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
] | 434 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone. | Objectives:
Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.
Secondary:
* To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
* T... | Gastric Ulcer | NSAID gastric ulcers Vimovo Naproxen Esomeprazole | null | 2 | arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen (500 mg) dosed twice daily (bid) orally | intervention 1: PN400 (VIMOVO) intervention 2: Naproxen | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00527787 |
[
3
] | 160 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC). | null | Non-small Cell Lung Cancer | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression intervention 2: oral, daily intervention 3: 500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until di... | intervention 1: enzastaurin intervention 2: placebo intervention 3: pemetrexed | 25 | Fayetteville | Arkansas | United States | -94.15743 | 36.06258
Lancaster | California | United States | -118.13674 | 34.69804
Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
Wichita | Kansas | United States | -97.33754 | 37.69224
Scarborough | Main... | 0 | NCT00530621 | |
[
4
] | 677 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to iden... | null | Post-Menopausal Osteoporosis | null | 1 | arm 1: Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study. | [
0
] | 1 | [
0
] | intervention 1: 150 mg orally once monthly for 6 months | intervention 1: Ibandronate | 32 | Tirana | N/A | Albania | 19.81866 | 41.32744
Banja Luka | N/A | Bosnia and Herzegovina | 17.19386 | 44.77842
Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864
Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864
Tuzla | N/A | Bosnia and Herzegovina | 18.66709 | 44.53842
Rijeka | N/A | Croatia | 14.... | 0 | NCT00545779 | |
[
5
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is designed to determine if different doses of buprenorphine (either tapering doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines. | Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Subo... | Opiate Addiction Refractory Pain | drug dependence substance abuse substance use disorders myofascial pain syndrome neuralgia back pain | null | 2 | arm 1: Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. arm 2: Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response) intervention 2: sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (dose... | intervention 1: buprenorphine/naloxone intervention 2: buprenorphine/naloxone | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT00552578 |
[
5
] | 451 | NON_RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | false | Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescriptio... | Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.
Screening visit : \> 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled dur... | Major Orthopaedic Surgery and Renal Impairment | major orthopaedic surgery venous thromboembolic events prevention renal impairment Arixtra anti-Xa activity | null | 1 | arm 1: patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery | [
0
] | 1 | [
0
] | intervention 1: Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery | intervention 1: fondaparinux 1.5 mg/day | 29 | Agen | N/A | France | 0.62055 | 44.20199
Annonay | N/A | France | 4.6707 | 45.23992
Bayonne | N/A | France | -1.473 | 43.49316
Bobigny | N/A | France | 2.45012 | 48.90982
Bordeaux | N/A | France | -0.5805 | 44.84044
Caen | N/A | France | -0.35912 | 49.18585
Clamart | N/A | France | 2.26692 | 48.80299
Clermont-Ferrand |... | 0 | NCT00555438 |
[
0
] | 20 | RANDOMIZED | PARALLEL | 9OTHER | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye. | Dry eye is a chronic condition that is believed to afflict more than 3 million patients in the United States.1 Symptoms of dry eye are very bothersome and impact quality of life, reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry eye are associated with a decreased ability to per... | Dry Eye Syndrome | Treatment Dry Eye | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: blink tears to be used twice a day intervention 3: systane to be used twice a day | intervention 1: Cyclosporin A Restasis® intervention 2: Blink tears intervention 3: Systane | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00565669 |
[
5
] | 37 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | true | 0ALL | false | The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers | null | Bacterial Infections Eye Infections | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: One drop ophthalmic solution at Visit 2 intervention 2: One drop ophthalmic solution at Visit 2 | intervention 1: AzaSite (azithromycin ophthalmic solution) intervention 2: Vigamox (moxifloxacin hydrochloride ophthalmic solution) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00575367 | |
[
3
] | 28 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent patients in spite of methadone maintenance treatment being highly effective for opiate dependence and having excellent treatment retention. Cocaine dependence has remained largely unresponsive to medications both in and outsid... | This 17-week double-blind, placebo controlled randomized pilot clinical trial will provide treatment for 40 cocaine-dependent opioid dependent patients. Participants, aged 18-65 years, will be randomized to receive levetiracetam 3000 mg/day or placebo while concurrently receiving treatment with methadone. Baseline coca... | Cocaine Dependence Opioid Dependency | GABAergic levetiracetam | null | 2 | arm 1: Levetiracetam tablets arm 2: matching placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD... | intervention 1: levetiracetam intervention 2: Placebo | 1 | West Haven | Connecticut | United States | -72.94705 | 41.27065 | 0 | NCT00577005 |
[
3
] | 169 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA. | null | Osteoarthritis of the Knee | Osteoarthritis Knee Lidoderm Lidocaine Topical patch Adjunct therapy | null | 2 | arm 1: Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) arm 2: Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical Patch intervention 2: Topical Patch | intervention 1: Lidoderm (Lidocaine 5% Patch) intervention 2: Placebo Patch | 20 | Paradise Valley | Arizona | United States | -111.94265 | 33.53115
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Milford | Connecticut | United States | -73.0565 | 41.22232
Trumbull | Connecticut | United States | -73.20067 | 41.24287
Clearwater | Flo... | 0 | NCT00589979 |
[
2
] | 10 | NA | SINGLE_GROUP | null | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C. | null | Chronic Hepatitis C | Chronic Hepatitis C Protease Inhibitor | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg) | intervention 1: MP-424 (Telaprevir) | 1 | Kawasaki | Takatsu-ku | Japan | 139.71722 | 35.52056 | 0 | NCT00591214 |
[
0
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.
