large clinical trials, more ... | Myocardial Infarction | Platelet function tests Erythropoietin Myocardial infarction | null | 2 | arm 1: recombinant human erythropoietin 200 U/kg IV daily for 3 days arm 2: Normal saline volume to match active treatment IV daily for 3 days | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days intervention 2: Normal saline to match active drug (rHuEpo) | intervention 1: Recombinant human erythropoietin alfa (drug) intervention 2: Placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00367991 |
[
2
] | 36 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | null | The purpose of this study is to investigate the effects of smoked marijuana on both risk taking and decision making tasks. | Cannabis abuse and dependence are the most prevalent drug use disorders in the United States (Compton et al., 2004), yet little is known about the factors contributing to successful marijuana treatment. Previously, we have shown that cognitive impairments in patients treated for substance disorders are associated with ... | Marijuana Use Disorder | Cannabinoids Risk taking Decision making | null | 2 | arm 1: In this randomized, placebo-controlled study, every participant received all 3 treatment interventions in randomized order. Inactive marijuana (0% THC) served as a placebo comparator. Participants received an inactive marijuana cigarette (0% THC; provided by NIDA) in 1 of the 3 outpatient sessions in randomized ... | [
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion. intervention 2: Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which pro... | intervention 1: Inactive Marijuana (0% THC) intervention 2: Low THC marijuana (1.8 %THC) intervention 3: High THC marijuana (3.9% THC) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00373399 |
[
5
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy. | This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety c... | Chemotherapy-Induced Peripheral Neuropathy | Pain chemotherapy | null | 2 | arm 1: flexible dosing arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 150- 600 mg/day (double blind in divided doses) intervention 2: Placebo | intervention 1: Pregabalin intervention 2: Placebo | 15 | St Leonards | New South Wales | Australia | 151.19836 | -33.82344
Adelaide | South Australia | Australia | 138.59863 | -34.92866
Bielefeld | N/A | Germany | 8.53333 | 52.03333
Essen | N/A | Germany | 7.01228 | 51.45657
Hamm | N/A | Germany | 7.82089 | 51.68033
Chieti Scalo | N/A | Italy | N/A | N/A
Potenza | N/A | Ital... | 0 | NCT00380874 |
[
0
] | 9 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 1FEMALE | true | The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience. | There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that... | Vulvar Pain Symptoms Vulvodynia (Chronic Vulvar Pain) | Vulvar Pain | null | 2 | arm 1: Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) arm 2: Placebo titration and dosing for total of 8 weeks (Cross over) | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsu... | intervention 1: Gabapentin intervention 2: Placebo oral capsule | 1 | Iowa City | Iowa | United States | -91.53017 | 41.66113 | 0 | NCT00390013 |
[
0
] | 80 | NON_RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in th... | Currently,about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicot... | Drug Addiction Smoking Cessation | Nicotine Replacement Therapy Tobacco Smoking Smoking stimuli Gender | null | 4 | arm 1: 21 mg patch/Nicotine-containing cigarette arm 2: 0 mg patch/nicotine-containing cigarette arm 3: 21 mg patch/no nicotine cigarette arm 4: 0 mg patch/no nicotine cigarette | [
0,
0,
0,
0
] | 4 | [
0,
0,
10,
10
] | intervention 1: 21 mg nicotine transdermal system intervention 2: Placebo nicotine patch intervention 3: Nicotine containing cigarette intervention 4: Non nicotine containing cigarette | intervention 1: nicotine transdermal system intervention 2: Nicotine transdermal system intervention 3: Nicotine containing cigarette intervention 4: Placebo cigarette | 1 | Richmond | Virginia | United States | -77.46026 | 37.55376 | 0 | NCT00390559 |
[
4
] | 154 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS. | null | Idiopathic Restless Legs Syndrome | null | 3 | arm 1: Pramipexole 0.25 mg given once daily arm 2: Pramipexole 0.5 mg given once daily arm 3: Pramipexole 0.75 mg given once daily | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Pramipexole 0.125 mg tablet intervention 2: Pramipexole 0.5 mg tablet | 34 | Aichi-gun, Aichi | N/A | Japan | 130.62158 | 32.51879
Fujisawa, Kanagawa | N/A | Japan | N/A | N/A
Fukuoka, Fukuoka | N/A | Japan | N/A | N/A
Hiroshima, Hiroshima | N/A | Japan | N/A | N/A
Kagoshima, Kagoshima | N/A | Japan | N/A | N/A
Kanagawa, Yokohama | N/A | Japan | N/A | N/A
Kanazawa, Ishikawa | N/A | Japan | N/A ... | 0 | NCT00390689 | |
[
3
] | 567 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 1FEMALE | false | This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary | This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.
Patients who meet all study entrance criteria will be randomly assigned to one of f... | Breakthrough Bleeding | oral contraceptives breakthrough bleeding spotting | null | 4 | arm 1: 42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. arm 2: 21 days combination active tablets (20 mcg EE /150 mcg LNG) fo... | [
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy ... | intervention 1: DR-1031 intervention 2: Seasonale® intervention 3: Portia® | 50 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Santa Ana | ... | 0 | NCT00394771 |
[
5
] | 46 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 3TRIPLE | false | 0ALL | false | Compare the efficacy of MultiHance and Magnevist | The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease. | Brain Tumor | null | 2 | arm 1: 0.5 M MultiHance at a single injection arm 2: 0.5 M Magnevist at a single injection | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 0.5 M at a single injection intervention 2: 0.5 M Magnevist at a single dose injection | intervention 1: Multihance intervention 2: Arm 2 - Magnevist | 1 | Princeton | New Jersey | United States | -74.65905 | 40.34872 | 0 | NCT00395863 | |
[
3
] | 243 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy. | null | Anemia Non-Myeloid Malignancies | anemia chemotherapy induced anemia darbepoetin alfa cancer | null | 4 | arm 1: Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 2: Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 3: Darbepoetin alfa 500 μg subcutaneous i... | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Darbepoetin alfa administered by subcutaneous injection. intervention 2: Administered by intravenous (IV) injection. | intervention 1: darbepoetin alfa intervention 2: IV iron dextran | 0 | null | 0 | NCT00401544 |
[
3
] | 118 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | null | After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Health... | Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. The prevalence of cigarette smoking among U.S. adults has declined from 42% in 1965 to 20.9% in 2004. However, the overall decline is not occurring at a rate that will meet nationa... | Smoking Nicotine Dependence | null | 3 | arm 1: Placebo pill was identical in appearance to the active medication. arm 2: St. John's Wort - 300 mg tablets, 3 times a day. arm 3: St. John's Wort - 600 mg 3 times per day | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Placebo (inactive drug) given 3 times per day intervention 2: St. John's Wort - 300 mg tables -3 times per day intervention 3: St. John's Wort - 600 mg tables - 3 times per day | intervention 1: Placebo intervention 2: St. John's Wort-900 mg/day intervention 3: St. John's Wort-1800mg/day | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00405912 | |
[
3
] | 142 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD) treated for 3 months with either extended release methylphenidate or behavioral therapy. | This study will determine whether the administration of extended-release methylphenidate in treatment-naïve children with Attention Deficit Hyperactivity Disorder (ADHD) affects the frequency of chromosomal abnormalities. | Attention Deficit Hyperactivity Disorder | Attention Deficit Hyperactivity Disorder, ADHD Cytogenetic abnormalities, extended-release methylphenidate, | null | 2 | arm 1: None arm 2: None | [
1,
5
] | 2 | [
0,
5
] | intervention 1: None intervention 2: None | intervention 1: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy intervention 2: Behavior Therapy | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00409708 |
[
4
] | 467 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months. | null | Pain | chronic pain joint pain back pain diabetic peripheral neuropathy post herpetic neuralgia ALO-01 Embeda Chronic Non-Malignant Pain | null | 1 | arm 1: Doses given once or twice daily | [
0
] | 1 | [
0
] | intervention 1: capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily | intervention 1: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) | 58 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United S... | 0 | NCT00415597 |
[
2
] | 60 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this trial is to evaluate the safety and effectiveness of lowering blood pressure using nicardipine in persons with acute hypertension associated with intracerebral hemorrhage. | An estimated 37,000 to 52,400 people in the United States have intracerebral hemorrhage (ICH) every year. ICH--a form of stroke that has poor outcome and is difficult to treat--is associated with the highest mortality rate of all strokes. Hematoma expansion has been identified as the most common cause of neurological d... | Intracerebral Hemorrhage Hypertension Stroke | cerebral hemorrhage intracerebral hemorrhage stroke hypertension blood pressure nicardipine antihypertensive agent hematoma expansion | null | 3 | arm 1: Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabiliz... | [
5,
5,
5
] | 1 | [
0
] | intervention 1: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.
