phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
2
] | 47 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design. | null | Multiple Myeloma | IGF-1R inhibitor CP-751871 multiple myeloma | null | 1 | arm 1: dose escalation design | [
0
] | 1 | [
0
] | intervention 1: CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability | intervention 1: CP-751,871 | 6 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tampa | Florida | United States | -82.45843 | 27.94752
Boston | Massachusetts | United States | -71.05977 | 42.35843
Rochester | Minnesota | United States | -92.4699 | 44.02163
New York | New York | Un... | 0 | NCT01536145 |
[
3
] | 185 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off" motor fluctuations and "on" period Dyskinesias. | null | Parkinson's Disease | null | 1 | arm 1: Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204), and dosed placebo or perampanel. Subjects started this open-label extension study on perampanel 1 mg once daily for two weeks, followed by 2 mg once daily for two weeks; if they did not tolerate the 1 mg dose, sub... | [
0
] | 1 | [
0
] | intervention 1: 1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential mann... | intervention 1: Perampanel | 0 | null | 0 | NCT01634360 | |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 2MALE | false | The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects. | Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study. | Parkinson | Opicapone, Parkinson, Bial, BIA 9-1067 | null | 2 | arm 1: A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fed Washout Period (7days) Period 2: Fasted arm 2: A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:
Period 1: Fasted Washout Period (7days) Period 2: Fed | [
0,
0
] | 1 | [
0
] | intervention 1: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days. | intervention 1: BIA 9-1067 | 1 | Mount Royal | Quebec | Canada | -73.64918 | 45.51675 | 0 | NCT02071823 |
[
5
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure leve... | null | Insomnia | Insomnia | null | 2 | arm 1: Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon. arm 2: 15 subjects will be randomized to receive the placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: ramelteon intervention 2: placebo | 0 | null | 0 | NCT02156271 |
[
0
] | 26 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation. | null | Opioid-induced Constipation | null | 1 | arm 1: Participants will receive single dose of MNTX 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC). Subsequent dosing could be adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. | [
0
] | 1 | [
0
] | intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the arm. | intervention 1: Methylnaltrexone | 1 | Tarrytown | New York | United States | -73.85875 | 41.07621 | 0 | NCT01368562 | |
[
3
] | 250 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus | null | Diabetes Mellitus, Type 2 | Diabetes mellitus HbA1c | null | 2 | arm 1: Participants will receive GSK189075 for 12 weeks arm 2: Participants will receive GSK189075 matching Placebo for 12 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet intervention 2: Available as Placebo matching tablet to GSK189075 | intervention 1: GSK189075 intervention 2: Placebo | 157 | Mesa | Arizona | United States | -111.82264 | 33.42227
Artesia | California | United States | -118.08312 | 33.86585
Buena Park | California | United States | -117.99812 | 33.86751
Fresno | California | United States | -119.77237 | 36.74773
Greenbrae | California | United States | -122.5247 | 37.94854
La Jolla | Califor... | 0 | NCT00495469 |
[
4
] | 18 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The painful episode is the most common problem experienced by children with sickle cell disease. Although various treatments are available during painful episodes, the medication most commonly given for pain is a pain medication such as morphine. Fluids are also used. Even with these treatments, many children still hav... | In the United States, 9% of African Americans have sickle cell trait and 1 in 600 has sickle cell disease. Vaso- occlusive crises in sickle cell disease remain a frequent cause of severe pain, leading to emergency room visits, hospitalizations, and dependence upon narcotics for analgesia. Current treatments for vaso-oc... | Sickle Cell Disease Vaso-occlusive Crisis | Sickle cell disease vaso-occlusive crisis steroid treatment | null | 2 | arm 1: Receipt of methyprednisolone pulse dose: 15mg/kg to a maximum of 1 gram; following this, the patients also received a steroid taper with oral prednisone:Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily arm 2: Patients receiving ... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily intervention 2: Patients received normal saline in lieu of intravenously-administered methylprednisolone and placebo pills equ... | intervention 1: Steroid arm intervention 2: Placebo | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00263562 |
[
4
] | 2,414 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values. | null | Primary Hypercholesterolemia Mixed Dyslipidemia | null | 4 | arm 1: After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks. arm 2: After a 2-week placebo run-in, participants will be co-admini... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet intervention 3: None intervention 4: None | intervention 1: Comparator: simvastatin intervention 2: MK-0524A intervention 3: Placebo intervention 4: MK-0524B | 0 | null | 0 | NCT00479882 | |
[
4
] | 7,808 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis. | null | Osteoporosis | Postmenopausal Osteoporosis | null | 2 | arm 1: Placebo administered subcutaneously once every 6 months for 3 years. arm 2: Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Placebo administered by subcutaneous injection intervention 2: Denosumab 60 mg administered by subcutaneous injection | intervention 1: placebo intervention 2: Denosumab | 0 | null | 0 | NCT00089791 |
[
3
] | 366 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating... | null | Amyotrophic Lateral Sclerosis | null | 2 | arm 1: Pre-filled syringe of 40 mg glatiramer acetate (GA) for injection, administered subcutaneously once a day. arm 2: Pre-filled syringe of matching placebo, administered subcutaneously once a day. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: parenteral drug intervention 2: None | intervention 1: 40 mg glatiramer acetate intervention 2: Placebo | 7 | Haarlem | N/A | Belgium | N/A | N/A
Leuven | N/A | Belgium | 4.70093 | 50.87959
Paris | N/A | France | 2.3488 | 48.85341
Mörfelden-Walldorf | N/A | Germany | 8.58361 | 49.99472
Tel Aviv | N/A | Israel | 34.78057 | 32.08088
Milan | N/A | Italy | 12.59836 | 42.78235
Aylesbury | N/A | United Kingdom | -0.81458 | 51.81665 | 1 | NCT00326625 | |
[
5
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patie... | Induction of labor is a common obstetrical practice. In fact, the rate of induction has risen to 184/1000 live births. It is well known that a favorable Bishop score, defined as Bishop score 5-8, improves the safety and success rate for induction of labor and vaginal delivery. Several methods for cervical ripening, bot... | Cesarean Section | Pregnancy Extra amniotic saline infusion Misoprostol Labor induction | null | 2 | arm 1: Patients randomized to this arm will receive 25 micrograms of misoprostol every four hours. arm 2: Patients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter | [
1,
0
] | 2 | [
0,
1
] | intervention 1: Misoprostol,25 micrograms every 4 hours. intervention 2: A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen | intervention 1: Misoprostol intervention 2: Catheter | 1 | Maywood | Illinois | United States | -87.84312 | 41.8792 | 0 | NCT00383942 |
[
3
] | 24 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | true | This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol) on the human immunodeficiency virus (HIV). If not treated, HIV infection causes an incurable, progressive deficiency in the immune system that leads to death, usually from disease that takes advantage of weakened immunity. Prev... | This protocol is a randomized, double blind, placebo controlled trial designed to study the effects of the lipid lowering statin, atorvastatin on HIV-1 viremia.