This research is being done because there is no completely safe and effective prevention for graft-versus-host disea... | null | Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplasia Lymphoma, Non-Hodgkin's Mantle-Cell Lymphoma Hodgkin's Disease Multiple Myeloma Myelofibrosis | null | 0 | null | null | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 60mg/kg/day for two consecutive days (-7,-6). intervention 2: 25mg/m2/day for 5 consecutive days intervention 3: 3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1. intervention 4: 1000 mg will be administered through day +60 and then discontinued if there is no GVHD. interv... | intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Cyclosporine intervention 4: Mycophenolate mofetil intervention 5: Basiliximab | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00594308 | |
[
3
] | 239 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder. | This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population. | Generalized Anxiety Disorder | GAD | null | 2 | arm 1: 500 mg 1 week, followed by 1000 mg for 7 weeks arm 2: 0 mg tablets | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 500 mg for 1 week followed by 1000 mg for 7 weeks intervention 2: 0 mg tablets | intervention 1: SYN111 intervention 2: Placebo | 2 | Atlanta | Georgia | United States | -84.38798 | 33.749
Dayton | Ohio | United States | -84.19161 | 39.75895 | 0 | NCT00595231 |
[
3
] | 602 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD) | null | Pulmonary Disease, Chronic Obstructive | Chronic Obstructive Pulmonary Disease (COPD) COPD GW642444 | null | 2 | arm 1: GW642444 arm 2: None | [
1,
2
] | 6 | [
0,
0,
0,
0,
0,
10
] | intervention 1: GW642444 6.25 intervention 2: once daily intervention 3: GW642444 12.5mcg intervention 4: GW642444 25mcg intervention 5: GW642444 50mcg intervention 6: placebo | intervention 1: GW642444 6.25 intervention 2: GW642444 3mcg intervention 3: GW642444 12.5mcg intervention 4: GW642444 25mcg intervention 5: GW642444 50mcg intervention 6: placebo | 99 | Florence | Alabama | United States | -87.67725 | 34.79981
Jasper | Alabama | United States | -87.27751 | 33.83122
Montgomery | Alabama | United States | -86.29997 | 32.36681
Fullerton | California | United States | -117.92534 | 33.87029
Lakewood | California | United States | -118.13396 | 33.85363
Los Angeles | Califor... | 0 | NCT00606684 |
[
4
] | 263 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomi... | Lipodystrophy HIV Infections | HIV Lipodystrophy Abdominal fat accumulation Growth hormone releasing hormone HIV-associated lipodystrophy Treatment experienced | null | 3 | arm 1: Tesamorelin 2 mg/day for 12 months arm 2: Tesamorelin 2 mg/day for 6 months - Placebo for 6 months arm 3: Placebo 6 months - Tesamorelin 2 mg/day for 6 months | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Tesamorelin intervention 2: Placebo for Tesamorelin | 47 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Indio | California | United States | -116.21677 | 33.7207
Los Angeles | California | United States | -118.24368 | 34.05223
Palm Springs | California | United States | -116.54529 | 33.8303
San Francisco ... | 0 | NCT00608023 |
[
3
] | 94 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relie... | null | Post Operative Pain | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 2: Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 3: 10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention ... | intervention 1: Sufentanil NanoTab intervention 2: Placebo NanoTab intervention 3: Sufentanil NanoTab intervention 4: Sufentanil NanoTab | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00612534 | |
[
4
] | 179 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the safety of long-term treatment with HZT-501. | Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while pa... | Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain | null | 2 | arm 1: HZT-501: ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks | intervention 1: HZT-501 intervention 2: Ibuprofen | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00613106 | |
[
4
] | 901 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy. | Patients undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, and less frequently... | Arthralgia Bunion Hallux Valgus Pain | Acute pain bunionectomy tapentadol | null | 4 | arm 1: placebo 1 capsule q4-6 hrs for 3 days arm 2: oxycodone 10mg capsule q4-6 hrs for 3 days arm 3: Tapentadol (CG5503) 50mg capsule q4-6 hrs for 3 days arm 4: Tapentadol (CG5503) 75mg capsule q4-6 hrs for 3 days | [
2,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 50mg capsule q4-6 hrs for 3 days intervention 2: 75mg capsule q4-6 hrs for 3 days intervention 3: 10mg capsule q4-6 hrs for 3 days intervention 4: 1 capsule q4-6 hrs for 3 days | intervention 1: Tapentadol (CG5503) intervention 2: Tapentadol (CG5503) intervention 3: oxycodone intervention 4: placebo | 7 | Glendale | California | United States | -118.25508 | 34.14251
Pasadena | Maryland | United States | -76.57108 | 39.119
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412
San Marcos | Texas | United State... | 0 | NCT00613938 |
[
2,
3
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin). | The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis. | Moderate or Severe Submental Fullness | null | 4 | arm 1: Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Deoxycholic Acid Injection intervention 2: Placebo | 6 | Carina Heights | N/A | Australia | 153.09126 | -27.50721
Gold Coast | N/A | Australia | 153.43088 | -28.00029
Toorak | N/A | Australia | 145.01438 | -37.84165
Oakville | Ontario | Canada | -79.68292 | 43.45011
Niagara Falls | N/A | Canada | -79.06627 | 43.10012
London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00618722 | |
[
2
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg | This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven daily doses of Proellex® in separate, rising doses. Dosing must be accomplished between menstrual periods. The first six women will complet... | Healthy | Pharmacokinetics | null | 3 | arm 1: Proellex 100 mg daily for 7 days arm 2: Proellex 150 mg daily for 7 days arm 3: Proellex 200 mg daily for 7 days | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days | intervention 1: Proellex | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00619385 |
[
3
] | 128 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months. | null | Persistent or Permanent Non-valvular Atrial Fibrillation | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: ER formulation intervention 2: Oral form | intervention 1: AZD0837 intervention 2: Aspirin | 38 | Aalborg | N/A | Denmark | 9.9187 | 57.048
Arhus N | N/A | Denmark | N/A | N/A
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Esbjerg | N/A | Denmark | 8.45187 | 55.47028
Frederikssund | N/A | Denmark | 12.06896 | 55.83956
Horsens | N/A | Denmark | 9.85034 | 55.86066
Silkeborg | N/A | Denmark | 9.54508 | 56.1697
Svend... | 0 | NCT00623779 | |
[
5
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This proposed study will test the following hypothesis: Treating depression in Hispanics and African Americans with diabetes will improve their HbA1c and quality of life while on intervention and six months after intervention. | The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in clinical trials to be an effective and well tolerated prescription medication that improves the quality and enjoyment of life for adults suffering from depression . Sertraline is an antidepressant and a member of the family of ... | Diabetes Depression | Diabetes Depression diabetes outcomes quality of life | null | 2 | arm 1: Placebo 50 mg up to 100 mg daily for 6 months arm 2: Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 50 mg up to 100 mg daily for 6 months intervention 2: 50 mg up to 100 mg daily for 6 months | intervention 1: sertraline intervention 2: Placebo | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00624013 |
[
4
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass. | The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination. | Growth Hormone Deficiency | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or m... | intervention 1: Placebo intervention 2: Somatropin | 2 | Bad Aibling | N/A | Germany | 12.01055 | 47.8638
München | N/A | Germany | 13.31243 | 51.60698 | 0 | NCT00630487 | |
[
5
] | 668 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment. | null | Type IIa and IIb Hypercholesterolaemia | dyslipidemia | null | 2 | arm 1: Rosuvastatin and Pravastatin arm 2: Rosuvastatin and Atorvastatin | [
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 5mg oral intervention 2: 40mg oral intervention 3: 10mg oral | intervention 1: Rosuvastatin intervention 2: Pravastatin intervention 3: Atorvastatin | 170 | Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Allaire | N/A | France | -2.16514 | 47.63726
Amiens | N/A | France | 2.3 | 49.9
Ancerville | N/A | France | 5.02091 | 48.63574
Angers | N/A | France | -0.55202 | 47.47156
Annecy | N/A | France | 6.12565 | 45.90878
Anzin | N/A | France | 3.50387 | 50.37201
Arles | N/A |... | 0 | NCT00631189 |
[
5
] | 162 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness and safety of tramadol hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain. | This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center and randomized (study drug is assigned by chance) study to compare the effectiveness and safety of tramadol HCl 37.5 mg/acetaminophen 325 mg with gab... | Diabetic Neuropathy | Diabetic neuropathy Ultracet Tramadol hydrochloride Acetaminophen Gabapentin | null | 2 | arm 1: Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3, 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day f... | intervention 1: Tramadol hydrochloride/ Acetaminophen intervention 2: Gabapentin | 0 | null | 0 | NCT00634543 |
[
5
] | 244 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves. | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: Aggressive FPG (fasting plasma glucose) titration target range group arm 2: Conventional FPG (fasting plasma glucose) titration target range group | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL intervention 2: Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL | intervention 1: insulin detemir intervention 2: insulin detemir | 69 | Goodyear | Arizona | United States | -112.35821 | 33.43532
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Searcy | Arkansas | United States | -91.73625 | 35.25064
Artesia | California | United States | -118.08312 | 33.86585
Escondido | California | United States | -117.08642 | 33.11921
Fullerton | Califor... | 0 | NCT00634842 | |
[
2
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma. | null | Asthma | null | 6 | arm 1: Participants receive Montelukast inhalation powder, 0.1 mg.
* Part I: Administered as a single dose followed by at least a 3-day washout period. arm 2: Participants receive Montelukast inhalation powder, 0.3 mg.