* Started at 5mg/h
* Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour \*Once target systolic blood pre... | intervention 1: nicardipine | 12 | Los Angeles | California | United States | -118.24368 | 34.05223
Kansas City | Kansas | United States | -94.62746 | 39.11417
Kansas City | Kansas | United States | -94.62746 | 39.11417
Boston | Massachusetts | United States | -71.05977 | 42.35843
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
St Louis |... | 0 | NCT00415610 |
[
3
] | 48 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and ... | null | Epilepsy | null | 2 | arm 1: 2 mg E2007 once daily for 2 weeks (Days 1 to 14), then 4 mg E2007 once daily for 2 weeks (Days 15 to 28), then 6 mg E2007 once daily for 2 weeks (Days 29 to 42), then 8 mg E2007 once daily for 2 weeks (Days 43 to 56), then 10 mg E2007 once daily for 2 weeks (Days 57 to 70), then 12 mg E2007 once daily for 6 week... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: E2007 intervention 2: Placebo | 2 | Riga | N/A | Latvia | 24.10589 | 56.946
Riga | N/A | Latvia | 24.10589 | 56.946 | 0 | NCT00416195 | |
[
3
] | 1 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system an... | OBJECTIVES:
* Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine, alemtuzumab, and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and... | Leukemia | chronic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia relapsing chronic myelogenous leukemia | null | 1 | arm 1: (Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m\^2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T cell depleted and given on day 0 | [
0
] | 4 | [
0,
0,
4,
10
] | intervention 1: 30 mg on day -8 over 5-6 hours intervention 2: Fludarabine 30 mg/m\^2 on day -4 through day -2 intervention 3: Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0 intervention 4: Stem cells will be T cell depleted and given on day 0 | intervention 1: Campath intervention 2: Fludarabine intervention 3: Total Body Irradiation (TBI) intervention 4: T-Cell Deplete | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00416884 |
[
3
] | 469 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder. | null | Major Depressive Disorder | null | 3 | arm 1: LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks.
For the first week of treatment, participants received a starting dose of 3 mg/day. Then, based on tolerability, for the next 7 weeks, the dose could remain at 3 mg/day; it could be increased 3 mg a... | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: 3-mg and 6-mg tablets intervention 2: None intervention 3: 10-mg capsules | intervention 1: LY2216684 intervention 2: Placebo intervention 3: Escitalopram | 7 | Orlando | Florida | United States | -81.37924 | 28.53834
Prairie Village | Kansas | United States | -94.63357 | 38.99167
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
Media | Pennsylvania | United States | -75.38769 | 39.91678
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania... | 0 | NCT00420004 | |
[
5
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease. | null | Hypercholesterolemia Coronary Disease | null | 2 | arm 1: Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment arm 2: Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg.... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks intervention 2: 1 tablet containing 40 mg of simvastatin per day for 6 weeks | intervention 1: Ezetimibe/Simvastatin 10/20 mg intervention 2: simvastatin 40 mg | 0 | null | 0 | NCT00423579 | |
[
3,
4
] | 1,474 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, an... | null | Essential Hypertension | Hypertension, Valsartan, Amlodipine, high blood pressure | null | 9 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None | [
0,
0,
0,
0,
1,
1,
1,
1,
2
] | 9 | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 2: Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 3: Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once... | intervention 1: Valsartan + amlodipine 40/2.5 mg intervention 2: Valsartan + amlodipine 40/5 mg intervention 3: Valsartan + amlodipine 80/2.5 mg intervention 4: Valsartan + amlodipine 80/5 mg intervention 5: Valsartan 40 mg intervention 6: Valsartan 80 mg intervention 7: Amlodipine 2.5 mg intervention 8: Amlodipine 5 m... | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00425373 |
[
3
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objectives:
1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen.
2. To a... | Registration:
When you are willing to undergo stem cell transplantation for kidney cancer, have possible related donors, and the study doctor decides you are eligible to participate, you will be enrolled in this study.
Before treatment begins, you will have a complete physical exam, including blood (about 1-2 tablesp... | Renal Cell Cancer | Kidney Cancer Renal Cell Cancer Stem Cell Transplant Cyclophosphamide Fludarabine Melphalan NST | null | 2 | arm 1: ASCT=Allogeneic Hematopoietic Stem Cell Transplantation arm 2: ASCT=Allogeneic Hematopoietic Stem Cell Transplantation | [
0,
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: 25 mg/m\^2 intravenous (IV) daily for 5 Days intervention 2: 70 mg/m\^2 IV Daily for 2 Days intervention 3: 60 mg/kg IV Daily for 2 Days intervention 4: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor | intervention 1: Fludarabine intervention 2: Melphalan intervention 3: Cyclophosphamide intervention 4: Stem Cell Transplant | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00429026 |
[
4
] | 194 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections | null | Skin Diseases, Infectious Soft Tissue Infections | Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin Complicated skin and soft tissue infections | null | 2 | arm 1: 4 mg/kg intravenous (i.v.) once daily arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 4 mg/kg intravenous once daily intervention 2: 1 g intravenous twice daily intervention 3: 400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one. | intervention 1: Daptomycin intervention 2: Vancomycin intervention 3: Teicoplanin | 0 | null | 0 | NCT00430937 |
[
3
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "blood thinner") to pre... | Potential patients will be identified in the cardiac catheterization lab when an intra-aortic balloon pump is placed. Patients who agree to participate in this study will be randomized (they will be selected to receive heparin or not to receive heparin with their intra-aortic balloon pump) by a process that is similar ... | Cardiogenic Shock | Intraaortic balloon pumping Heparin Limb ischemia Bleeding | null | 2 | arm 1: Intra-Aortic Balloon Pump (IABP) with Heparin arm 2: Intra-Aortic balloon Pump (IABP) without Heparin | [
1,
1
] | 2 | [
0,
10
] | intervention 1: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP). intervention 2: Intra-Aortic balloon Pump (IABP) without Heparin. | intervention 1: Heparin intervention 2: Without Heparin | 1 | Royal Oak | Michigan | United States | -83.14465 | 42.48948 | 0 | NCT00445211 |
[
5
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist. | Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment. | Asthma | Asthma, anti-immunoglobulin E, omalizumab, IgE receptors | null | 2 | arm 1: Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. arm 2: Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosi... | intervention 1: Omalizumab intervention 2: placebo | 1 | Rueil-Malmaison | N/A | France | 2.18967 | 48.8765 | 0 | NCT00454051 |
[
4
] | 1,420 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment. | Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone an... | Multiple Sclerosis, Relapsing-Remitting | Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron | null | 3 | arm 1: Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind) arm 2: Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind) arm 3: Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day
\*(Subjects w... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). intervention 2: Phase A: 500ug administrated s.c. every other day (double blind). Fo... | intervention 1: Interferon beta-1b (Betaseron, BAY86-5046) intervention 2: Interferon beta-1b (Betaseron, BAY86-5046) intervention 3: Interferon beta-1b (Betaseron, BAY86-5046) | 184 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Cullman | Alabama | United States | -86.84361 | 34.17482
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Berkeley | California | United States | -122.27275 | 37.87159
La Jolla | California | Un... | 0 | NCT00459667 |
[
4
] | 374 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this stu... | null | Sinusitis | Respiratory Tract Infection Bacterial Sinusitis | null | 2 | arm 1: Moxifloxacin 400mg once daily for 5 days arm 2: Matching placebo for 5 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Moxifloxacin - 400 mg once a day for 5 days intervention 2: Placebo - 380 mg Microcrystalline Cellulose | intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Placebo | 51 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Northport | Alabama | United States | -87.57723 | 33.22901