Untreated HIV-1 infection results in an incurable, progressive immunodeficiency and death, usually from opportunistic infections. Combination antiretroviral t... | HIV | Viremia Statin HIV Replication Cholesterol Lipid Raft HIV Infection HIV Positive | ICF_002.pdf:
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY
MEDICAL RECORD
• Adult Patient or • Parent, for Minor Patient
INSTITUTE:
National Institute of Allergy and Infectious Diseases
STUDY NUMBER:
06-I-0197
PRINCIPAL INVESTIGATOR:
STUDY TITLE:
A Randomized ... | 2 | arm 1: Patients were randomized to receive Atorvastatin first for 8 weeks, followed by 4 weeks wash out, and then cross over to placebo for 8 weeks. arm 2: Patients were randomized to receive placebo first for 8 weeks, followed by 4 weeks wash out, and then cross over to 80 mg atorvastatin daily for 8 weeks. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 80 mg atorvastatin oral daily intervention 2: patients will be administered placebo | intervention 1: Atorvastatin intervention 2: Placebo | 3 | San Diego | California | United States | -117.16472 | 32.71571
Bethesda | Maryland | United States | -77.10026 | 38.98067
Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00367458 |
[
4
] | 335 | RANDOMIZED | SINGLE_GROUP | 9OTHER | 1SINGLE | true | 0ALL | false | Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick. | Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile de... | Topical Antisepsis | antimicrobial antisepsis | Prot_SAP_000.pdf:
| 5 | arm 1: Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time arm 2: Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially arm 3: Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base arm 4: Sterile swabstick w... | [
0,
0,
1,
2,
2
] | 5 | [
0,
0,
0,
10,
10
] | intervention 1: 3 swabsticks topically applied at the same time to intact skin intervention 2: Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin. intervention 3: Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) ... | intervention 1: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). intervention 2: CHG 2% w/v & IPA 70% v/v swab applied sequentially intervention 3: Aqueous CHG 4% w/v applied according to mfr's directions intervention 4: Sterile swabstick with sterile water (3 @ once) intervention 5: Sterile swabstick with sterile water... | 1 | Sterling | Virginia | United States | -77.4286 | 39.00622 | 0 | NCT00799812 |
[
3
] | 4 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine. | Psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. Treatment typically include drugs such as methotrexate, azathioprine, and etanercept, which suppress the immune system in a nonspecific fashion in an attempt to control the immune responses causing the di... | Arthritis, Psoriatic | Psoriatic Arthritis Arthritis Psoriasis Psoriatic PsA | null | 2 | arm 1: Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle arm 2: Intravenous dose of placebo given over 5 days of each 28 day cycle | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle intervention 2: Intravenous dose of placebo given over 5 days of each 28 day cycle | intervention 1: hOKT3gamma1(Ala-Ala) intervention 2: Placebo | 2 | Aurora | Colorado | United States | -104.83192 | 39.72943
Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00239720 |
[
3
] | 133 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008 | null | Irritable Bowel Syndrome (IBS) | Irritable Bowel Syndrome safety | null | 2 | arm 1: GW876008 arm 2: Placebo | [
0,
2
] | 2 | [
0,
10
] | intervention 1: None intervention 2: None | intervention 1: GW876008 intervention 2: Placebo | 23 | Sherwood | Arkansas | United States | -92.22432 | 34.81509
Concord | California | United States | -122.03107 | 37.97798
Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
Stockbridge | Georgia | United States | -84.23381 | 33.54428
Louisville | Kentuc... | 0 | NCT00421707 |
[
3
] | 21 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | null | This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in prevent... | PRIMARY OBJECTIVES:
I. Determine whether pioglitazone (pioglitazone hydrochloride) reverses leukoplakia in patients with hyperplastic or dysplastic oral cavity or oropharyngeal leukoplakia.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label ... | Head and Neck Cancer Oral Leukoplakia | null | 1 | arm 1: Patients receive pioglitazone hydrochloride PO QD for 12 weeks in the absence of disease progression, unacceptable toxicity, or the development of carcinoma. | [
0
] | 1 | [
0
] | intervention 1: Given PO | intervention 1: pioglitazone hydrochloride | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00099021 | |
[
4
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy | null | Diabetes Mellitus, Non-Insulin-Dependent | null | 3 | arm 1: sitagliptin + metformin arm 2: metformin + any other oral antidiabetic drug arm 3: metformin | [
0,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: sitagliptin 100 mg Once a day (QD) for 24 weeks intervention 2: metformin 850 mg Twice a day (BID) for 24 weeks intervention 3: metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks intervention 4: Patient can take any oral antidiabetic drug (other than metformin) | intervention 1: sitagliptin phosphate intervention 2: Comparator: metformin intervention 3: Comparator: metformin intervention 4: Comparator: Antidiabetic Standard of Care | 0 | null | 0 | NCT00875394 | |
[
3
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients. | null | Carcinoma, Small Cell | null | 1 | arm 1: Total Patients | [
0
] | 1 | [
0
] | intervention 1: Intravenous Infusion | intervention 1: BI 2536 | 10 | Fayetteville | Arkansas | United States | -94.15743 | 36.06258
Chicago | Illinois | United States | -87.65005 | 41.85003
Evanston | Illinois | United States | -87.69006 | 42.04114
Boston | Massachusetts | United States | -71.05977 | 42.35843
St Louis | Missouri | United States | -90.19789 | 38.62727
Chapel Hill | North... | 1 | NCT00412880 | |
[
0
] | 96 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Past research has demonstrated that cocaine dependent women experience less severe responses to cocaine during the luteal phase of the menstrual cycle, when estrogen and progesterone concentrations are high. The purpose of this study is to determine whether administered progesterone reduces subjective and physiological... | Changes in ovarian hormones across the menstrual cycle impact responses to cocaine in women. Studies have shown that cocaine's effects are dampened during the luteal phase of the menstrual cycle, when estrogen and progesterone concentrations are high, relative to the other phases of the cycle, when concentrations of th... | Cocaine Abuse Cocaine-Related Disorders | Cocaine | null | 2 | arm 1: 200mg progesterone twice daily arm 2: Placebo twice daily | [
1,
2
] | 2 | [
0,
10
] | intervention 1: 200mg progesterone twice daily intervention 2: placebo | intervention 1: Progesterone intervention 2: Placebo | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00218257 |
[
0
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and pr... | Parkinson's disease (PD), while defined by its motor abnormalities and associated dopaminergic loss, is invariably accompanied by cognitive impairment. Early in the disease course, the deficits are characterized by executive dysfunction with difficulties on tasks that involve information processing, attention, sorting,... | Parkinson's Disease | Parkinson's disease executive dysfunction impairment motor skills cognitive | null | 1 | arm 1: Open-Label Uncontrolled Active Drug Intervention, No comparator | [
5
] | 1 | [
0
] | intervention 1: Open Label uncontrolled active Drug intervention | intervention 1: Atomoxetine | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00286949 |
[
4
] | 4,128 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied. | null | Congestive Heart Failure | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years intervention 2: Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years | intervention 1: Irbesartan intervention 2: Placebo | 229 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Peoria | Arizona | United States | -112.23738 | 33.5806
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | Californ... | 1 | NCT00095238 | |
[
4
] | 831 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients hav... | null | Schizophrenia | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1). intervention 2: Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks. interven... | intervention 1: Asenapine - Open Label intervention 2: Placebo - Double Blind intervention 3: Asenapine - Double Blind | 0 | null | 1 | NCT00150176 | |
[
5
] | 359 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone. | This was a prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to carbidopa/levodopa/entacapone on motor function and quality of life in patients with Parkinson's disease with end-of-dose wearing off. | Parkinson's Disease With End of Dose Wearing Off | Parkinson's disease, tremor | null | 2 | arm 1: Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The ... | [
0,
1
] | 1 | [
0
] | intervention 1: Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. | intervention 1: Carbidopa/levodopa/entacapone | 42 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fullerton | California | United States | -117.92534 | 33.87029
Irvine | California | United States | -117.82311 | 33.66946
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | Ca... | 1 | NCT00219284 |
[
4
] | 251 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology. | null | Turner Syndrome Renal Insufficiency, Chronic Pituitary Diseases Dwarfism | growth child development growth hormone inadequate growth hormone secretion growth failure | null | 1 | arm 1: Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/k... | [
0
] | 1 | [
0
] | intervention 1: Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months. | intervention 1: Somatropin (rDNA origin) | 45 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Edegem | N/A | Belgium | 4.44504 | 51.15662
Prague | N/A | Czechia | 14.42076 | 50.08804
Aalborg | N/A | Denmark | 9.9187 | 57.048
Herning | N/A | Denmark | 8.97662 | 56.13615
Helsinki | N/A | Finland | 24.93545 | 60.16952
Angers | N/A | France | -0.55202 | 47.47156
Bordeau... | 1 | NCT00234533 |
[
3,
4
] | 451 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated. | This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of p... | Diabetic Neuropathy | Painful Distal Diabetic Neuropathy | null | 1 | arm 1: Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day | [
0
] | 1 | [
0
] | intervention 1: Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period. | intervention 1: lacosamide | 84 | Anniston | Alabama | United States | -85.83163 | 33.65983
Hoover | Alabama | United States | -86.81138 | 33.40539
Huntsville | Alabama | United States | -86.58594 | 34.7304
Northport | Alabama | United States | -87.57723 | 33.22901
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Peoria | Arizona | United St... | 1 | NCT00235443 |
[
4
] | 1,123 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis. | Tapentadol (CG5503) is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is a randomized (patients are assigned different treatments based on chance in a ratio of 4 patients on tapentadol (CG5503) PR to every 1 patient on oxycodone CR), open-label (both th... | Osteoarthritis, Hip Osteoarthritis, Knee Lower Back Pain Pain | Osteoarthritis Pain Low Back Pain Hip Pain Knee Pain Backache Tapentadol | null | 2 | arm 1: Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year. arm 2: Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks. intervention 2: Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID adminis... | intervention 1: Oxycodone CR intervention 2: Tapentadol (CG5503) ER | 52 | Mesa | Arizona | United States | -111.82264 | 33.42227
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Cudahy | California | United States | -118.18535 | 33.96057
Encinitas | California | United States | -117.29198 | 33.03699
San Diego | California | ... | 1 | NCT00361504 |
[
4
] | 601 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ). | null | Hypertension | Hypertension, aliskiren, valsartan, HCTZ, blood pressure | null | 2 | arm 1: Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or ... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Aliskiren 300 mg intervention 2: Valsartan 320 mg intervention 3: Hydrochlorothiazide (HCTZ) 12.5-25 mg | intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Hydrochlorothiazide (HCTZ) | 4 | San Diego | California | United States | -117.16472 | 32.71571
Canada | N/A | Canada | N/A | N/A
Germany | N/A | Germany | N/A | N/A
Netherlands | N/A | Netherlands | N/A | N/A | 1 | NCT00386607 |
[
4
] | 330 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with... | null | Diabetes Diabetes Mellitus, Type 1 | null | 2 | arm 1: Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks arm 2: Individually adjusted dosage of insulin detemir produced by the NN7... | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: NN304 injected s.c. (under the skin). Given as basal insulin. intervention 2: Injected s.c. (under the skin). Given as bolus insulin. intervention 3: NN729 injected s.c. (under the skin). Given as basal insulin | intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin detemir | 5 | Frankfurt | N/A | Germany | 10.53333 | 49.68333
Skopje | N/A | North Macedonia | 21.43141 | 41.99646
Moscow | N/A | Russia | 37.61556 | 55.75222
Belgrade | N/A | Serbia and Montenegro | N/A | N/A
Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 | 1 | NCT00447382 | |
[
3
] | 199 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 1FEMALE | false | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in p... | OBJECTIVES:
* Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer.
* Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers.
* Determine if cytologic improvement is associated with initial presentation of the various s... | Breast Cancer | breast cancer | null | 2 | arm 1: Placebo arm 2: LY353381, 20 mg daily | [
2,
0
] | 2 | [
0,
0
] | intervention 1: one tablet daily intervention 2: matched tablet dialy | intervention 1: arzoxifene intervention 2: Placebo | 2 | Kansas City | Kansas | United States | -94.62746 | 39.11417
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00005879 |
[
2,
3
] | 39 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine. | ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. | Schizophrenia | Electroconvulsive Therapy | null | 2 | arm 1: Electroconvulsive therapy ECT plus clozapine for 8 weeks arm 2: Clozapine for 8 weeks | [
0,
1
] | 2 | [
3,
0
] | intervention 1: ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. intervention 2: Patients with psychotic symptoms will receive clozapine | intervention 1: Electroconvulsive Therapy (ECT) intervention 2: Clozapine | 1 | Glen Oaks | New York | United States | -73.71152 | 40.74705 | 0 | NCT00042224 |
[
3
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined ... | 40 ppm of either nitric oxide for inhalation or N2 (placebo) will be continuously administered to the patient starting at least 5 minutes prior to initiating the first weaning attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study drug for 48 ho... | Congestive Heart Failure | Left Ventricular Assist Device Implantation Progressive Left Ventricular Failure | null | 2 | arm 1: Inhaled Nitric Oxide (iNO) at 40 parts per million (ppm) arm 2: Nitrogen (N2) administered at 40 ppm. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 40 ppm of Nitric Oxide continuously administered for 48 hours intervention 2: Nitrogen (N2) administered at 40 ppm for 48 hours | intervention 1: Nitric Oxide intervention 2: Nitrogen | 11 | Newark | New Jersey | United States | -74.17237 | 40.73566
Durham | North Carolina | United States | -78.89862 | 35.99403
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cleveland | Ohio | United States | -81.69541 | 41.4995
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Dallas | Texas | Unit... | 0 | NCT00060840 |
[
3
] | 140 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD. | This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for... | Temporomandibular Joint Disorders | null | 4 | arm 1: Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. arm 2: Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT. arm 3... | [
0,
0,
0,
1
] | 4 | [
0,
0,
5,
5
] | intervention 1: Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile. intervention 2: Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. intervention 3: Six... | intervention 1: Nortriptyline Oral Capsule intervention 2: Benztropine Oral Product intervention 3: CBT intervention 4: Disease MGT | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00066937 | |
[
3
] | 131 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study was designed to evaluate and compare the efficacy of two dose schedules of an oral investigational drug for the treatment of advanced or metastatic non-small cell lung cancer. | null | Lung Cancer, Non-Small Cell | EGFR ErbB1 ErbB2 metastatic lapatinib Her-2/neu protein kinase inhibitor BAC GW572016 Advanced NSCLC | null | 1 | arm 1: Randomized, open-label, parallel group, 2-stage study to evaluate and compare 2 dose schedules (1500 mg once daily and 500 mg twice daily) of oral lapatinib. | [
5
] | 1 | [
0
] | intervention 1: tyrosine kinase inhibitor | intervention 1: GW572016 (lapatinib) | 31 | Jasper | Alabama | United States | -87.27751 | 33.83122
Greenbrae | California | United States | -122.5247 | 37.94854
La Jolla | California | United States | -117.2742 | 32.84727
Long Beach | California | United States | -118.18923 | 33.76696
Poway | California | United States | -117.03586 | 32.96282
Rancho Mirage | Ca... | 0 | NCT00073008 |
[
3
] | 45 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Study evaluating SOM230 in patients with metastatic carcinoid tumors | null | Carcinoid Tumors | SOM230 Sandostatin Carcinoid syndrome | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was requi... | intervention 1: Pasireotide (SOM230) | 4 | Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
Iowa City | Iowa | United States | -91.53017 | 41.66113
New Orleans | Louisiana | United States | -90.07507 | 29.95465 | 0 | NCT00088595 |
[
4
] | 153 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not cont... | null | Epilepsy, Tonic-Clonic | antiepileptic drugs seizures primary generalized tonic-clonic seizures Epilepsy lamotrigine anticonvulsants LAMICTAL | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Primary experimental dosage form intervention 2: Placebo control | intervention 1: lamotrigine (LAMICTAL) extended-release intervention 2: Placebo | 146 | Anniston | Alabama | United States | -85.83163 | 33.65983
Birmingham | Alabama | United States | -86.80249 | 33.52066
Northport | Alabama | United States | -87.57723 | 33.22901
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | Unite... | 0 | NCT00104416 |
[
4
] | 337 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either s... | null | HIV Infections | null | 2 | arm 1: saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. arm 2: lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1000 milligram (mg) Oral (po) twice daily (bid) intervention 2: Lopinavir/ritonavir 400/100 mg po bid intervention 3: Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd intervention 4: 100 mg po bid | intervention 1: saquinavir [Invirase] intervention 2: Lopinavir/ritonavir intervention 3: Emtricitabine/tenofovir disoproxil fumarate intervention 4: Ritonavir | 44 | Hobson City | Alabama | United States | -85.84413 | 33.62149
Tucson | Arizona | United States | -110.92648 | 32.22174
Berkeley | California | United States | -122.27275 | 37.87159
Los Angeles | California | United States | -118.24368 | 34.05223
Washington D.C. | District of Columbia | United States | -77.03637 | 38.895... | 0 | NCT00105079 | |
[
4
] | 230 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs... | BACKGROUND:
Growth impairment is common in infants and children with congenital heart disease, most often in the presence of congestive heart failure and/or cyanosis. Growth failure is noted in many infants with a single ventricle who manifest both cyanosis and heart failure that commonly persist after palliative surg... | Heart Defects, Congenital Heart Failure, Congestive | null | 2 | arm 1: Enalapril (angiotensin converting enzyme inhibitor) arm 2: Placebo (Ora-Plus and Ora-Sweet) | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Enalapril to target dose of .4mg/kg/day divided to twice per day (BID) intervention 2: Participants will receive placebo | intervention 1: Enalapril intervention 2: Placebo | 9 | Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Durham | North Carolina | United States | -78.89862 | 35.99403
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charleston |... | 0 | NCT00113087 | |
[
5
] | 302 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial... | Naltrexone has been established as an efficacious medication to treat alcohol dependence but studies thus far have focused mostly on the acute phase of treatment rather than long-term management and have not offered alternative treatment strategies when patients do not respond to an initial course of naltrexone. For th... | Alcoholism | Alcoholism alcohol abuse therapy drug resistance naltrexone patient care management human subject | null | 6 | arm 1: From the start of baseline subjects were randomly assigned to this arm which defined relapse/non-responder as having 5 or heavy drinking days in the first 8 weeks of treatment otherwise the subject was considered a responder. arm 2: From the start of baseline subjects were randomly assigned to this arm which def... | [
0,
0,
0,
0,
2,
0
] | 5 | [
0,
0,
5,
5,
5
] | intervention 1: 100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2. intervention 2: placebo comparer for 16 weeks in phase 2. intervention 3: Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2. intervention 4: 45-60 minute sessions with a certified therapist focused on resolving am... | intervention 1: Naltrexone intervention 2: placebo intervention 3: Medication Management (MM) intervention 4: Combined Behavioral Intervention (CBI) intervention 5: Telephone Counseling | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00115037 |
[
4
] | 523 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression. | Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determ... | Depression | Cognitive therapy Antidepressants Psychotherapy | null | 3 | arm 1: Participants received acute phase and continuation phase cognitive therapy arm 2: Participants received acute phase cognitive therapy and continuation phase pill placebo arm 3: Participants received acute phase cognitive therapy and continuation phase fluoxetine | [
0,
2,
1
] | 4 | [
5,
0,
10,
5
] | intervention 1: Continuation phase cognitive therapy included 10 sessions over 8 months. intervention 2: The dosage of fluoxetine was increased to 40 mg over 8 months. intervention 3: The dosage of pill placebo was increased to 40 mg over 8 months. intervention 4: For the first 12 weeks, all participants received betwe... | intervention 1: Continuation phase cognitive therapy intervention 2: Continuation phase fluoxetine intervention 3: Continuation phase pill placebo intervention 4: Acute phase cognitive therapy | 2 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00118404 |
[
4
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects wil... | Prepubertal growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, primary IGFD is defined as short stature (height standard deviation score\[SDS\]\<-2 below the mean for age and gende... | Growth Disorders Insulin-Like Growth Factor-1 Deficiency | Primary IGF-1 Deficiency | null | 4 | arm 1: Observational Group arm 2: Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not ca... | [
4,
0,
0,
0
] | 1 | [
0
] | intervention 1: Twice Daily Injection | intervention 1: rhIGF-1 (mecasermin, Tercica, Inc.) | 1 | Brisbane | California | United States | -122.39997 | 37.68077 | 0 | NCT00125164 |
[
3
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this research is to evaluate the effects of L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of sickle cell crises. | The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in the therapy of sickle cell anemia and sickle ß0-thalassemia.