* Part I: Administered as a single dose followed by at least a 3-day washout period. arm 3: Partici... | [
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg intervention 2: Placebo dry powder inhaler | intervention 1: Montelukast intervention 2: Placebo | 0 | null | 0 | NCT00636207 | |
[
3
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) ... | null | Attention Deficit Hyperactivity Disorder | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted accor... | intervention 1: Atomoxetine | 11 | Beijing | N/A | China | 116.39723 | 39.9075
Changsha | N/A | China | 112.97087 | 28.19874
Guangzhou | N/A | China | 113.25 | 23.11667
Busan | N/A | South Korea | 129.03004 | 35.10168
Incheon | N/A | South Korea | 126.70515 | 37.45646
Jeonju | N/A | South Korea | 127.14889 | 35.82194
Seoul | N/A | South Korea | 126.9784... | 0 | NCT00636818 | |
[
4
] | 543 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood. | null | Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 135 mg capsule, daily, 12 weeks intervention 2: placebo capsule, daily, 12 weeks intervention 3: 40 mg, tablet, daily, 12 weeks intervention 4: 10 mg capsule, daily, 12 weeks | intervention 1: ABT-335 intervention 2: placebo intervention 3: atorvastatin intervention 4: ezetimibe | 118 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Columbiana | Alabama | United States | -86.60721 | 33.17817
Hueytown | Alabama | United States | -86.99666 | 33.45122
Ozark | Alabama | United States | -85.64049 | 31.45906
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Sierra Vista | Arizona | Un... | 0 | NCT00639158 | |
[
3
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle ... | 20 million Americans are actively treated with statins at an annual cost of 16 billion dollars. Statins are effective therapeutic agents for reducing LDL cholesterol and have documented effectiveness. However, a significant subset of patients (5-18%), cannot tolerate lipid lowering statin therapy due to intolerable mus... | Hypercholesterolemia Statin-Associated Myopathy | Statin related myalgia Hyperlipidemia Red yeast rice Cardiovascular Diseases Nutritional and Metabolic Diseases | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 3 | [
7,
0,
5
] | intervention 1: Four 600mg capsules twice daily for 12 weeks intervention 2: One 20mg capsule twice daily for 12 weeks intervention 3: Weekly sessions each lasting 3 1/2 hours for 12 weeks | intervention 1: Red Yeast Rice intervention 2: Pravastatin intervention 3: Lifestyle modification program | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00639223 |
[
3
] | 382 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone. | Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the cur... | Opioid-Related Disorders | Opioid dependence | null | 2 | arm 1: Buprenorphine/naloxone film strip administered sublingually arm 2: Buprenorphine/naloxone film strip administered buccally | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route intervention 2: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route | intervention 1: Buprenorphine/naloxone Film Strip intervention 2: Buprenorphine/naloxone Film Strip | 3 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Haleyville | Alabama | United States | -87.62141 | 34.22649
Jacksonville Beach | Florida | United States | -81.39314 | 30.29469 | 0 | NCT00640835 |
[
3,
4
] | 156 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-da... | This is a multi-center (conducted in more than one center) study, consisting of two periods: Period 1 is open-label (all people know the identity of the intervention), non-comparative dose titration phase and Period 2 is double blind (neither physician nor participant knows the treatment that the participant receives),... | Pain Cancer | Pain Cancer Fentanyl JNS020QD JNS005 | null | 3 | arm 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end o... | [
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment ... | intervention 1: Fentanyl 1-day transdermal patch (Titration Phase) intervention 2: Fentanyl 1-day transdermal patch (Double Blind Phase) intervention 3: Fentanyl 3-day transdermal patch (Double Blind Phase) intervention 4: Placebo intervention 5: Placebo | 43 | Asahi | N/A | Japan | 140.65 | 35.71667
Asahikawa | N/A | Japan | 142.36489 | 43.77063
Bunkyō City | N/A | Japan | 139.4217 | 35.5331
Chiba | N/A | Japan | 140.11667 | 35.6
Chikushino-shi | N/A | Japan | 130.5156 | 33.49631
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fushimi | N/A | Japan | 138.89742 | 35.11426
Higashi-Ib... | 0 | NCT00644787 |
[
0
] | 65 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 1SINGLE | true | 0ALL | false | The purpose of this study is to determine whether sedation affects saccadic eye movements. | null | Saccadic Eye Movements | Sedation Eye Movements | null | 4 | arm 1: active drug arm 2: sedative arm 3: Sedative arm 4: placebo control | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: sedative intervention 2: Sedative intervention 3: sedative intervention 4: saline placebo | intervention 1: propofol intervention 2: dexmedetomidine intervention 3: Midazolam intervention 4: saline placebo | 1 | Birmingham | Alabama | United States | -86.80249 | 33.52066 | 0 | NCT00646646 |
[
5
] | 101 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | true | The primary purpose of this study is:
1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and post-operative analgesia.
2. To determine an analgesic dose response relationship for dexmedetomidine.
3. Compare recovery characteristics of dexmedetomidine to fentanyl. | null | Tonsillitis | Dexmedetomidine, fentanyl, tonsillectomy and adenoidectomy, | null | 4 | arm 1: Fentanyl 1 micrograms (mcg)/kilogram (kg) arm 2: Fentanyl 2 micrograms (mcg)/kilogram (kg) arm 3: Dexmedetomidine 2 micrograms (mcg)/kilogram (kg) arm 4: Dexmedetomidine 4 micrograms (mcg)/kilogram (kg) | [
1,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Fentanyl 1mcg/kg, Intravenous (IV) intervention 2: Fentanyl 2mcg/kg, Intravenous (IV) intervention 3: Dexmedetomidine, 2mcg/kg, Intravenous (IV) intervention 4: Dexmedetomidine, 4mcg/kg Intravenous (IV) | intervention 1: Fentanyl intervention 2: Fentanyl intervention 3: Dexmedetomidine intervention 4: Dexmedetomidine | 1 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT00654511 |
[
0
] | 171 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.
We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide,... | null | Nausea | null | 4 | arm 1: Ondansetron 4 mg intravenous administration arm 2: Metoclopramide 10 mg intravenous administration arm 3: Promethazine 10 mg intravenous administration arm 4: Volume-matched saline placebo | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 2: 10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter intervention 3: 12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous c... | intervention 1: Ondansetron intervention 2: Metoclopramide intervention 3: Promethazine intervention 4: Normal Saline | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00655642 | |
[
5
] | 56 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study is to evaluate the efficacy and safety of Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (IPL) treatments in Subjects diagnosed with moderate to severe melasma during a 10 week treatment period. | Same as above. | Melasma | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face. intervention 2: Applied once daily at ... | intervention 1: Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% intervention 2: Cetaphil® Moisturizing Cream as Inactive Control | 2 | La Jolla | California | United States | -117.2742 | 32.84727
Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00669071 | |
[
0
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of the study is to determine whether adding a low dose of testosterone to current antidepressant therapy improves depression and fatigue in women who remain depressed despite necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week period.