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | California | United States | -119.77237 | 36.74773
Fresno | California ... | 0 | NCT00492024 |
[
3
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules. | A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
Stable kidney transplant patients who fulfill all I/E criteria will be ... | Renal Failure | Tacrolimus Pharmacokinetics Kidney Transplantation | null | 1 | arm 1: Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets. | [
1
] | 2 | [
0,
0
] | intervention 1: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw f... | intervention 1: LCP Tacro (tacrolimus) intervention 2: Prograf | 2 | Cincinnati | Ohio | United States | -84.51439 | 39.12711
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00496483 |
[
4
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis. | null | Cystic Fibrosis | Pancreatic exocrine insufficiency Cystic Fibrosis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 24000 unit Capsule intervention 2: Placebo | intervention 1: Pancrelipase Delayed Release intervention 2: Placebo Comparator | 23 | Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Iowa City | ... | 0 | NCT00510484 |
[
2,
3
] | 47 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temozolomide together with bortezomib ma... | null | Brain and Central Nervous System Tumors Melanoma Solid Tumor | stage III melanoma stage IV melanoma recurrent melanoma unspecified adult solid tumor, protocol specific recurrent adult brain tumor melanoma (skin) | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 5 | [
0,
0,
10,
0,
0
] | intervention 1: Dose Levels PS-341 (day 1)
* Level -1 0.7 mg/m2
* Level 1 1.0 mg/m2
* Level 2 1.0 mg/m2
* Level 3 1.3 mg/m2
* Level 4 1.5 mg/m2 intervention 2: Temozolomide (day 8)
* Level - 1 50 mg/m2
* Level 1 50 mg/m2
* Level 2 75/mg/m2
* Level 3 75 mg/m2
* Level 4 75 mg/m2 intervention 3: Not noted intervention 4... | intervention 1: PS-341 (VELCADE) intervention 2: temozolomide intervention 3: immunoenzyme technique intervention 4: PS-341 (VELCADE) intervention 5: Temozolomide | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00512798 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in a... | OBJECTIVES:
Primary
* To determine the 12-month progression-free survival (PFS) rate of women with ovarian epithelial, fallopian tube, or peritoneal cancer in second or greater remission treated with oral sorafenib tosylate.
Secondary
* To determine the safety and tolerability of prolonged treatment with oral soraf... | Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer | recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer | null | 1 | arm 1: Sorafenib is supplied as 200-mg tablets. Sorafenib will be administered as 400 mg orally daily x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). In the absence of intoler... | [
0
] | 5 | [
0,
10,
10,
10,
10
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None | intervention 1: sorafenib tosylate intervention 2: immunoenzyme technique intervention 3: immunohistochemistry staining method intervention 4: laboratory biomarker analysis intervention 5: pharmacological study | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00522301 |
[
4
] | 149 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | null | Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacem... | null | Hypogonadism | Hypogonadism | null | 1 | arm 1: 2% testosterone gel | [
0
] | 1 | [
0
] | intervention 1: 2% gel | intervention 1: Testosterone | 0 | null | 0 | NCT00522431 |
[
0
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications.
Enrolled patien... | Outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate.
They will receive varenicline dosed according to FDA-approved smoking cessation regime; patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and clinical glob... | Depressive Disorder Smoking | varenicline depression anhedonia smoking | null | 1 | arm 1: open label varenicline | [
5
] | 2 | [
0,
0
] | intervention 1: varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration. intervention 2: up to 1 mg twice daily | intervention 1: fixed dose varenicline intervention 2: varenicline | 1 | Providence | Rhode Island | United States | -71.41283 | 41.82399 | 0 | NCT00525837 |
[
5
] | 70 | RANDOMIZED | SINGLE_GROUP | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | true | The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap). | Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the ... | Pain | pain lumbar puncture neonates infants emergency department topical anesthesia LMX4 | null | 2 | arm 1: Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing arm 2: Placebo Cream made on same run at factory but without active Lidocaine 4% drug | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure intervention 2: inactive placebo without LMX4 | intervention 1: Lidocaine Cream 4% intervention 2: Placebo | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT00533468 |
[
3
] | 2 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer. | null | Breast Cancer | null | 2 | arm 1: Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.
Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analys... | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression intervention 2: 10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression intervention 3: 90 milligrams per square meter (mg/m\^2), intravenous... | intervention 1: Enzastaurin intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Placebo | 7 | Newark | Delaware | United States | -75.74966 | 39.68372
Galesburg | Illinois | United States | -90.37124 | 40.94782
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Goshen | Indiana | United States | -85.83444 | 41.58227
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lafayette | Indiana | Unit... | 0 | NCT00536939 | |
[
2
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.
Bevacizumab is an anti VEGF... | Eligibility criteria:
Diabetic tractional retinal detachment-complexity score between 4 and 8
Main outcome measures:
best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina) | Intravitreal Bevacizumab Injection Pars Plana Vitrectomy Tractional Retinal Detachment Diabetic Retinopathy | Intravitreal Bevacizumab injection Pars plana vitrectomy tractional retinal detachment Diabetic retinopathy | null | 2 | arm 1: Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy arm 2: no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy | [
0,
4
] | 1 | [
0
] | intervention 1: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy | intervention 1: Bevacizumab | 1 | Tehran | N/A | Iran | 51.42151 | 35.69439 | 0 | NCT00548197 |
[
3
] | 53 | RANDOMIZED | CROSSOVER | 1PREVENTION | 2DOUBLE | true | 2MALE | false | This study will examine whether oral intake of 1200mg N-Acetylcysteine/day will prevent temporary threshold shift in hearing among workers exposed to noise | Both genetic and environmental factors contribute to noise-induced hearing loss (NIHL). The cellular antioxidant system appears to protect cochlear hair cells from oxidative stress due to noise. Previous animal studies showed protective effects of anti-oxidant medicines against NIHL.The objective of this study is to te... | Hearing Loss | noise hearing loss temporary threshold shift | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 600mg twice daily for 2 weeks intervention 2: 1 gm glucose capsule | intervention 1: N-acetylcysteine (NAC) intervention 2: glucose | 1 | Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 0 | NCT00552786 |
[
3
] | 32 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days. | null | Asthma | Adult Asthmatics | null | 4 | arm 1: Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebuliza... | [
5,
5,
5,
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol intervention 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol intervention 3: a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twi... | intervention 1: MAP0010 low dose intervention 2: MAP0010 high dose intervention 3: Budesonide inhalation suspension 0.25mg intervention 4: Budesonide inhalation suspension 0.5mg | 1 | Long Beach | California | United States | -118.18923 | 33.76696 | 0 | NCT00554970 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery. | The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively. | Marginal Ulcers | gastric bypass surgery anastomosis, Roux-en-Y Complication, Postoperative | null | 2 | arm 1: 40 mg Omeprazole daily arm 2: 40 mg Famotidine daily | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery. intervention 2: 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of... | intervention 1: Omeprazole intervention 2: Famotidine | 1 | Columbia | Missouri | United States | -92.33407 | 38.95171 | 0 | NCT00557349 |
[
5
] | 12 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon | The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression... | Inflammatory Bowel Disease | null | 1 | arm 1: Rosiglitazone; 8mg tablet once a day for 14 days | [
5
] | 1 | [
0