The secondary purpose is to assess the effect of L-glutamine frequency of hospitalizations for sickle cell pain, frequency of emergency room visits for sickle cell pain... | Sickle Cell Anemia Thalassemia | sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle ß0-Thalassemia | null | 2 | arm 1: L-glutamine arm 2: maltodextrin | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams. intervention 2: Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose ... | intervention 1: L-glutamine intervention 2: Placebo | 5 | Bellflower | California | United States | -118.11701 | 33.88168
Torrance | California | United States | -118.34063 | 33.83585
Atlanta | Georgia | United States | -84.38798 | 33.749
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
The Bronx | New York | United States | -73.86641 | 40.84985 | 0 | NCT00125788 |
[
4
] | 114 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients. | This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both. | Organ Transplantation, Renal Transplantation | Renal transplantation, everolimus, immunosuppressants, basiliximab, cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization | null | 2 | arm 1: Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL u... | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. intervention 4: None | intervention 1: Everolimus (Certican) intervention 2: Cyclosporine (Neoral) intervention 3: Steroid intervention 4: Basiliximab (Simulect) | 0 | null | 0 | NCT00154284 |
[
2
] | 35 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies. | null | Solid Malignancies | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Intravenous (IV) Infusion; 10, 20, 30, 35, 40 \& 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles | intervention 1: Ixabepilone | 3 | Baltimore | Maryland | United States | -76.61219 | 39.29038
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00162136 | |
[
5
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatmen... | Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child, adolescent and adult patients with ADHD. It is possible Strattera could be a viable alternative treatment for ADHD individuals. The purpose of this stud... | ADHD NOS | ADHD NOS Adults Strattera (atomoxetine) Open-Label | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less). | intervention 1: Strattera (atomoxetine) | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00181766 |
[
3,
4
] | 49 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as p... | This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immuno... | End Stage Renal Disease Kidney Transplantation | null | 1 | arm 1: Thymoglobulin induction, sirolimus and no maintenance corticosteroid. | [
0
] | 1 | [
0
] | intervention 1: Thymoglobulin induction, sirolimus and no maintenance corticosteroid | intervention 1: Sirolimus | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00189202 | |
[
5
] | 160 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genoty... | This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which all subjects should participate in the Pilot Treatm... | Hepatitis C, Chronic | null | 2 | arm 1: Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization) arm 2: Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during ... | [
0,
1
] | 4 | [
2,
2,
0,
0
] | intervention 1: Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program intervention 2: Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatm... | intervention 1: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 2: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 3: Ribavirin intervention 4: Ribavirin | 0 | null | 0 | NCT00202839 | |
[
3
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variet... | This study compares divalproex sodium and placebo in the treatment of autistic disorder. Twenty six child or adolescent outpatients, with age ranges from 5-17, will be randomized into a 12-week double-blind, placebo-controlled parallel treatment study. During the 12 weeks, patients will be monitored by the treating psy... | Autism | autism aggression irritability divalproex sodium | null | 2 | arm 1: Subjects in this arm will receive a placebo comparative to the study drug divalproex sodium. arm 2: Subjects will receive the study drug, divalproex sodium. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Study drug. intervention 2: Placebo comparator. | intervention 1: Divalproex sodium intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00211757 |
[
5
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goals of this pilot study are as follows:
1\) To disseminate and examine the effectiveness of a manualized, individual, cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD), 2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in participants w... | This pilot investigation will examine the effectiveness of augmenting cognitive behavioral therapy (CBT) with antidepressant pharmacotherapy (escitalopram\[Lexapro\]) in adults with generalized anxiety disorder (GAD) who do not fully respond to a temporally primary trial of CBT. A secondary aim of this study is to asse... | Generalized Anxiety Disorder | Anxiety Disorders Anxiety Neuroses Behavior Therapy, Cognitive Escitalopram | null | 1 | arm 1: 12 weeks of open label escitalopram, 10-20 mg/day (after 14 weeks of cognitive behavioral therapy | [
0
] | 2 | [
5,
0
] | intervention 1: 14 weekly sessions of individualized CBT intervention 2: 10-20 mg per day for 12 weeks | intervention 1: Cognitive Behavioral Therapy intervention 2: escitalopram | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00219349 |
[
3
] | 39 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included using paclitaxel and carboplatin with daily thorac... | In this trial we adopted the approach of using both induction and concurrent chemotherapy together with Thoracic Radiation Therapy (TRT) planned conformally to a tumor dose of 74 Gy. Substitution of gemcitabine for paclitaxel in the induction chemotherapy allowed us to evaluate the impact of RRM1 expression on the acti... | Lung Cancer | non-small cell lung cancer carcinoma unresectable Stage IIIA Stage IIIB thoracic radiation | null | 1 | arm 1: In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy. | [
0
] | 4 | [
0,
0,
0,
3
] | intervention 1: Induction Chemotherapy. intervention 2: Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy. intervention 3: Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy. intervention 4: Radiation Therapy will begin on day 57 if there has been adequate hema... | intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Radiation | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00226590 |
[
0
] | 6 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI). | Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI... | Facial Neuropathy | pain neuropathic face trigeminal | null | 2 | arm 1: The drug lamotrigine will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, placebo (cross over) will be administered. At the end of the trial (after imagi... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: : 25mg and 50mg tablets intervention 2: Sugar pill manufactured to mimic Lamotrigine tablets | intervention 1: Lamotrigine intervention 2: Placebo (for Lamotrigine) | 1 | Belmont | Massachusetts | United States | -71.17867 | 42.39593 | 0 | NCT00243152 |
[
3,
4
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the effectiveness and tolerability of atomoxetine (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder characterized by a fear of interpersonal interactions). | Controlled studies show that approximately 50% of patients with generalized social anxiety disorder(GSAD)will respond to treatment with available pharmacotherapeutic agents such as SSRI's. This still leaves 50% that respond partially or not at all. Those who do respond, often experience adverse events (e.g., sexual dys... | Generalized Social Phobia | null | 2 | arm 1: Atomoxetine arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Flexible dose, up to 50 mg per day intervention 2: placebo (matching to atomoxetine) | intervention 1: atomoxetine intervention 2: placebo | 0 | null | 0 | NCT00260533 | |
[
4
] | 664 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tabl... | null | Human Immunodeficiency Virus Infections | Human Immunodeficiency Virus Infections | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD intervention 2: LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD intervention... | intervention 1: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) intervention 2: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs) intervention 3: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleosid... | 129 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Beverly Hills | California | United States | -118.40036 | 34.07362
Fountain Valley | California | United States | -117.95367 | 33.70918
Long Beach | California | United States | -118.18923 | 33.76696
Newp... | 0 | NCT00262522 |
[
5
] | 541 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).
The primary response criterion is the percentage of patients with clin... | null | Deep Vein Thrombosis | Acute, symptomatic and objectively confirmed DVT | null | 2 | arm 1: innohep® 175 anti-Xa IU/kg once daily arm 2: Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 175 anti-Xa IU/kg administered subcutaneously (SC) once daily intervention 2: Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily. | intervention 1: innohep® intervention 2: Heparin | 9 | Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Zagreb | N/A | Croatia | 15.97798 | 45.81444
Prague | N/A | Czechia | 14.42076 | 50.08804
Brest | N/A | France | -4.48628 | 48.39029
Darmstadt | N/A | Germany | 8.65027 | 49.87167
Szczecin | N/A | Poland | 14.55302 | 53.42894
Bucharest | N/A | Romania | 26.10626 | 44.43225
B... | 0 | NCT00277394 |
[
3
] | 98 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA).