Testosterone is a hormone that occur... | null | Depression | Depression Major Depressive Disorder | null | 1 | arm 1: Testosterone patch delivering 300mcg daily for 8-weeks. | [
1
] | 1 | [
0
] | intervention 1: Testosterone atch delivering 300mcg daily for 8-weeks | intervention 1: Testosterone | 0 | null | 0 | NCT00676676 |
[
4
] | 96 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipat... | null | Pemphigus Vulgaris (PV) | null | 3 | arm 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks arm 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks intervention 2: Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks intervention 3: Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twic... | intervention 1: Mycophenolate Mofetil 2 g/Day intervention 2: Mycophenolate Mofetil (MMF) 3 g/Day intervention 3: Placebo | 26 | Los Angeles | California | United States | -118.24368 | 34.05223
Atlanta | Georgia | United States | -84.38798 | 33.749
Baltimore | Maryland | United States | -76.61219 | 39.29038
St Louis | Missouri | United States | -90.19789 | 38.62727
New York | New York | United States | -74.00597 | 40.71427
Toronto | Ontario | Ca... | 0 | NCT00683930 | |
[
4
] | 323 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis. | null | Psoriasis | Plaque-type Psoriasis psoriasis | null | 2 | arm 1: U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. arm 2: Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). intervention 2: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding... | intervention 1: U0267 Foam intervention 2: Vehicle foam | 12 | Mobile | Alabama | United States | -88.04305 | 30.69436
Fremont | California | United States | -121.98857 | 37.54827
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Overland Park | Kansas | United States | -94.67079 | 38.98223
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Rochester | Ne... | 0 | NCT00689481 |
[
3
] | 103 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI). | null | Age-Related Memory Disorders | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. intervention 2: A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time. intervention 3: Matching placebo dosi... | intervention 1: LX6171 High Dose intervention 2: LX6171 Low Dose intervention 3: Placebo | 2 | Utrecht | N/A | Netherlands | 5.12222 | 52.09083
Zuidlaren | N/A | Netherlands | 6.68194 | 53.09417 | 0 | NCT00691808 | |
[
2
] | 24 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736. | null | Hepatic Insufficiency | hepatic impairment | null | 3 | arm 1: Subjects with mild hepatic impairment (Child Pugh class A, score 5-6) arm 2: Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9) arm 3: Group 1
1\) subjects with normal hepatic function | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet. intervention 2: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet. intervention 3: Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release t... | intervention 1: AG-013736 intervention 2: AG-013736 intervention 3: AG-013736 | 2 | Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834 | 0 | NCT00692341 |
[
5
] | 28 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial. | This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructe... | Pruritis | Uremic Pruritis | null | 2 | arm 1: 1% pramoxine Sarna lotion arm 2: Placebo Cetaphil lotion | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Active Ingredient: Pramoxine Hydrochloride Inactive ingredients:Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate (\&) PEG-100 Stearate, Isopropyl Myristate, Petrolatum, PEG 8 Stearate, Purified Water, Stearic Acid, Sodium Hydroxide intervention 2: Purified Water, Glycerin, Hyd... | intervention 1: Sarna intervention 2: Cetaphil | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00693654 |
[
4
] | 1,275 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension. | Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause ... | Hypertension | Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks. intervention 2: Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-... | intervention 1: Azilsartan medoxomil and olmesartan intervention 2: Azilsartan medoxomil and olmesartan intervention 3: Azilsartan medoxomil and olmesartan intervention 4: Olmesartan intervention 5: Placebo | 85 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Little Rock | Arkansas | United ... | 0 | NCT00696241 |
[
5
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses. | The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adu... | Actinic Keratosis | null | 1 | arm 1: each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions | [
0
] | 1 | [
0
] | intervention 1: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions | intervention 1: Fluorouracil 0.5% | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00696488 | |
[
4
] | 91 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | null | This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects. | null | Healthy Subjects Sleep Initiation and Maintenance Disorders | Zopiclone Hypnotic Residual effects Eszopiclone | null | 1 | arm 1: All subjects received all three treatments in a randomised order | [
0
] | 1 | [
0
] | intervention 1: Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone | intervention 1: GSK1755165; placebo; zopiclone | 1 | Guildford | Surrey | United Kingdom | -0.57427 | 51.23536 | 0 | NCT00699608 |
[
3
] | 265 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp. | null | Actinic Keratosis | Peplin Actinic keratosis PEP005 | null | 8 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None | [
0,
0,
0,
2,
0,
0,
0,
2
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 0.005%, two days treatment intervention 2: 0.01%, two days treatment intervention 3: 0.015%, two days treatment intervention 4: two days treatment intervention 5: 0.005%, three days treatment intervention 6: 0.01%, three days treatment intervention 7: 0.015%, three days treatment intervention 8: three d... | intervention 1: PEP005 Topical Gel intervention 2: PEP005 Topical Gel intervention 3: PEP005 Topical Gel intervention 4: Vehicle gel intervention 5: PEP005 Topical Gel intervention 6: PEP005 Topical Gel intervention 7: PEP005 Topical Gel intervention 8: Vehicle gel | 28 | Hot Springs | Arizona | United States | N/A | N/A
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Riverside | California | United States | -117.39616 | 33.95335
San Diego | Cal... | 0 | NCT00700063 |
[
4
] | 256 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. | This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extrac... | Pain Post-Operative Pain Third Molar Extraction | null | 2 | arm 1: One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain). arm 2: Eighty subjects will be randomly assigned to the Placebo treatm... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered ... | intervention 1: Ibuprofen 600 mg Extended-Release Tablets intervention 2: Placebo | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00707057 | |
[
4
] | 65 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated. | Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. There is a g... | Dental Caries | toothpaste plaque fluid fluoride | null | 4 | arm 1: Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds. arm 2: Participants brushed for one timed minute with 1.6g... | [
0,
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF intervention 2: Fluoride free toothpaste (0ppmF) | intervention 1: Sodium Fluoride (NaF) intervention 2: Placebo | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 0 | NCT00708305 |
[
3
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections. | null | Skin Structure Infections Bacterial Skin Diseases Staphylococcal Skin Infections | complicated skin | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 300 mg intravenous every 12 hours intervention 2: 450 mg intravenous every 12 hours intervention 3: 100 mg then 50 mg intravenous tigecycline every 12 hours | intervention 1: delafloxacin intervention 2: delafloxacin intervention 3: tigecycline | 14 | Anaheim | California | United States | -117.9145 | 33.83529
Hawaiian Gardens | California | United States | -118.07284 | 33.8314
Oceanside | California | United States | -117.37948 | 33.19587
Santa Ana | California | United States | -117.86783 | 33.74557
Fort Myers | Florida | United States | -81.84059 | 26.62168
Augus... | 0 | NCT00719810 |
[
4
] | 314 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients. | This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and... | Bipolar I Disorder | Bipolar 1 disorder, agitation, acute, treatment | null | 3 | arm 1: Inhaled Staccato Placebo, may repeat after 2 hours x 2 arm 2: Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2 arm 3: Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2 | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Inhaled loxapine Placebo, may repeat after 2 hours x 2 intervention 2: Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2 intervention 3: Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2 | intervention 1: Inhaled Placebo intervention 2: Inhaled loxapine 5 mg intervention 3: Inhaled loxapine 10 mg | 6 | Escondido | California | United States | -117.08642 | 33.11921
Garden Grove | California | United States | -117.94145 | 33.77391
Atlanta | Georgia | United States | -84.38798 | 33.749
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Bellevue | Washington | Uni... | 0 | NCT00721955 |
[
4
] | 333 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis. | null | Allergic Rhinitis | null | 2 | arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray | [
0,
2
] | 2 | [
0,
0
] | intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days | intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray | 0 | null | 0 | NCT00728416 | |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | true | The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers. | This was a Phase I, double-blind, cross-over, single-dose study of the orally administered anti-orthopoxvirus compound, ST-246, to 12 healthy, fed volunteers between the ages of 18 and 50 years. Subjects were randomized such that 6 subjects received either ST-246 Form I (monohydrate) followed 10 days later after a wash... | Orthopoxviral Disease Smallpox Monkey Pox | Orthopoxviral Smallpox Monkey pox | null | 2 | arm 1: Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemih... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2). intervention 2: Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 p... | intervention 1: ST-246 Days 1 - 3 intervention 2: ST-246 Days 11 - 13 | 1 | Orlando | Florida | United States | -81.37924 | 28.53834 | 0 | NCT00728689 |
[
4
] | 324 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis. | null | Allergic Rhinitis | null | 2 | arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray | [
0,
2
] | 2 | [
0,
0
] | intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days | intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray | 0 | null | 0 | NCT00733005 | |
[
5
] | 80 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels. | Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.