] | intervention 1: 8mg tablet once a day for 14 days | intervention 1: Rosiglitazone | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00567593 | |
[
5
] | 33 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD. | This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a fol... | Chronic Obstructive Pulmonary Disease | COPD Chronic Bronchitis Emphysema | null | 2 | arm 1: Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit. arm 2: Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit fol... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID) intervention 2: Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD) intervention 3: Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day | intervention 1: Arformoterol Tartrate Inhalation Solution intervention 2: Arformoterol Tartrate Inhalation Solution intervention 3: Placebo | 4 | Medford | Oregon | United States | -122.87559 | 42.32652
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Spartanburg | South Carolina | United States | -81.93205 | 34.94957 | 0 | NCT00571428 |
[
3
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life. | null | Crohn's Disease | gastrointestinal GI Crohn's disease Japan Japanese | null | 3 | arm 1: D9421-C 9 mg arm 2: D9421-C 15 mg arm 3: Placebo | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: D9421-C 9 mg was given once daily for 8 weeks. intervention 2: D9421-C 15 mg was given once daily for 8 weeks. intervention 3: D9421-C matching placebo was given once daily for 8 weeks. | intervention 1: D9421-C, 9mg intervention 2: D9421-C, 15mg intervention 3: Placebo | 22 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Sakura | Chiba | Japan | 140.23333 | 35.71667
Chikushino-shi | Fukuoka | Japan | 130.5156 | 33.49631
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Kurume | Fukuoka | Japan | 130.51667 | 33.31667
Hashima-gun | Gifu | Japan | N/A | N/A
Fukuyama | Hiroshima | Japan | 133.36... | 0 | NCT00573469 |
[
3
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting | null | Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
2,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: subcutaneous injections at 6 visits intervention 2: subcutaneous injections at 6 visits intervention 3: subcutaneous injections at 6 visits intervention 4: subcutaneous injections at 6 visits | intervention 1: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) intervention 2: House dust mite allergen extract in combination with CYT003-QbG10-placebo intervention 3: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo intervention 4: CYT003-QbG10-placebo ... | 0 | null | 0 | NCT00574704 | |
[
4
] | 221 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis | null | Ocular Inflammation Associated With Blepharaconjunctivitis | Ocular inflammation blepharaconjunctivitis | null | 2 | arm 1: Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes arm 2: TOBRADEX 1 drop 4 times daily in both eyes | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days intervention 2: TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days | intervention 1: Tobramycin 0.3%/Dexamethasone 0.05% intervention 2: TOBRADEX | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00576251 |
[
0
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases | Primary Endpoints:
1. Engraftment of donor cells
2. Regimen related toxicities
Secondary Endpoints:
1. Disease-free survival
2. Overall survival | Hematological Neoplasms Hematopoietic Stem Cell Transplantation | Allogenic stem cell transplant Hematologic diseases | null | 1 | arm 1: Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 | [
5
] | 1 | [
0
] | intervention 1: Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1 | intervention 1: Busulfex, Fludarabine, ALemtuzumab | 1 | Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 0 | NCT00582894 |
[
5
] | 20 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.
In addition, the effect of prophylactic treatment on the joint function, the numbe... | null | Hematologic Disease Hemophilia A | Coagulation Disorders | null | 1 | arm 1: On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose. | [
0
] | 1 | [
0
] | intervention 1: One group two treatment schedules, first on-demand then switch to prophylaxis | intervention 1: Kogenate (BAY14-2222) | 11 | Aurora | Colorado | United States | -104.83192 | 39.72943
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Houston | Texas | United States | -95.36327 | 29.76328
Strasbourg | N/A | France | 7.74553 | 48.58392
Florence | N/A | Italy | 11.24626 | 43.77925
Pavia | N/A | Italy | 9.15917 | 45.19205
Roma | ... | 0 | NCT00586521 |
[
3
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study is being done to see if St. John's wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes. | Eligibility criteria:
1. Established diagnosis of IBS
2. 18-70 years of age
4\) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study
You will be asked to do the following:
* Undergo a screening interview and physical examination
*... | Irritable Bowel Syndrome | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day intervention 2: Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day | intervention 1: St. John's wort intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00587860 | |
[
3
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity,... | Patients will need to come for 24 study visits in all. Most study visits will take about 2 hours. At some of these study visits, the doctor
* Will do a physical exam
* Will take blood for routine lab tests
* Will do a urinalysis
* Will administer study medication Some study visits may be longer because patient will ha... | Pancreatic Cancer | advanced unresectable metastatic endocrine tumors | null | 1 | arm 1: Protocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin.
Premedications: Dexamethasone, Ondansetron | [
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Every 28 Days: Avastin 5mg/kg iv days 1 and 15 intervention 2: Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5 intervention 3: Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1 intervention 4: Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5 intervention 5: Premedication: De... | intervention 1: Avastin intervention 2: Fluorouracil intervention 3: Doxorubicin intervention 4: Streptozocin intervention 5: Dexamethasone intervention 6: Ondansetron | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00609765 |
[
0
] | 44 | RANDOMIZED | FACTORIAL | null | 0NONE | true | 0ALL | false | To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetic... | This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for pharmacokinetics (PK) sampling and a follow-up visit. The scr... | Healthy | Healthy Subjects Pharmacokinetics study Pharmacokinetics of medications | null | 6 | arm 1: Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID arm 2: Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID arm 3: Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir ... | [
1,
1,
1,
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 400mg BID intervention 2: 1400mg BID, 700 mg BID or 1400 mg QD intervention 3: 100 mg BID or QD | intervention 1: Raltegravir intervention 2: Fosamprenavir intervention 3: Ritonavir | 0 | null | 0 | NCT00614991 |
[
2
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic ... | The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms. | Seasonal Allergic Rhinitis | Sublingual immunotherapy Rhinitis Conjunctivitis Allergen challenge Allergen exposition chamber Grass pollen tablet Allergic rhinoconjunctivitis | null | 2 | arm 1: 300 IR grass pollen allergen extract tablet arm 2: Placebo tablet | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 300 IR grass pollen allergen extract tablet once daily during four months intervention 2: Placebo tablet once daily during four months | intervention 1: 300 IR grass pollen allergen extract tablet intervention 2: Placebo tablet | 1 | Vienna | N/A | Austria | 16.37208 | 48.20849 | 0 | NCT00619827 |
[
3
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary... | The specific aims of this study are to collect preliminary data relevant to the following hypotheses:
1. Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
2. Secondary Hypotheses: Combined CBT plus medication will be superi... | Generalized Anxiety Disorder | Generalized Anxiety Disorder Cognitive Behavioral Therapy Psychotherapy plus medication Combined treatment | null | 2 | arm 1: Patients who receive combined cognitive behavioral therapy (CBT) plus medication (venlafaxine XR, flexibly dosed between 75-225 mg/day) treatment for GAD. CBT was once/week sessions for 12 weeks. Medication continued for the full 6 months. arm 2: These patients receive only medication treatment for GAD. Patients... | [
0,
1
] | 2 | [
5,
0
] | intervention 1: This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxi... | intervention 1: Cognitive Behavioral Therapy intervention 2: Venlafaxine XR | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00620776 |
[
4
] | 405 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery. | This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.