Primary objective:
* To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg int... | The study included :
* A screening phase up to 21 days followed by registration
* Treatment initiation within 5 working days of registration
* A treatment phase with 14-day study treatment cycles until a study withdrawal criterion was met or up to the clinical database cut-off date (18 July 2008)
* A follow-up phase -... | Pulmonary Diseases Neoplasms, Lung | lung cancer non-small-cell lung cancer metastatic carcinoma lung neoplasm lung diseases angiogenesis anti-angiogenesis anti-angiogenesis inhibitors cancer and other neoplasms respiratory tract (lung and bronchial) diseases | null | 1 | arm 1: Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept every 2 weeks until a study withdrawal criterion was met. | [
0
] | 1 | [
0
] | intervention 1: Aflibercept 4.0 mg/kg administered intravenously (IV) over a period of at least 1 hour once every 2 weeks.
Aflibercept could be reduced by 1 dose level (to 3.0 mg/kg) or 2 dose levels (to 2.0 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation w... | intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | 3 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Laval | N/A | Canada | -73.692 | 45.56995
Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00284141 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder. | Research has shown an alarming coincidence of binge eaters also reporting serious alcohol abuse. Evidence has shown this population to have higher rates of psychiatric comorbidity, higher caloric intakes during meals, higher rates of tobacco use, more frequent binge episodes, and an earlier age of onset for binge eatin... | Alcohol Dependence Binge Eating | drinking eating obesity alcohol binge eating | null | 1 | arm 1: Drug: Topiramate Other Name for Topiramate: Topamax | [
0
] | 1 | [
0
] | intervention 1: Topiramate up to 300 mg per day. | intervention 1: Topiramate | 2 | Charlottesville | Virginia | United States | -78.47668 | 38.02931
Richmond | Virginia | United States | -77.46026 | 37.55376 | 0 | NCT00300742 |
[
4
] | 67 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce... | null | Pulmonary Hypertension | PAH Pulmonary Arterial Hypertension | null | 5 | arm 1: inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period arm 2: Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period arm 3: Inhaled placebo 6×/day plus sildenafil with or ... | [
0,
0,
2,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: iloprost inhalation solution (Ventavis) (5 μg) intervention 2: inhaled placebo intervention 3: oral sildenafil (dosage between 60 and 300 mg/day) intervention 4: oral bosentan (dosage between 62.5 and 125 mg BID) | intervention 1: Inhaled Iloprost (5 μg) intervention 2: Inhaled Placebo intervention 3: Sildenafil intervention 4: Bosentan | 0 | null | 0 | NCT00302211 |
[
4
] | 155 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characte... | This is an open label, multicentre extension study to trial 42603ATT3002. Patients, who were enrolled to trial 42603ATT3002 must have had a diagnosis of ADHD with some symptoms already present at the age of 7 and continuing in adulthood. The patients must have had at least mild to moderate symptoms of ADHD. In trial 42... | Attention Deficit Disorder With Hyperactivity | Attention Deficit Hyperactivity Disorder Adult Long term safety Efficacy Quality of life | null | 3 | arm 1: open label PR OROS methylphenidate Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) arm 2: double blind PR OROS methylphenidate 18 36 54 72 or 90 mg/day once daily for 4 weeks arm 3: double blind placebo matching placebo tablets once daily for 4 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: matching placebo tablets once daily for 4 weeks intervention 2: 18, 36, 54,72 or 90 mg/day once daily for 4 weeks intervention 3: Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) | intervention 1: double blind placebo intervention 2: double blind PR OROS methylphenidate intervention 3: open label PR OROS methylphenidate | 21 | Paris | N/A | France | 2.3488 | 48.85341
Ahrensburg | N/A | Germany | 10.22593 | 53.67515
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704
Berlin | N/A | Germany | 13.41053 | 52.52437
Cologne | N/A | Germany | 6.95 | 50.93333
Essen | N/A | Germany | 7.01228 | 51.45657
Freiburg I. Br. | N/A | Germany | N/A | N/A
Hombu... | 0 | NCT00307684 |
[
3
] | 961 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease. | null | Asthma GERD | Moderate to severe Asthma Gastroesophageal Reflux Disease esomeprazole GERD | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Esomeprazole 40 mg twice daily intervention 2: Esomeprazole 40 mg once daily intervention 3: Placebo twice daily | intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Placebo | 130 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fountain Valley | California | United States | -117.95367 | 33.70918
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Geo... | 0 | NCT00317044 |
[
3
] | 15 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well sorafenib works in treating patients with soft tissue sarcoma. Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow to the tumor and blocking some of the enzymes needed for tumor cell growth | PRIMARY OBJECTIVES:
I. To determine if the combined vascular endothelial growth factor receptor 2 (VEGF-R2)/platelet-derived growth factor receptor (PDGFR)-beta inhibitor BAY 43-9006/ sorafenib can decrease interstitial fluid pressure (IFP) in soft tissue sarcomas.
II. To investigate the effects of BAY 43-9006/sorafe... | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Metastatic Osteosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Osteosarcoma Stage I Adult Soft Tissue Sarcoma Stage II Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarco... | null | 2 | arm 1: Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥... | [
0,
0
] | 6 | [
0,
3,
10,
10,
3,
3
] | intervention 1: Given PO intervention 2: Undergo surgery intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies | intervention 1: sorafenib tosylate intervention 2: therapeutic conventional surgery intervention 3: laboratory biomarker analysis intervention 4: pharmacological study intervention 5: computed tomography intervention 6: dynamic contrast-enhanced magnetic resonance imaging | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00330421 | |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5HT) and norepinephrine (NE)to therapeutic responses. | This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD). | Major Depressive Disorder | Depression Pharmacotherapy Duloxetine | null | 1 | arm 1: Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg. | [
1
] | 1 | [
0
] | intervention 1: Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg. | intervention 1: Duloxetine | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00331799 |
[
5
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In diabetes, blood sugar is higher than normal and... | In healthy subjects, low-grade inflammation, as measured by serum levels of cytokines or acute phase proteins, is positively associated with adiposity. Recent studies indicate that chronic low-grade inflammation in non-diabetic individuals may cause decline in insulin sensitivity and increases the risk of developing ty... | Type 2 Diabetes Diabetes | Salsalate Insulin Resistance Diabetes Mellitus Inflammation Diabetes HCV | null | 2 | arm 1: Salsalate (3g/day) for 7 days arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The intervention was salsalate (3g/day) for 7 days. intervention 2: Identical placebo for 7 days. | intervention 1: Salsalate intervention 2: Placebo | 1 | Phoenix | Arizona | United States | -112.07404 | 33.44838 | 0 | NCT00339833 |
[
5
] | 54 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Open label, two year study of the clinical efficacy of the combination of FTC, Tenofovir, and Nevirapine. Sixty HIV infected patients without previous exposure to antiretroviral therapy will be enrolled. Study will include a pharmacokinetic substudy to evaluate the interaction of FTC and Nevirapine. Truvada may be used... | Description of study design This is an open-labeled clinical trial evaluating an antiretroviral treatment regimen in which the drugs have demonstrated in vitro activity in both, resting and activated mononuclear cells. These drugs include: FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d.
... | HIV | null | 1 | arm 1: Open Label Drugs- Nevirapine 200 mg twice a day, FTC 200 mg once a day and Tenofovir 300 mg once a day for 96 weeks. | [
0
] | 1 | [
0
] | intervention 1: One arm only - Open label using FTC 200 mg p.o. qd, and Tenofovir 300 mg p.o. qd, and Nevirapine 200 mg b.i.d. | intervention 1: Nevirapine, FTC, and Tenofovir | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00344461 | |
[
4
] | 13 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy. | null | Hepatic Encephalopathy | Encephalopathy, Hepatic Portosystemic Encephalopathy Encephalopathy, Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Portosystemic Hepatic Coma Hepatic Stupor Hepatocerebral Encephalopathy Portal-Systemic Encephalopathy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
10
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Rifaximin intervention 2: Lactulose intervention 3: Placebo | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00364689 |
[
4
] | 197 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (T... | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic p... | Purpura, Thrombocytopaenic, Idiopathic | ITP idiopathic platelets purpura thrombocytopenia Idiopathic Thrombocytopenic Purpura thrombocytopenic | null | 2 | arm 1: Subjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down. arm 2: Subjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the su... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will initiate treatment with either 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down. intervention 2: Subjects will initiate treatment with either 50 mg eltrombopag or matching place... | intervention 1: eltrombopag intervention 2: Placebo | 115 | Duarte | California | United States | -117.97729 | 34.13945
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Washington D.C. | District of Columbia | United St... | 0 | NCT00370331 |
[
4
] | 504 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects. | null | Postmenopausal Osteoporosis | RANKL RANK denosumab AMG 162 osteoporosis bone turnover bone mineral density clinical trial postmenopausal osteoporosis alendronate total hip bone mineral density | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 70 mg oral QW intervention 2: 60 mg SC q 6 mos | intervention 1: alendronate intervention 2: Denosumab (AMG 162) | 0 | null | 0 | NCT00377819 |
[
2
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted. | null | Pancreatic Cancer | Pancreatic cancer advanced solid tumors | null | 1 | arm 1: Participants were to receive 7, 10 or 12 mg/m\^2 of romidepsin intravenously on either Days 1, 8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28-day cycle, followed by 800 or 1000 mg/m\^2 of gemcitabine. Subsequent doses of both drugs were based on treatment-related toxicities. The planned duration ... | [
0
] | 2 | [
0,
0
] | intervention 1: 7, 10 or 12 mg/m\^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle. intervention 2: 800 or 1000 mg/m\^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle. | intervention 1: Romidepsin intervention 2: Gemcitabine | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00379639 |
[
5
] | 100 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic. | Acamprosate has been shown to reduce drinking days in alcohol dependent patients and promote abstinence, with few reported side effects. A limitation of these studies, however, has been their lack of generalizability due to restrictive inclusion and exclusion criteria. Furthermore, most of the previous studies of acamp... | Alcohol Dependence | Alcohol Dependence Family Medicine Setting University of North Carolina at Chapel Hill | null | 2 | arm 1: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. arm 2: The study is a double-blind, randomized, pl... | [
1,
2
] | 1 | [
0
] | intervention 1: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. | intervention 1: Acamprosate (Campral) | 2 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389 | 0 | NCT00381043 |
[
3
] | 54 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy.
PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in pa... | OBJECTIVES:
Primary
* Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.
Secondary
* Assess the per... | Colorectal Cancer Nausea and Vomiting | nausea and vomiting recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer | null | 1 | arm 1: None | [
0
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
3
] | intervention 1: Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle intervention 2: Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4 intervention 3: as per institutional standard of care intervention 4: as per institutional standard of care interventio... | intervention 1: aprepitant intervention 2: dexamethasone intervention 3: fluorouracil intervention 4: irinotecan hydrochloride intervention 5: leucovorin calcium intervention 6: oxaliplatin intervention 7: palonosetron hydrochloride intervention 8: quality-of-life assessment | 6 | Savannah | Georgia | United States | -81.09983 | 32.08354
Hilo | Hawaii | United States | -155.09073 | 19.72991
Harvey | Illinois | United States | -87.64671 | 41.61003
Kansas City | Missouri | United States | -94.57857 | 39.09973
Portland | Oregon | United States | -122.67621 | 45.52345
Temple | Texas | United States ... | 0 | NCT00381862 |
[
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Trial to determine the safety, efficacy and tolerability of acamprosate for the treatment of cocaine dependence. | The primary objective of the trial is to evaluate the safety, tolerability and efficacy of acamprosate for the treatment of 60 treatment seeking cocaine dependent outpatients. The study will be an exploratory, double-blind, placebo-controlled 9-week trial, with a 2-cell design (30 subjects per cell) in which either 199... | Cocaine Dependence | cocaine | null | 2 | arm 1: 1998mg/day for 8 weeks arm 2: placebo pills for 8 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1998 mg/dau fpr 8 weeks intervention 2: placebo pills | intervention 1: acamprosate intervention 2: placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00385268 |
[
4
] | 1,732 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 ... | null | Chronic Obstructive Pulmonary Disease | chronic obstructive pulmonary disease COPD indacaterol long-acting β2 agonist | null | 4 | arm 1: Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were ... | [
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®). intervention 3: Placebo to indacaterol was supplied in powder-filled cap... | intervention 1: Indacaterol intervention 2: Formoterol intervention 3: Placebo to indacaterol intervention 4: Placebo to formoterol | 183 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Mendoza | N/A | Argentina | -68.84582 | -32.88946
San Miguel | N/A | Argentina | -58.71229 | -34.54335
Santa Fe | N/A | Argentina | -60.70868 | -31.64881
Rancagua | N/A | Chile | -70.74053 | -34.1691
Santiago |... | 0 | NCT00393458 |
[
3
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence. | This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase. | Cannabis Dependence | Cannabis treatment marijuana treatment | null | 2 | arm 1: 1200 mg/daily of Gabapentin arm 2: 1200mg/d of Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Placebo intervention 2: None | intervention 1: Placebo intervention 2: Gabapentin | 1 | La Jolla | California | United States | -117.2742 | 32.84727 | 0 | NCT00395044 |
[
3
] | 550 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in m... | A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo in a 1:1:1:1:1 ratio in parallel groups on a... | Overactive Bladder Syndrome (OABS) | null | 6 | arm 1: Placebo run-in phase. 2 week duration. arm 2: To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). arm 3: 20mg dose of SMP-986 to be taken once daily for 8 week duration. arm 4: 40mg dose of SMP-986 to be taken for 8 week duration. arm 5: 80mg dose of SMP... | [
2,
2,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Placebo, 2 week duration. intervention 2: Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). intervention 3: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration... | intervention 1: Placebo intervention 2: Placebo intervention 3: SMP-986 | 69 | Tuscon | Arizona | United States | N/A | N/A
Atherton | California | United States | -122.19774 | 37.46133
San Bernadino | California | United States | N/A | N/A
San Diego | California | United States | -117.16472 | 32.71571
Aventura | Florida | United States | -80.13921 | 25.95648
Boynton Beach | Florida | United Stat... | 0 | NCT00409539 | |
[
4
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-cont... | null | Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic lateral sclerosis free radical scavenger | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 2... | intervention 1: MCI-186 intervention 2: Placebo of MCI-186 | 0 | null | 0 | NCT00415519 |
[
4
] | 743 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on sa... | null | Chronic Obstructive Pulmonary Disease | COPD Roflumilast | null | 2 | arm 1: Roflumilast 500 µg
underlying medication: tiotropium 18 µg, once daily, inhaled arm 2: Placebo
underlying medication: tiotropium 18 µg, once daily, inhaled | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 500 µg, once daily, oral administration in the morning intervention 2: once daily | intervention 1: Roflumilast intervention 2: Placebo | 103 | Feldbach | N/A | Austria | 15.88833 | 46.95306
Gänserndorf | N/A | Austria | 16.72016 | 48.33925
Hallein | N/A | Austria | 13.1 | 47.68333
Linz | N/A | Austria | 14.28611 | 48.30639
Spittal an der Drau | N/A | Austria | 13.5 | 46.8
Beuvry | N/A | France | 2.68541 | 50.51674
Chauny | N/A | France | 3.21857 | 49.61514
Gr... | 0 | NCT00424268 |
[
3
] | 87 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease. | null | Pulmonary Disease, Chronic Obstructive | Dry Powder for Inhalation Chronic Obstructive Pulmonary Disease Lung Function testing | null | 2 | arm 1: Active treatment given BID via a double pin monodose capsule inhaler device arm 2: Placebo treatment given BID via a single pin monodose inhaler device | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID. intervention 2: Capsules containing 100% lactose administered BID using an atomizer device | intervention 1: UK-432,097 intervention 2: Placebo | 22 | Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Glebe | New South Wales | Australia | 151.18426 | -33.87884
Daw Park | South Australia | Australia | 138.58407 | -34.98975
Nedlands | Western Australia | Australia | 115.8073 | -31.98184
Calgary | Alberta | Canada | -114.08529 | 51.05011
Red Deer | Albert... | 0 | NCT00430300 |
[
5
] | 110 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months. | null | Osteoporosis | Osteoporosis Post-menopausal Bone mineral density | null | 2 | arm 1: Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group) arm 2: Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group) | [
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Raloxifene intervention 2: Zoledronic acid intervention 3: Placebo oral pills intervention 4: Placebo intravenous (i.v.) infusion | 17 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Buena Park | California | United States | -117.99812 | 33.86751
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Jacksonville | Florida | United States | -81.65565 | 30.33218
Jacksonville | Florida | United States | -81.65565 | 30.33... | 0 | NCT00431444 |
[
5
] | 309 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. | This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be evaluated at each visit by the investigator.... | Attention Deficit Hyperactivity Disorder | null | 1 | arm 1: To characterize the dermal reactions seen with the use of DAYTRANA | [
0
] | 1 | [
0
] | intervention 1: Methylphenidate Transdermal System (MTS) | intervention 1: Daytrana | 29 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Irvine | California | United States | -117.82311 | 33.66946
San Marcos | California | United States | -117.16614 | 33.14337
Spring Valley | California | United States | -116.99892 | 32.74477
Wildomar | California | United States | -117.28004 | 33.59891
Boulde... | 0 | NCT00434213 | |
[
3
] | 218 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines. | This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s). | Migraine | Lacosamide migraine prophylaxis Vimpat | null | 3 | arm 1: Placebo arm 2: 100mg lacosamide arm 3: 300mg lacosamide | [
2,
0,
0
] | 3 | [
0,
10,
0
] | intervention 1: Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart intervention 2: Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart intervention 3: Lacosamide 300mg, immediate-release film coated tablet (whi... | intervention 1: Lacosamide intervention 2: Placebo intervention 3: Lacosamide | 24 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Walnut Creek | California | United States | -122.06496 | 37.90631
Boulder | Colorado | United States | -105.27055 | 40.01499
Palm Beach Gardens | Florida | United States | -80.13865 | 26.82339
South ... | 0 | NCT00440518 |
[
3
] | 176 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will evaluate the safety and efficacy of PF 03187207. | null | Primary Open Angle Glaucoma Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma | null | 2 | arm 1: One drop of each, once daily in study eye for 28 days arm 2: One drop of each, once daily in study eye for 28 days | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: PF-03187207 and Latanoprost Vehicle intervention 2: Latanoprost 0.005% and PF-03187207 Vehicle | 19 | Artesia | California | United States | -118.08312 | 33.86585
Newport Beach | California | United States | -117.92895 | 33.61891
Petaluma | California | United States | -122.63665 | 38.23242
Poway | California | United States | -117.03586 | 32.96282
Danbury | Connecticut | United States | -73.45401 | 41.39482
Jacksonvil... | 0 | NCT00441883 | |
[
4
] | 140 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous c... | This study included an Initial and a Repeat Treatment period.