Objective: To determine if using OM-85 BV diminish the number and ... | Asthma | wheezing asthma childhood OM-85 BV Broncho-Vaxom | null | 2 | arm 1: The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. arm 2: The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months intervention 2: 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months | intervention 1: OM-85 BV (Broncho-Vaxom) intervention 2: OM-85 BV (placebo) | 2 | Ankara | Kec.oren | Turkey (Türkiye) | 32.85427 | 39.91987
Ankara | Keçiören | Turkey (Türkiye) | 32.85427 | 39.91987 | 0 | NCT00733226 |
[
5
] | 314 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment. | null | Gastroesophageal Reflux Disease | heartburn reflux proton pump inhibitor | null | 1 | arm 1: None | [
0
] | 4 | [
0,
3,
10,
3
] | intervention 1: Once a day intervention 2: every visit intervention 3: every visit intervention 4: as needed | intervention 1: Esomeprazole 40 mg intervention 2: Physical Exam intervention 3: Quality of Life Questionnaires intervention 4: pregnancy test, if applicable | 10 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Santiago | N/A | Chile | -70.64827 | -33.45694
Temuco | N/A | Chile | -72.59738 | -38.73628
Viña del Mar | N/A | Chile | -71.55183 | -33.02457
Barranquilla | N/A | Colombia | -74.78132 | 10.96854
Bogotá | N/A | Colombia | -74.08175 | 4.60971
Medellín | N/A | Colomb... | 0 | NCT00734097 |
[
2
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 1FEMALE | false | This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed. | This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will ... | Drug Interactions | Drug-drug interactions DDI | null | 1 | arm 1: Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe | [
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: 2, 25 mg Proellex capsules administered daily intervention 2: Caffeine (200 mg) intervention 3: Tolbutamide (250 mg) intervention 4: Omeprazole (20 mg) intervention 5: Dextromethorphan (30 mg) intervention 6: Midazolam (2mg) | intervention 1: Proellex intervention 2: CYP1A2 probe intervention 3: CYP2C9 probe intervention 4: CYP2C19 probe intervention 5: CYP2D6 probe intervention 6: CYP3A4 probe | 1 | Hackensack | New Jersey | United States | -74.04347 | 40.88593 | 0 | NCT00741468 |
[
5
] | 355 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 1FEMALE | null | The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol. | This is a randomized, open-label, active-controlled, multicenter study in healthy sexually active females to evaluate cycle control with norgestimate/ethinyl estradiol versus drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day cycles. Approximately 300 patients will be randomized ... | Contraception | contraception bleeding cycle control | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol | 0 | null | 0 | NCT00745901 |
[
2
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes. | null | Diabetes Mellitus, Non-Insulin-Dependent | null | 6 | arm 1: Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 2: Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two tr... | [
0,
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Placebo tablets before every meal (q.a.c) Treatment period is 5 days. intervention 2: MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days. | intervention 1: Placebo intervention 2: MK-0941 | 0 | null | 0 | NCT00754130 | |
[
3
] | 229 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005 | This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo. | Type 2 Diabetes Mellitus | null | 1 | arm 1: Technosphere® Insulin Inhalation Powder | [
0
] | 1 | [
0
] | intervention 1: Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U | intervention 1: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler | 40 | San Mateo | California | United States | -122.32553 | 37.56299
Santa Barbara | California | United States | -119.69819 | 34.42083
Middlebury | Connecticut | United States | -73.12761 | 41.52787
New Britain | Connecticut | United States | -72.77954 | 41.66121
Norwalk | Connecticut | United States | -73.4079 | 41.1176
Mi... | 0 | NCT00754624 | |
[
3
] | 74 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A. | null | Major Depressive Disorder | Major Depressive Disorder Long-term Safety Open-label | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 5 or 10 mg/day; tablets; orally | intervention 1: Vortioxetine (Lu AA21004) | 0 | null | 0 | NCT00761306 |
[
3
] | 135 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's... | Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the... | Tinea Pedis Athlete's Foot | Econazole Foam Quinnova | null | 3 | arm 1: Econazole Nitrate Cream 1% arm 2: Econazole Nitrate Foam 1% arm 3: Vehicle Foam | [
1,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Topical cream, applied once daily for 4 weeks. intervention 2: Topical foam, applied once daily for 4 weeks. intervention 3: Topical foam, applied once daily for 4 weeks. | intervention 1: Econazole Nitrate Cream 1% intervention 2: Econazole Nitrate Foam 1% intervention 3: Vehicle Foam | 6 | San Diego | California | United States | -117.16472 | 32.71571
Clinton Township | Michigan | United States | -82.91992 | 42.58698
Fridley | Minnesota | United States | -93.26328 | 45.08608
Nashville | Tennessee | United States | -86.78444 | 36.16589
Austin | Texas | United States | -97.74306 | 30.26715
Salt Lake City |... | 0 | NCT00768599 |
[
5
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate lev... | This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase... | Attention Deficit Hyperactivity Disorder | Attention Deficit Hyperactivity Disorder Methylphenidate Concerta CONQoL | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56. | intervention 1: Long-Acting Methylphenidate | 5 | Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083
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 | NCT00783835 |
[
2
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult subjects. | Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy adult subjects.