Patients underwent a primary unilateral first metat... | Pain | Pain | null | 3 | arm 1: Tablet arm 2: Oxycodone HCl 5mg/Niacin 30mg tablet arm 3: Oxycodone HCl 7.5mg/Niacin 30mg tablet | [
2,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 2 tablets every 6 hours for 48 hours intervention 2: 2 tablets every 6 hours for 48 hours intervention 3: 2 tablets every 6 hours for 48 hours | intervention 1: Placebo intervention 2: Acurox 5/30 mg intervention 3: Acurox 7.5/30 | 0 | null | 0 | NCT00654069 |
[
4
] | 1,498 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 1FEMALE | true | The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women. | Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on... | Cognition Aging | breast cancer Tamoxifen Raloxifene hormone therapy | null | 2 | arm 1: Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment. arm 2: Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: oral tamoxifen plus placebo daily for 5 years intervention 2: oral raloxifene plus placebo daily for 5 years | intervention 1: tamoxifen intervention 2: raloxifene | 134 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Camp Pendleton | California | United States | -117.44759 | 33.35731
Duarte | California | United States | -117.97729 | 34.13945
Duarte | California | United States | -117.97729 | 34.13945
Duarte | Californ... | 0 | NCT00687102 |
[
1
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | In this randomized, double-blind, placebo controlled trial we used positron emission tomography to determine if lovastatin or recombinant human activated protein C exhibit anti-inflammatory effects in humans following intrabronchial installation of lipopolysaccharide (LPS or endotoxin). | Quantitative, noninvasive biomarkers for lung-specific inflammation have yet to be developed but can potentially contribute significantly to the development of therapies to treat lung inflammation. The purpose of this study was to demonstrate that positron emission tomographic (PET) imaging with \[18F}fluorodeoxyglucos... | Lung Inflammation | randomized positron emission tomography lung inflammation lovastatin recombinant human activated protein C endotoxin fluorodeoxyglucose | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 4 | [
0,
0,
0,
2
] | intervention 1: Placebo pill every four hours, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS intervention 2: lovastatin pill every four hours, total of 80 milligrams a day, star... | intervention 1: placebo pill and placebo IV intervention 2: Lovastatin pill and placebo IV intervention 3: placebo pill and recombinant human activated protein C IV intervention 4: Endotoxin | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00741013 |
[
0
] | 43 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis | null | Vasomotor Rhinitis | non-allergic rhinitis, laryngopharyngeal reflux | null | 2 | arm 1: esomeprazole 40mg po bid arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 40mg by mouth twice daily intervention 2: None | intervention 1: esomeprazole intervention 2: placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00745849 |
[
4
] | 259 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia. | In the western world, there are several people affected by chronic insomnia. Numerous studies estimate that 30% to 40% of the general population is affected at some time in their lives with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime sympt... | Sleep Initiation and Maintenance Disorders | Chronic Insomnia DIMS (Disorders of Initiating and Maintaining Sleep) Disorders of Initiating and Maintaining Sleep Insomnia Disorder Sleep Initiation Dysfunction Transient Insomnia Drug Therapy Sleep Disorders, Intrinsic | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks. intervention 2: Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks. | intervention 1: Ramelteon intervention 2: Placebo | 0 | null | 0 | NCT00756002 |
[
5
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks. | null | Intraocular Pressure | IOP lowering efficacy and safety of Azopt plus Travatan | null | 2 | arm 1: Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) arm 2: Travoprost 0.004% (once daily) + Tears Naturale (twice daily) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) intervention 2: Travoprost 0.004% (once daily) + Tears Naturale (twice daily) | intervention 1: Travoprost 0.004% + Brinzolamide 1.0% intervention 2: Travoprost 0.004% + Tears Natural | 0 | null | 0 | NCT00758342 |
[
4
] | 19 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | true | 0ALL | false | Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method. | null | Dental Plaque | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Brush teeth and evaluate plaque score after one use of the study toothpaste intervention 2: Brush teeth and evaluate plaque score after one use of the study toothpaste | intervention 1: Sodium Monofluorophosphate intervention 2: Triclosan/Fluoride/Copolymer | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00759031 | |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis. | This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaq... | Psoriasis | Plaque Type Psoriasis Topical | null | 2 | arm 1: AN2728 Ointment, 5% arm 2: AN2728 Ointment Vehicle | [
1,
2
] | 2 | [
0,
0
] | intervention 1: AN2728 Ointment, 5%, twice daily for 4 weeks intervention 2: AN2728 Ointment Vehicle, twice daily for 4 weeks. | intervention 1: AN2728 intervention 2: AN2728 Ointment Vehicle | 1 | Mexico City | Mexico City | Mexico | -99.12766 | 19.42847 | 0 | NCT00759161 |
[
3
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a study to test the safety and efficacy of an investigational chemotherapy agent in patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medi... | Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United States. The majority of deaths occur in men with androgen-independent prostate cancer \[AIPC\]. Although 80% of men with advanced cancer will initially respond to androgen ablation with disease regression or stabilization, their mali... | Prostate Cancer | Aplidin Plitidepsin Prostate Cancer | null | 1 | arm 1: Aplidin (Plitidepsin) | [
0
] | 1 | [
0
] | intervention 1: Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks. | intervention 1: Aplidin (plitidepsin) | 2 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00780975 |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development. | Estimation of Relative Bioavailability | Hypercholesterolemia | Cardiovascular Diseases | null | 2 | arm 1: Extemporaneous preparation suspension Atorvastatin prototype formulation arm 2: Commercial atorvastatin tablet (Lipitor®) | [
5,
5
] | 2 | [
0,
0
] | intervention 1: A single dose of 80 mg Atorvastatin suspension intervention 2: A single dose of 80 mg Lipitor tablet | intervention 1: Atorvastatin suspension intervention 2: Lipitor | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00844376 |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days. | null | Heartburn | null | 3 | arm 1: Famotidine/antacid combination tablet with water arm 2: Famotidine/Antacid EZ Chew tablet without water arm 3: Famotidine/Antacid EZ Chew tablet with water | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods intervention 2: A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods intervention 3: A single dose of famotidine/antacid combination EZ Chew tablet ... | intervention 1: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet intervention 2: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water intervention 3: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water | 0 | null | 0 | NCT00944671 | |
[
4
] | 105 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Dexmedetomidine is an alpha 2-adrenoreceptor agonist, which provides sedation, analgesia and anxiolysis in clinical practice (Cortinez et al., 2004,Hall et al., 2000). Three types of alpha 2-adrenergic receptor subtypes are found in the human body and they have been designated alpha 2A, alpha 2B and alpha 2C. The alpha... | The study protocol was approved by our local Institutional Review Board and written consent was obtained from all the participants. Eligibility for recruitment included American Society of Anesthesiologists (ASA) physical status I and II, age between 18 and 50 years of age with 4 bilateral impacted third molar teeth sc... | Third Molar Extraction | Analgesia Dental pain Dexmedetomidine Pain Peripheral effects | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Preoperative normal saline infusion and 1mcg/kg dexmedetomidine infiltrated locally to wound at the end of operation. intervention 2: Same volume of normal saline as dexmedetomidine is infiltrated and IV infusion. intervention 3: IV dexmedetomidine 1mcg/kg peroperative and normal saline infiltrated to w... | intervention 1: local dexmedetomidine intervention 2: Peripheral normal saline intervention 3: IV dexmedetomidine | 0 | null | 0 | NCT00971178 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absor... | Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of Lamivudine, Stavudine and Nevirapine in HIV-infected subjects who were receivi... | HIV/AIDS | HIV;Bioequivalence;Triomune | null | 2 | arm 1: generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune) arm 2: 3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day intervention 2: Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily. | intervention 1: Triomune intervention 2: Zerit/Epivir/Viramune | 1 | Kampala | N/A | Uganda | 32.58219 | 0.31628 | 0 | NCT01025830 |
[
2
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | null | The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when a... | null | Healthy Subjects Bioavailability Pharmacokinetics | Healthy subjects Bioavailability Pharmacokinetics Trazodone Steady-state | null | 2 | arm 1: OAD: Once A Day arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Dosage form:
Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study).