The Initial Treatment period was a subject and evaluator-blinded, randomized split face study in which subjects received DGE in one nasolabial fold and Restylane in the other nasolabial fold. Both safety and efficacy were evaluated.
In the Repeat Treatment... | Facial Wrinkles at the Nasolabial Folds | nasolabial folds facial wrinkles | null | 2 | arm 1: Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment period were treated with DGE as an open-label treatment. arm 2: Participants received Restylane in one nasolabi... | [
0,
1
] | 3 | [
1,
1,
0
] | intervention 1: Dermal Gel Extra (DGE) Injectable Gel contains hyaluronic acid with lidocaine. DGE was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of DGE to ensure full correction of the NLF wrinkles (i.e., to the optimal level of c... | intervention 1: Dermal Gel Extra (DGE) intervention 2: Restylane intervention 3: EMLA Cream | 6 | Birmingham | Alabama | United States | -86.80249 | 33.52066
La Jolla | California | United States | -117.2742 | 32.84727
Miami Beach | Florida | United States | -80.13005 | 25.79065
Westwood | New Jersey | United States | -74.03264 | 40.99121
White Plains | New York | United States | -73.76291 | 41.03399
Nashville | Te... | 0 | NCT00444626 |
[
5
] | 244 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will recruit 316 ischemic stroke patients taking aspirin.
They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.
The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid... | \[Goal\] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.
\[Trial Design\] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
\[Participants\] Ischemic stroke patients taking aspirin
\[Methods\]
* Double-Blind, Placebo-Controlled, Randomized, Multi... | Cerebral Infarction | Infarction, Cerebral Cilostazol Aspirin Resistance | null | 2 | arm 1: 100mg of Cilostazol twice a day arm 2: matching placebo to cilostazol | [
0,
2
] | 2 | [
0,
0
] | intervention 1: cilostazol 100mg twice a day for 4 weeks intervention 2: placebo 1 tablet twice a day matching for cilostazol | intervention 1: Cilostazol intervention 2: placebo | 4 | Busan | Busan | South Korea | 129.03004 | 35.10168
Daejeon | N/A | South Korea | 127.38493 | 36.34913
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566 | 0 | NCT00446641 |
[
5
] | 331 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo.
The key secondary objectives are to assess the effects on clinical global impressions - ... | null | Restless Legs Syndrome | null | 2 | arm 1: 4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. arm 2: 4 weeks of flexible dose-titration as for the ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Pramipexole intervention 2: Placebo | 42 | Innsbruck | N/A | Austria | 11.39454 | 47.26266
Linz | N/A | Austria | 14.28611 | 48.30639
Edegem | N/A | Belgium | 4.44504 | 51.15662
Espoo | N/A | Finland | 24.6522 | 60.2052
Helsinki | N/A | Finland | 24.93545 | 60.16952
Joensuu | N/A | Finland | 29.76316 | 62.60118
Oulu | N/A | Finland | 25.46816 | 65.01236
Tampere... | 0 | NCT00472199 | |
[
0
] | 15 | NON_RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | This study will determine whether the protease inhibitor lopinavir/ ritonavir (Kaletra (Trademark)), which is used to treat HIV disease, lowers blood levels of the lipid-regulating drug gemfibrozil (Lopid (Trademark)) in HIV-negative healthy volunteers. Many patients with HIV infection who take protease inhibitors have... | Hyperlipidemia continues to be a common problem in individuals with HIV, particularly those receiving HIV protease inhibitors (PIs) or the nucleoside reverse transcriptase inhibitor, stavudine. PI-treated patients have been noted to have increases in low-density lipoprotein (LDL), triglycerides (TG), and total choleste... | Healthy Volunteers | Pharmacokinetic HIV Drug-Drug Interaction Lopinavir/Ritonavir Gemfibrozil Healthy Volunteer HV | null | 2 | arm 1: Subjects received a single 600 mg dose of gemfibrozil without concurrent lopinavir-ritonavir 400mg/100mg; this is the "control" arm of a crossover study design. arm 2: Single dose (600 mg) Gemfibrozil pharmacokinetics (i.e. plasma concentrations collected over time to calculate area under the concentration vs. t... | [
3,
0
] | 2 | [
0,
0
] | intervention 1: lopinavir 400 mg + ritonavir 100 mg twice daily for 2 weeks intervention 2: Control arm (no intervention used in this arm) | intervention 1: Lopinavir/Ritonavir intervention 2: Gemfibrozil | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00474201 |
[
4
] | 990 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR) tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a medication without active substance). In addition the t... | This is a randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows which patient gets which study medication, i.e. CG5503, placebo, oxycodone), placebo and active control study. The primary objective is to evaluate the efficacy and safety of orally administered ... | Pain Knee Osteoarthritis | Osteoarthritis Knee Pain Assessment CG5503 PR Centrally acting analgesic Placebo Oxycodone Chronic Pain due to knee Osteoarthritis Tapentadol | null | 3 | arm 1: The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in ... | [
2,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance) intervention 2: Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance) intervention 3: 10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks m... | intervention 1: Tapentadol ER (100 to 250 mg twice daily) intervention 2: Matching Placebo (twice daily) intervention 3: Oxycodone CR (20 to 50 mg twice daily) | 100 | Innsbruck | N/A | Austria | 11.39454 | 47.26266
Mitterdorf | N/A | Austria | 13.35041 | 48.16723
Salzburg | N/A | Austria | 13.04399 | 47.79941
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485
Karlovac | N/A | Croatia | 15.55... | 0 | NCT00486811 |
[
3
] | 238 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatmen... | null | Bipolar Disorder | Mania Bipolar I Disorder Acute Mania Associated with Bipolar I Disorder | null | 2 | arm 1: Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. arm 2: Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Cariprazine 3 mg - 12 mg oral administration, once per day. intervention 2: Dose-matched placebo oral administration, once per day. | intervention 1: Cariprazine (RGH-188) intervention 2: Placebo | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00488618 |
[
3
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this exploratory study is to assess the efficacy and safety of nesiritide in participants with acute (a quick and severe form of illness in its early stage) heart failure (when the heart inadequately pumps blood through the body) including acute exacerbation of chronic (lasting a long time) heart failure... | 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 (when more than 1 hospital or medical school team work on a medical research study), randomized (study medication assigned by chance), stepwise, bolu... | Heart Failure, Congestive | Heart failure, congestive Nesiritide and JNS004 | null | 3 | arm 1: Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/kg/min eve... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Intravenous bolus treatment will be administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which is comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage will be increased by 0.005 mcg/k... | intervention 1: Nesiritide (1+0.01) intervention 2: Nesiritide (2+0.005) intervention 3: Nesritide (2+0.01) | 11 | Amagasaki | N/A | Japan | 135.41667 | 34.71667
Chikushino-shi | N/A | Japan | 130.5156 | 33.49631
Hiroshima | N/A | Japan | 132.45 | 34.4
Ikoma | N/A | Japan | 135.7 | 34.68333
Komatsushima | N/A | Japan | 140.88696 | 38.28306
Kumamoto | N/A | Japan | 130.69181 | 32.80589
Moriyama | N/A | Japan | 135.98333 | 35.06667
O... | 0 | NCT00490724 |
[
5
] | 35 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Chronic hepatitis C virus (HCV) infection is common in dialysis patients. Interferon (IFN)-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients. Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic resp... | Chronic hepatitis C virus (HCV) infection is common in dialysis patients, with the reported prevalence varying from 3% to 80% worldwide.(1-3) Although these patients usually have mild symptoms and moderate elevation of alanine transaminase levels, recent international collaborative survey and prospective studies found ... | Chronic Hepatitis C Hemodialysis | Chronic hepatitis C hemodialysis interferon ribavirin | null | 2 | arm 1: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks for HCV genotype 1 arm 2: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks for HCV... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks intervention 2: Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks | intervention 1: Pegylated interferon alfa-2a and ribavirin intervention 2: Pegylated interferon alfa-2a and ribavirin | 1 | Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 0 | NCT00491179 |
[
3
] | 83 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on it... | Issues on "Safety" outcomes are addressed in the Adverse Event section. | Melanoma | null | 1 | arm 1: Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid) | [
0
] | 1 | [
0
] | intervention 1: Dacarbazine 1000 mg/m\^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid) | intervention 1: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC) | 12 | Bordeaux | N/A | France | -0.5805 | 44.84044
Lyon | N/A | France | 4.84671 | 45.74846
Toulouse | N/A | France | 1.44367 | 43.60426
Villejuif | N/A | France | 2.35992 | 48.7939
Cambridge | Cambridgeshire | United Kingdom | 0.11667 | 52.2
Southampton | Hampshire | United Kingdom | -1.40428 | 50.90395
London | London | Un... | 0 | NCT00492297 | |
[
5
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known... | null | Asthma | Rhinovirus Asthma | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: comparator intervention 2: Comparator intervention 3: Placebo | intervention 1: fluticasone propionate/salmeterol intervention 2: fluticasone propionate intervention 3: placebo | 1 | Charlottesville | Virginia | United States | -78.47668 | 38.02931 | 0 | NCT00503009 |
[
3
] | 220 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate. | This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia.