On study Day 1 after a fast of at... | Healthy | rosiglitazone quinine sulfate drug interactions cytochrome p450 | null | 2 | arm 1: Baseline rosiglitazone pharmacokinetics. arm 2: Rosiglitazone pharmacokinetics in the presence of steady state quinine sulfate. | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Rosiglitazone 4 mg tablet administered as a single oral dose on the morning of Day 1. intervention 2: Co-administered single oral doses of rosiglitazone 4 mg (1 x 4 mg tablet) and quinine sulfate 648 mg (2 x 324 mg capsules) on the morning of Day 7. intervention 3: Co-administered single oral doses of r... | intervention 1: Rosiglitazone 4 mg Tablets intervention 2: Rosiglitazone 4 mg Tablets intervention 3: Quinine Sulfate 324 mg Capsules | 1 | East Grand Forks | Minnesota | United States | -97.02452 | 47.92998 | 0 | NCT00785213 |
[
2
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate. | Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate. In the morning on study Day 1 after a fast of at least 10 hours... | Healthy | quinine sulfate ciprofloxacin drug interactions cytochrome p450 male female adult pharmacokinetics | null | 2 | arm 1: Baseline quinine sulfate pharmacokinetics arm 2: Quinine sulfate pharmacokinetics in the presence of steady state ciprofloxacin | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: A single dose of quinine sulfate (2 x 324 mg capsules) administered on the morning of Day 1 after an overnight fast of at least 10 hours. intervention 2: A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 1... | intervention 1: Quinine Sulfate Capsules 324 mg intervention 2: Ciprofloxacin 500 mg intervention 3: Quinine Sulfate Capsules 324 mg | 0 | null | 0 | NCT00785980 |
[
2
] | 27 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | true | 1FEMALE | null | This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers. | null | Postmenopause | Biomarkers of estrogen receptor beta activation | null | 3 | arm 1: Placebo arm 2: Estrace 0.5 mg arm 3: Estrace 2 mg | [
2,
1,
1
] | 2 | [
0,
0
] | intervention 1: placebo capsule once daily for 7 days. intervention 2: Estrace 0.5 mg or 2 mg tablets once daily for 7 days. | intervention 1: Comparator: placebo intervention 2: Comparator: Estrace | 0 | null | 0 | NCT00799708 |
[
3
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture. | The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:
* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
* Tabulation as to the organisms ... | Chronic Ulcer of Lower Extremity | chronic cutaneous ulcers Nitric Oxide topically applied Biofilm Colonized chronic non-healing ulcers | null | 1 | arm 1: Topically applied Nitric Oxide for 8 hours daily for 2 weeks. | [
0
] | 1 | [
0
] | intervention 1: Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights. | intervention 1: Nitric Oxide | 1 | Loma Linda | California | United States | -117.26115 | 34.04835 | 0 | NCT00823095 |
[
5
] | 165 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris | null | Acne Vulgaris | null | 2 | arm 1: 1 pea-size amount, QD x 16 weeks arm 2: 1 pea-size amount, QD x 16 weeks | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 1 pea-size amount, QD x 16 weeks intervention 2: 1 pea-size amount, QD x 16 weeks | intervention 1: Tazarotene Cream 0.1% intervention 2: Adapalene | 1 | Fremont | California | United States | -121.98857 | 37.54827 | 0 | NCT00829049 | |
[
5
] | 24 | RANDOMIZED | SINGLE_GROUP | null | 0NONE | true | 0ALL | false | The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung. | null | Aspergillosis Candidemia | PK fungal infection | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazo... | intervention 1: anidulafungin and voriconazole | 1 | Hartford | Connecticut | United States | -72.68509 | 41.76371 | 0 | NCT00940017 |
[
0
] | 15 | RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | false | 0ALL | true | The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury. | This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated ... | Spinal Cord Injuries | Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design | null | 2 | arm 1: None arm 2: None | [
0,
5
] | 2 | [
0,
0
] | intervention 1: Pregabalin 150mg capsules BID for 7.5 days intervention 2: Placebo capsules BID for 7.5 days | intervention 1: Pregabalin intervention 2: Placebo for pregabalin | 4 | Randwick | New South Wales | Australia | 151.24895 | -33.91439
St Leonards | New South Wales | Australia | 151.19836 | -33.82344
Warrawong | New South Wales | Australia | 150.88833 | -34.485
Heidelberg | Victoria | Australia | 145.06667 | -37.75 | 0 | NCT00978341 |
[
0
] | 15 | RANDOMIZED | CROSSOVER | null | 2DOUBLE | false | 0ALL | true | Overview of Protocol:
Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\< 10 RDI or \> 25 RDI... | The propensity to experience sleep disordered-breathing (SDB) is controlled by the interplay of anatomic factors (i.e. BMI, neck circumference, retrognathia) and neurological drive (sleep stage, arousal). The interaction of baseline anatomic factors and drug-induced altered neurologic drive may also convey a risk for u... | Obstructive Sleep Apnea | Obstructive Sleep Apnea | null | 2 | arm 1: Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties. arm 2: Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects. | [
5,
5
] | 2 | [
0,
0
] | intervention 1: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constan... | intervention 1: Propofol intervention 2: Dexmedetomidine | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT01045122 |
[
4
] | 583 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a f... | This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned treatment), multicentre study in Poland and the United Kingdom designed to assess the mycological (fungal) cure rate and clinical efficacy of a new formulation of ketoconazole 2% crea... | Tinea Pedis | Tinea Pedis Ketoconazole (NIZORAL) Antifungal Agents Miconazole (DAKTARIN) | null | 3 | arm 1: ketoconazole 2% cream (formulation F126) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks. arm 2: ketoconazole 2% cream (formulation F012) (Nizo... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks. intervention 2: A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoco... | intervention 1: Placebo cream intervention 2: Ketoconazole 2% cream (formulation F012) (Nizoral) intervention 3: Ketoconazole 2% cream (formulation F126) | 11 | Bydgoszcz | N/A | Poland | 18.00762 | 53.1235
Lodz | N/A | Poland | 19.47395 | 51.77058
Lublin | N/A | Poland | 22.56667 | 51.25
Torun | N/A | Poland | 18.59814 | 53.01375
Cardiff | N/A | United Kingdom | -3.18 | 51.48
Chorley | N/A | United Kingdom | -2.61667 | 53.65
Glasgow | N/A | United Kingdom | -4.25763 | 55.8651... | 0 | NCT01110330 |
[
2
] | 19 | RANDOMIZED | CROSSOVER | null | 2DOUBLE | true | 2MALE | false | Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof... | Cold pain methodology development | Healthy | Cold pain methodology Healthy male volunteers gabapentin Diphenhydramine morphine | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Capsule, single 1200mg dose intervention 2: Tablet, single 50mg dose intervention 3: IV, single 10mg dose intervention 4: Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion). | intervention 1: Gabapentin intervention 2: Diphenhydramine intervention 3: Morphine intervention 4: Placebo | 1 | Brussels | N/A | Belgium | 4.34878 | 50.85045 | 0 | NCT01119222 |
[
4
] | 420 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone. | Objectives:
Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.
Secondary:
* To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
* T... | Gastric Ulcer | NSAID gastric ulcers Vimovo Esomeprazole Naproxen | null | 2 | arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen 500 mg dosed twice daily (bid) orally | intervention 1: PN400 (VIMOVO) intervention 2: Naproxen | 0 | null | 0 | NCT01129011 |
[
2
] | 48 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.