Dose regimen:
75 mg trazodone HCl (½ x 150 mg extended-release c... | intervention 1: Trazodone HCl intervention 2: Trazodone HCl | 0 | null | 0 | NCT01121926 |
[
5
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Elderly persons with dementia are at risk for seizures, however, traditional anticonvulsants are poorly tolerated in this population. Our goal is to examine Levetiracetam (Keppra) in elderly dementia patients with seizures. While it has been established that Keppra controls seizures in this age group, it is important t... | This is a prospective, phase 4, open label, twelve week study. The study will consist of a 4 week titration phase followed by an 8 week assessment phase. All clinic visits will be conducted at Drexel University College of Medicine Department of Neurology at 219 N. Broad St., Phila., PA.
Visit one will include reviewin... | Epilepsy | null | 1 | arm 1: Levetiracetam was titrated over 4 weeks, with initial dosing of 250 mg bis in die (BID). Dosing was flexible and was based on the prescribing physician's discretion. | [
0
] | 1 | [
0
] | intervention 1: Titration of Keppra will start at 250 mg by mouth twice daily for three days. Then 500 mg by mouth twice daily for three days. Then 750 mg by mouth twice daily for the duration of the study, or for as long as treatment is necessary. This titration schedule is subject to change based on subject's tolerab... | intervention 1: Levetiracetam | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT01318408 | |
[
2
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | This was a non-randomized, open label study in healthy male and female volunteers. A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone propionate on Days 2-6. Subjects remained resident in... | null | Healthy Subjects | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. intervention 2: Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6 | intervention 1: Ketorolac tromethamine intervention 2: Fluticasone Propionate | 1 | Manchester | N/A | United Kingdom | -2.23743 | 53.48095 | 0 | NCT01365611 | |
[
5
] | 245 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients. | null | Inflammation | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months intervention 2: The control arm is the standard local ... | intervention 1: CsA+Rapamune+CS intervention 2: CsA+MMF+CS | 4 | Tehran | N/A | Iran | 51.42151 | 35.69439
Tehran | N/A | Iran | 51.42151 | 35.69439
Tehran | N/A | Iran | 51.42151 | 35.69439
Tehran | N/A | Iran | 51.42151 | 35.69439 | 0 | NCT01601821 | |
[
5
] | 53 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal int... | This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of ... | Schizophrenia | Schizophrenia Risperidone Risperdal consta | null | 1 | arm 1: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and... | [
0
] | 1 | [
0
] | intervention 1: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decr... | intervention 1: Risperidone prolonged release | 5 | Curitiba | N/A | Brazil | -49.27306 | -25.42778
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642
Salvador | N/A | Brazil | -38.49096 | -12.97563
São Paulo | N/A | Brazil | -46.63611 | -23.5475 | 0 | NCT01726335 |
[
5
] | 39 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in Thai participants with chronic (lasting a long time) non-malignant (non-cancerous) pai... | This is an open label (all people know the identity of the intervention), single arm study to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic non-malignant pain (except for headaches or central spinal cord mediated pain). The study will consist of 2 phases: stabilization phase (up to 7 ... | Chronic Pain | Chronic Pain Chronic Non-Malignant Pain TTS-fentanyl Durogesic | null | 1 | arm 1: Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in st... | [
0
] | 2 | [
0,
0
] | intervention 1: Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escala... | intervention 1: TTS-Fentanyl intervention 2: Morphine | 2 | Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398 | 0 | NCT01816243 |
[
3
] | 45 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months. | null | Liver Cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle. intervention 2: 1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle. | intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] | 7 | Melbourne | N/A | Australia | 144.96332 | -37.814
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Singapore | N/A | Singapore | 103.85007 | 1.28967
Kueishan | N/A | Taiwan | N/A | N/A
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.0530... | 0 | NCT02013830 | |
[
5
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. | This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomize... | Dilated Cardiomyopathy | Coenzyme O10 Children Idiopathic Dilated Cardiomyopathy | null | 2 | arm 1: Known cases of idiopathic dilated cardiomyopathy who received supplementation of coenzyme Q10 as a part of their medical regimen.
Dosage administered: 2 milligram/kilogram/day in 2 or 3 divided doses, these being increased to the maximum dose of 10 milligram/kilogram/day according to tolerance or the appearance... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance intervention 2: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance | intervention 1: Coenzyme Q10 intervention 2: Placebo | 1 | Tehran | Tehran Province | Iran | 51.42151 | 35.69439 | 0 | NCT02115581 |
[
3
] | 11 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. The primary o... | null | Akathisia, Drug-Induced Dyskinesia, Drug-Induced Parkinsonian Disorders | Anti-Dyskinesia Agents Antipsychotic Agents | null | 2 | arm 1: Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period. arm 2: Participants received one matching placeb... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: capsules intervention 2: capsules | intervention 1: Preladenant intervention 2: Placebo | 0 | null | 0 | NCT00686699 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | Study to evaluate the safety, tolerability, 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. The study consisted of a 4-week screening period, during which participants' galactosidase (GLA) genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat. Participants were required to have α-Gal A activity res... | Fabry Disease | Amicus Therapeutics AT1001 Galafold Migalastat Substrate | null | 1 | arm 1: Migalastat 150 milligrams (mg) was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: migalastat HCl | 2 | Paris | N/A | France | 2.3488 | 48.85341
London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00283933 |
[
3
] | 265 | RANDOMIZED | PARALLEL | 0TREATMENT | null | false | 0ALL | false | The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior tre... | null | Cirrhosis, Liver | Hepatitis C liver fibrosis | null | 3 | arm 1: Participants received GI262570 0.5 milligrams (mg) tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. arm 2: Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to break... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: GI262570 0.5 mg intervention 2: GI262570 1.0 mg intervention 3: Placebo | intervention 1: GI262570 0.5 mg intervention 2: GI262570 1.0 mg intervention 3: Placebo | 121 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
North Little Rock | Arkansas | United States | -92.26709 | 34.76954
Bakersfield | California | United States | -119.01871 | 35.37329
La Jolla | California | United States | -117.2742 | 32.84727
Los Angel... | 0 | NCT00244751 |
[
3
] | 111 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanc... | null | Pancreatic Neoplasms | Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks intervention 2: Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. intervention 3: Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of e... | intervention 1: Gemcitabine intervention 2: AG-013736 intervention 3: Gemcitabine | 38 | Antioch | California | United States | -121.80579 | 38.00492
Berkeley | California | United States | -122.27275 | 37.87159
Concord | California | United States | -122.03107 | 37.97798
Concord | California | United States | -122.03107 | 37.97798
Stamford | Connecticut | United States | -73.53873 | 41.05343
Miami | Flori... | 0 | NCT00219557 |
[
2,
3
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung. | null | Osteosarcoma Metastatic | Osteosarcoma relapsed progressive metastatic lung | null | 2 | arm 1: Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles. arm 2: The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg... | [
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Cisplatin liposomal | 2 | New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00102531 |
[
2,
3
] | 144 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2. The trial was to be stopped if no participants showed a response in stage 1. POC was achieved if at least 2 participants out of 1... | null | Acute Myeloid Leukemia Myelodysplastic Syndromes | AML MDS high risk myelodysplastic syndrome | null | 9 | arm 1: Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity. arm 2: Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of un... | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Itraconazole was commercially available. intervention 2: PKC412 was supplied as soft gelatin capsules containing 25 mg PKC412. | intervention 1: Itraconazole intervention 2: PKC412 | 4 | Los Angeles | California | United States | -118.24368 | 34.05223
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00045942 |
[
3
] | 176 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions. | Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day.... | Myelodysplastic Syndrome Iron Overload | ICL670 Deferasirox Iron chelation Chelator Desferal | null | 1 | arm 1: Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS | [
0
] | 1 | [
0
] | intervention 1: 20 mg/kg/day over one year in patients with MDS | intervention 1: Deferasirox | 48 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Concord | California | United States | -122.03107 | 37.97798
Duarte | California | United States | -117.97729 | 34.13945
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | Ca... | 0 | NCT00110266 |
[
2
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 2MALE | false | The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.
Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum. | PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infec... | HIV Infections | null | 5 | arm 1: Intravenous placebo for PRO 140 arm 2: 0.1 mg/kg PRO 140 by intravenous infusion arm 3: 0.5 mg/kg PRO 140 by intravenous infusion arm 4: 2.0 mg/kg PRO 140 by intravenous infusion arm 5: 5.0 mg/kg PRO 140 by intravenous infusion | [
2,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Monoclonal antibody to CCR5 | intervention 1: PRO 140 | 1 | Lincoln | Nebraska | United States | -96.66696 | 40.8 | 0 | NCT00110591 | |
[
4
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 1FEMALE | false | This is a multi-center study to evaluate hormone levels with the oral contraceptive regimen DR-1021. | Female volunteers, aged 18-35 years old who met all Inclusion and no Exclusion Criteria, were enrolled in this study. All participants were current users of a standard 21/7 oral contraceptive regimen (21 days of combination progestin/estrogen followed by 7 days placebo) and had completed at least one 28-day cycle prior... | Healthy | null | 2 | arm 1: After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consistin... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus seven 10 μg EE tablets. intervention 2: Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. intervention 3: Twenty-one 150 μg desogestrel/20... | intervention 1: DR-1021 intervention 2: Mircette® intervention 3: Kariva® | 4 | Lawrenceville | New Jersey | United States | -74.7296 | 40.29733
Columbus | Ohio | United States | -82.99879 | 39.96118
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00544882 | |
[
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require CPB. | null | Cardiac Surgery Subjects Subjects Undergoing CABG and/or Cardiac Valve Replacement | multi-center placebo-controlled randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. intervention 2: Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB. intervention 3: Placebo will begin immediately following cross-clamp release and 12 hour... | intervention 1: sitaxsentan (Thelin) intervention 2: sitaxsentan (Thelin) intervention 3: Placebo | 3 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charleston | South Carolina | United States | -79.93275 | 32.77632
Chattanooga | Tennessee | United States | -85.30968 | 35.04563 | 0 | NCT00838383 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)" | null | Breast Cancer | Prot_000.pdf:
Page: 1
Protocol Number: CA139387
Date: 25-May-2005
Clinical Protocol CA139387
Rollover Study of weekly Paclitaxel (BMS-181339) in Patients with Breast Cancer
Study Director:
Taku Seriu, M.D. PhD., Director
24-hr Emergency Telephone Number ... | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent | intervention 1: Paclitaxel | 4 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Hiroshima | Hiroshima | Japan | 132.45 | 34.4
Kagoshima | Kagoshima-ken | Japan | 130.55 | 31.56667
Toshima-ku | Tokyo | Japan | N/A | N/A | 0 | NCT00971945 | |
[
3
] | 387 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and... | null | Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia | Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML) | null | 1 | arm 1: Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance. | [
0
] | 1 | [
0
] | intervention 1: Tablets; oral; 70 mg BID, depending on response | intervention 1: Dasatinib | 85 | Anaheim | California | United States | -117.9145 | 33.83529
Loma Linda | California | United States | -117.26115 | 34.04835
Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Vallejo | California | United States | -122.25664 | 38.10409
Hartford... | 1 | NCT00101660 |
[
2
] | 41 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study. | null | Lung Cancer Pancreatic Cancer Esophageal Cancer | Advanced Cancer AMG 706 Panitumumab Gemcitabine-Cisplatin | null | 6 | arm 1: Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle. arm 2: AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, ... | [
0,
0,
0,
0,
0,
0
] | 4 | [
0,
2,
0,
0
] | intervention 1: AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1. intervention 2: Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week c... | intervention 1: AMG 706 intervention 2: Panitumumab intervention 3: Gemcitabine intervention 4: Cisplatin | 0 | null | 1 | NCT00101907 |
[
3
] | 184 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1. | This is a multicenter, double-blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.
One hundred eighty (180) subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mg/day of lenalidomide or placebo (90 subjects per treat... | Complex Regional Pain Syndrome, Type I | CRPS RSDS Pain CC-5013 Revlimid Complex Regional Pain Syndrome Reflex Sympathy Dystrophy Syndrome Lenalidomide CRPS Type I Celgene | null | 2 | arm 1: 10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure. arm 2: Placebo orally f... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Two 5 mg capsules taken one time per day intervention 2: Two placebo capsules taken one time per day | intervention 1: lenalidomide intervention 2: Placebo | 27 | Peoria | Arizona | United States | -112.23738 | 33.5806
La Jolla | California | United States | -117.2742 | 32.84727
Loma Linda | California | United States | -117.26115 | 34.04835
Palm Bay | Florida | United States | -80.58866 | 28.03446
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | Un... | 1 | NCT00109772 |
[
4
] | 1,850 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinical... | null | Type 1 Diabetes | Diabetes mellitus type 1 | null | 2 | arm 1: candesartan cilexetil 32 mg once daily arm 2: control | [
0,
4
] | 1 | [
0
] | intervention 1: 32 mg oral tablet | intervention 1: candesartan | 0 | null | 1 | NCT00252720 |
[
4
] | 5,238 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate... | null | Type 1 Diabetes | Diabetes Mellitus, Insulin-Dependent | null | 2 | arm 1: Placebo arm 2: candesartan cilexetil | [
4,
0
] | 1 | [
0
] | intervention 1: 32 mg once daily oral tablet given over 60 months | intervention 1: candesartan cilexetil | 3 | Herston | N/A | Australia | 153.01852 | -27.44453
Perth | N/A | Australia | 115.8614 | -31.95224
Odense | N/A | Denmark | 10.38831 | 55.39594 | 1 | NCT00252733 |
[
4
] | 504 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release h... | Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short duration of action that require dosing every 4 to 6 hours. To counterbalance the drawback of repeated opioid intake, sustained-release formulations of oxycodone and hydromorphone were developed that allow twice-daily dosing. Sub... | Pain | chronic noncancer pain pain analgesia analgesic opioid oxycodone hydromorphone | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 8 to 32 mg once daily for 52 weeks (flexible dosing) intervention 2: 10, 20, or 40 mg twice a day for 52 weeks (flexible dosing) | intervention 1: OROS hydromorphone HCl intervention 2: Oxycodone | 52 | Brno | N/A | Czechia | 16.60796 | 49.19522
Pilsen | N/A | Czechia | 13.37759 | 49.74747
Prague | N/A | Czechia | 14.42076 | 50.08804
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Esbjerg | N/A | Denmark | 8.45187 | 55.47028
Nyborg | N/A | Denmark | 10.78964 | 55.31274
Svendborg | N/A | Denmark | 10.60677 | 55.05982
... | 1 | NCT00261495 |
[
4
] | 1,053 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (ex... | null | Gastric Cancer | Gastric Cancer | null | 2 | arm 1: In Arm A, S-1 25 mg/m² was administered orally BID from Day 1 through Day 21 followed by a recovery period from Days 22 through Day 28. On Day 1, the morning dose of S-1 was administered before cisplatin 75 mg/m2 administration as a 1- to 3-hour IV infusion. This regimen was repeated every 4 weeks. S-1 was admin... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day... | intervention 1: S-1/Cisplatin intervention 2: 5-FU/cisplatin | 33 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Burbank | California | United States | -118.30897 | 34.18084
Gilroy | California | United States | -121.56828 | 37.00578
Los Angeles | California | United States | -118.24368 | 34.05223
Palm Springs | California | United States | -116.54529 | 33.8303
San Franci... | 1 | NCT00400179 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous effusions and lymphangioleiomyomas. Treatment of many of these symptoms h... | Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous ascites, chylous pleural effusions, chyluria, peripheral lymphedema, and/... | Lymphangioleiomyomatosis Lymphangiomyomas Pleural Effusions Ascites | Chylous Ascites Chylous Pleural Effusion Inhibitory Effects Lymphangioleiomyoma Somatostatin Lymphangioleiomyomatosis (LAM) | null | 1 | arm 1: Patients with lymphangioleiomyomatosis and lymphatic tumors, ascites or pleural effusions who are symptomatic will receive subcutaneous injections of octreotide starting at a dose of 100 micrograms per day. Doses will be gradually increased to a maximum of 800 micrograms per day, two months after enrollment, if ... | [
0
] | 1 | [
0
] | intervention 1: Treatment with octreotide starts at a dose of 50 micrograms(ug) twice a day which is increased to 100 ug twice a day after two weeks and to 200 ug twice a day two weeks later. After two months, if there is no response the dose shall be increased to 400 ug twice a day. | intervention 1: Octreotide | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00005906 |
[
2,
3
] | 49 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases. | OBJECTIVES:
* Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases (phase I accrual completed).