After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to ei... | Dyslipidemia | LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol LDL cholesterol Atorvastatin Fenofibrate | null | 3 | arm 1: LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia arm 2: atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia arm 3: fenofibrate 145mg tablet (Tricor), as an adjunct to diet and e... | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia intervention 2: dyslipidemia and mixed dyslipidemia intervention 3: dyslipidemia and mixed dyslipidemia | intervention 1: LCP-AtorFen intervention 2: atorvastatin intervention 3: fenofibrate | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00504829 |
[
3,
4
] | 352 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy. | This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. P... | Diabetic Neuropathy | Diabetic neuropathy | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
1,
1,
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Placebo tablets, once daily, for 15 weeks (taken orally). intervention 2: Perampanel, 2 mg once daily, for 15 weeks (taken orally). intervention 3: Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally). intervention 4: Perampanel, 2 mg once daily for thre... | intervention 1: Placebo intervention 2: E2007 (2 mg) intervention 3: E2007 (4 mg) intervention 4: E2007 (6 mg) intervention 5: E2007 (8 mg) | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00505284 |
[
5
] | 23 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe. The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes. | The study had been temporarily halted due to an unplanned interim analysis. The Sponsor is now aware that a further interim analysis has been performed by the site and therefore a decision has been made not to recommence the study | Diabetes Diabetes Mellitus, Type 1 | null | 2 | arm 1: Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart arm 2: Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insul... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection intervention 2: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection intervention 3: Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) inj... | intervention 1: insulin detemir intervention 2: insulin NPH intervention 3: insulin aspart | 1 | Guildford | N/A | United Kingdom | -0.57427 | 51.23536 | 0 | NCT00509925 | |
[
5
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing. | A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is admini... | Asthma | asthma allergen challenge IL-5 eosinophils | null | 6 | arm 1: Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period arm 2: Placebo in the first treatment period: Salmeterol/Fluticasone Propionat... | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Fluticasone Propionate 100 mcg BD intervention 2: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BD intervention 3: Matching Placebo | intervention 1: FP intervention 2: SFC intervention 3: Placebo | 2 | Madison | Wisconsin | United States | -89.40123 | 43.07305
Manchester | N/A | United Kingdom | -2.23743 | 53.48095 | 0 | NCT00517634 |
[
4
] | 248 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory stud... | null | Fissure in Ano Pain | Pain associated with chronic anal fissure | null | 2 | arm 1: Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. arm 2: Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, par... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin. intervention 2: Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin. | intervention 1: Cellegesic intervention 2: Placebo | 0 | null | 0 | NCT00522041 |
[
5
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | true | This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy. | This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those mon... | Epilepsy Partial Epilepsy | Epilepsy VNS Therapy | null | 2 | arm 1: VNS Therapy + Best Medical Practice arm 2: Best Medical Practice | [
0,
1
] | 2 | [
1,
0
] | intervention 1: VNS Therapy + Best Medical Practice including anti-epileptic drugs intervention 2: Best Medical Practice including anti-Epileptic Drugs | intervention 1: Vagal Nerve Simulation (VNS) Therapy intervention 2: Best Medical Practive | 48 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Ghent | N/A | Belgium | 3.71667 | 51.05
Calgary | Alberta | Canada | -114.08529 | 51.05011
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
Grenoble | N/A | France | 5.7... | 0 | NCT00522418 |
[
3
] | 186 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne. | Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug. | Acne Vulgaris | acne | null | 4 | arm 1: Vehicle control cream applied topically to the face twice daily for 12 weeks arm 2: 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks arm 3: 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks arm 4: 0.025% ASC-J9 cream applied topically to the face twice daily for... | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Topical application to the face twice daily for 12 weeks. intervention 2: vehicle control applied topically twice daily for 12 weeks | intervention 1: ASC-J9 cream intervention 2: placebo | 10 | Fremont | California | United States | -121.98857 | 37.54827
San Diego | California | United States | -117.16472 | 32.71571
Boise | Idaho | United States | -116.20345 | 43.6135
Paramus | New Jersey | United States | -74.07542 | 40.94454
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Knoxville | Tennes... | 0 | NCT00525499 |
[
3
] | 100 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl. | Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital st... | Postoperative Pain | hemorrhoidectomy pain Postoperative analgesia | null | 4 | arm 1: SKY0402, single administration arm 2: SKY0402, single administration arm 3: SKY0402, single administration arm 4: Bupivacaine HCl | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: SKY0402 intervention 2: Bupivacaine HCl | intervention 1: SKY0402 intervention 2: Bupivacaine HCl | 7 | San Clemente | California | United States | -117.61199 | 33.42697
Miami | Florida | United States | -80.19366 | 25.77427
Houston | Texas | United States | -95.36327 | 29.76328
Tacoma | Washington | United States | -122.44429 | 47.25288
Kutaisi | N/A | Georgia | 42.69459 | 42.26791
Tbilisi | N/A | Georgia | 44.83412 | 4... | 0 | NCT00529126 |
[
4
] | 1,613 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension. | null | Hypertension | Hypertension, Aliskiren, Ramipril | null | 4 | arm 1: Aliskiren 300 mg once daily arm 2: Aliskiren 150 mg once daily arm 3: Aliskiren 75 mg once daily arm 4: Ramipril 5 mg once daily | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Aliskiren intervention 2: comparator | intervention 1: Aliskiren intervention 2: Ramipril | 3 | China | N/A | China | N/A | N/A
India | N/A | India | 75.36261 | 23.01533
Thailand | N/A | Thailand | N/A | N/A | 0 | NCT00529451 |
[
5
] | 201 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of paliperidone ER (extended-release), an antipsychotic, treatment in patients with schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but who are not satisfied with their treatment. | Paliperidone ER has been shown to be effective compared to placebo ("a sugar pill") in the acute treatment and maintenance of patients with schizophrenia. Paliperidone ER combines an active metabolite of another antipsychotic, risperidone, with manufacturing technology allowing more gradual release of the drug and less... | Schizophrenia | schizophrenia medication satisfaction, Invega | null | 2 | arm 1: Oral Risperidone 4 or 6 mg MG once daily for 0-2 weeks arm 2: Paliperidone ER 6, 9 or 12 MG once daily for 4-6 weeks | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 4 or 6 mg MG once daily for 0-2 weeks intervention 2: 6, 9 or 12 MG once daily for 4-6 weeks | intervention 1: Oral Risperidone intervention 2: Paliperidone ER | 40 | Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
Huntington Beach | California | United States | -117.99923 | 33.6603
Pico Rivera | California | United States | -118.09673 | 33.98307
San Diego | California | United States | -117.16472 | 32.7... | 0 | NCT00535132 |
[
2
] | 103 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes. | null | Type 2 Diabetes | null | 3 | arm 1: sitagliptin 100 mg arm 2: sitagliptin 200 mg arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: sitagliptin 100 mg tablets q.d. (once daily) for 7 days. intervention 2: sitagliptin 200 mg tablets q.d. (once daily) for 7 days. intervention 3: sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days. | intervention 1: sitagliptin phosphate intervention 2: sitagliptin phosphate intervention 3: Comparator: Placebo | 0 | null | 0 | NCT00541229 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.