The purpose is to monitor clinical status, adverse events, laboratory investigations and to asse... | An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets \[ODT® (Containing Ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the... | Healthy | null | 2 | arm 1: single dose of Ondansetron Orally Dissolving Filmstrip 8 mg arm 2: Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS) intervention 2: Ondansetron Orally Disintegrating Tablet Ondanestron (ODT) | intervention 1: Ondansetron (ODFS) intervention 2: Ondansetron (ODT) | 1 | Adyār | Chenni | India | 74.92257 | 12.87033 | 0 | NCT01217801 | |
[
3,
4
] | 179 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study. | Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)... | Type 2 Diabetes Mellitus | Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. | intervention 1: Alogliptin and voglibose intervention 2: Alogliptin and voglibose | 0 | null | 0 | NCT01263509 |
[
3,
4
] | 339 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose. | Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)... | Type 2 Diabetes Mellitus | Diabetes Mellitus - Type2 Diabetes Mellitus Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks. intervention 3: Pioglitazone 15 or 30 mg, tablets... | intervention 1: Alogliptin and pioglitazone intervention 2: Alogliptin and pioglitazone intervention 3: Pioglitazone | 0 | null | 0 | NCT01318070 |
[
4
] | 218 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy. | null | Vaginal Atrophy | Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 3: Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing wi... | intervention 1: Placebo intervention 2: DHEA (0.25%) intervention 3: DHEA (0.5%) intervention 4: DHEA (1.0%) | 8 | Cleveland | Ohio | United States | -81.69541 | 41.4995
Norfolk | Virginia | United States | -76.28522 | 36.84681
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
Shawinigan | Quebec | Canada | -72.74913 | 46.56675
Sherbrooke | Quebec | Canada | -71.89908 | 45.40008
Qué... | 0 | NCT01846442 |
[
2
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia. | null | Schizophrenia | null | 3 | arm 1: 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. arm... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection. intervention 2: Aripiprazole tablets 10 mg once daily in the morning for 14 days. | intervention 1: aripiprazole IM depot intervention 2: aripiprazole tablets | 7 | Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California | United States | -118.25508 | 34.14251
Paramount | California | United States | -118.15979 | 33.88946
St Louis | Missouri | United States | -90.19789 | 38.62727
Willingb... | 0 | NCT01870999 | |
[
2
] | 2 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (\< 7 points). | null | Hepatitis C Liver Cirrhosis | null | 1 | arm 1: BI 201335 two single oral doses, separated by 14 days washout period | [
0
] | 1 | [
0
] | intervention 1: single oral doses | intervention 1: BI 201335 | 1 | Mainz | N/A | Germany | 8.2791 | 49.98419 | 0 | NCT01909778 | |
[
5
] | 40 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | true | 0ALL | false | It is important to wake up without any problem and comfortably from the general anesthesia. The aim of this study is to investigate the effects of addition dexmedetomidine to the balanced intravenous anesthesia with propofol over the cognitive functions and also it is considered that the addition of dexmedetomidine wou... | After the approve of the Ethics Committee and the patients were informed and taken informed consent form from them (18 female and 23 male) totally 41 patients between the age of 20-60 years old, who had lumbar disc hernia, under general anesthesia have been taken under the study. The patients with hepatic, renal or neu... | Postoperative Confusion | Dexmedetomidine cognitive functions MMSE | null | 2 | arm 1: Only propofol (started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1) and rocuronium for intubation arm 2: Propofol started as firstly 12 mg. kg-1 for the 30 minutes, the second 30 minutes 9 mg. kg-1) and remifentanil infusion (0.5 μg.kg-1),an... | [
2,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased intervention 2: BIS values were arranged 40-60 until the end of operation intervention 3: 0.5 microgram/kg infusion, no changes intervention 4: 0.5 mg/kg iv for intuba... | intervention 1: Remifentanil intervention 2: Propofol intervention 3: Dexmedetomidine intervention 4: Rocuronium | 1 | Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 | 0 | NCT02631135 |
[
4
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis. | The treatment comprised of one PDT session. If 12 weeks after PDT all lesions were cleared the patient entered the follow-up period. In case of remaining lesions or not completely cleared lesions the patient received a second PDT on the same day. The final assessment was performed 12 weeks after the last PDT and the pa... | Actinic Keratosis | null | 2 | arm 1: Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin. arm 2: Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering ea... | [
2,
1
] | 2 | [
0,
0
] | intervention 1: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation). intervention 2: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or... | intervention 1: Vehicle intervention 2: BF-200 ALA | 0 | null | 0 | NCT02799082 | |
[
3
] | 599 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to determine if the investigational drug is effective and safe in individuals with asthma. | A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Pers... | Asthma | Adults Pharmacokinetics Pharmacogenetics Asthma Adolescents GW685698X | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: GW685698X intervention 2: placebo comparator | intervention 1: GW685698X intervention 2: Placebo | 149 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fort Smith | Arkansas | United States | -94.39855 | 35.38592
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | California | United States | -119.77237 | 36.74773
Granada Hills | California | United States | -118.52314 | 34.26472
Huntington B... | 0 | NCT00603382 |
[
2,
3
] | 48 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast. | This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 p... | Nausea and Vomiting, Postoperative Nausea With Vomiting Chemotherapy-Induced | Bioequivalence, safety, and tolerability | null | 2 | arm 1: Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods arm 2: Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Test Article intervention 2: Comparator | intervention 1: Ondansetron (ODFS) intervention 2: Zofran (ODT) | 1 | Adyār | Chennai | India | 74.92257 | 12.87033 | 0 | NCT01217190 |
[
4
] | 641 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: sitagliptin arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: sitagliptin 100 mg tablet qd for a 24-wk treatment period. intervention 2: sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period. | intervention 1: sitagliptin phosphate intervention 2: Comparator : placebo (unspecified) | 0 | null | 0 | NCT00395343 | |
[
3
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 253... | null | Pancreatic Neoplasms | null | 2 | arm 1: Day 1 arm 2: Day 1 - 3 | [
0,
0
] | 1 | [
0
] | intervention 1: Intravenous Infusion | intervention 1: BI 2536 | 10 | Vienna | N/A | Austria | 16.37208 | 48.20849
Celle | N/A | Germany | 10.08047 | 52.62264
Düsseldorf | N/A | Germany | 6.77616 | 51.22172
Essen | N/A | Germany | 7.01228 | 51.45657
Freiburg/Breisgau | N/A | Germany | N/A | N/A
Hamburg | N/A | Germany | 9.99302 | 53.55073
Herne | N/A | Germany | 7.22572 | 51.5388
München... | 1 | NCT00710710 | |
[
4
] | 277 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery. | The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine. | Postoperative Pain | null | 3 | arm 1: DIC075V (IV diclofenac) arm 2: IV Ketorolac arm 3: Placebo | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: IV Diclofenac q6h intervention 2: IV ketorolac q6h intervention 3: Placebo q6h | intervention 1: IV Diclofenac intervention 2: IV ketorolac intervention 3: Placebo | 8 | Sheffield | Alabama | United States | -87.69864 | 34.76509
Phoenix | Arizona | United States | -112.07404 | 33.44838
San Clemente | California | United States | -117.61199 | 33.42697
Ft. Pierce | Florida | United States | -80.32561 | 27.44671
Louisville | Kentucky | United States | -85.75941 | 38.25424
Raleigh | North ... | 0 | NCT00507026 | |
[
3
] | 492 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy. | null | Depressive Disorder | MDD flexible-dose Major Depressive Disorder paroxetine GSK372475 | null | 3 | arm 1: GSK372475 1.0- 1.5 mg/day arm 2: Paroxetine 20-30 mg/day arm 3: Placebo to Match | [
0,
0,
5
] | 3 | [
0,
0,
10
] | intervention 1: GSK372475 1.0-1.5 mg/day intervention 2: Paroxetine 20-30 mg/day intervention 3: Placebo to Match | intervention 1: GSK372475 intervention 2: Paroxetine intervention 3: Placebo | 33 | Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Miramichi | New Brunswick | Canada | -65.50186 | 47.02895
Burlington | Ontario | Canada | -79.83713 | 43.38621
Markham | Ontario | Canada | -79.2663 | 43.86682
Mississauga | Ontario | Canada | -79.6583 | 43.5789
Providencia / Santiago... | 1 | NCT00420641 |
[
3
] | 65 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. | ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline ... | Uterine Fibroids | Uterine fibroids | null | 3 | arm 1: Two Proellex® 12.5 mg capsules once daily arm 2: One Proellex® 12.5 mg capsules once daily arm 3: Capsule once a day | [
0,
0,
2
] | 1 | [
0
] | intervention 1: 25 mg daily (two 12.5 mg capsules) | intervention 1: Proellex® | 11 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Tampa | Florida | Uni... | 0 | NCT00958334 |
[
3
] | 45 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration. If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given once daily. The bronchodilatation after inhalation of... | GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration. If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given once daily. The bronchodilatation after inhalation of... | Pulmonary Disease, Chronic Obstructive | salbutamol, Chronic Obstructive Pulmonary Disease (COPD) GSK961081 muscarinic receptor antagonist, COPD ipratropium bromide, Asthma ß2-adrenergic agonist, | null | 6 | arm 1: 400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing. arm 2: 1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumul... | [
0,
0,
0,
0,
2,
2
] | 2 | [
0,
0
] | intervention 1: Inhaled GSK961081 administered via Dry Powder Inhaler. intervention 2: Inhaled GSK961081 adminisntered via dry powder inhaler. | intervention 1: 400 microgrammes GSK961081 intervention 2: 1200 microgrammes GSK961081 | 4 | Wellington | N/A | New Zealand | 174.77557 | -41.28664
Chiang Mai | N/A | Thailand | 98.98468 | 18.79038
Khon Kaen | N/A | Thailand | 102.833 | 16.44671
Manchester | N/A | United Kingdom | -2.23743 | 53.48095 | 0 | NCT00674817 |
[
5
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week. | Long-term total parenteral nutrition (TPN) is a supportive, rather than curative, therapy for patients with severe short bowel syndrome (SBS). Because of the complications (liver and kidney dysfunction, bone demineralization, nutrient deficiencies, catheter sepsis) and costs (\>$100,000/ patient/year) associated with t... | Short Bowel Syndrome | Growth Hormone TPN Total Parenteral Nutrition Glutamine Short Bowel Syndrome Increase in absorption of small bowel. | null | 1 | arm 1: Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose). | [
5
] | 1 | [
0
] | intervention 1: dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days. | intervention 1: Growth Hormone | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00742157 |
[
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. | PRIMARY OBJECTIVES:
I. To estimate the response rates of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.
II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.
III. To evaluate the scope and extent of acute toxicities ass... | Adult Alveolar Soft-part Sarcoma Adult Angiosarcoma Adult Epithelioid Sarcoma Adult Extraskeletal Chondrosarcoma Adult Extraskeletal Osteosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Malignant Hemangiopericytoma Adult Malignant Mesenchymoma Adult Neurofibr... | null | 1 | arm 1: Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. | [
0
] | 1 | [
0
] | intervention 1: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting. | intervention 1: romidepsin | 0 | null | 0 | NCT00112463 | |
[
2
] | 17 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 1FEMALE | false | Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states. | This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states. | Pharmacokinetics | PK Pharmacokinetics | null | 5 | arm 1: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose
Fed State arm 2: 25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose
Fasting State arm 3: 2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose
Fed State arm 4: 2, 25 mg Proellex... | [
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules ad... | intervention 1: Proellex | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00749879 |
[
5
] | 49 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | true | This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities. | null | Asthma | Asthma and Poor Coordinators of Asthma Inhalers | null | 2 | arm 1: Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. arm 2: Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Inhalation Aerosols, 90 mcg, 1 dose per treatment period intervention 2: Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period. | intervention 1: Albuterol-HFA-MDI intervention 2: Albuterol-HFA-BAI | 5 | Huntington Beach | California | United States | -117.99923 | 33.6603
Lakewood | Colorado | United States | -105.08137 | 39.70471
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Lake Oswego | Oregon | United States | -122.67065 | 45.42067 | 0 | NCT00530062 |
[
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subj... | null | Breast Neoplasm | null | 1 | arm 1: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.
Stage 2: s... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m\^2 on day 1, every 3 weeks
Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks. intervention 2: Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, eve... | intervention 1: Pegylated Liposomal Doxorubicin intervention 2: Docetaxel intervention 3: Trastuzumab | 0 | null | 0 | NCT00687440 | |
[
3
] | 215 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether MK-8435 (Org 25935) is more effective than placebo in improving negative symptoms in participants with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic. | The primary features of schizophrenia are characterized by positive (irrational thoughts and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal behavior and emotions, and usually include a general lack of engagement, social withdrawal, and loss of goal-directed behavior.
Negative sym... | Schizophrenia | Negative symptoms Glycine Uptake inhibitor Add-on treatment Second Generation Antipsychotic | null | 3 | arm 1: Participants will be maintained on a stable dose of Second Generation Antipsychotic (SGA) and receive 4-8 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as neede... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day intervention 2: Matching placebo for MK-8435 (Org 25935) administered orally BID intervention 3: Administered orally BID for a final concentration of 24-32 mg/day | intervention 1: MK-8435 (Org 25935) 4-8 mg intervention 2: Placebo intervention 3: MK-8435 (Org 25935) 12-16 mg | 0 | null | 0 | NCT00725075 |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | null | The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body. | null | Healthy Volunteers | Drug Interaction Study | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 50mg capsule intervention 2: 20mg capsule | intervention 1: Lisdexamfetamine Dimesylate intervention 2: Adderall XR (mixed salts amphetamine) | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00746733 |
[
2
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer. | null | Neoplasms, Colorectal | Metastatic Colorectal Cancer oxaliplatin fluoropyrimidines cancers Advanced Colorectal Cancer capecitabine lapatinib | null | 2 | arm 1: Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. arm 2: Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: onced daily Days 1-21 intervention 2: Day one of each cycle intervention 3: given BID days 1-14 | intervention 1: lapatinib intervention 2: oxaliplatin intervention 3: capecitabine | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00536809 |
[
4
] | 4,150 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.
Anti-HIV therapy has been very successful... | Much progress has been made in implementing potent antiretroviral therapy that is able to maximally suppress viral replication. However, these drug combinations do not result in viral eradication and, for many patients, virologic and immunologic control cannot be maintained. Even among patients with apparent virologic ... | HIV Infections | Recombinant Proteins Injections, Subcutaneous HIV-1 Interleukin-2 Drug Therapy, Combination CD4 Lymphocyte Count Disease Progression Follow-Up Studies Anti-HIV Agents | null | 2 | arm 1: Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice. arm 2: Control arm uses anti-HIV medication of choice without rIL-2. | [
0,
4
] | 1 | [
0
] | intervention 1: Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles. | intervention 1: Recombinant interleukin-2 (rIL-2) | 248 | Los Angeles | California | United States | -118.24368 | 34.05223
Mill Valley | California | United States | -122.54498 | 37.90604
Oakland | California | United States | -122.2708 | 37.80437
Oakland | California | United States | -122.2708 | 37.80437
San Francisco | California | United States | -122.41942 | 37.77493
San... | 1 | NCT00004978 |
[
4
] | 9,406 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide). | This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this stu... | Myocardial Ischemia Acute Coronary Syndrome | myocardial infarction acute coronary syndrome non-ST-segment elevation eptifibatide Integrilin glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa) percutaneous coronary intervention (PCI) coronary artery bypass graph surgery (CABG) catheterization angina ischemia cardiac ischemia cardiovascular disease | null | 2 | arm 1: Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. arm 2: Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG \[coronary artery bypass graft\]); second bolus of 180 mcg/kg administered 10 minutes ... | intervention 1: Eptifibatide (Integrilin) intervention 2: Placebo | 0 | null | 1 | NCT00089895 |
[
4
] | 747 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | null | The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease. | null | Parkinson's Disease | Parkinson's disease, levodopa therapy, dyskinesia | null | 2 | arm 1: Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. arm 2: Patient... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules. intervention 2: Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules. | intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa | 73 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Scottsdale | Arizona | United States | -111.89903 | 33.50921
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Sunnyval... | 1 | NCT00099268 |
[
4
] | 154 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma. | null | Exercise Induced Asthma | null | 2 | arm 1: Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Sa... | [
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Montelukast 5 mg chewable tablet once daily intervention 2: Salmeterol 50 mcg dry powder per actuation inhaled twice daily intervention 3: Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily intervention 4: Matching placebo to montelukast oral tablet administered once daily. intervention 5: M... | intervention 1: Montelukast sodium intervention 2: Salmeterol xinafoate intervention 3: Fluticasone propionate intervention 4: Montelukast matching placebo intervention 5: Salmeterol matching placebo | 0 | null | 1 | NCT00127166 |
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