* Determine the safety and feasibility of this treatment regimen in these patients.
* Determine the efficacy of this treatment re... | Metastatic Cancer | tumors metastatic to brain | null | 1 | arm 1: Patients will be treated with vinorelbine on days 1 and 8 of each cycle; temozolomide will be administered on days 1 to 7 and 15 to 21 of each cycle. The dose level of temozolomide will be given at a dose of 150 mg/m2/day. A cycle will be defined as 28 days of treatment. | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: temozolomide intervention 2: vinorelbine tartrate | 2 | Chicago | Illinois | United States | -87.65005 | 41.85003
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00026494 |
[
4
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM). Study participants will include infants in the United States and Canada who have HSV disease of the skin, eyes, and mouth, wit... | Neonatal herpes simplex virus (HSV) disease complicates approximately one in every 3,000 births in the United States. This study will be a placebo-controlled Phase III evaluation of suppressive therapy with oral Acyclovir suspension following neonatal HSV infections limited to the skin, eyes, and mouth (SEM). This stud... | Herpes Simplex | Herpes Simplex, Acyclovir, Infants | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Oral suspension 300 mg/m\^2/dose, 3 times per day (TID), for 6 months. intervention 2: Placebo identical to oral acyclovir suspension in appearance and taste. | intervention 1: Acyclovir intervention 2: Placebo | 28 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Diego | California | United States | -117.16472 | 32.71571
Stanford | California | United States | -122.16608 | 37.42411
Jacksonville | Florida | United States | -81.65565 | 30.33218
Chicago | I... | 0 | NCT00031447 |
[
4
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of this study is to test whether long term treatment with acyclovir given orally (by mouth) improves the outcome for infants with herpes simplex virus infection of the brain or spinal cord (known as the central nervous system \[CNS\]). Infants with herpes viral infection of the CNS that has or has not sprea... | Neonatal herpes simplex virus (HSV) disease complicates approximately 1 in every 3,000 deliveries in the United States, resulting in an estimated 1, 500 cases annually in this country. HSV-1 and HSV-2 infections in the neonate can manifest as: disseminated disease; central nervous system (CNS) disease; or disease limit... | Herpes Simplex | acyclovir, central nervous system, Herpes Simplex Virus | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral banana flavored acyclovir suspension: 300 mg/m\^2/dose three times a day (TID), to be given at least 6 to 8 hours apart for 6 months. Dosage adjustments will be made monthly to compensate for increases in body surface area. intervention 2: Oral banana flavored placebo suspension: to be given at lea... | intervention 1: Acyclovir intervention 2: Placebo | 29 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Stanford | California | United States | -122.16608 | 37.42411
Jacksonv... | 0 | NCT00031460 |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that ... | OBJECTIVES:
I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.
II. Determine the duration of remission and survival of patients treated with this d... | Extensive Stage Small Cell Lung Cancer Limited Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer | null | 1 | arm 1: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: Given IV | intervention 1: becatecarin | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00084487 | |
[
3,
4
] | 77 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | true | Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition. | II. SPECIFIC AIMS
Severe osteopenia is a prevalent complication of anorexia nervosa (AN), affecting over half of all women with this disease. Loss of 25-50% of total bone mass occurs frequently and is often permanent. Although anorexia nervosa affects from 0.5-1.0% of college age women, no successful therapeutic inter... | Anorexia Nervosa | Eating Disorders Osteopenia | null | 4 | arm 1: Placebo Actonel (risedronate) and active testosterone patch arm 2: Active Actonel (risedronate) and active testosterone patch arm 3: Active Actonel (risedronate) and placebo testosterone arm 4: Placebo testosterone patch and placebo Actonel (risedronate) | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Testosterone patch 150mcg daily intervention 2: Actonel (risedronate) 35mg PO one time weekly intervention 3: Placebo tablet identical in appearance to active Actonel (risedronate) tablet intervention 4: Placebo patch identical in appearance to testosterone patch | intervention 1: Testosterone intervention 2: Actonel (risedronate) intervention 3: Placebo Actonel (risedronate) intervention 4: Placebo testosterone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00089843 |
[
3
] | 32 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (pr... | null | Melanoma Skin Neoplasms | melanoma antiangiogenesis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: VEGFR \[vascular endothelial growth factor Receptor\] and PDGFR \[Platelet-Derived Growth Factor Receptor\] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs. | intervention 1: Axitinib [AG-013736] | 12 | Orange | California | United States | -117.85311 | 33.78779
Miami Beach | Florida | United States | -80.13005 | 25.79065
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Clairton | Pe... | 0 | NCT00094107 |
[
4
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine. | null | Hepatitis B Chronic Disease | chronic hepatitis B infection | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks intervention 2: Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks | intervention 1: entecavir intervention 2: adefovir | 24 | San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Torrance | California | United States | -118.34063 | 33.83585
Miami | Florida | United States | -80.19366 | 25.77427
North Miami Beach | Florida | United States | -80.16255 | 25.93315
Baltim... | 0 | NCT00096785 |
[
3
] | 126 | RANDOMIZED | PARALLEL | 9OTHER | 3TRIPLE | false | 0ALL | true | The objective of this study is to identify immune intervention strategies that will preserve residual beta cell function at the onset of type 1 diabetes. Scientific evidence developed over the last 10 - 20 years suggests that type 1 diabetes is a chronic, slowly progressive autoimmune disease and that clinical symptoms... | Design of Study:
The study is a multi-center, three-arm, randomized, double-masked, placebo-controlled clinical trial. Comparisons will be made among the three groups, which are:
* Mycophenolate mofetil active drug with Daclizumab (DZB) placebo IV
* Mycophenolate mofetil active drug with active Daclizumab IV
* Mycoph... | Diabetes Mellitus, Type 1 | immunosuppressive therapy Type 1 Diabetes TrialNet TrialNet POPPII POPPII-1 | null | 3 | arm 1: DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and MMF given orally at dose of 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years. arm 2: MMF given orally at dose of 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at... | [
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: Placebo pills taken orally intervention 4: saline intravenous infusions | intervention 1: Mycophenolate mofeteil (MMF) intervention 2: Daclizumab (DZB) intervention 3: Placebo control for Mycophenolate mofeteil (MMF) intervention 4: Placebo control for Daclizumab (DZB) | 11 | Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Stanford | California | United States | -122.16608 | 37.42411
Denver | Colorado | United States | -104.9847 | 39.73915
Gainesville | Florida | United States | -82.32483 | 29.65163
Indianap... | 0 | NCT00100178 |
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